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

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed. The various regulatory bodies’ requirements such as 21 CFR Part 211 (mostly relevant 211.113 “Control of microbiological contamination”, ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice”) amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products.

There are seven (7) key topics that will be discussed on Day 1 and Day 2 of the Seminar are as follows:

• Cleanroom Regulations, Classifications, Basic Background and Design Considerations
• Cleanroom Qualification, Cleaning Validation (IOQ/PQ), Routine Monitoring and Excursion Investigation
• Environmental Monitoring Program (Monitoring, Excursion Investigation and Trending of Data)
• Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures)
• Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy)
• Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program
• Basics of Sterilization Processes- Physical and Chemical Processes

Learning Objectives:

• Discuss Cleanroom Classification, Regulations and Guidelines
• Summarize how to Perform Cleanroom Design, Validation/Qualification, Operation, Environmental Monitoring Program and ensuring a state of control
• Describe Aseptic Practices, Personnel Health Practices, Gowning and Trafficking Patterns in a Cleanroom
• Establish and describe the Requirements of Cleanroom Cleaning/Disinfection and Contamination Control Practices
• Summarize various Sterilization Processes, Advantages and Disadvantages –both Physical and Chemical
• Describe the Sterilization Processes and Controls

Who will Benefit:

This training will benefit those involved in the manufacturing, processing, testing and release of sterile and non-sterile products. It will provide the attendee an understanding of the basic concept of microbiology, microbiological and contamination control practices, cleanroom design, routine testing, qualification/validation and use of cleanrooms as well as the typical sterilization processes (Physical and Chemical) within various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially personnel and management in:

• Quality Assurance
• Quality Control
• Manufacturing
• Validation
• Supplier Quality Assurance
• Regulatory Affairs
• Shipping and Receiving
• Facility and Maintenance