The BioPhorum Operations Group’s (BPOG) Best Practices Guideline for Mitigating Risk from Leachables in Polymeric Single-Use Components Used in Biomanufacturing will be presented at BioProduction, Dublin in October 2016. This leachables guidance builds upon the success of the BPOG Extractables Protocol to form a completed picture of the impact of using Single Use Systems (SUSs) for the biopharmaceutical industry.
There is a regulatory requirement to demonstrate that product contact surfaces of manufacturing equipment is not reactive, additive or absorptive in a manner that impacts the safety, identity strength, quality or purity of drugs manufactured. The BPOG approach is the result of an extensive industry-wide collaborative effort of Subject Matter Experts (SMEs) from nineteen BPOG member companies. The purpose of the guideline is to present a:
- Practical and adaptable approach for assessing SUS for the risks they present to biopharmaceutical manufacturing processes,
- Method for designing studies to assess polymeric SUS components, using appropriate analytical methodologies for detection of potential leachable compounds,
- Robust methodology and that has the flexibility to be adapted appropriately to individual biopharmaceutical company’s needs.
A risk based approach is presented that assesses each component based on five key weighted factors:
- Distance Along the Production Stream (DAS),
- Exposure Temperature (ET),
- Exposure Duration (ED),
- Process-Fluid Interaction (PFI) &
- Dilution Ratio (DR).
Based on the total of these weighted factors the leachables risk is identified a low, medium or high and suggested requirements are presented for each risk grouping.
The suggested leachables study methodologies are identified in the guide along with the concomitant analytical methodology and a standardized reporting structure.
The BPOG Best Practices for Mitigating Leachables Risk from Polymeric Single Use Systems Used in Biopharmaceutical Manufacturing will be published in full on the BPOG website (http://www.biophorum.com/), and will be freely available to all users, by end of January 2017.