Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"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"
Different types of contamination inherent in compressed air
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.
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.
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
• 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
Industries who can attend
This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.