The Inspection Technology Pharma (ITP) division of Bosch is poised to meet the growing demands for Leak Detection and Container Closure Integrity (CCI) testing in pharmaceutical and biological medicines.
Fused containers, such as glass ampoules, are required to be 100% integrity tested as per EU GMP Annex 1. But other containers, such as vials, cartridges and syringes, filled with liquid or lyophilized products, are required to have a robust container closure process and testing evidence to assure product sterility and stability.
Various technologies available through Bosch provide the highest level integrity assurance and provide flexibility for manufacturers producing a wide range of products. Factors to be considered when making technology choices include product conductivity, alcohol content, headspace volume, headspace gas composition and internal container pressure.
Sub-visible cracks or pinholes as well as improperly sealed or stoppered containers can be identified and removed from batches with 100% integrity testing using a stand-alone or inline machine.
Key features among such machine technologies include:
- speeds up to 600 containers per minute
- safe container handling to prevent cosmetic or integrity defects
- fast size changeover for improved OEE
- user friendly operator interface with validated recipe database
- non-destructive methods, which impart little or no energy to the product
- repeatable results
- reliable machine performance
- ease of calibration
- local technical support
For a complimentary application analysis, please contact:
Tel. +49 (7951) 402-1620