Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Sterility assurance and contamination control depend on how well a cleanroom is designed, qualified, run and monitored. This 90-minute cleanroom, microbiology and sterility assurance training covers those elements for drug and medical device manufacturers.

You'll look at cleanroom regulations and classification, particle sources and types, design requirements, qualification and validation, and daily operations. The session then covers environmental monitoring program requirements, excursion investigations and data trending, microbiological methods, and cleanroom cleaning and disinfection.

It also covers the types of microorganisms involved, personnel and material flow, gowning controls and the basics of physical and chemical sterilization.

• Explain cleanroom regulations, classifications and design considerations
• Describe cleanroom qualification, cleaning validation and routine monitoring
• Run an environmental monitoring program, including excursion investigation and data trending
• Apply aseptic practices, cleanroom behavior and gowning controls
• Control personnel, material and equipment transfers into and out of the cleanroom
• Outline cleaning, disinfection and the basics of physical and chemical sterilization

• Cleanroom regulations, classifications, background and design considerations
• Cleanroom qualification, cleaning validation (IOQ/PQ), routine monitoring and excursion investigation
• Environmental monitoring program: monitoring, excursion investigation and data trending
• Personnel training: aseptic practices, cleanroom behavior and contamination control procedures
• Cleanroom traffic: personnel, material, product and equipment transfer practices and entry and exit policy
• Cleanroom gowning, contamination control, cleaning and disinfection program
• Basics of physical and chemical sterilization processes

Aseptic processing and contamination control during manufacturing and testing directly affect whether finished products can be judged acceptable and released. Regulators set clear expectations, including 21 CFR Part 211 (in particular 211.113, control of microbiological contamination), the parts of ISO 14644 and FDA's guidance on sterile drug products produced by aseptic processing.

The session suits QA managers and associates responsible for QC oversight, QC analysts and managers, and QA, compliance and regulatory affairs professionals.

• QA Managers and Associates responsible for QC Oversight
• QC Analyst and Manager
• QA/QC/Compliance/Regulatory affairs professionals

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.