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LIVE FROM HEALTHPACK: Controlled environments merit detailed attention

Medical Device Packaging Technical Committee member examines the multiple considerations in sterile packaging environments, from concept to compliance.

HealthPack 2015
HealthPack 2015

Changing regulations, global regulatory differences, for medical devices and combination products that add the complexity of pharmaceutical requirements are all factoring into the importance of controlled environments as integral parts of packaging process control. Considering them as such better ensures the success of your sterile packaging process development project and ongoing compliance.

Here are some key considerations regarding producing sterile packaging in controlled environments:

• Design your environment around your process; not the other way around.

• Take a risk management-approach that includes input from packaging engineering, product development, sterility assurance, manufacturing, facilities management, and other key groups within your company.

• Never underestimate the value of collaborative design as their inputs can provide help early on and potentially avoid unnecessary and costly changes later in the process.

• In assessing facilities, factor in what utilities will be needed to support the room, to meet product/process requirements, to meet permit laws, to meet timetables, and to mitigate compliance issues.

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