Genesis Logo

Vial Optimization

Vial Icon

Optimizing for Container Closure Integrity

Genesis's onsite vial optimization procedure determines capping machine parameters through analysis of component structure, variation, and stopper compression.

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's critical to recognize that optimized machine settings are directly tied to the specific components used during the optimization process. A change in any component—overseal, stopper, or vial—renders the settings invalid and requires new studies.

The following procedures are carried out during the optimization procedure:

01

Precise package measurements:

  1. Vial Height
  2. Stopper Thickness
  3. Overseal Height
  4. Pre-sealed Package Height
  5. Post-sealed Package Height
02

Stopper compression analysis based on package measurements.

03

Vials processed below optimal compression (spring related).

04

Vials processed above optimal compression (spring related).

05

Vials processed at optimal compression (spring related).

06

Residual Seal Force studies of vials processed at all levels of compression.

07

If requested by the customer, leak testing of randomly selected vials from each compression group can be provided.

08

Sealing Rail Setup (performed only at optimal compression and head height settings) – Vials processed:

  1. Sealing Rail at Maximum Rail to Neck Clearance
  2. Sealing Rail at Optimal Rail to Neck Clearance
  3. Sealing Rail at Direct Interference Neck (Zero Clearance)
  4. Sealing Rail Shim at Minimum (Zero Shim)
  5. Sealing Rail Shim at Optimal
  6. Sealing Rail Shim Above Optimal
09

Head Height Setup (performed only at optimal compression and rail settings) – Vials processed:

  1. Head Height Below Optimal
  2. Head Height at Optimal
  3. Head Height Above Optimal
Further Reading

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