LYOPHILIZERS COMMISSIONING AND VALIDATION

These subjects aim to cover areas of freeze drying qualification which are relevant to the professionals in the Pharmaceutical Industry. Theory and practice will be fully interrelated. New developments continuously challenge to professionals in terms of regulations, technology and trends, and participants will gain a better knowledge of the process as well as validation.

1. Qualification and Validation

This session provides information on the rules of validation a freeze drying process.

Qualification and Validation

• Validation Master Plan
• User Requirement Specs
• Functional Design Specs
• DQ, IQ, OQ, PQ.

Media/Structure
Lecture session, lots of opportunities for Q&A
Duration ca. 45 minutes

2. Software Validation

• Regulatory requirements
• GAMP and 21 CFR Part 11 (not forgetting new FDA reviews)
• Software qualification structure

• Software Design Specs
• Software Module Design Specs
• Software Module Test Specs
• Software Integration Test Specs

Media/Structure
Lecture session, lots of opportunities for Q&A
Duration ca. 60 minutes

3. Specifying a GMP lyophilizer

Reviews of different engineering approaches in freeze dryer design. Which are the best suited for my process?

Plant main subsystems

• Drying chamber and shelves
• Mechanical refrigeration (piston or screw compressors) vs. LN2 cooling
• Refrigerants
• Ice condenser (internal / external, direct expansion / fluid cooling)
• Vacuum pumps (oil sealed / dry) and measurement
• Control system (PLC / PC, Data logging)

Ancillary processes

• Stoppering
• Loading / unloading
• Clean In Place (CIP)
• Sterilization (SIP / Chemical methods)
• Filter integrity test methods (diffusive, intrusion, DOP)

Media/Structure
Lecture session, lots of opportunities for Q&A
Duration ca. 60 minutes

4. Auditing a vendor

With the aid of an independent user, a review of all the points in an auditing exercise will be reviewed.

Media/Structure
Interactive session
Duration ca. 30 minutes

5. Final review

Wrap-up of the workshop with final review and conclusions by the attendees

Duration ca. 15 mins

[Return to Workshops]