Enviromental monitoring of production

LEGAL REQUIREMENTS

Monitoring the production environment is one of the most important elements of Good Manufacturing Practice (GMP). The obligation to monitor the production environment in production plants is regulated by Regulations relevant to the given production area.

  • for medicinal products: Regulation of the Minister of Health of October 1, 2008 on the requirements of Good Manufacturing Practice
  • for cosmetic products: ISO 22716 standards (GMP set up in the Regulation of the European Parliament and of the Council (WE) No. 1223/2009 / EC of 30.11.2009)
  • for food: Regulation (EC) No 2023/2006 of 22 December 2006.

WHY SHOULD THE MICROBIOLOGICAL PURITY OF THE ENVIRONMENT BE TESTED?

The purpose of monitoring is to obtain information on the hygienic condition of production conditions, i.e .:

  • the microbiological quality of the air
  • effectiveness of filters (eg HEPA)
  • effectiveness of cleaning and disinfection of surfaces and devices
  • hygiene of employees

Interpretation of the test results obtained during environmental monitoring allows action to be taken in the event of non-compliance, and thus prevent any contamination that could affect the quality of the manufactured product or human health.

The microbiological purity of the manufacturing environment is one of the most important elements affecting the quality of the finished product. Permanent and proper monitoring of the manufacturing environment allows to capture the source of infection and take early action to eliminate infection in production.

FOR WHOM IS OUR OFFER?

The laboratory monitors the manufacturing environment for:

  • Pharmaceutical manufacturers
  • Cosmetics manufacturers
  • Food producers
  • Packaging manufacturers

WHAT TESTS WE OFFER?

  1. examination of microbiological purity of air by collision (volumetric) method
  2. microbiological purity testing of air by sedimentation method
  3. testing the microbiological purity of the surface by swabbing
  4. testing of microbiological cleanliness of the surface (tops, walls, clothing) by contact method
  5. testing of microbiological purity of employees’ hands by contact method

Criteria for product evaluation and test methods:

We carry out tests by:

  • accredited methodological procedures developed in the Mikrolab laboratory
  • customer methodology