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.
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.
Areas Covered in the Webinar:
- Compressed Air - Importance of Quality
- Pharmaceutical Compressed Air System Design
- Contamination Types and Sources
- Contamination Prevention
- International GMP Testing Standards
- Testing Methods and Specifications
Speakers
Roger Cowan,
Pharmaceutical Consultant ,
R Cowan Consulting Services LLCRoger 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.
Who Should Attend
This webinar will provide valuable assistance to all personnel in pharmaceutical manufacturing and compounding pharmacies:
- Quality assurance
- Environmental monitoring
- Microbiology
- Manufacturing
- Validation
- Engineering
- Maintenance
