2022 - Pharmaceutical Compressed Air: Quality GMP Standards and Requirements

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 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 the cause and effect. Suggestions are also provided for the prevention of contamination. Finally, a compilation of all FDA/EU GMP Guidances, USP/EP, and ISO air standards are presented. The sampling and testing methodology for each of these specifications is discussed.
LEARNING OBJECTIVES
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
Microbiology
Manufacturing
Validation
Engineering
Maintenance
SPEAKER PROFILE
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.
Email: info-AT-247compliance.us
Tel: +1-661-336-9555
https://www.linkedin.com/in/whitney-jones-87357317...