Basics of cleaning and cleaning validation

The STERIS Corporation is a leading provider across the industry of solutions for cleaning, cleaning validation, and microbial control in the pharmaceutical industry. The expert team has been holding non-commercial seminars and presentations for over 20 years, in which the challenges faced by regulated industries in cleaning, cleaning validation, and microbial control are discussed based on cGMP standards (current Good Manufacturing Practice) and practical experience. This seminar presents industry-specific examples and practical insights into the development of effective cleaning programs. Additionally, participants will receive an overview of relevant regulatory guidelines and practical information on validating effective cleaning programs. The focus of the seminar is on cleaning process equipment and cleaning validation.

The Target Audience
This seminar is aimed at professionals in pharmaceutical manufacturing who need to deliver efficient, economical, and compliant production results of high quality: Quality Assurance, Regulatory Affairs, Plant Managers, Quality Control, Operations, Compliance Officers, Microbiology, Engineering, Research and Development

The Speakers
George Verghese is Head of Technical Customer Service in the Life Sciences Division of STERIS Corporation.
Destin LeBlanc is the owner and principal consultant of Cleaning Validation Technologies, advising in the field of cleaning validation.

Topics of the Event
- Introduction to cleaning validation, planning and development of cleaning processes (cleaning agents and methods, issues and challenges regarding cleaning and process equipment, laboratory investigations and standards).
- Residues and limits (calculation of MACO value and Risk-MaPP, cleaning agent residues, microbial limits, endotoxin and microbial thresholds).
- Sampling and analysis (rinse and swab sampling, principles of method validation, recovery studies).
- Preconditions for cleaning (protocols and associated challenges, strategies for grouping, special programs for equipment planning).
- Ongoing process verification (preventive maintenance, derouging and passivation, microbial counts and biofilms).
- Regulatory aspects (global regulations: GMP (USA), GMP (EU), ICH, guidelines: FDA, PIC/S, WHO, others).

The seminar will be conducted in English, with a translation into German offered.