Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
|Date||:||4th June 2019|
|Time||:||10:00 AM PST | 01:00 PM EST|
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 are 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:
- Compressed Air - Importance of Quality
- Pharmaceutical Compressed Air System Design
- Contamination Types and Sources
- Contamination Prevention
- International GMP Testing Standards
- Testing Methods and Specifications
Who Will Benefit:
- Quality Assurance
- Environmental Monitoring
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC. Roger has more than 30 years of direct experience in pharmaceutical quality assurance and manufacturing at major pharmaceutical companies in Canada and the U.S. 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. His experience covers management of the Clinical Supplies Manufacturing Facility and handling GMP and ISO audits from both domestic and international regulatory agencies. He has extensive experience in GMP audits covering various suppliers and contract manufacturing organizations.
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.