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To meet 6.3.4 performance testing on the worst case sterile barrier system, should I make packages at the extremes of the specification?

Last Updated On May 15, 2008

Clause 6.3.4 requires that sterile barrier systems that represent the range of the process window (“the specified limits of forming and sealing”) be evaluated. Because the validated process window is designed to yield product that falls comfortably within the specification, to produce product at the limits of the specification can generally only be achieved by moving outside of the validated window. Often significant modifications to the process are required to produce sterile barrier systems that fall consistently at the limits of the specification. If this is attempted, it should be realized that:

• The modified process may create issues that would not be seen within the validated window; and

• Because of normal variation that exists in any process, some of the sterile barrier systems evaluated will actually be outside of the specification.

To meet 6.3.4 the medical device manufacturer may choose to source from a fully validated process selecting an appropriate sample size from multiple lots to represent the range of package characteristics. For further assurance, the final closure seal can be made at the specified process limits of sealing. Alternatively, the medical device manufacturer may utilize sterile barrier systems where all seals are made at the worst-case conditions of manufacture within the validated window. With either approach, it is not necessary to make packages at the extremes of the specification.