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Aseptic ProcessingWorkshop
Classroom
Successful manufacture of a sterile product by aseptic processing requires in-depth understanding of the sources of contamination and the controls applied to prevent them from finding their way into the product. This course, presented by two professionals highly experienced in the intricacies of contamination control, allows participants to understand basic microbiology, how to analyze risks to product sterility and how...Continue reading
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Issues to be covered
- Regulations: EU Annex 1, FDA Aseptic Processing Guide, PIC/s, 483s/ warning letters
- Basic microbiology: sources of contamination; replication; preventing access versus reacting to an outbreak of contamination
- Control of particles and visual inspection of finished product
- Identifying hazards: interactive exercise using fishbone and other risk assessment tools to brainstorm potential sources of contamination
- Contamination Control Strategy (CCS): what is it; how to go about it; FMEA vs word table
(interactive with templates provided and breakouts to populate the document)- Facility, Utilities Design: WFI, compressed air, nitrogen, CO2
- Process Design
- Personnel: Training, Awareness, Culture, Hygiene, Gowning and gowning qualification
- Facility & Equipment Design
- Cleaning and Disinfection: Facilities, Equipment
- Materials Management: vendors, sampling and testing, controls for:
- Raw materials
- Consumables
- Containers and Closures (CCI)
- In-process bioburden
- Disinfectants
- Qualification and Validation, Maintenance, Repairs, Monitoring
- Aseptic Process simulation
- Environmental Monitoring
- Data Trending; Rapid Contamination Response and Remediation:
- Investigations, Corrective Actions and Change Control
Who should attend
Anyone in sterile / aseptic pharma, biopharma, sterile / low bioburden API manufacturing and ATMPs. R&D personnel developing aseptic processes will benefit greatly from the course. Personnel working with sterile medical devices and pharmacy compounding will obtain a broad insight into the risks associated with such manufacturing and how to develop a plan for their ongoing control. CDMOs offering sterile / aseptic processing and / or laboratory services should attend. Anyone working with CDMOs / overseeing CDMOs for sterile products. The workshop is suitable for senior managers, operations, production, logistics, purchasing, procurement, regulatory, quality control, quality assurance and especially personnel overseeing aseptic projects the more so where outsourced services are used and they are responsible for oversight
Benefits to the Participants
- Become familiar with regulatory requirements and current expectations
- Understand basic microbiology
- Learn how to PREVENT contamination
- Through interactive exercises learn how to develop a meaningful, manageable and defensible contamination control strategy
- Gain an all-around familiarity with aseptic processing risks and their management along the entire supply chain
- Develop a Data Collection Plan for valuable data analysis and feedback into the CCS
Toolkits / Bonus Material
- A comprehensive list of regulatory guidelines and links to download
- Two different templates for the CCS
- Reference to inspectors’ audit checklists / aide memoire for inspection from the PIC/s
- A complete list and references to PDA Technical Reports (available for purchase) related to aseptic processing
- Links to URL’s for FDA 483 inspectional observations and warning letters
About The Lecturer
