MicroBios laboratory, a benchmark in challenge testing under GLP certification

Laboratorio MicroBios is positioned as a reference in spain for the performance of Challenge tests under the Good Laboratory Practice (GLP) certification.

The Antimicrobial Preservative Efficacy Test (also known as Challenge Test, Preservative Efficacy Test or PET) helps to evaluate the resistance of a formula to withstand microbiological contamination during its use by the consumer and to adjust as much as possible the concentration of preservatives, it can even be useful to decide not to additionally preserve a formula. It can also serve, just as a guide, to know if a raw material needs additional preservation or if the added preservatives are adequate.

Micro-Bios Laboratory is highly specialized in Antimicrobial Preservative Efficacy Testing and has several certifications that guarantee the rigor of its tests:

• ISO 11930:2019 Cosmetics - Microbiology - Evaluation of the Antimicrobial Protection of a Cosmetic Product.
• EUROPEAN PHARMACOPOEIA 5.1.3. EFFICACY OF ANTIMICROBIAL PRESERVATION
• USP '51' Antimicrobial Effectiveness Test

In addition, Laboratorio MicroBios has a certification that very few laboratories have in Spain. This is the Certification of Good Laboratory Practices for the performance of Preservative Efficacy Studies granted by the Spanish Agency of Medicines and Health Products (AEMPS). This certificate was obtained for the first time in 2004 and is still held by Laboratorio MicroBios today.

One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies. The manner in which study data, which support human, animal and environmental safety assessment, are generated, managed, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies. However, the primary purpose of the GLP Principles requirements remains the same: to have confidence in the quality, integrity of the data and to be able to reconstruct the activities performed during the conduct of non-clinical safety studies. 

Micro-Bios Laboratory's team of professionals offers a broad scope of assays to test the antimicrobial resistance of specific cosmetic products for different applications and body sites:

• Challenge Test for parenteral preparations, ocular preparations, intrauterine preparations and intramammary preparations.
• Challenge Test for ear preparations, nasal preparations, preparations for skin application and preparations for inhalation.
• Challenge Test for oral preparations, oromucosal preparations and rectal preparations.

Its framework can be extended, for example, by incorporating additional strains (e.g. B. cepacia or endogenous strains) or by performing recontaminations during the study, based on the specific qualities of the product and the stage of its development.

MicroBios Laboratory has more than 30 years of experience supporting pharmaceutical and cosmetic companies. Do not hesitate to contact the Micro-Bios Laboratory team, they will offer you technical advice and will guide you in the process of introducing the cosmetic product in the market.