GPMT (Kligman Guinea Pig Maximization Test)

Ethylene oxide gas (EO) is a flammable and colorless gas commonly used in medical device sterilization. Its permitted maximum residual levels are set by a range of international and local organizations, including the International Organization for Standardization (i.e., ISO 10993-7:2008) and Japanese Industrial Standards (i.e., JIS T 0993-7:2012).

1. Biological Effect: Sensitization
2. Turnaround time: 12 weeks
3. Sample Requirements:

ISO

240 cm² (test item < 0.5 mm thick);
15 cm² (test item ≥ 0.5 mm thick);
8 grams;
at least 6 test items;

4. Animal Quantity: 35 guinea pigs

ISO 10993-10

The purpose of the study is to determine the sensitizing capacity or allergenic potential of the medical device in guinea pigs. The animal is exposed to the test item (or extract). Extracts of the test article are prepared in a polar vehicle (saline) and/or non-polar (cotton seed oil) vehicle. 7 days later the injection sites are covered with the test item (or extract) for a period of 48 hours. 14 days later a new site is challenged with a topical application of the test item (or extract) and scored out to 72 hours. A sensitization reaction to the medical device is scored based on the defined evaluation criteria in ISO 10993-10.