Optimizing for Container Closure Integrity
The onsite vial optimization procedure carried out by Genesis is a means by which capping machine parameters are obtained through a careful process of studying component structure, variation and stopper compression analysis.
Machine settings are considered optimal when optimum stopper compression has been achieved. Genesis bases its optimal compression standards on research and experience. Where feasible, a quality, aesthetic package appearance is also obtained.
It is extremely important to understand and it should be noted that the optimized machine settings are directly related to the components being processed during the optimization procedure. If any one component i.e. overseal, stopper or vial, is changed, the machine parameters are no longer applicable and new studies need to be carried out.The following procedures are carried out during the optimization procedure:
Precise package measurements:
- Vial Height
- Stopper Thickness
- Overseal Height
- Pre-sealed Package Height
- Post-sealed Package Height
Stopper compression analysis based on package measurements.
Vials processed below optimal compression (spring related).
Vials processed above optimal compresson (spring related).
Vials processed at optimal compression (spring related).
Residual Seal Force studies of vials processed at all levels of compression.
If requested by the customer, leak testing of randomly selected vials from each compression group can be provided.
Sealing Rail Setup (performed only at optimal compression and head height settings) – Vials processed:
- Sealing Rail at Maximum Rail to Neck Clearance
- Sealing Rail at Optimal Rail to Neck Clearance
- Sealing Rail at Direct Interference Neck (Zero Clearance)
- Sealing Rail Shim at Minimum (Zero Shim)
- Sealing Rail Shim at Optimal
- Sealing Rail Shim Above Optimal
Head Height Setup (performed only at optimal compression and rail settings) – Vials processed:
- Head Height Below Optimal
- Head Height at Optimal
- Head Height Above Optimal
Balancing Container Closure Integrity and Aesthetics for Robust Aseptic or Sterile Vial Packaging System | PDA Journal
Container Closure Integrity (CCI) is one of the requirements for an aseptic or sterile packaging system. For vial-based systems, the capping process is a critical step in creating and ensuring an adequate seal with acceptable CCI. Closure Integrity Tests (CCIT) such as Dye Ingress test and Helium Leak rate test are two methods among many that, in the appropriate scenario, can provide the right methods to challenge this required attribute.
Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri