Qualis

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.

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. The Qualis Laboratorium GmbH offers pooled human whole blood 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
Our 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 and ParvoV 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.

Pyrogen Testing
Cryo-preserved blood cells and multi well plates used with the In-vitro Pyrogen Test kit IPT were successfully validated in summer 2004 for pyrogen testing according to the European Commission (ECVAM). The Primary Cell Culture offered by the Qualis Laboratory 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.

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 grade A in B. Production is performed in a closed system in compliance with the EC Directive 2000/54/EC. Each lot is tested and certified. Shelf life at -80°C is validated. Reports of the blood donation tests are included in the documentation.

Shipment and Customs
According to the IATA (DGR 3.6.2.1.3) our Primary Cell Culture is a Biological Product (customs subheading 3002.90.51-50) that does not require PI 650 compliance of the packaging and is not consigned as UN classified substance. It is shiped on dry ice (UN 1845) and stored at -80°C. For safety reasons triple packaging is used.





		Example for application of artificial dust





		Cryo-preserved human blood was validated successfully In-vitro Pyrogentest by Endosafe Certificates of Analysis lot 0408.3100 lot 0410.2900 lot 0502.0200 lot 0502.2400 lot 0509.2000.1 current lot 0509.2000.2 View pricing of different units of CryoBlood and RPMI. Reserve your vials now !