Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system, It will also detail GMP standards and requirements pertaining to compressed air quality, and will discuss cause and effect, also prevention of the contamination.
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Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.
Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.
Why should you Attend:
Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.
A detailed description of a typical pharmaceutical compressed air system with its individual components is provided. Engineering schematics are included. All component functions are detailed with recommendations as to which component type is considered optimal.
The four contamination sources in compressed air are discussed.These are:
- Solid Particulate
- Water Content
- Total Oil Content
- Microbial Bioburden
For each of these, the presentation will discuss cause and effect.Suggestions are also provided for prevention of the contamination.
Finally, a compilation of all FDA/EU GMP Guidances,USP/EP and ISO air standards are presented. Sampling and testing methodology for each of these specifications is discussed.
Areas Covered in the Session:
Who Will Benefit:
- Compressed Air - Importance of Quality
- Pharmaceutical Compressed Air System Design
- Contamination Types and Sources
- Contamination Prevention
- International GMP Testing Standards
- Testing Methods and Specifications
- Quality Assurance
- Environmental Monitoring
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 37 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.
Roger's areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.