Validation and Qualifications of machines, tools and sealed products

Our teams are accredited to qualify all the sealing machines in our range, as well as the tools and products of the sealing process. 
What is the benefit of qualification?  It is twofold : 

  • firstly, you totally safeguard your product, 
  • secondly, you comply with ISO 11 607 standard.

All our proposals include a detailed written price offer, including:

  • Installation Qualification for the machine and tools: to ensure that the set up of the system and equipment complies with purchasing specifications and the manufacturer's documentation and to demonstrate that the equipment complies with the technical characteristics. Checks that all tooling components are present in the right dimensions. 
  • Operational Qualification for the machine: demonstrates that the machine is capable of producing compliant products within established tolerance ranges. 
  • DOE: evaluates the quality of sealing of the blister pack with the lid by one of our machines. Definition of a range of parameters used for Operational and Performance Qualifications for the product.
  • Operational Qualification for the product: demonstrates the integrity of the seal before sterilization, at the lower and upper bounds of the critical parameters.
  • Performance Qualification for the product: Validates the repeatability and reproducibility of the sealing process. To that end, tests are carried out on various sealed batches successively by different operators at the customer's, sealed blister packs with their contents to demonstrate the integrity of sealing at nominal parameters after sterilization.  Capability study. 

This service comprises the drafting of qualification protocols, tests on samples for each fitted tool, drafting reports including an analysis of measurements.