Good Engineering Practices: What Can We Learn from the Pharmaceutical Industry

Transcription

1 Good Engineering Practices: What Can We Learn from the Pharmaceutical Industry ISA EXPO 2009 Standards Certification Education & Training Publishing Conferences & Exhibits Welcome Background George Buckbee, P.E. Over 20 Years in many industries Author of Automation Applications in Bio-Pharmaceuticals What You Will Learn: Good Engineering Practices for Automation & Control That Can be Applied in Other Industries Definition Design Reviews [Course code] (version#) 1

2 Why is Pharma Different? Yet the Same? Government Regulation Documentation Testing Many Similar Processes, Smaller Scale Good Engineering Practice leads to: A System that Works! It Meets the Objectives Good Documentation Cost Reductions Maybe! More Formalized Process for Engineering: Degree of Rigor Required??? The GAMP V-Model Retirement Planning Process Requirements Equipment URS URS Verifies Operation & Maintenance Performance Operational GXP and Safety Review Installation Equipment FS FS Operational Check Mechanical and Electrical Design Operator Interface Design Design Installation Check FAT & SAT Design Review and Approval Module Integration and Developmental Testing Mechanical and Electrical Build Operating Interface Build Programming [Course code] (version#) 2

3 Benefits of Validation Using GAMP Process Understanding of the Process Improved Operational Efficiency Reduced Risk of Failure Maintenance of Quality Standards Faster to Start-up??? Definition User Requirements Functional Requirements Design Documents Planning Process Requirements Equipment URS URS GXP and Safety Review Equipment FS FS Mechanical and Operator Interface Electrical Design Design Design Design Review and Approval Verifies Mechanical and Operating Electrical Interface Build Control Build System Programmin g Operation & Maintenance Performance Operational Installation Operational Check Installation Check FAT & SAT Module Integration and Developmental Testing Retirement [Course code] (version#) 3

4 User Requirements Short Descriptions (250 words max, each req.) Can Be Understood by Users Requirements, not Designs WHAT, not HOW Calculations, not Implementation Functions, Procedures & Sequences Testable, Verifiable Performance and Timing Must achieve and hold reaction temperature, +/- 1 degree F within 20 minutes Failure Modes, Upsets, Emergency Situations Constraints Procedural, regulatory, skill levels Safety, Environmental Include Dynamics: Setpoint reaches new value within 60 seconds, with no overshoot. Pressure responds to upsets within 60 seconds, without overshooting. Cools a full vessel from 75 to 25 degrees C within 3 minutes May affect Process and/or Control Design [Course code] (version#) 4

5 Functional Requirements HOW it will be done. Traceable to the User Requirements Much more detailed Includes Traditional Design Docs P&ID s Instrument List Narratives Specs Simple Complex Formal Reviews At Each Key Stage in the DEFINITION User Requirements Functional requirements Multi-Functional Groups Involved Operations Maintenance Quality Process Engineers I.T. Engineering Purchasing DOCUMENT the Reviews Formal Sign-Offs [Course code] (version#) 5

6 Validation, Commissioning, Testing Validate Against the Design Item-by-Item Pass/Fail Validate Design Details First, Then Overall Function Is the System Built to Specifications? Valve Sizes, Instrument Loop checks, etc etc. Functional Checks Individual controls, mode changes, sequences, etc. Complete all the right steps in the sequence Performance Maps to User Requirements Ex. One batch in less than 5 hours Good Engineering Practices: What Can we Learn from Pharma? More Time and Effort Defining the Requirements Design, then Build, then Test Test Against Each Requirements Reduces the Overall: Risk Time Cost Degree of Rigor: Balance vs. Cost, Schedule [Course code] (version#) 6

7 Q & A Any questions about the topics covered? [Course code] (version#) 7