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Pharmaceutical Compressed Air: Quality GMP Standards and Requirements

instructor
By: Roger Cowan
Recorded Session
Duration
60 Minutes
Training Level
Intermediate to Advanced

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Webinar Details

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 are 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?

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:

  • solid particulate
  • water content
  • total oil content
  • microbial bioburden

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. The sampling and testing methodology for each of these specifications is discussed.

LEARNING OBJECTIVES

  • 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?

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering 
  • Maintenance

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:

  • solid particulate
  • water content
  • total oil content
  • microbial bioburden

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. The sampling and testing methodology for each of these specifications is discussed.

  • Compressed Air - Importance of Quality
  • Pharmaceutical Compressed Air System Design
  • Contamination Types and Sources
  • Contamination Prevention
  • International GMP Testing Standards
  • Testing Methods and Specifications
  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering 
  • Maintenance

SPEAKER PROFILE

instructor

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. He has 37 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 Toronto, Canada.

Roger's areas of expertise 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.

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