BioPhorum Operations Group’s (BPOG) Best Practices Guideline for Mitigating Risk from Leachables

cell media, bottles, medicine

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:

  1. Practical and adaptable approach for assessing SUS for the risks they present to biopharmaceutical manufacturing processes,
  2. Method for designing studies to assess polymeric SUS components, using appropriate analytical methodologies for detection of potential leachable compounds,
  3. 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:

  1. Distance Along the Production Stream (DAS),
  2. Exposure Temperature (ET),
  3. Exposure Duration (ED),
  4. Process-Fluid Interaction (PFI) &
  5. 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.

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