Cleaning validation

LEGAL REQUIREMENTS

Creating a product of appropriate quality, safe for the patient and the consumer is the basic task and responsibility of each manufacturer. The cleaning procedure is a very important stage in every manufacturing process. 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

In accordance with the guidelines of Good Manufacturing Practice (GMP) it is necessary to provide proof that the procedures used to clean equipment and production rooms are effective and do not pose a risk to the quality of the product. Such proof is the validation of cleaning equipment and production rooms.

WHY SHOULD THE CLEANING VALIDATE BE PERFORMED?

The validated and properly documented cleaning procedure ensures that the used cleaning and disinfection conditions as well as disinfectants are effective, and therefore the rooms and production facilities meet the requirements of adequate microbiological purity.
This gives the manufacturer a sense of security that the devices used in the production do not cause contamination of the manufactured product, which may affect the safety and health of consumers.

Proper cleaning and disinfection process also protects the manufacturer against financial losses, as it does not allow for quality incidents resulting from infections, which entail large economic losses.

The cleanliness of equipment and production facilities should also be regularly monitored, regardless of the performance and good cleaning validation results.

OUR CERTIFICATES AND PERMITS

The Mikrolab company is authorized by the Main Pharmaceutical Inspector to manufacture (study) 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 Main Pharmaceutical Inspector.

WHAT TESTS ARE WE OFFER?

The Mikrolab company offers microbiological testing of equipment surfaces and production rooms as part of the cleaning validation:

  • contact method
  • swab method
  • washing method

Evaluation criteria and test methods:

  • methodological procedures developed in the Mikrolab laboratory
  • Customer methodology