Objectives of the Presentation:
- Compressed Air - Importance of Quality
- Pharmaceutical Compressed Air System Design
- Contamination Types and Sources
- Contamination Prevention
- International GMP Testing Standards
- Testing Methods and Specifications
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.
- Solid particulate
- Water content
- Total oil content
- 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.
Pharmaceutical Consultant ,
R Cowan Consulting Services LLC
Roger cowan has 32 years of experience in pharmaceutical R&D, manufacturing and QA management. He has established his own Consulting Services LLC, (http://www.pharmaconsultation.com/), Presently he is a Independent consulting to the pharmaceutical industry primarily in the area of pharmaceutical. His specialties 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.