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Artificial dust containing spores of bacteria

  Microbial integrity testing of functional packages for medicinal products often requires the application of a dry microbial challenge. Therefore we have developed a carbon based mixture with definded concentrations of colony forming units of Bacillus subtilis.

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Cryo-preserved human blood for non-invitro Diagnostics

  Limited availability of human whole blood for research and routine applications initiated the development of cryo techniques for blood preservation. Cryoblood as well as the Testkit is available from Merck Chemicals GmbH (www.merckmillipore.com). Human whole blood is stored at -80°C and shipped on dry ice for various applications. Because of extensive safety testing this cryoblood may be declared as primary cell culture.

Biohazard Information

The Primary Cell Culture is for research only and not for in-vitro diagnostic nor therapeutic purposes. Personal protective equipment is required when working with this biological material. The code of practice for biosafety level 1 (Laboratory Biosafety Manual, 3rd edition, WHO) must be followed. All blood components are tested negativ for HIV, HAV, HBV, HCV antigens. Differential hemograms by a certified medical doctor qualify all donors of the components as healthy. Each lot is tested for sterility and qualified for pyrogen detection. As there is no raw material of animal origin. BSE/TSE does not concern.

Pyrogen Testing

Pyrogen Testing with cryo-preserved blood cells and multi well plates were successfully validated for pyrogen testing according to the European Commission (ECVAM).

Ref.: JIM 316 (2006) 42-51: Internat. Validation of pyrogen tests based on cryopreserved human primary blood cells (with our Lab involved).

The Primary Cell Culture offered by Merck Chemicals GmbH complies with the validation of this inter-laboratory study and with international regulatory requirements. It is a blood product and is considered as cell culture (2000/54/EC) for diagnostic purposes; it is not an in-vitro diagnostic medical device nor a blood donation to be used in humans.
We perform the Test for Pyrogens routinely with Fluid Samples as well as Medical Devices

Good Manufacture Practice and Certificates

The Primary Cell Culture is produced by mixing 5 blood donations free of specified infective agents (see above) with cryopreservative and is filled under clean room conditions.

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Example for application (.pdf) of artificial dust

Cryo-preserved human blood was validated (.pdf) successfully