This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met.
Join this session by expert speaker Ms. Kelly Thomas, where she will explain basic principles of aseptic processing, including: Cleanliness classifications, Process differences between aseptically produced and terminally sterilized product, Relation of manufacturing and handling procedures to sources of product contamination and the differences between cleaning, disinfection and sanitization.
Session Highlights:
The role of environmental monitoring
Types & sources of microorganisms
The impact of microorganisms on product and patient health and safety
Process differences between aseptically produced and terminally sterilized product
Relation of manufacturing and handling procedures to sources of product contamination
The differences between and the purposes of cleaning, disinfection and sanitization
Proper cleaning techniques
The role of isolator technology
Personnel gowning requirements
Good clean area behaviors/practices
Practices to avoid – and why
Review site-specific EM/aseptic behavior observations/risks & ask attendees to brainstorm ways to change/improve/eliminate these behaviors & risks
Why You Should Attend:
Explain the difference between Aseptic and Bulk processing
Understand facility and personnel requirements necessary to maintain microbial control
Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
Understand the gowning requirements associated with different cleanroom classifications
Who Should Attend:
Operations employees who are required to enter controlled environments as part of their job function – includes some or all of the employees in the following departments:
Production
QC Micro
Engineering & Validation
Facilities / Maintenance
Quality Assurance
*You may ask your Question directly to our expert during the Q&A session
.** You can buy On-Demand and view it as per your convenience.
Kelly Thomas
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.