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Date: 19th - 21st May, 2008

Location: Bethesda, Maryland, USA

Summary:
Pharmaceutical - Training

This course provides attendees with a complete, hands-on cleaning validation education program covering both automated (CIP) and manual cleaning. This three-day course includes the use of a new 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 helps 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 using a state-of-the-art TOC analyzer with sampling coupons. This course will utilize PQ protocols developed during the class to execute a full CIP cleaning validation study.

The different elements of the hands-on aspect of the course include: spray ball coverage testing (riboflavin), visual detection, TOC 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.