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Advanced Cleaning Issues:
Multiple Product and Equipment Cleaning, Carryover, and Nonconventional Sources of Contamination
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
April 4, 2014
This webinar we review the cleaning and cleaning validation life cycle for pharmaceutical operations. We will start by discussing the cleaning continuum and sources of contamination of product. Once the review is complete we will discuss some of the more complex and less obvious issues of contamination in the manufacture of pharmaceuticals. We start with the premise that cleaning individual pieces of equipment is not a guarantee that the product will not be contaminated by previously processed material.
The reasons for determining an appropriate level of cleanliness will be reviewed as well as the opportunity for contamination by people, utilities and the facility itself. Once these issues have been defined, we will address them one by one. We will start by addressing how to clean multiple equipment used for processing multiple products. We will introduce the concept of risk analysis and bracketing as a way for defining the scope of cleaning, establishing appropriate cleaning levels, and how to conduct cleaning validation in such cases. We will look at solid dosage and sterile liquids as examples for applying the concepts discussed.
Next we will address the concept of how to establish acceptance criteria for cleanliness in utilizing the concept of dilution of contaminants. Then we will look at applying the concept of dilution to address the problem of carryover and the cumulative effect in multiple equipment trains. This will then be expanded further to address the cleaning of multiple products within multiple equipment using the dilution of contaminants concept.
We will then review the role the utilities, facility and personnel may play in contamination and cross contamination and how to address such issues. Finally, we will discuss the importance of establishing a robust quality system to ensure that the products are not contaminated due to poor cleaning and inadequate design of the facility, utilities, and personnel actions.
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GMP140404E - MP3 audio file and Handout materials
Advanced Cleaning Issues
Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.
Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.
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