Standard:

• European Pharmacopoeia
• United States Pharmacopoeia
• Polish Pharmacopoeia

Method:

• Gel clot technique – method A – limit test
• Gel clot technique – method B – quantitative test
• Kinetic-chromogenic technique – method D – quantitative test

Requirements:

• Test method validation shell be performed for each medical device or product family
• For validation purpose 3 batches of 1-10 sterile medical devices (based on future batch quantity)
• For routine analysis 1-10 sterile medical devices (based on validation results)

If necessary we can perform the Identification of Microorganisms.