Test Procedure
The Pyrogen-Test is done in two parts: the Pre- or Shamtest and the main test. According to the European pharmacopoeia, the pre test is 1 to 3 days befor the main test. A pyrogen-free isotonic sodiumchlorid (10 ml/kg KG) is injected and the temperature is measured. Is there no differences less then 0,6°C, the rabbits are used for the main test. For the main test, 3 animals will be injected after 90 minutes with the sample. Then, the temperature is measured 3 hours. The sample is pyrogenfree, if the sum of three animals temperature differences are less then 1,15°C.
But this is only a part of the checks, Pharmalab does: also the grouping or the eliminaton of animals is done automatically.
Of course, if a sample has to be extended, Pharmalab does this for you.
The animals can be used once or many times. The system takes also care, if you use albumin samples.
The animal management can have up to 99 rooms containing 999 cages. An animal history report gives you a detailed list about all activities of each rabbit.
A digital electronical balance is directly connected to the Pharmalab System. It is automatically calibrated and sends the weighs to the server.
All documents are made as PDF's and can be printed automatically or manually. The documents include besides the electronical signature also a md5-checksum.
Pharmalab verifies according to the following pharmacopoeias: USP, CFR, JAP, EUR.
