Trust is good, monitoring is better

In order to make certain that manufacture and processing really do take place according to the required parameters we have constructed a monitoring system which seamlessly documents each individual parameter.

Parameters

  • particle concentration
  • pressure difference
  • temperature
  • air moisture
  • flow rate

Monitoring system

  • validation according to GAMP
  • meets the requirements of 21 CFR part 11

Luck of the draw
or being on the safe side with hygiene monitoring

The manufacture of medicinal products of flawless quality is the luck of the draw – or is it? In any case not at SAMAPLAST AG. We adhere to the manufacturing instructions (Device Master Record etc.) in painstaking detail and guarantee comprehensive and seamless hygiene measures. We have implemented a further monitoring procedure for this purpose, hygiene monitoring. Because we deliver what we promise.

Hygiene monitoring

  • adherence to the air and surface microbial count (paddle test)
  • microbiological contamination of the medicinal products (bioburden)