Validation of cleaning and disinfection

WHAT TESTS DO WE OFFER?

Mikrolab offers microbiological tests of equipment surfaces and production rooms as part of the validation of cleaning and disinfection:

1. contact method
2. swab method
3. washings method

Evaluation criteria and research methods

1. methodological procedures developed in the Mikrolab laboratory
2. client's methodology

After the microbiological tests of the samples are carried out, the results are compared with the established acceptance criteria - the limits of microbiological contamination of the tested surfaces.

WHO DO WE ADDRESS OUR OFFER TO?

to all branches of industry

LEGAL REQUIREMENTS

In accordance with the Good Manufacturing Practice (GMP) guidelines, it is necessary to provide proof that the procedures used for cleaning equipment and production rooms are effective and do not pose a risk to product quality. Such proof is the validation of cleaning and disinfection, i.e. activities aimed at confirming in a documented manner and in accordance with the principles of Good Manufacturing Practice that the procedures, preparations, devices and activities used give the planned results, and thus ensure the required quality of production.

Properly developed cleaning, washing and disinfection procedures as well as properly performed activities should effectively reduce the risk of microbiological infections in the manufacturing process.

OUR CERTIFICATES AND AUTHORIZATIONS

Mikrolab has the permission of the Chief Pharmaceutical Inspector for the production (testing) of medicinal products and investigational medicinal products (for clinical trials) in the field of microbiological quality control of non-sterile products.

Mikrolab has a GMP certificate approved by the Chief Pharmaceutical Inspector.

Mikrolab has a research laboratory accreditation certificate issued by the Polish accreditation center, accreditation number AB 1531.

Mikrolab has been approved by the State Sanitary Inspection for water testing. The test results are honored by the Sanitary and Epidemiological Stations.

WHY SHOULD I VALIDATE CLEANING AND DISINFECTION?

1. A validated and properly documented cleaning procedure ensures that the used cleaning and disinfection conditions as well as disinfectants are effective, and thus the premises and production equipment meet the requirements of appropriate microbiological purity.
   This gives the manufacturer a sense of security that the devices used in production will not cause contamination of the manufactured product, which may affect the safety and health of consumers.
2. The correct washing and disinfection process also protects the manufacturer against financial losses, as it prevents quality incidents resulting from infections, which entail large economic losses.
3. The cleanliness of equipment and production premises should also be monitored on a regular basis, regardless of the performance and achievement of good cleaning validation results.