Determination of antimicrobial protection (Maintenance Test)

WHAT TESTS DO WE OFFER?

The determination of antimicrobial protection (Challenge Test) is performed to verify the effectiveness of the preservative or preservative system used to preserve the product.

Tests are performed:

1. accredited method according to PN-EN ISO 11930
2. accredited method according to Ph. Euro.

WHO DO WE ADDRESS OUR OFFER TO?

1. Cosmetic manufacturers
2. pharmaceutical manufacturers
3. assistance in the selection of preservatives at the implementation and research stage
4. advisory services relating to the use of preservatives

LEGAL REQUIREMENTS

Cosmetic products

In the European Union, and thus in Poland, the law on cosmetic products is regulated by Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009. According to which the manufacturer is obliged to have the results of load tests of products, i.e. carry out the so-called. Maintenance Test

Pharmaceutical products, medical devices

Carrying out preservation tests for pharmaceutical products is governed by Ph. Euro.

OUR CERTIFICATES AND AUTHORIZATIONS

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

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

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 PERFORM MAINTENANCE TESTS?

The Preservation Test, i.e. the assessment of the effectiveness of preservatives, in other words the determination of antimicrobial protection, also known as the Challenge Test, is performed in order to:

1. checking the effectiveness of the preservative or preservative system used to preserve the product.
2. choosing the lowest effective concentration of the preservative, thanks to which the product is safer.

The task of preservatives is to protect the product against the development of microorganisms, including pathogenic microorganisms. The use of preservatives serves to protect the consumer and the product against the development of microbiological contamination during use.

The preservation test is performed at different stages of production and storage of the product:

1. at the stage of laboratory product development in order to confirm the effectiveness of the selected preservative system
2. in production series to confirm that the technological process does not adversely affect the stability of the preservation system and the effectiveness of their operation
3. to protect the product from uncontrolled contamination during production and consumer use
4. to confirm the stability of preservatives during the shelf life of products
5. for safety assessment in the presence of environmental strains causing microbiological problems

Maintenance tests are considered to be properly carried out if the conditions guaranteeing the repeatability and reproducibility of the tests are met. This is especially important when studies on the effectiveness of preservatives are carried out within the same product. Test reproducibility is particularly important if the product fails to meet the performance criteria in the original test and further testing is required to establish the effectiveness of the preservative system. The factors determining the repeatability and reproducibility of tests include, among others: correct use of test strains, culture media, validation of test methods, correct neutralization of preservatives, as well as qualification of personnel in the required scope.

Only the fulfillment of these conditions guarantees that the Maintenance Test has been carried out correctly.