GLP Research Unit – Skin sensitization – Guinea Pig Maximization Test (GPMT) according to PN/EN ISO 10993-10:2015-02

The guinea pig maximization test (GPMT), is an in vivo test to evaluate skin sensitization. It is one of the methods for biological evaluation of medical devices in the PN/EN ISO 10993 group of standards in addition to the Buehler in vivo test. It is used to evaluate the skin sensitization potential of various chemicals, medical devices or medicinal products.

Skin sensitization is an allergic reaction that occurs when the immune system reacts to a substance after previous exposure, causing symptoms such as redness, itching and inflammation after subsequent contact. In vivo studies using a small animal model, such as biocompatibility assessments, are conducted in our unit at the Facility for Small Animal under the GLP standard. With a standard like GLP, we can ensure that experiments are performed at the highest quality level.

The guinea pig maximization test (GPMT) consists of the following phases:

• Induction Phase: During this phase, guinea pigs are initially exposed to the test substance through topical application (usually on the skin). This is followed by a series of repeated applications of the substance over a specific period.
• Challenge Phase: After the induction phase, a challenge dose of the substance is applied to the guinea pigs’ skin, which has not been previously exposed to the substance. The goal is to determine if the animals develop a delayed hypersensitivity reaction or allergic contact dermatitis in response to this challenge.

The GPMT helps identify substances that have the potential to cause allergic reactions in humans. If the guinea pigs exhibit a sensitization response during the challenge phase, it suggests that the substance may pose a risk for sensitization in humans.

The guinea pig maximization test (GPMT) is a useful method in the biological evaluation of medical devices because of its compliance with GLP regulations. It provides assurance that the evaluation of the biocompatibility of a substance or medical device is carried out according to the highest quality standards and ensures the safety of products used in contact with the human body.

We are certified by Good Laboratory Practice in the biocompatibility section (scope 9) for the biological evaluation of medical devices for in vivo testing on both small and large animal models, among others.

Feel free to contact us to match the appropriate testing method to your medical device.