Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
Roger Cowan is the Keynote Spaker at ComplianceKey. He 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, 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 Toro........
Overview
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 this webinar?
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:
a) solid particulate
b) water content
c) total oil content
d) 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 can Benefit:
This webinar will provide valuable assistance to all personnel in:
- Quality Assurance
- Environmental Monitoring
- Microbiology
- Manufacturing
- Validation
- Engineering
- Maintenance
