The Engineering World

Engineering is Planification into Thought, implemented, that simplifies a Need.

find EVERYTHING you NEED for your Planification, Thought and Action



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We are working daily to improve your experience in this Piece of Forest.

World Regulatory Bar: To improve the Engineering World, The Synthetic Forest seeks to explore and compare differences in World Engineering Regulations.



Value Management

Predictive Study

Project Planning

Risk Management

Design Management

Information Management

Supply Chain Management




Engineering Finances



Benefit Analysis

Sources of Finance

Equity, Loans, Working Capital

Microsoft Project

Tank Inspections (Pharmaceutical)

Storage Tanks


Portable Tanks


Electropolishing and Surface Priming

Impeller Selection, Mixing Profiles, Heat Profiles

Turnover Packages Inspections, Materials Selection, Pipeline Installations, Leak Tests, Seals and Gaskets

Cleaning Skits, Soap Selection, Cleaning Strategies, Cleaning Validation

Laboratory Inspections


Quality Laboratory Inspections

Non Conformance

Investigations LIR's

Product Performance

Product Release

Material Inspections

CAPAs and EVs


21CFR is FDA

Pressure Stage vs Temperature Stage

High Vacuum, ISO5 to ISO8 Facility

Particle Counters Viable and Non Viable

Point Differential Finite Element Analysis CFD

Cell Culture (Biotechnology)


21CFR610 General Biological Products

Cell Growth and Scale Up: From Clones to Grafts.

Cell Culturing and Lab Analysis: PCR, North to West Blots. Electrophoresis, Gene Chips, Sequencing Analysis.

Biotechnological Testing Equipment Comissioning. Centrifuges, Filters, Pumps, Dispensing Systems.

Test Selection and Design of Experiments.


Marine Vessel Inspections
(Fuel Carriers)




Oil Carriers, Food Carriers, Vessel Entry Permits.

Enclosed Vessels

Cryogenic Vessels


Water Treatment Inspections

40 CFR414 Effluent Guidelines

OCPSF Organic, Chemical, Plastics,

Synthetic Fibers

Waste Water Pretreatment

Release Permitting




Document Qualification

User Requirements

GMP/ISO Specifications





HVAC System Validation



Installing Compressed Air Lines

Installing Chillers

Installing Refrigeration Units

Installing Boilers


Flammable Hot Work

Working with Flammables

Fire Safety and Regulations


Storage and Safety

Explosion Prevention

Fire Management


Computer System Validation CSV





LAN Connection

Data Storage

Audit Trails

Electronic Signature

Data logs and Forms

Network Infrastructure

Communication Protocols

Integrity and Security


Energy Savings



LED Systems

Control Panels

Power Consuption Estimation





Non Conformance


Package Tracking

Safety Material Storage

Stability Packaging

Packaging Materials

Laser Printing


Food and Drug

Quality Risk Management

Management Systems

Quality Engineering

Quality Assurance



Workflow Optimization

Workflow Streamlining


Catalysis and Reconstitution

Fischer Tropsch Reactors

Inductive Heating into Syn Gas

Sugars and Derivatives

Exothermal Control

Drug Delivery Systems


Controlled Release Systems

Compounding Strategies

Solid Blending

Solutions, Emulsions, Suspensions.

Drug Delivery Technologies

Synthetic Materials


Semiconductors / Superconductors

Organic / Inorganic Polymers

The Engineering World





Call 1.787.685.9808

for material queries.


The Engineering World


Consulting Expertise Available. Hire Consultants Here. Call us at 1.787.685.9808.

We can match your project needs with our consultats. Please call us to let us know what you need. From Training Services to Installations, Comissioning, Retrofit Modifications. We are involved in all areas of Engineering: Electrical, Chemical, Mechanical and Civil Engineering.

We also provide Legal Services like Experts for litigation, Permitting for Local and State requirements, and Attorneys.

Our goal is to service your needs Here!

-Under Construction- If you are a State or Local Government Representative and would like to post information on this site please email us at

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World Law Bodies
Country Links
United States of America
European Union

South Korea
South Africa


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INSTALLATIONS: Have you ever bought an item you've had to assemble at home? Well, Engineering Installations are like that multiplied by a factor of 10^5... So let's picture an installation... it is not only you assemblying your new LEGO, there are about 15 to 50 people depending on the magnitude of the project, that are impacted by, are accountable for, or have a direct or indirect responsibility with the installation. So picture yourself in stalling a new armchair with your distant relatives, your neighbor, the lawnmower man, and the village genius. The fun factor of science get covered under the prioritizing of tasks and the egomaniacal organizational struggle of some politically structured organizations to take credit about installing the initial screw on a Billion dollar global project. Welcome to the world of installations. Organizations may be what are dubbed "Political" or "Hierarchical", "Vertical" or "Progressive", "Open", "Relaxed" or "Horizontal", make no mistake, at all times someone is loosing a spot and someone is seeking a callous advantage. Is there common sense in an organization? Yes. Or we'd like to think so. Imagine rowers rowing towards the horizon. That is common sense. Meanwhile at the Site there are 500, or maybe 3000 rowers with their own horizon, Life's ambitions and carry their problems and motivations as drag or thrust to drive the boat spearheading the horizon. Here at the SSSSSSFFFFFF we'd like to explore the Cultural differences in spearheading the Industrial boat towards bulding common sense in the wide cultural settings where Installations take place. Write to us and tell us your story. We'd like to hear from perspectives of expatriates in far away countries working for large or small organizations. Are you a CEO, CFO, Chairman or Site Leader? Share your thoughts with us at ... Installations are Big Job Creators. Whenever a new site opens many roleplayers are needed: Accountants, Construction Workers, Foreman, Civil-Electrical-Chemical-Mechanical-Computational Engineers, Inspectors, Internal Regulators,

Some Units (unsponsored) (unsponsored) (unsponsored)

Design Planning and Qualification

Initial Stage of Project Engineering. Originated by Site Engineers. Units are requested to Sales Engineers to adjust User Requirements.
User Requirements Specification URS

Site's performance and capacity needs for the unit.

Contraints on Performance.

Validation Master Plan

Draft of Planned qualification activities. Includes upstream, downstream process logistic impacts. It is presented to QA for revision and approval. It also included expected completion dates for IQ, OQ, PQ.

Outlines commitments to be met on the Validation Report.

Change Management Informs Quality Assurance of changes to existing process documentation. It is carried out in agreement with QA officials and involves thorough checks of impact to production schedules and to final product characteristics.
Commissioning Processs of Identification, Performance Optimization, and Vefification of new process units or of retrofit repair work on existing units.
Sales Engineering Sales Engineer provide the units that sites buy. They also customize the unit to fit space, voltage, performance and size requirements. All sale documentation is included as evidence in the Installation Qualificatin as part of the Transfer Protocol Binder.
Intallation Qualification (IQ) Documentation to support the unit's structural, electrical and mechanical parts. No performance parameters are checked during this qualification. IQ may be merged with SAT.
Operational Qualification (OQ) Documentation to Support Operational parameters: Upper and Lower Operational Limits. Tests Include Optimization of Process Parameters and Multiple Mass, Temperature, Pressure, and Flow Loadings.

Performance Qualification Qualifies unit under process manufacturing conditions. A minimum of 3 lots are run.
SOP Edition Protocols of Calibration, Operation, Maintenance, Data Access, Repair work are drafted and approved by QA.
Routine Meetings Daily, Weekly, Monthly, meetings to update project status.
Deviations Deviations are oftern encountered under executions. Deviations are investigated and corrected prior to a subsequent qualification run.
Reports Progress Reports are Expected to Update Site Managers on the progress of work and any Remaining Issues to be addressed.
21CFR11 Compliance Traceability, Data Management, Storage, Recovery and Backup of Information. It make electronic records supplant paper record and allows for electronic data record to be legally binding by authorizing signatures.
CSV Computer System Validation. Equipments possesing data storage and data processing need to be qualified per 21CFR part11.
Inputs Checklist of Inputs
Outputs Checklist of Outputs
Software Changes Existing Modifications and Updates per User Requirements
Hardware Changes Existing Modifications and Updates per User Requirements
Final Installation Checklist As Is Unit Installation Checklist.
Personnel Training Final Stage. Operator, Technicians and Engineers are Trained on proper operation of unit As Is.








Heat Exchangers, Chillers, Air Handling Units, Compressors, Pump, Ducts, Piping, Refrigerant


Oral Solids Sterile Products & Medical Devices
HVAC requirements for GMP
Design to Qualify, EconomicsQualification and Risk
IQ - OQ - PQ
Wrap UpAir Filter References

GMP References

Design References

Qualification References

HVAC system concepts
HVAC system-critical parameters

Cleanroom air classifications and explain how they are applied
Role of HVAC in protecting products
Examine typical HVAC system designs utilized for bulk, oral solid dosage, sterile, biopharmaceutical, and packaging and warehousing operations
Understand the basics of process laboratory HVAC
HEPA filter theory, application, monitoring, testing, and repair

Cite HVAC maintenance requirements

Tests Description
Airflow Volume / Velocity Readings Assures that both unidirectional and non-unidirectional flow areas are properly balanced and unidirectional zones are maintaining proper air patterns

Room Air Exchange rates States if the area is meeting its design airflow
HEPA Filter Integrity Testing Tests HEPA filters and system for leaks
Non-viable Particle Counting Reports the amount of airborne particulate of a specified size in the clean zone
Temperature / Relative Humidity Testing Examines whether the air HVAC controls are functioning properly and uniformly
Pressure Cascade Monitoring Verifies that room differential pressures are operating according to design
Air balancing Adjusts airflow in the air handling systems to achieve design airflow, room air exchange rates, and pressure cascade

Airflow Visualization Testing Qualitatively verifies airflow direction using a source of visible fog
Viable Environmental Monitoring Samples both the air and surface for microbe enumeration and identification
Compressed Gas Testing Assures that the compressed gas sources meet the requirements of the controlled environment for contamination and microorganisms
Lighting, vibration, and sound tests – assures worker comfortAll other special tests from the ISO/IEST guidelines



 References: [cGMP], Institute of Environmental Sciences Technologies [IEST], and International Organization for Standardization [ISO].


Waste Water Systems

Sprinkler Systems

Steam Systems



Typical Water Management Systems used by manufacturing and power plants include the following processes:






Iron Removal


Reduction of Inorganic and Organic Material


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Article 1: Determining How Much Validation is Needed



Are you managing an unmaneagable process? What are the bottlenecks? Personnel, Systems, Budget, Seasonal Variations, Publicity, Vendors?

Personnel Bottlenecks: Rotten Apples: One employee...


PROJECT TRACKING:Conceptualization-Planning-Initiation--Evaluation-Closing-Monitoring; Concept on Paper-Concept on Plastic, Planning; Funding-Capital Costs-Acquisitions. Closing-Output-Handover-Long Term Support-Contract Closing: Documenting Deliverables-Lessons Learned-Possible Improvements

PROJECT MANAGEMENT: What is Project Management (PM)? What do Project Managers(PMN) do? Are you a Project Manager? Please share your perspective with us. Write to us!

Project Management (PM) does not deal with "Business as Usual", PM deals with projects or with tasks that have a beginning, middle and end, and evolve over the course of time until the project is handed over to a client.

PMN balance Budget, Time, and Money and Staff in the phases of Planning/Initation, overseeing Execution and Monitoring, Troubleshooting and Closing.

PMN execute in different ways under Information Technology, Biotech, or Construction. Generally PMN deal with Scheduling, Tracking, Budget Control, Risk Management, Strategizing, Quality Management, Workflow Control, involving Resource Allocation, Human Resource Management, Material Resource Management, and Tme Mangement.

Identify Deliverables: Benchmarks

Draft Project Plan:

Draft Project Checklists: Outline all Tasks needed to complete the project and check tasts as they are completed.

Update Stakeholders with Presentations


Value Management

This post is about learning the basic fundaments about calculating value, reducing losses, and understanding the constraints related to projec management. The list will not be exhaustive, however, with your help this list can be refined and sharpened to focus on the more salient or pertinent calculations regarding this matter. Most projects can be manages with simple spreadsheets but Engineering Projects involve short term and long term predictions on the impact of expenditures on the overall budget and these considerations are communicated frequently to investors and stakeholders. The results of these calculations have imminent effects on the final physical structure and often lead to drastic project overhaul or expansions.

Planned value (PV): The approved budget for the work scheduled to be completed by a specified date; also referred to as the budgeted cost of work scheduled (BCWS). The total PV of a task is equal to the task’s budget at completion (BAC)— the total amount budgeted for the task.

Earned value (EV): The approved budget for the work actually completed by the specified date; also referred to as the budgeted cost of work performed (BCWP).

Actual cost (AC): The costs actually incurred for the work completed by the specified date; also referred to as the actual cost of work performed(ACWP).

Schedule variance (SV): The difference between the amounts budgeted for the work you actually did and for the work you planned to do. The SV shows whether and by how much your work is ahead of or behind your approved schedule.

Cost variance (CV): The difference between the amount budgeted and the amount actually spent for the work performed. The CV shows whether and by how much you’re under or over your approved budget.

Schedule performance index (SPI): The ratio of the approved budget for the work performed to the approved budget for the work planned. The SPI reflects the relative amount the project is ahead of or behind schedule, sometimes referred to as the project’s schedule efficiency. You can use the SPI to date to project the schedule performance for the remainder of the task.

Cost performance index (CPI): The ratio of the approved budget for work performed to what you actually spent for the work. The CPI reflects the relative value of work done compared to the amount paid for it, sometimes referred to as the project’s cost efficiency. You can use the CPI to date to project the cost performance for the remainder of the task.

Schedule and cost variances and performance indicators are defined mathematically as follows:

Schedule variance (SV) = Earned value (EV) – Planned value (PV)

Cost variance (CV) = Earned value (EV) – Actual cost (AC)

Schedule performance index (SPI) = Earned value (EV) / Planned value (PV)

Cost performance index (CPI) = Earned value (EV) / Actual cost (AC)

The final step when assessing task performance to date is to update what you expect your total expenditures will be upon task completion. Specifically, you want to determine the following:

PM: ISO3100 RISK MANAGEMENT Risks are about events that, when triggered, cause problems or benefits. Any event that may endanger achieving an objective partly or completely is identified as risk.

Identification: Once risks have been identified, they must then be assessed as to their potential severity of impact (generally a negative impact, such as damage or loss) and to the probability of occurrence. 

Assessment: Once risks have assessed, all techniques to manage the risk fall into one or more of these four major categories:

  • Avoidance (eliminate, withdraw from or not become involved)
  • Hazard Prevention: Prevent or Mitigate Emergencies: Identify sources of posible events that may trigger an emergency
  • Reduction: (optimize – mitigate):
  • Sharing: Transfer, Outsource,Insure)
  • Retention (accept and budget)
  • Implementation and Review: Evaluate whether the previously selected security controls are still applicable and effective

    Prioritizing the risk management processes too highly could keep an organization from ever completing a project or even getting started.

    Risk Analysis Tools:

    Fault tree analysis (FTA)

    Failure mode and effect analysis (FMEA)

    Hazard and operability study (HAZOP)

    Risk traceability analysis

    Tracking Tables
    Identify (Source Risk) Analyze Response Control (Monitoring
    ID Description Category Probability Impact Added Days Status of Response Response Cost Total Cost
    x Chiller Efficiency Drop Utilities 0.01 High 4 Chiller Maintenance Pending $x,xxx.xx USD $x,xxx.xx USD

    Project Plan Template 1

    Scheduling Risks Template 1

    Methodologies and Project Life Cycles 1

    Project Management Certifications

    ENGINEERING TRENDS: PROJECT LIFE CYCLE Maintaining Structure vs Control: Planned Structure vs Regulated Chaos, vs Working under pressure vs Working without support or planned structure. Projects are literaly works in domestication... release the Kraken, and go get Excalibur to tame the beast, sometimes without support and in the best instances flowing with the right team work. We'll explore some keys in maintaining structure when the work environment tilts towards chaos and unpredictability.

    Do you really need MS Project?


  • Recruit, interview and select staff and/or volunteers with appropriate skills for the project activities.

  • Keep personnel documentation private and confidential. Avoid unauthorized personnel access to employee files.

  • Establish key policies and guideliness for "business conduct" in all aspects of the organization, from the parking lot, to attire, to work functions outside of the project site.

  • Track personnel development and provide Career Tracks to ensure Vertical Development of Human Resources.

  • Identify when external sources like Consultants and Contractors are needed.
  • ENGINEERING TRENDS: PROJECT LIFE CYCLE: Maintaining Structure vs Control: Planned Structure vs Regulated Chaos, vs Working under pressure vs Working without support or planned structure. Projects are literaly works in domestication... release the Kraken, and go get Excalibur to tame the beast, sometimes without support and in the best instances flowing with the right team work. We'll explore some keys in maintaining structure when the work environment tilts towards chaos and unpredictability.

    Do you really need MS Project?




    ENGINEERING TRENDS: QUALITY MANAGEMENT SYSTEMS: Trends in Administrations systems, phylosophical differences between QMS, Hierarchical and Organizational Differences.

    Drug Manufacturing Quality Documentation: Managing a Drug Manufacturing Site requires precise control over all steps that impact the Identity, Purity, Efficacy, and Quality of the product. The high level of precision requires that manufacturing tasks are well understood by personnel and these tasks are not limited to steps making the drug product. Control requires ALL areas to provide the highest standards of as required by local and international standardizing and regulatory bodies.

  • Water

  • Air

  • Waste Disposal
  • Raw Chemicals
  • Manufacturing Instruction
  • Product Specification Sheet
  • Intermediate Process Chemicals
  • Finished Products
  • Imported Manufacturing Materials
  • Imported Packaging Materials
  • Packed Finished Product
  • Cafeteria Food
  • Pest Control
  • Automation Control
  • Environmental Control

  • Personel Security

  • Document Security

  • Patient Information
  • Data Storage
  • Data Analysis

  • Manufacturing Instructions
  • Laboratory Protocols
  • Health and Safety
  • Incident Reporting
  • Natural Disasters Coordination

    Have you covered all aspects of the working site? Are you missing a an area? Would you imagine working in areas where tasks were not defined? Documentation needs to describe the areas, processes, machines, units as well as steps, calculations and precautions.

    There are many more areas that require precise documentation to provide the rigor and control required to produce a high quality chemical product.

    In order to produce and control such documents facilities have document management systems that provide easy access to employees. Employees become familiar with the tasks before executing them and with these documents employees are Trained-and-Tested to provide a level of proficiency prior to execution. These documents are "Living Documents", what this means is that once drafted the documents are not destroyed. Instead they go through a lifetime of changes and these changes however minor are docmented and tracked within the document so people reading the document can see the changes to the document through revisions.

    Changes do not become effective until 75-85% of all employees have been trained on the changes. So after rigorous control it is expeced that changes howere impactful or minor are taken into account by all employees driving continuous improvement.


  • PROCESS TRENDS: PROCESS TRANSFORMATIONS: A -> B, A + B -> C + A + B, A + B -> C + D etc. understanding the fundaments of chemical change, from stoichiometry to physicochemical separators to catalysis, mutations, and nuclear transformations.

    PROCESS TRENDS: SYNTHESIS: CHEMICAL SYNTHESIS: How to control reactions in vessels, Stirred Tanks, CSTR, Continuous Flow and Batch Synthesis. Catalysis, absorbtion, adsorption, External vs Internal Controls, Simulations, Scale up - Scale down, Units of Control.

    PROCESS TRENDS: SERIALIZATION, GLOBAL HARMONIZATION: Packaging, Stacking, Monitoring, Storage, Shipment and Control.

    Global harmonization


    PROCESS TRENDS: INSPECTIONS Auditing, Requirements, Compliance and Remediation Engineering.

    New Medical Products

    What considerations are needed to Manufacture a New Product

    New Drug Application

    New Dietary Supplements

    New Biomedical Devices

    New Drug Application

    Investigational New Drug

      Investigational IND includes:

    • Animal study data and toxicity (side effects that cause great harm) data

    • Manufacturing information

    • Clinical protocols (study plans) for studies to be conducted

    • Data from any prior human research

    • Information about the investigator

      Permissions to transport drugs across state boundaries.


      Medical Review

    New Drug Application

    Drug Patent

    Laboratory Data, Patient Data

    Clinical Trials 21CFR312
      Drugs Medical Devices
    Phase 1

    Tested on Healthy Patients

    Maximum Tolerated Dose. Safety, Dose threshold, Biological Therapeutic Effect

    Sie of Population <100


    Phase 2

    Tested on Patients with the Condition

    Side Effects


    Phase 3

    Tested on General Population Volunteers

    100-1000 Patients

    Comparing Placebo and Current Therapies to New Therapy






    New Dietary Supplements

    Dietary Supplement Information for Industry

    New Biomedical Devices

    Therapeutic Biologic Application (BLA)



    International Medical regulations

    European Medical Agency

    EDQM European Directorate for the Quality of Medicines and Healthcare

    Japanese Pharmacopoeia

    Japan Medical Devices

    Japan Medical Regulations




    Storage and Handling of Chemicals

    Maximum Allowable Quantities

    International Fire Code

    Ladder Supports and Clearances

    Voltage Requirements and Related Ground Faulting

    Laminar Flow Hood Qualification

    Clean Room Qualification



    Fire Management Consulting: Prevention, Planning, Rescue Operations, Hazard Identification, Communication Protocols, Adherence and Enforcement of Policy are all elements of Fire Management

    Goals(General): Prevent Injury, Preventl loss of Life, Prevent loss of Property

    Objective (Metrics): Prevent ocurrence of fire and explosion (#). Provide Means of Escape (t). Contain, Control and Suppress fire and explosion origins. Decrease total number of work related casualties (h). Decrease total number of loss work hours. Decrease total number of work related injuries. Increase the level of safety by introducing added meeasures of protection in each task performed.

    Fire Prevention Plans must be kept in writing and must be communicated orally to all personnel.

    Establish a Storage and Handling Zone. Isolate zone from heat sources at least 35ft away. Consider mass transfer of vapors. Consider also temperature effects that may volatilize liquids far away from a heat source.

    Isolate the Handling Zone from electric conduction by grounding the casing.

    In the Event of a fire Understand the Elements of the Fire Triangle and how to isolate the heat source from the oxidant, or how to lower the temperature of the fire.

    Know Fire Chemistry: Stoichiometry, LEL, UEL, LFL, UFL, Heat of Combustion, Latent Heat, Heat of Vaporization, Conduction, Convetion, Radiation, Reid Vapor Pressure, Ignition energy, Ignition Temperature, Heat Value, BLEVE, Vapor Cloud Explosion, Overpressure, Backdraft, Flashover, Flash Point,

    Causes of Explosions: Spark, Arc, Heat Conduction, Convection, Radiation, Deflagration, Collision, Friction, Nature, Chemical Reaction, Nuclear Reaction

    Two Types of Explosion: Deflagration vs Detonation

    Effect of Pressure and Temperature on the LEL and UEL. The Flash Point is the lowest temperature and pressure at which a vapor/liquid may spark or ignite.

    Explosions are divided into two different categories. Deflagration and Detonations, both invove equilibrium procesess of a gas, an oxidizer, and heat in a medium undergoing expansion. Deflagrations occur with mass transfer at low velocites directed at the reaction zone wheras Detonations are violent and the expansive gas is the reactive zone.

    Design Considerations: Spacing, Protocols, Procedures, Sewage Control, Diking, Housekeeping, Tool Inspections, Heat source elimination, area desinations, Training.

    Fire and Electricity: Eliminate Arc, or Sparks by using rated currents far from the boundary limits for conduction or arcing of current. Ground, and Bond equipment, tanks, storage bins, Understand Charge dissipation, Capacitance, Resistivity, Induction

    Understand Fixed and Portable Fire Protection Systems (OSHA29CFR1910.160): Extinguishing Agent, Nozzle, Piping, Control Pane, Alarm, Detector, Visual and Audible Warnings.. Semianual inspections, Desired extinguishing concentrations shall be dispensed under 30seconds.

    Fire Extinguishers: Located every 75ftA/D fire, 50ftBfire, when close to a flammable liquid storage area. 1 Fire Extinshisher per 3000sqft of building area.

    Fire Extinguishing Materials
    Substance Supresses Capacity
    Water A Fire  

    B/C Fires:

    Oil Fires

    Gas Fires

    Electrical Fires

    22, 9, 7, 5, 3kg.
    Ammonium Phosphate ABC Fires 10, 5, 1kg
    Halon ABC Fires low mass
    Sodium Chloride C Fires dry powder only
    Sodium Carbonate C Fires dry powder only


    PPE Capacities
    Fire Hose   100gpm-1000gpm
    Fire Truck    
    Dry Chemical   Hydrostatic Test 6 years


    PROCESS TRENDS: AUDITING Supply Chain, Vendors, Internal Auditing



    Develop Cost Reduction Strategy

    Develop Service Requirements:
    Material Specifications for product, packaging, and labeling
    Testing requirements
    Quantities required
    Shipping Timeframes

    Vendor List: QA Screens Vendor List for Compliance issues from FDA, Recalls and Warning Letters. Operational Licenses, Certifications, Company Structure, Data Management and General Operational Qualit of the Vendor is Rated by QA.

    Vendor Selection: Involve a Cross Functional Team: R&D, Engineering, QA, Corporate.  Material selection impacts directly product quality and company identity. All players should be involved in detecting vendor strengths and weaknesses.

    Perform Facility Audit: Confirm strategic, logistic and productio infrastructure is present. Note any Structural issues that may affect product characteristics. Address long term manufacturing plan with site leaders to ensure no manufacturing changes will impact your supply.

    Develop Quality Agreement: Agree thatn changes in the manufacturing process or issues related to FDA inspections are reported and prevent their impact in your manufacturing process. Ensure that CAPAs, OOS, Customer Complaints are reported and addressed.

    Monitor Qualification Status: Re-qualification process and on-site audit




    Certifications: QUALITY: ASQ: Master Black Belt (MBB) Trains and coaches Black Belts and Green Belts. Functions more at the Six Sigma program level by developing key metrics and the strategic direction. Acts as an organization’s Six Sigma technologist and internal consultant. Six Sigma Black Belt (CSSBB) Understands Six Sigma philosophies and principles, including the supporting systems and tools. Demonstrates team leadership and understands all aspects of the DMAIC model in accordance with Six Sigma principles. Six Sigma Green Belt (CSSGB)Supports a Six Sigma Black Belt by analyzing and solving quality problems and is involved in quality-improvement projects. Six Sigma Yellow Belt (CSSYB) Has a small role, interest, or need to develop foundational knowledge of Six Sigma, whether as an entry level employee or an executive champion. ref ASQ




    Key words: Safety, Identity, Strength, Quality, Purity... Quality Control Unit...Batch Records Controls, Uniformity,Complaints, Surfaces not reactive, additive, absortive; Sanitization vs Sterilization; Justification of Deviations; Pyrogen, Containers, Second Person Verificatin, In-process testing; Bioburden, Time limitations, Reprocessing, 100% Visual/electronic Inspection. Tamper-Evident, Laboratory, Stability Testing, Release, Warehousing, Reserve Samples, Laboratory Animals, Records and Results. Are we now experts? Certainly not! Compliance is an ongoing Business, and Ongoing opportunity to correct everyday problems, new products require new solutions and as technology evolves, new facets require polishing by regulatory compliance. Quality is by Design!

    CLEANING VALIDATION: The following bullets come from the Institute for Thermal Processing Specialists:

    The pointers are considered voluntary guidelines:


  • Sterilization: Absence of Bacterial growth. Sterility Assurance Level of 1 in 1,000,000 contamination probability. Exponential bacterial elimination
  • Dvalue = Dose required to eliminate 90% of all microorganisms. Relates to microorganism resiliency. Log of Surviving Organisms vs Time.

  • Methods of Sterilization: Moist Heat, Dry heat, Gas, Radiation, UV, Gamma, Filtration.

  • Lethality Factor F: measure of capacity to kill bacteria as a function of temperature
  • 121C
  • 132C Metals: Passivation layer preservation. Less micro fractures, less water deposition.
  • Logarithmic Cycle Reduction (LCR) – A commonly used measure of the efficacy of a sterilization process, it is the decimal logarithm of the ratio of the initial count (N0) of a well defined micro-organism and the count of the same organism (NR) after the sterilization process has been run. 0 10 log R N LCR N =
  • Aseptic Zone – The aseptic zone includes all direct and indirect product contact pathways and surfaces that must be brought to a condition of commercial sterility prior to the start of filling operations. Pictures, drawings, and schematics may be used to document the aseptic zone.
  • Spore Kits.

  • Count Reduction Test – The Count Reduction test is based on knowing the initial count on the inoculated carrier/substrate and then recovering and enumerating the number of microorganisms that have survived the sterilization process. This method requires the presence (recovery) and enumeration of surviving test microorganisms. The experiment should be designed so that the colony forming units are in the countable range when the target LCR is achieved. Absence of surviving organisms indicates that the target LCR has been exceeded.

  • End Point Test – The End Point test is based on exposing inoculated carriers/substrates with known initial counts to the sterilization process, incubating the carriers/substrates using appropriate methods (e.g., media and growth temperature) and observing for growth of surviving microorganisms. A binary response—growth or no growth—is obtained, where “no growth” implies sterility of the sample. Estimation of mean survivor load is done using statistical tools when several replicate samples are available, some of which show growth. This method can also be applied to a single inoculated sample; in that case, no growth (sterility) of the sample is required for the test to be considered successful though the uncertainty associated with the binary information should be taken into account.

  • Multiple thermocouples throughout chamber (not inside product containers) to determine effect of load configuration on temperature distribution temperature distribution for all loads using all container sizes used in production should be tested –position of thermocouples should be documented Slowest to heat/cold spots in each run should be documented, inlcuding the drain –repeat runs should be performed to check variability temperature distribution profile for each chamber load configuration should be documented


  • Heat Penetration Studies to detect the maximum and minimum temperature within all loads
  • All parts of each load must be on contact with steam
  • Need to determine lowest and highest temperature locations and slowest and fastest to heat locations (measured inside product containers)
  • Need to consider all variables such as container size, design, material, viscosity of solution and fill volume. Container with maximum fill volume and slowest to heat solution should be used
  • Maximum and Minimum load configurations for each sterilization cycle using routine cycle parameters
  • Biological challenge studies
    • Used when Probability of Survival approach is used
    • May not be necessary when cycle is > 121°C for 15 minutes (except US and Australia)
    • Biological indicators (BI) containing spores of Geobacillus stearothermophilus are most commonly used (considered “worst case”).
    • BIs containing other organisms may be used
    • performance studies based on product bioburden require a considerable amount of work
    • BI should be placed throughout the load, adjacent to thermocouples, at “cold spots” and slowest to heat locations (identified during heat penetration studies)
    • any growth is unacceptable unless processing errors demonsrated
    • Each sterilization cycle must be monitored
    • temperature, time and pressure recorded
    • temperature recorder independent from cycle controller
    • second independent temperature recorder
    • drain temperature should be recorded
    • chemical and biological indicators (if applicable)
  • Altitude and environmental temperatures may impact the effect of kill kinetics (humidity, barometric pressure, environmental temperature, and dew point) for newly installed and relocated systems, even if they were validated elsewhere (e.g., tropics vs. arid or sea level vs. high altitude).

    Identification of Critical Factors and Operational Ranges. The performance of the sterilization process is linked to the maintenance and control of a set of defined critical factors:Parameters to evaluate as critical factors may include, but are not limited to:

  • Temperature
  • Pressure
  • Relative humidity (e.g., dew point)
  • Elevation
  • Chemical sterilant concentration
  • Sterilant flow rate (e.g., high pressure hot water)
  • Sterilant residence time/contact time • Sterilant phase characteristics (e.g., vapor, liquid, spray, fog, or mist)
  • Radiation intensity and dose
  • Piping and ductwork design
  • Presence of optional components or devices such as head space injection
  • Activation timing of valve actuators, pumps, heating elements
  • Transition to next state of operation
  • Chemical sterilant removal
  • Package splicing
  • Surface tension
  • Interruptions, short stops and jams
  • Effect of concurrent practices (e.g., product path sterilization concurrent with aseptic zone sterilization)

  • Identification of Worst Case Conditions 6.5.1. Microbiological validation testing is often conducted under a pre-defined set of realistic operative conditions under which the sterilization process is expected to be the lowest. 6.5.2. Critical factors of the sterilization process must be defined with the appropriate values or levels at which the factor is critical to the process that delivers a commercially sterile system or package. 6.5.3. Points to consider when establishing the worst case condition include, but are not limited to: • Limiting values, both high and low, for identified critical factors • Permitted variation ranges for critical factors/parameters inclusive of the procedures (e.g. calibration) and instruments used to assure that the permitted variation is not exceeded. • Allowed manual operations or interventions • Interactions among critical factors, other variables and conditions, resulting in a reduction in sterilization process delivery
  • Interfaces between the aseptic zone and ancillary equipment • Interfaces between different sterilization processes within the aseptic zone • Sterilant contact time • Loading and speed of conveying systems through the package sterilization process and into the aseptic zone of the filler • Motion of conveying equipment • Hot and/or cold re-start of equipment • Ramp-up and ramp-down • Changeovers, including product and package • Brand new versus aged machines • Presence of remnant containers in the aseptic zone, partial rolls • Splicing of rolls, longitudinal seal strips • Idling in a sterile mode – limits before re-CIP and re-SIP 6.5.4.
  • The worst case condition is not necessarily setting all critical factors and other sterilization parameters to the allowed minimum (e.g., temperature) and maximum (e.g., throughput) values.
  • 6.5.5. Note that the alarm structure on the filling machine under study might prevent the machine from running in the established worse case conditions. In such a case, the relevant alarms should be disabled until the validation is completed. This would require alarm verification to be conducted or repeated at the end of a successful microbiological validation.
  • Outline of a Microbiological Challenge Test
    • 6.3.1. Identify critical factors and operational ranges. (See 6.4) 6.3.2.
    • Define the worst case conditions for the sterilization process and the specific filler and package being validated. (See 6.5) 6.3.3.
    • Identify the locations/boundaries in the aseptic zone and package surface to be challenged, for example, pictures, marking a P&ID or other equipment drawing. (See 6.6-6.8) 6.3.4.
    • Develop a protocol for the validation testing (See 6.9) that addresses the following:
  • The test methodology that will be used for each sterilization process is defined. (See 6.9.1) The target organism is identified and the desired LCR is established. (See 6.9.2)


  • The test microorganism (surrogate), including resistance to the specific sterilization process being validated, is characterized. (See 6.9.3) The expected LCR of the test organism is defined. (See 6.9.4)


  • The suitable carrier or substrate being used is identified. Note that different carriers may be needed in some locations or due to differences in sterilization processes. (6.10.1)
  • A suitable inoculation method is developed. (See 6.10.2)
  • The appropriate inoculation load is determined. (See 6.10.3)
  • Inoculated carriers are placed in predetermined locations. (See 6.10.4)
  • Microbiological recovery methods are defined and the actual load of the test microorganism on the carrier/substrate is determined. (See 6.10.5)
  • Culture media, incubation temperature considerations are made.
  • Set aseptic filling machine and package sterilization processes to predefined worst-case conditions for the validation test.
  • Execute the validation tests.
  • Recover the exposed carriers or packages and determine the outcome of the test based on the microbiological validation method chosen. Tailing and inactivation effects due to the presence of residual sterilant should be confirmed as not being present. 6.3.8.
  • Document results.
  • Confirm identity of any recovered microorganisms (may be dependent on method selected).
  • Repeat replicate studies as defined in the protocol.
  • Analyze the data.
  • Inoculation Method Methods such as spraying or depositing drops may be used to directly inoculate carriers and surfaces. When selecting a method, the following points should be considered:

    LogD vs T:   da Z. para un log10 reduction de D
    F(12D)= Kill time 12 fold reduction of known



    Use on: Metals, Ceramics, Polymers, Thermodegradable or Thermosusceptible materials.




    SAL of 10^-6

    Probability of a viable micro-organism present on the device must be equal to or less than 1 in a million.

    One in a million (or less) devices are expected to remain contaminated after terminal sterilization.

    A sterility test on 10-100 samples isn’t even close to reliably measuring a failure rate of 1/1,000,000 devices.

    CFU Unit of Viable bacterial or fungall cells reproducing by Binary Fission
    [kGy] absorbed units / unit mass
    D10 [kGy]

    1 log reduction on viable count.

    90% reduction of total count.

    Sample Item Portion Proportion of Sample manipulable in a laboratory.
    Sterility Test



    selected sterilization doses of 25 kGy and 15 kGy. The method for 25 kGy is applicable to products having an average bioburden less than or equal to 1,000 CFUs (colony forming units) per device. The method for 15 kGy is applicable to products having an average bioburden less than or equal to 1.5 CFUs per device.

    VDmax Method: Justification for a sterilising dose of 25 kGy or 15 kGy Bellow is an example of the procedure for the VDmax 25 method on multiple production batches

    1- Obtain product samples The product samples must be representative of routinely sterilised products.

    2- Determine the average microbial load of 3 batches of 10 pieces

    3- According to the table of ISO11137-2, determine the verification dose

    4- Conduct verification dose experiments; irradiate 10 products at the verification dose and perform a sterility test on each of the products

    5- Interpret the results: Accept the 25 kGy sterilisation dose if 0 or 1 of the 10 pieces is positive. Conduct verification dose confirmation experiments if 2 are positive. Do not accept the verification if there are more than 2 positives 40 products are required for this method. This method is only viable for validating sterilising doses of 15 or 25 kGy.

    Method 1

    1- Select the sterility assurance level (SAL) and select 10 product samples from 3 independent production batches (or 30 samples)

    2- Determine the average microbial load of the 3 batches of 10 items (method based on ISO 11737-1)

    3- Obtain the verification dose (referring to table 5 of ISO11137-2)

    4- Conduct verification dose experiments on 100 irradiated pieces (method based on ISO 11737- 2)

    5- Interpret the results

    6- Establish the sterilisation dose based on the results (maximum of 2 positives out of 100 pieces) 130 products are therefore required for this method. The advantage of this method is that it enables any sterilising dose to be validated.

    Method 2A

    Method 2B

    1- Select the sterility assurance level (SAL) and obtain samples of the product (at least 280 samples for 2 independent production batches) The product samples must be representative of the products routinely sterilised.

    2- Conduct the incremental dose experiments; irradiate 20 pieces at incremental doses of 2 kGy beginning with the 2 kGy dose and using at least 9 values. This is to be done for each of the 3 batches involved. Perform a sterility test on each of the products.

    3- Conduct verification dose experiments; irradiate 100 pieces at the verification dose and perform a sterility test on each of the products

    4- Examine the results 5- Establish the sterilising dose based on the results

    Performance Qualification (PQ)

    Product PQ: carried out under the supervision of the product manufacturer. This determines compliance of the sterilization process on the product.

    1) Dose Mapping: The first step of the validation is to verify that every product in the sterilization container receives a dose complying with the specifications (for example 25-40 kGy). As the dose received by the products can depend of the density of the products and their position in the sterilization container, before performing the dose mapping validation, the product loaded patter shall be established. With this product loaded pattern, dosimeters will be placed to measure the dose received by the products at different points of the sterilization container.

    2) Validation of the sterilising dose: This part of the product PQ makes it possible to validate the minimum irradiation dose required to sterilise the product (i.e. to guarantee a sterility assurance level (SAL) of 10-6). 3) Validation of the maximum dose: This part of the validation procedure verifies by means of various kinds of tests that product characteristics are not degraded by irradiation, even at the maximum dose.







    How can you determine that a new process is in control?



    Analytics, Mechanistics, Statistical Mechanics, Risk Analysis, Severity, Probability, Detection. Risk Analysis, ANOVA, MANOVA, MANCOVA, SAS, MATLAB, GREEN BELT, BLACK BELT, 3.4/10^6, SCAR, DFSS: QdB: DMAIC: define-> complete task. Big Data, ANOVA, P-Value, Gauge R&R, Test Method Validation,



    (USL- Avg.)/3σ or (Avg. - LSL.)/3σ

    Engineering Tolerance / Natural Tolerance

    Processes in control are close to Cp = 2.

    This parameter tells you what is the "process spread" assuming that manufacturing is normal.

    Cp shows whether the distribution can potentially fit inside the specification

    A high Cp tells you that variation in output is low around process specification.

    Uses Subgroup Variation.


    Cpk = Min(CpU,CpL)

    Ability to produce outcome within specification

    Desribes how mean is centered within Specification. Shows whether the overall average is centrally located.

    Cpk =2 means your width can grow 2 times before going OOS

    Cpk can never exceed Cp.

    Cp can be seen as the potential Cpk if the overall average is centrally set. If Cp is 1.20 and Cpk is 0.69. This shows that the distribution can potentially fit within the specification. However, the overall average is currently off center. The Cpk value does not state whether the overall average is offset on the upper or lower side.

    Cpk=1.0), a process will produce approximately 99.73% good product or .27% bad product. At Cpk = 1.33.the process will manufacture approximately 99.9937% good product or .0063% bad product.



    (Upper Spec - Lower Spec) / 6 sigma


    (USL- Avg.)/3σ or (Avg. - LSL.)/3σ

    Uses Overall Variation


    Ppk = Min(PpU,PpL)

    Sshould be close to Cpk if process is stable and variation is small.

    Estimator of process control before process has been controlled, usually when process has output a low number of products Ppk is used to determine how "in control" a process is.


    Accuracy = Xbar - X

    Residuals = Difference between observed and Estimated value

    P/T = 6sigma / USL - LSL  
    P/T < 0.1 Acceptable  
    0.1 < P/T < 0.3 Marginaly Acceptable  
    P/T > 0.3 Unacceptable.  
    Repeatability: Equipment Variation EV  
    Reproducibility: Appraiser Variation AV  
    R&R= (EV^2+AV^2)^(1/2)  
    Part Variation PV = R*K  
    Total Variation (TV) = ((R&R)^2)+(PV)^2)^(1/2)  


    Nelson Rules

    Special Variation Rules:

    Rule 1: 3std from mean

    Rule 2: 9 consecutive points above or below mean

    Rule 3: 6 or more points continually increasing or decreasing

    Rule 4: 14 or more points continually oscillating.

    Rule 5: 2 or more points are consecutively more than 2std from mean in same direction.

    Rule 6: 4 or more points are consecutively more than 1std from mean in same direction.

    Rule 7: 15 or more points are consecutively within 1std from mean.

    Rule 8: 8 points are out outside of 1 std deviation from mean in both directions.

    Tolerance Difference between the USL and LSL.
    Confidence Interval

    "We are 95% confident that our interval will contain the sample mean of the population... that is to say that we are 95 times out of a 100 finding the mean of the population within our confidence interval and 5 times out of a 100 we are not. 95% speaks about the process of finding the confidence interval and has Nothing to do with the mean of the population"

    Reference 1

    Reference 2

    Power of Test


    Increase: Required Sample Size, n; Detectable Difference, between the mean under H0 and H1, µ0 − µ1 ; Level of significance, α;

    • Decrease: Variability

    Gauge R&R

    Gauge R&R is a test of variance between the effect of The Part, The Operator and the System

    • Whether your measurement system variability is small compared with the process variability.
    • How much variability in the measurement system is caused by differences between operators.
    • Whether your measurement system is capable of discriminating between different parts.

    Variation = Vpart + Vgauge(R&R)

    Crossed R&R: Xbar and R

    Crossed gage R&R study
    A study in which each operator measures each part. This study is called crossed because the same parts are measured by each operator multiple times. To perform a crossed gage R&R study in Minitab, choose Stat >Quality Tools > Gage Study > Gage Study (Crossed).
    Often, you will use a crossed gage R&R study to determine how much of your process variation is due to measurement system variation.
    Nested gage R&R study
    A study in which only one operator measures each part, usually because the test destroys the part. This study is called nested because one or more factors is nested under another factor and, thus, not crossed with the other factors.
    Expanded gage R&R study
    A study in which one or more of the following conditions exists:
    • More than two factors, usually, operator, gage, and part
    • Fixed or random factors
    • Both crossed and nested factors
    • An unbalanced design

    resolution= Sigma/Mu
    Accuracy : long term average : Xbar - X
    Accuracy: Linearity/Bias
    Precission: long term variability


    Nested R&R: 1op,

    Gauge Run Chart by Operator

    Repeatable: Instrument
    Reproducible: Operator

    COPQ: cost of poor quality.
    QFD:Qualify Function Deployment
    AIAG; Automotive Industry Action Group

    Z score

    Standardized value of how one score compares with Population in terms of Standard Deviations.A z-score equal to 1 represents an element that is 1 standard deviation greater than the mean.

    Z = (x - mu) / sigma

    Z test Hypothesis Testing PDF

    Z Score PPT


    Hypothesis Testing

    Null Hypothesis

    Statement of rejection adopted to commence a statistical analysis.

    Null hypotheses are not inferred directly.The Null hypothesis is rejected by testing the validity of the opposite statement.

    Null Hypothesis Decision  
      True False  
    Fail to Reject Correct Decision (probability = 1 - α) Type II Error - fail to reject the null when it is false (probability = β)  
    Reject Type I Error - rejecting the null when it is true (probability = α) Correct Decision (probability = 1 - β)

    P Value

    Small p-value (typically ≤ 0.05) indicates STRONG evidence AGAINST the NULL hypothesis, so you reject the null hypothesis.

    Large p-value (> 0.05) indicates WEAK evidence AGAINST the NULL hypothesis, so you fail to reject the null hypothesis

    p-values very close to the cutoff (0.05) are considered to be marginal (could go either way).

    Error Tipo 1

    False Positive: Incorrect Rejection of null hypothesis.

    The probability of making a type I error is α, which is the level of significance you set for your hypothesis test.

    An α of 0.05 indicates that you are willing to accept a 5% chance that you are wrong when you reject the null hypothesis.

    For a fixed sample size, the probability of making a Type II error is inversely related to the probability of making a Type I error. Thus, in order to achieve a desirable power for a fixed level of significance, the sample size will generally need to increase.

    EX.: Null: Two medications are the same. A type I error occurs if the researcher rejects the null hypothesis and concludes that the two medications are different when, in fact, they are not. 

    Error Tipo 2

    False Negative: Failure of rejection of False Null Hypothesis.

    The probability of making a type II error is β, which depends on the power of the test. You can decrease your risk of committing a type II error by ensuring your test has enough power. You can do this by ensuring your sample size is large enough to detect a practical difference when one truly exists.

    EX.:Null Two medications are the same.  the researcher concludes that the medications are the same when, in fact, they are different

    Isolating Special Causes

    Pareto Charts

    Ishiawa Diagrams

    SIPOC: Supplier Input Process Output Customers


    Group Effort driven towards Continuous Improvement



    T Test

    Hypothesis test comparing the Mean of a Population vs a Reference Mean

    Student's T test: small population, deviates from Normal Distribution, gives a Probability Density Function.

    1 sample T-Test compares mean of a population to the reference standard when the standard deviation of the population is unknown.

    2-sample T-Test compares means of two populations.

    T Paired: Compares two ligated observations. Ex.: Before and After weight loss.

    T value Measures Difference in terms of Standard Deviations. The greater T value (+/-) the greater evidence against (to reject) Null Hypothesis
    P value

    Probabilty that the Two Sided T value is above and below the T value in a T distribution.

    When the Null hypothesis is true the T value falls in this probability region with.

    High P value = True Null.

    Low P value = Data does not contradict Null Hypothesis.

    P values are calculated on the assumption that the Null is true for the population and that the difference between populations is by random effects.


    Analysis of Variance: Hypothesis test that allows the comparison of variation between groups.

    F-Statistic: Similar to T-Statistic from a T Test.

    Normality Test

    Skewness and Kurtosis should be close to 0 in a Normality Test.

    Shapiro Wilk Test with p < 0.05

    System Suitability Test to ensure Systems, Analytes, Columns, Reagents and Operators are functioning properly prior to formal Analysis Execution.
    Limit of Linearity See Test Method Validation
    Limit of Detection See Test Method Validation
    Attribute Charts


    Attribute Charts
      Defectives Defects
    Sample Size Constant NP C
    Variable Sample Size P U

    NP-Chart: for monitoring the number of times a condition occurs, relative to a constant sample size, when each sample can either have this condition, or not have this condition

    P-Chart: for monitoring the percent of samples having the condition, relative to either a fixed or varying sample size, when each sample can either have this condition, or not have this condition

    c-Chart: for monitoring the number of times a condition occurs, relative to a constant sample size, when each sample can have more than one instance of the condition.

    u-Chart: for monitoring the percent of samples having the condition, relative to either a fixed or varying sample size, when each sample can have more than one instance of the condition.

    DOX Design of Experiments

    References: ASQ, ICH

    HVAC BasicsAir Filters
    HVAC Controls
    Air Balance
    Cleanroom Basics

    Boilers: Boiler Video


    [cGMP], Institute of Environmental Sciences Technologies [IEST], and International Organization for Standardization [ISO].

    Airflow volume / velocity readings - assures that both unidirectional and non-unidirectional flow areas are properly balanced and unidirectional zones are maintaining proper air patterns

    Room air exchange rates - states if the area is meeting its design airflow
    HEPA filter integrity testing - tests HEPA filters and system for leaks
    Non-viable particle counting - reports the amount of airborne particulate of a specified size in the clean zone
    Temperature / relative humidity testing - examines whether the air HVAC controls are functioning properly and uniformly
    Pressure cascade monitoring - verifies that room differential pressures are operating according to design

    Optional tests include:

    Air balancing - adjusts airflow in the air handling systems to achieve design airflow, room air exchange rates, and pressure cascade

    Airflow visualization testing – qualitatively verifies airflow direction using a source of visible fog
    Viable environmental monitoring [EM] - samples both the air and surface for microbe enumeration and identification

    Compressed gas testing [compressed dry air (CDA) testing] – assures that the compressed gas sources meet the requirements of the controlled environment for contamination and microorganisms

    Lighting, vibration, and sound tests – assures worker comfort

    All other special tests from the ISO/IEST guidelines


    SIX SIGMA: One Sigma, Two Sigma, Three Sigma, Four Sigma, Five Sigma, Six Sigma... yeah... we got there... is it that simple? SSSFFF currently at one sigma...Statistical Tools allow to predict future failures when past behavior is well understood. For this the variables affecting the process need to be well understood and well accounted. Enter Six Sigma...


    ENGINEERING TRENDS: STATISTICS ANALYSIS: All statistical analysis rest on IMPLEMENTATION. All numbers are followed by Human Decision Factors HDF and are Masked by interpretaion of the Statistics. Clear understanding of what the statistic represents and THE LIMITS of the refered to Statistical Analysis will incide in the Decision Making Process DMK. So at the the end of the Analytical process what you need to know is that you have successfully completed a DFSSQBDSASSCARQEQAIQOQFATHTetc... the point is to guide events to ZWR0 error.Statistics are extremely powerful.

    Computational power presents the ability of modelling and making very accurate predictions in a variety of PROCESS or SYSTEM model analysis. Although advanced Mathematical Skills allow interpretation it is through experience of MODEL ADJUSTMENT that Statistical Analysis tour-de-forces into a Continous Monitoring Program.

    Implementation of Continuous Monitoring Programs are the result of Human and Technological capabilities. Humans place the sensors and interpret data, technology gathers data and accelerates computational calculations. In the End, the role of the Quality Officer / sea un engineer, biologist, statistician, technician, operator / su rol es de 1-Ajustar el proceso para prevenir errores continuos. 2-Predecir modos de fallas para evitar tiempo perdido 3-Desarrollar estrategias que maximizen el uso de recursos 4-Ganar un entendimiento completo del proceso y sus variables para destinar recursos.

    Ya entendido esto y habiendo ganado un tren de conocimiento en estadistica aparecen los verdaderos retos de considerar las variables y tomar decisiones que consumiran tiempo y costo. Enter Design of Experiments DOX. Leaders in process inovation understand that the allocation of funds destined to the execution of tasks along with the managerial accumen of project leaders is the half fraction of the process improvement process gains equation. The flow of information from decision to execution may cascade through usually 3 to 5 levels (Cascade Decision Loss). In each step of the two way communication ladder data is Lost, Misinterpreted, mistakenly calculated, held back by professional jealousy, held back by impunctuality or even top level project rearrangements. It is in this crucial step that most companies loose their capital. Swift decision execution forecast are backlogged by every single employees ability to carry the execution of the plan without interference from outside influence to the project. Error prediction is an applied science highly valuable and continually reevaluated. The responsibility of managers in adequately interpreting data is also key in maintaining a forward vision of process improvement. Process analysis may get recirculated in the plan-do-check-check-plan cycle without swift determination of task execution. Understanding the 4th dimension is key in making accurate and timely Value Added solutions to improce Company Performance in the era of the information tsunami.

    Reconsidering the role of a leader in today's dynamic business models: Who leads a project? the CEO, the Manager, the Team Lead, the leading Tech, the rookie? In some business models the True Leader is the Rookie. The novice is outside the box, has no prejudice, has not formed clans within the company, has not offended the next door cubicle, and is looking to make an impression within the organization. More importantly than imagery, is the actual execution of the task and its measurable impact in daily, monthly and quarterly business goals. In a group of 4 there is a high probability that someone is prioritizing outside of the main focus and seeking to politicize a process advancement by acting in the last second. This is the same as taking the baton from a relay team in the last meter to claim the goal. This strategery is extremely common in the workplace because the work load is compressed. In compressed work loads there is no tracking of what each employee is executing and how the employee is prioritizing tasks, less time there is to rearrange priorities, so each employee is 'free' to jump in the final phase of the project once someone else took it from 1st gear to fourth. Sometimes the manager is aware of the individual and group contributions and eliminates the need for employees to make claims in the meeting spaces. Competition is key but the goal of any company is to align employees with the Common Goal. Microscopic gaining works to foment competition within a division but it may halter progress by creating internal division.

    What are some other instances where a manager needs to eye internal conflict?



    Normal Probability Plot: Tests data for normality, skewness, abnormal distributions. See Histogram.
    Histogram Graphical Representation of numerical data, like. a Bar chart relating the frequency of numerical values. It helps to visualize the type of distribution of the population, wether it is normal or skewed.

    Data is presented in Quartiles, Median, Maximum and Minimum values.

    Boxplot explanation

    X-Bar, R-Chart, vs Individual

    X-Bar charts the process mean through time.

    R-Chart charts the process range though time. Range = Xmax - Xmin

    Always look at R-Chart first. If R-Chart is Out of Control then the X-Bar chart is meaningless.

    R-Chart Trends: Repeated Values, OOS points.



    Whether mean differs significantly. Relates T values to P values.

    Chi squared

    Whether Categorical data from two data sets are related and if their differences are due to sampling methods or purely random effects.

    Chi square tests can only be used on actual numbers and not on percentages, proportions, means, etc.



    NC... NCs... material or process failures lead to NON Conformance... but who is conforming here? The Manufacturer is conforming to expected material performance and leading product performace by implementing quality measures to ensure the delivery of a good product to market.

    How is a Non Conformance generated? Again, a non conformance is Detected.

    Is a Non Conformance a CAPA? What is a CAPA? No, NCs may trigger a CAPA but an NC in itself is the detection of deviation or error in expected product, packaging or delivery performance.

    In the Industrial setting NCs are generated out of the high expentancy of delivering a high quality product. Any minor deviation in expected results is a Root Cause for an NC.

    NCs are investigated under several possible root causes stemming from Machine Behavior, Environmental Triggers, or Human Behavior and as such root causes are established when the determining factors have been dully and fully investigated. Machine Behavior takes into account the Tolerance and the acceptable boundary performance of the unit under NC. When a machine breaches Upper or Lower boundaries of performace an NC is triggered. Yet it is possible by Statistical means to detect NCs prior to occurring, like predicting the future.

    About Root Causes: Lets Establish Machine-Environment-Human as the three main Root causes. The cause-fault tree is then stemmed from Machine-Maintenance Schedule-Material Failure-Material Reaction-Unknown Material Reaction-Power Failure due to Machine action... then enter Environmental: Rain, Snow, Humidity, Lightning, Power Failure, and other unnatended keys to root an adverse action, then Human: Lack of Training, Lack of Attention, Excessive Overwork, Work Flow Interruptions, Social Interruptions, Error, or Slack. The classification of these Root Causes is set upon by Management in each Site. Managing these Root Causes is key in preventing future failures and understanding -in depth- the root cause is key in establishing the actions to prevent future occurrences. The balance of managing and correcting actions when humans are involved is a delicate subject because most of the times the Root Cause contains several main root causes in conjunction that lead to the NC event recorded.

    Denial, Commitment, Ethos, Diligence, Leadership, Accountability, Stewardship, Role Description, Task Load, Past Performance, Training Record, even Personal and Familial issues are brought into the balance equation to determine the root cause of an event. Recall that Process Failures are costly, sometimes very very costly, all the while there are internal competition within organizations that lead to push and pull responsability for the NC. While it is natural for humans to fail, and failure is even expected, it is also natural to -chide blame-......who wants chastisement? who takes blame? who is ultimately responsible and who takes the blame? These are very delicate issues and are at the core of what make up any major company, organization or work structure. It is why here at SSSSFFFF we are interested in learning your perspective in these details. How does Culture, Polical Stability, Economy, and Technology interplay. What are the best models of management and do they work in the corners of Earth? How can micromanagement and laxity coexist? Are there tools to measure this amalgam of Human-Machine-Environment issues or is it fundamentally decided by gut feelings or by numerical calculations? The answer is always yes. Write to us at for your perspective.

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    Tanks are vessels where materials are stored temporarily from years to seconds or permanently from decades to centuries. The Dead Sea Scrolls where in a tank (open top ceramic tank). Take Fukushima, more than Half a Billion Tons of Radioactive Water are currently stored in Radioactive Tanks. Only a simple leak from one of these tanks spilled a material that takes Hundreds of Millions of years to decompose and spreading cancerous radioactive radiation anywhere it remains. The importance of a Tank. Here at SSSFFF we explore the materials contruction, surface finish, wall width, hydrostatic pressure, gravity pressure, gauge pressure, vents, inlets and outlets of the Tank. How does the tank fill. What is the Tank Chemistry. Is there a Precipitate formed by decomposition, or Exposure with Oxygen, or Nitrogen, a Spark, or a Static Discharge, or simply by accident... Here at the SSSSFFFF care about Tanks.

    What are equations governing Tank Loading, what are the thermodynamic ambience of the Tank, what are the clearance and dikes of the walls, are there Firefighting Measures to support a spill. Take the Tianjin Explosion: likely caused by either an Error in Loading, or an Error in Ventilation. The magnitude of tank explosions or BLEVES, Boiling Liquid Expanding Vapor Explosion can be witnessed in Tianjin or simply YouTube BLEVE... Tank safety is very important.

    BLEVE 1: Train Car Explosion. Funny how the narrator at 1:10 claims a record was established for a tank blown by a bleve. Not funny that perhaps firefighters died in that explosion. It is why most Plant fires are either immediately contained or let to consume the matter it combusts. Decomposition gases in fires are extremely toxic, many material classes are combusted so fighting the fire becomes a difficult task of both accessing the source to prevent additional combustion and in the selection of fire retardant or fire extinguishing material to add to the flames.

    BLEVE 2: The Tianjin Explosion.

    Here at SSFF we take matters into accountability for Tank installations. Is your tank for Biotech? Pharma? Cosmetics or Food? Petroleum or Fuels? Gases? There are many considerations into tank work. Take a Fermentor for example. A Fermentor runs a biological reaction that once started it will see its product completed in 30 days. Any basic tank profile or design failure will affect the outcome each and every time, and it could take years to discover that a tank design feature was the root cause of a drop in yield in a site. Take a food tank, is it leaking, is the heat vest broken, are the transfer lines clean? Where good care meets good quality, excelent products emerge. Let us take good of your tank.

    Each Tank is birthed through a process involving welders, engineers and inspectors. First select the right material supplier and review the material requested once on-site. Double check to ensure quality, chemical caracteristics, surface polish, electrodeposited finish, etc, is it 3XX? You need to know. The tank will sleep in a bed of rock, or will it need a safety layer underneath to prevent leakage. Was a geologist contacted to study the soil? A stable base is key in ensuring tank safety and longevity. Will your tank arrive prefabricated or will a civil engineer construct the wall. This is called Bunding and Ring Wall Construction. It takes into account natural disaster factors such as storm winds, tornado force shear, earthquake recurrence, and lightning strikes, even tsunami recurrence. So all weld points, joints, bolts and connections need to pass inspection before the next stages. Non destructive Ultrasonic or X Ray tests may be performed to ensure right connections. The roof is lifted and bolted, so now fill it up! Water quality test, corrosion prevention, and stirring measures should follow in place.

    Next up Piping: What are the inlet and outlet pipings into a tank? Ball Valves, Needle Valves, Butterfly Valves, Diaphragm Valves, Gaskets, Seals, Metals, and Ratings. Where does the piping run from. Are there any intersections that flow into or out from the tank. What are the friction losses and how to account them. What is the tank insulation and Piping insulation. You need to understand blueprints to understand the flow into a complex installation. Usually tank are grouped in buldings called tank farms. Many pipes will flow into and out from the tank farm so it is of utmost importance to properly trace flow and to note any changes from blueprint to physical reality. A single change can mean a drop in quality or a loss of millions due to pressure losses or material product contact with a misplaced flow regulation unit.

    Are there any environmental factors affecting the Tank use or is the tank heat cooled or coil warmed? All tanks have temperature operating ranges that ensure the quality of the materials inside. Here at SSSSFFFF we care about ensuring your tank's alarms are in place and that each valve works where it is intended and as intended. So tanks are a bit civil, mechanical, chemical and electrical.

    Are you installing a Tank? Inspecting a Tank? Let us know. Our Engineers will Reach your Tanks to meet your cost and production requirements.

    COMPUTER SYSTEM VALIDATION CSV TRENDS: Software in a Machine? y/n; y-> SCV:

    IEEE, Statics and Dynamics, down to computer language... How to separate URS from CSV?

    Other Types of Testing  Stress Testing: Ensures the system and its network components can remain in tact during high utilization periods.  System Integration: Where unit testing is performed on individual system components,  this phase of testing is performed on all components/modules to ensure they work together as specified.  Performance Testing: Ensures the system and its network components can remain in tact during normal usage.  Backup/Recovery: Ensures that the type of backup media chosen for system backup can be executed and restored correctly. 
    Disaster Recovery: Much like Backup and Recovery but would determine how the  system would be recovered during a mass system failure or natural disaster.  Negative Testing: Most tests are performed to determine how the system will act if user executes a system action correctly (positive testing) This test determines how the  system would react to a user action executed incorrectly to find fault in a system exception handling.



    Electricity: Current. Current. Current. Current flows. The flow is of charges. When the charges are negative the charges are called electrons and the flow of electrons is called current. Current flows through like water, down a potential of energy, in water governed by bernoulli's equation, in current governed by Ohm's law. V = IR. ...

    Circuits: Parallel, Series, Capacitors, AC-DC Rectifiers, Diodes, Switches, EMF, Lenz Law.

    Batteries: Lead Batteries, Anodes, Cathodes, Electrodepositon.

    Motors, ICCE, Crank to Cam, Alternators, Starting Voltage / Running Voltage = 6

    Electrical Safety: Color Codes, Leather and Rubber Gloves, The neutral-ground-hot wire, electric shock safety, contact resistance . Welding. Wiring Installations. Here is a good link to understand home lighting installations.

    Electric Motors, Alternators, rheostats potentiometer, variable resistances. Brushes, Commutators, Impellers, Harmonic Oscillators...

    The electric motor works this way: First we have to ensure we are dealing with an Electric Motor and not an Electric Generator. An electric motor converts electrical energy into mechanical energy.

    The electric generator works this way: Dynamos, Alternators take Power to Induce an electric Current. Rotor-Stator-Armature. Dynamos convert Power into Direct Current.. Alternators into Alternating Current.

    Alternating Current: Lenz Law: when a coil cuts through magnetic field lines, that cut generates a current flow proportional to the angle it makes with the magnetic flow, with a max current flow at 0 degrees and 0 current at 90 degreens.

    Direct Current: Commutator: Insulated Collar connected to a segment of the inducing coil. This produces pulsating half wave direct current.

    See the video here.



    Transformers V2/V1=N2/N1, The primary coil, the secondary. Inductance.

    Rectifiers: like diodes. AC to DC one directional transmitters.

    Resistance, Impedance, Permittivity, Conduction and Radiative Flow.

    Electrical Repairs and Inspections are performed only by qualified personnel

    No electrical connections withing 50ft of flammable.

    No Electric chord Interference with ladders.

    Explosion Proof lighting.

    Ground Fault Interrupter.

    Proper circuit voltage and amperage.

    Grounded Tools, Temporary Lighting, or Double Insulated Tools

    A great weath of knowledge is needed to completely evaluate these systems.

    Routine Monitoring and Evaluation is required to sustain acceptable concentration levels of substances in water.

    Change Control documentation is warranted for planning and execution of process changes.

    Refer to 40CFR, and 21CFR for the latest USA Federal Regulation Standards. Standards are included within the FDA, EPA, CWA, WHO and other standardizing bodies.


    ENGINEERING TRENDS METAL WORKING Welding, Brazing, Soldering, Melting, Fusing, Transmutations. Flux, Tinning,

    Welding Inspections and Certifications.

    Bonding Metals, Metallic Transmutations


    Nuclear Reactions

    What tools do you need?

    Return to Site Menu


    The Engineering World
    MACHINES: What is a Machine?

    The history of machines.... Initially there were tools................(Boston Pops...).....

    Many years have passed since humanity developed tools... takes a grasp and gasp at evolution..............

    Complex Machines

    Virtual Machines

    Are you a Company that is selling a Machine? Get a spot here!


    Process Machines: Conveyors, Elevators, Mills, Cranes, Compressors, Precission Cutting,


    Simple Machines Complex Machines Virtual Machines:

    Simple Machines are Archetypes of what Complex machines are made up off. Newtonian Mechanics govern the use of Simple Machines. Complex and Virtual Machines are out of the current scope.

    Levers, Pulleys, Gears, Roller, Winch, Knife, Inclined Plane, what else?

    Know your Lever: Effort Arm, Resitance Arm, Pivot. Types of Lever. Type 2 Levers MA>1, Type 3 Lever MA<1

    Know your Gear: Gear Teeth, Gear Diameter

    Winch: Compounded Roller

    Knife and Inclined Plane: A knife is an inclined plane where the plane moves sliding the load over it. Does a knife cut an atom? NO! A knife cuts a macromolecular structure that is composed of atoms. Can you cut a macromolecular structure? yes.

    Know a Pulley: Moveable Pulleys, Fixed Pulleys, Compounded Pulleys.

    Mechanical Advantage = Effort/Load

    ENGINEERING TRENDS: CIVIL ENGINEERING TRENDS: Houses Roads, Bridges, Buildings, Tunnels, Waterways, Material Trends here...



    Let's build Something Together!!!







    Step 1 Plan your list of expenditures and draw a schematic model of the finished home. Be as descriptive as possible.

    Total Square footage of Site

    Total Square footage of House

    Total Number of Rooms: X

  • Living Room

  • Dining Room

  • Bathrooms

  • Master Room

  • Bedrooms

  • Garage

  • Deck

    - - - - - - - -
  • City Permits

  • Soil and Septic Tests

  • Site Surveying

  • Excavation

  • Drilling

  • Foundation

  • Interior Finish

  • Exterior Finish

  • Electrical Connections
  • Plumbing: Septic Tank
  • Heating and Ventilation
  • Natural Gas Connectivity
  • Materials of Construction: Steel Beams, Containers, Cement, Blocks

    Step #2 Start The Build

    Who do I call first? the engineer, the architect, the state permitting... Can I prefabricate the interior with finishes to shorten lead time?

    Can I prefabricate plumbing or do I have to wait until the modules are completed?


    Step #3 Routine Inspections and Correcting Errors

    Step #Z Detecting Defects and Adressing their Correction

    Step #ZZ Finishing. Terminaciones.


    Modular Home Links:

    1 acre = 43560sq-ft = 4047sq-m




    Preserves Radiative Heat by trapping absorbed heat.

    Increases, and sustaing Temperature

    Protects from Weather, Insects and Pests

    Isolates growth from other Plants

    Soil and Nutrient Standardization

    Types of Greenhouses


    The Engineering World

    Get TESTS:
    Ultrasonic Testing
    Infrared Camera
    Air Velocity
    Gas Composition
    Ash Resistivity
    Particle Size Distribution
    Flow Regime
    Temperature Mapping
    Computational Flow Dynamics
    Finite Element Analysis
    Kaye Validator
    Gas Chromatography
    Nuclear Magnetic Resonance
    Mass Spectrometry

    TEST METHOD VALIDATION: Experiments rating Test Method Performance. Test Method Validation involves editing and executing protocols (the METHOD) to test the adequacy of a given analytical procedure (the TEST), and by analytical we mean any activity that is measuring an observable wether qualitatively (categorical) or quantitavely. Test Method Validation answers the following questions:

    Can the measurement system adequately discriminate between different parts?

    Is the measurement system stable over time? Is the gauge response linear?

    Is the measurement system accurate throughout the range of parts?

    Does a gauge require Recalibration?

    Is there any difference in measurement methods, or operators measuring the same part?


    Test Method Table


    Closeness between the average of one or more test results and an accepted reference value.

    Involves selecting a Standard or Reference point if none is available.

    ICH: minimum of 9 determinations over a minimum of 3 concentration levels covering the specified range (for example, three concentrations with three replicates each).

    Accuracy should be reported as percent recovery by the assay of known added amount of analyte in the sample or as the difference between the mean and the accepted true value, together with the confidence intervals.

    Precision the closeness of agreement among test results obtained under prescribed conditions.

    Operator. The ability of an operator to consistently repeat the same measurement of the same part, using the same gage, under the same conditions.

    Closeness of the agreement between the results of successive measurements of the same part, carried out under the same conditions of measuremen (same operator)

    The ICH requires repeatability to be tested from at least 6 replications measured at 100% of the test target concentration or from at least 9 replications covering the complete specified range. For example, the results can be obtained at three concentrations with three injections at each concentration (3x3)


    Gauge. The ability of a gauge to consistently repeat the same measurement of the same part, using the same gage, under the same condition.

    Closeness of the agreement between the results of measurements of the same part carried out by different operators.

    Also called Ruggedness.


    Indicates that gage response increases in equal increments to equal increments of stimulus

    Beers Law A=eABC

    Evaluated graphically, in addition to or as an alternative to mathematical evaluation. The evaluation is made by visually inspecting a plot of signal height or peak area as a function of analyte concentration

    +-5% of expected response is considered linear.


    The values within which a measuring instrument is capable of measuring or which a generating instrument is capable of generating.

    ICH defines the range of an analytical procedure as the interval from the upper to the lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity

    ICH requires the minimum specified range to be 80 to 120 percent of the test concentration on Assay Tests.


    Interval around a group of measurement on which a certain measurement will fall.

    Link to Uncertainty

    Bias Systematic selection resulting in a measureable difference between the reference value and the expected value.

    Limit of Blank


    LoB is the highest apparent analyte concentration expected to be found when replicates of a blank sample containing no analyte are tested. LoB = meanblank + 1.645(SDblank)

    Limit of Detection LOD

    LoD is the lowest analyte concentration likely to be reliably distinguished from the LoB and at which detection is feasible. LoD is determined by utilising both the measured LoB and test replicates of a sample known to contain a low concentration of analyte.

    LoD = LoB + 1.645(SD low concentration sample)

    The lowest quantity of a substance that can be distinguished from the absence of that substance (a blank value) within a stated confidence limit (generally 1%). Lowest detectable quantity but not necessarily proportionally quantifiable.

    Expressed in terms of Noise level S/N = 2-3

    Limit of Quantitation LOQ

    ICH defines the limit of quantitation (LOQ) of an individual analytical procedure as the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.

    Quantitation limit is the lowest concentration of analyte in a sample that can be determined with acceptable precision and accuracy under the stated experimental conditions.

    LoQ is the lowest concentration at which the analyte can not only be reliably detected but at which some predefined goals for bias and imprecision are met. The LoQ may be equivalent to the LoD or it could be at a much higher concentration.

    Expressed in terms of Noise level S/N = 10-20

    Expressed in terms of RSD%

    Recovery Data Data is run in 80, 100, and 120% of label claim are run in duplicates or triplicates to serve as backup.

    Difference in Multiple Injections of a Homogeneous Sample.

    Presented as RSD = std deviation / mean

    Indicates Precision (Repeatability).

    System Suitability

    Instruments, Reagents, Columns and Analysts are working properly.

    Instrument Qualification-Method Validation-System Suitability: set of internal controls to ensure the unit performs as intended.

    Method Validation After qualifying a measuring unit a method to operate the unit is written. Method Validation is Instrument Specific and should demonstrate that under the method the machine is able to reproduce results as expected for standard values. During Method Validation the Acceptance criteria for the method is defined.
    Sampling Plan  
    Reference Standards Internal Standard: Sample with known purity and no interaction with the analyte is inserted into sample. Quantitation is measured as the ratio of detection of one peak to another.
    Acceptability Criteria  
    Stability Testing

    Estimates the allowed time span between sample collection and sample analysis. It is also important to evaluate an analytical method’s ability to measure drug products in the presence of its degradation products.

    Stability is tested by comparing the instrument response with that of freshly prepared solutions. System stability is determined by replicate analysis of the sample solution and calculation of the RSD of the responses. System stability is considered appropriate when the RSD does not exceed more than 20% of the corresponding value of the short term system precision.


    Test Method Validation Primer

    Reference 1

    Reference 2 Validation of Chromatographic Methods

    Reference 3 Viscometer Calibration Presentation

    Reference 4 Labcompliance website


    Validation is needed to make sure a developed procedure fulfill the purpose for which it was designed for. Full validation is needed for New Methods or when major changes to an existing method affect the scope.

    Partial validation is performed on previously validated methods that have undergone minor modifications. Generally, fewer tests are needed and are based on the potential effects of the modifications.

    Cross-validation can be used as a means of assessing inter-laboratory execution of the same method.

    Instrument Qualification-Method Validation-System Suitability: set of internal controls to ensure the unit performs as intended.


    Please read the Center for Drug Evaluation Research guidelines for Chromatographic Validations, published by the FDA.



    See Cleaning Validation (above)


    FACTORIAL:  2^3:  3 factors. 2 levels.

    CI: In each of the above, the following applies: If the true value of the parameter lies outside the 90% confidence interval once it has been calculated, then an event has occurred which had a probability of 10% (or less) of happening by chance.






    Emulsions: Micro Emulstions, Trojan Horses, Micelles.





    API Synthesis and Storage

    Techniques, Soxhlet Extraction, Sonication, Pelleting, Granulation, Mixing

    Sonication: Match Tip size of sonicator with sample volume size; select narrow vessels to direct energy into solution. Amplitude and Intensity are directly proportional. Vary Amplitude to prevent foaming.

    STP Volume 22.4 m2kmol-1
    Earth Escape Velocity 1.1 (104)m/s
    Gravitational Constant 6.66 (10-11Nm2kg-2)
    Electron Charge -1.6 (10-19)C
    Bar 0.9869atm
    Btu 1055J
    Btu/hr 0.293W
    1kWh 3413 Btu
    N 0.22lbf
    W 1.341(10-3)hp
    1lbm 0.45kg
    R F+460
    K C+273
    ∫cos (104)xdx ∫cos (104)xdx
    sec(θ) cos(θ)-1
    Polar Form

    z = a + ib

    z = re-iθ

    z r (cos(θ) + i sin(θ))
    a · b  |a| × |b| (cos(θ)
    a · b  b · a

    Total P(A+B)

    P(A) + P(B) - P(A,B)




    P(A) P(B/A)


    T distribution t = x/r
    Confidence Interval  
    Confidence Limit  
    Hypothesis Testing  
    Probability Distribution

    OR events

    And events

    Binomial Distribution  
    Combination In how many ways can F1 pilots arrive 1-2-3. How many ways can specific F1 pilots arrive 1-2-3? How many combinations of A items and B items can result?
    Moment of Inertia  
    Vector Fields  
    Truss, Pulley, Cables, Beams Sections, Joints, Parallel axis theorem, Deflection
    Resolution,Resultant, Couples, Systems, Equilibrium, Concurrent Forces, Reactions  
    Homogeneus Constant Differential Equations  
    Linear Nonhomogeneous Differential Equations Constant Coefficient  

    Fourier Series

    LaPlace Transform  
    Euler Approximation  

    The Engineering World

    Under Construction