Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

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 will be provided. Engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered optimal.

The four contamination sources in compressed air will be discussed. They are:

• Solid particulate
• Water content
• Total oil content
• Microbial bioburden

For each of these, the presentation will discuss cause and effect. Suggestions will also be provided for preventing contamination. Finally, a compilation of all FDA/EU GMP guidelines, USP/EP and ISO air standards will be presented. Sampling and testing methodology for each of these specifications will be discussed as well.

Areas Covered in the Webinar:

• 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:

This webinar will provide valuable assistance to all personnel in pharmaceutical manufacturing and compounding pharmacies:

• Quality assurance
• Environmental monitoring
• Microbiology
• Manufacturing
• Validation
• Engineering
• Maintenance

Roger Cowan
Pharmaceutical Consultant, R Cowan Consulting Services LLC

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 35 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada.

His 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.

Topic Background:

The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without product contamination. Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system as well.

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