Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products
Karoline Bechtold-Peters1, Stephen Chang2, Andrew C Lennard3
1Novartis Pharma AG, Basel, Switzerland.
Summary
Applying holistic concepts and understanding product attributes can reduce risks before bioburden testing and sterile filtration, improving bioburden risk management.
Area of Science:
- Microbiology
- Pharmaceutical Science
- Risk Management
Background:
- Bioburden testing and sterile filtration are critical control points in pharmaceutical manufacturing.
- Current risk management strategies may not fully address pre-filtration bioburden.
- Enhanced understanding of process and product attributes is needed.
Purpose of the Study:
- To propose holistic concepts for proactive bioburden risk management.
- To emphasize the importance of process and product attribute understanding.
- To reduce risks before final bioburden testing and sterile filtration.
Main Methods:
- Literature review on current bioburden control strategies.
- Analysis of process parameters influencing microbial growth.
- Development of a framework for enhanced bioburden risk assessment.
Main Results:
- Holistic approaches can significantly minimize microbial contamination risks.
- Detailed process and product understanding is key to effective risk mitigation.
- Proactive risk reduction complements traditional end-product testing.
Conclusions:
- Implementing enhanced process and product understanding is crucial for successful bioburden risk management.
- Proactive risk reduction strategies should be integrated before bioburden testing and sterile filtration.
- A shift towards holistic bioburden control is recommended for pharmaceutical manufacturing.
Keywords:
Bacterial by-productsBioburden limitsCFUCase-by-case assessment of bioburden excursions (CCAB)Filter break-throughMicrobial bioburdenRisk-basedSpecificationSterile filtrationMore Related Videos
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