Basic Information
The proper quality grade

The proper quality grade for every application

The right quality grade should be used in each application. Consequently, BRAND offers a range of quality grades so that the optimal one is always available.

  BIO-CERT® products correspond to the highest quality grade. They are sterile, free from human DNA, RNases, endotoxins and ATP.

Sterility means being free of living organisms. BRAND products are sterilized with beta radiation according to ISO 11 137 and the AAMI Guidelines. The radiation dose is at least 12.1 kGy. The inertGrade™ microplates are an exception; these are sterilized with ethylene oxide due to their special surface characteristics. An SAL (sterility assurance level) of 10-6 is guaranteed, meaning no more than one part in 1 x 106 is contaminated! This level of sterility complies with the requirements of USP 29 and the Ph.Eur.

Endotoxins refer to the components present in the outer membranes of Gram-negative bacteria. These components are lipopolysaccharides that are released when cells are destroyed. Endotoxins make up the largest group of pyrogens, and these two are often falsely believed to be synonymous. Depending on the concentration, these heat-stable substances lead to fever, circulatory collapse, shock, etc., and can be fatal in very high doses. The concentration of endotoxins in BIO-CERT® products is determined by the kinetic-turbidimetric limulus amebocyte lysate (LAL) test. The detection limit is 0.01 EU/ml. This corresponds to an endotoxin concentration of < 1 x 10-12 g/tip (1 pg/tip). Freedom from endotoxins is required in pharmaceutical manufacture and cell culture.

DNA and RNases
DNA (deoxyribonucleic acid) is the carrier of genetic information. RNases (ribonucleases) are enzymes that can degrade ribonucleic acid (RNA) through hydrolysis. Ribonucleic acids serve as transmitters of genetic information. RNases are ubiquitous and extremely stable. To protect the RNA molecules from undergoing enzymatic degradation, one must be absolutely certain that plastic items are free from RNases. BIO-CERT® products are free from DNA (< 4 x 10-14 g/tip = 40 fg), to avoid false positive results, e.g., in PCR*, and free from RNases (< 8.6 x 10-15 g/tip = 8.6 fg), to make it possible to work with RNA.

* The Polymerase Chain Reaction (PCR) is covered by international patents. Use of the PCR process may require a license.

Adenosine triphosphate is the energy source for every living cell. ATP is an energy-rich, transportable molecule. It is an indicator for living cells, and can serve as a marker for detecting viable bacteria, yeasts, and human cells, etc. BIO-CERT® products are free of ATP (ATP concentration < 1 x 10-15 g/tip = 1 fg) and thus are especially suitable for luminescence measurements, e.g., those employed in the hygiene monitoring field according to the HACCP concept.

Various substances are capable of damaging cells. Extracts from BRANDplates® for cell culture are checked for their effects on cell cultures using an in vitro cytotoxicity test. BRANDplates® are free from cytotoxic substances according to DIN EN ISO 10 993.