How to Keep Pharma/Biotech/Device Manufacturing Facilities Open Using Expedited Change Control

Jack Garvey |

For life science manufacturers concerned about third-party access to facilities, we have been recommending they add pre-entrance gowning to existing gowning procedures and extend the gowning envelope to the building exterior. This can be accomplished through an expedited change control – and should incorporate risk-based considerations. The objective is to minimize or eliminate human bioburden release prior to facility entrance. Focus should be on covering street clothes, along with prevention of droplet release and exposure to mucous membranes – essentially, from the neck up. These principles are well-understood in our industries, and extension of these principles and actions to the exterior of the building envelope can reduce any potential impacts or concerns from third-party access.

It’s unrealistic to think that we can lock down modern manufacturing facilities from access and continue producing these critical products. Extending principles we already know and understand to the external envelope of a facility can help reduce any existing risk and increase worker confidence.

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