This course is a biotechnology modification of the general laboratory cleaning validation course. It includes the lab elements of the standard course modified to focus specifically on issues for biotechnology manufacture. The lecture elements of the course will review all sections of PDA Technical Report #49, Points to Consider for Biotechnology Cleaning Validation.
This course is ideal for anyone involved in cleaning validation for biotechnology manufacture. This course provides attendees with a complete, hands-on cleaning validation education program covering both automated (CIP) and manual cleaning for biotech manufacture.
This three-day course includes the use of a CIP skid, which helps the attendees understand everything from the impact of system design on cleanability to how to take swab samples and set acceptance criteria. Participants will gain direct experience setting up an effective cleaning program by going through a systematic approach to cleaning validation. The approach used includes initial evaluation of the equipment to be cleaned, analytical techniques, worst-case conditions, multi-product cleaning, cleaning cycle development, and validation of the cleaning process.
Extensive use of wet labs will help to emphasize the principles learned in the lecture material. These labs demonstrate the application of current cleaning principles to modern pharmaceutical equipment. Use of riboflavin for spray ball coverage testing, as well as swabbing techniques for surface analysis, will be demonstrated. Each student will determine his or her own swab recovery percentage with sampling coupons. The different elements of the hands-on aspect of the course include: spray ball coverage testing (riboflavin), visual detection, swab recovery, cycle development - cleaning agent concentration determination, cycle development - CIP cycle exposure time determination, cycle development - CIP cycle rinse time determination, manual cleaning process validation and CIP process validation.
- TR#49 Points to Consider for Biotechnology Cleaning Validation
- Spray ball coverage testing
- Swab recovery/analysis
- Cleaning agent concentration determination
- CIP cycle exposure time determination
- Complete CIP cycle development
- Manual cleaning procedure validation
- Cleaning validation acceptance criteria