To help assure proper package selection and avoid potential incompatibilities between product and closure, West offers a Screening Analysis, PakScreen™.
PakScreen™ is an 8-week investigational study that West designed to aid customers in selecting packaging components for new applications.
To gain knowledge of the customer’s product, Technical Support requires the customer to fill out a Product Requirement Questionnaire (PRQ). From this information, a list of potentially suitable elastomeric formulations is chosen for the study.
The gross compatibility study is designed to accelerate any incompatibilities that may exist between the drug product and the packaging. To accomplish this, the following steps are followed:
- Customer supplies bulk product or placebo for testing.
- Customer processing of components is simulated.
- The sample vials are inverted to maximize closure to solution contact.
- Accelerated conditions are used (e.g. 50 °C).
Analysis includes the following screening techniques:
- Inductively Coupled Plasma Screening
- pH Shift
- Turbidity
- Ultraviolet Spectrum
- Visual Inspection in High Intensity Light
- Ion Chromatography Screening
- High Performance Liquid Chromatography / Mass Spectroscopy Screening*
- Gas Chromatography/Mass Spectroscopy Screening*
*These screenings involve the use of a general method, which may qualitatively uncover extractables that are present. We recommend a more through leachable analysis be performed on the chosen closure candidate during later evaluations.