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Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards
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, It will also detail GMP standards and requirements pertaining to compressed air quality, and will discuss cause and effect, also prevention of the contamination.
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.
Areas Covered in the Session:-
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:
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. Sampling and testing methodology for each of these specifications is discussed.
Who Will Benefit?
