Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
Roger Cowan is the Keynote Spaker at ComplianceKey. He 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 35 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toro........
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 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.
Why should you attend this webinar?
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:
a) solid particulate
b) water content
c) total oil content
d) 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.
Areas Covered in the Session:
- 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 can Benefit:
This webinar will provide valuable assistance to all personnel in:
- Quality Assurance
- Environmental Monitoring
- Microbiology
- Manufacturing
- Validation
- Engineering
- Maintenance
