Impact of Container Closure on Drug Safety

Impact of Container Closure on Drug Safety
The following activities are expected to be conducted during the
development and validation phases:
1. Selection of container closure (CC) suitable to the product
2. Selection of the container closure integrity test method, including limit of
detection:
a. CCIT test method suitable for the type of container closure
b. CCIT limit of detection able to detect “leaks of concern” (those that may
result in impact to product quality and safety)
c. Validation of the CCIT, including selection of breached positive controls,
parameters, etc.
3. Demonstration of CCI after worst‐case process conditions:
a. Worst‐case vial crimping
b. Worst‐case sterilization cycles
4. Demonstration of CCI after secondary assembly (PFS into autoinjectors, assembly
of plunger rod, finger flange, safety device, etc.)
5. Demonstration of CCI after shipping