Closed Systems in CNC Space

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Closed-systems: Risk-based selection of environmental classifications for biopharmaceutical operations

Closed-systems: Risk-based selection of environmental classifications for biopharmaceutical operations

This article published in the PDA Journal details a risk-based methodology designed to assign environmental classifications to the different operations in biopharmaceutical facilities manufacturing non-sterile (low bioburden) drug substance. The authors propose a formal risk assessment-based methodology that is applicable in the early design phase of new facilities and facilitates the fast selection of the environmental conditions required for the different process steps. The risk assessment describes the risk to product quality or patient safety from environmental contamination, and this is expressed in terms of impact, probability, and detectability. The assessment considers growth potential in terms of time, nutrients, and temperature; bioburden limit; level of closure of the system; and the ability of the process to detect contamination to assign an environmental classification. Because closure is a key factor in the methodology, the authors propose a practical definition of closed systems, building on existing International Society for Pharmaceutical Engineering guidance.

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Closed systems: How much harm can a single droplet do? Considerations for a viral inactivation step

Closed systems: How much harm can a single droplet do? Considerations for a viral inactivation step

This paper discusses a systematic approach to assessing virus segregation measures, which can help biopharmaceutical developers achieve sufficient segregation for the low-pH inactivation steps in their downstream processes. It covers a process description, mathematical modeling, failure modes and the effects on viral clearance, and the importance of proper design.

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