Compressed gasses are vital excipient and utility in pharmaceutical and bio-pharmaceutical industry. Their criticality to pharmaceutical and bio-pharmaceutical production sometimes overlooked. Their potential to be a source of clean room and product contamination seldom considered. This webinar will give you an understanding of different types of compressed gasses used in pharmaceutical and bio-pharmaceutical industry and their purpose, designs of these utility systems and their qualification and validation considerations as well as continued monitoring throughout life-cycles of these systems. We will also discuss possibilities of contamination types inherent in compressed air and other gasses systems and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed gasses system with their individual components will be provided. Typical engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered critical and optimal. The sample contamination sources in compressed gasses that will be discussed are:

• Solid particulate
• Water content
• Total oil content
• Microbial bioburden

Recommendations will also be provided for preventing contamination. Additionally, points to consider for post-expansion and/or post-changes for optimization, qualification and validation planning and implementation are also covered. A compilation of all FDA/EU GMP guidelines, USP/EP and ISO (8573, 7183, 12500) standards will be presented. Sampling and testing methodology for these specifications will be discussed as well. Finally, case studies describing compressed gasses use related deviations will be covered.

Course Objectives:

• Understanding which compressed gasses are used in pharmaceutical and bio-pharmaceutical industry
• Knowledge of typical uses of compressed gasses in pharmaceutical and bio-pharmaceutical industry
• Learn design and components of compressed gas systems
• Understand criticality of compressed gasses systems components
• Receive an overview of qualification and validation activities for compressed gasses systems
• Understand regulations, regulatory guidance, international specifications and best industry practices for compressed gasses testing and use
• Learn how to prevent contamination originated from compressed gasses
• Learn post-expansions and/or post-changes optimization, qualification and validation planning and implementation points to consider

Course Outline:

Topics covered include: Compressed gasses used in pharmaceutical and bio-pharmaceutical industry and their uses

• Compressed Air Systems coverage
• Selection of the compressed air systems
• Major components of systems (schematics)
• Criticality of major components
• Qualification of compressed air systems
• International standards and pharmacopeia testing specifications
• International guidance
• Validation of compressed air systems
• Contamination potential examples (case studies) and prevention
• Optimization, qualification and validation planning and implementation for post-expansion and/or post-changes
• Nitrogen Systems coverage
• Special considerations for design
• Qualification of nitrogen systems
• Other Gasses:
• Argon,
• Liquid Nitrogen,
• Carbon Dioxide,
• Cryogenic Storage Solutions,
• Oxygen
• Special considerations for design
• Qualification of special gas systems

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Control
• Quality Assurance
• Production/Operations
• Microbiologist
• Chemist
• Analysts
• Manufacturing
• Validation
• Facilities
• Materials Management
• Engineering
• Vendors/Suppliers
• Regulatory Affairs
• All levels of management