The processes and procedures used to develop and test our products and the standard references we apply.
Not all products have each process or method that applies. Refer to product specifications to determine if one of these protocols are used for your product.
Endotoxin Testing uses the Limulus Amebocyte Lystate (LAL) coagulation assay to confirm the absence of neurotoxic, pyrogenic membrane lipids produced by bacterial species.
This test, using an FDA suggested standard of 0.05 Endotoxin Units (EU) as a maximum value, confirms that products are free of bacterial contamination.
The sterilization procedure for Labcon products is validated through quarterly bioburden and sterility testing and conforms to the ISO 11137 standard. These tests confirm that the radiation dose is sufficient for a Sterility Assurance Level (SAL) of between 10⁻⁵ and 10⁻⁶
Nuclease testing confirms the absence of RNAse and DNAse enzymes through the lack of degradation of ribosomal RNA and DNA in an aqueous solution that has been incubated in Labcon products. DNA and RNA are examined by agarose gel electrophoresis to confirm molecular integrity.
DNA testing uses the Polymerase Chain Reaction (PCR) to confirm the absence of human DNA using DNA primers that will amplify Alu human DNA elements. PCR results are examined by gel electrophoresis to confirm the lack of amplified human DNA product.
Heavy metal content in products is testing using a colorimetric assay that examines extractables from plastic resin. All resins used for Labcon products are qualified by this test to fall below one part per million for all heavy metals.
Adenosine triphosphate (ATP) is the universal molecule of energy storage that is used and produced by all living things. ATP testing of manufacturing processes and products can identify potential bacterial, fungal and human sources of contamination, and ensures that all certified products are free of biological contamination. An extensive survey of products is used to confirm that that certified ATP-free products are free of contamination.
Protease testing confirms the absence of protein-degrading enzymes through the lack of degradation of a series of protein standards in an aqueous solution that has been incubated in Labcon products. Protein standards are examined by polyacrylamide gel electrophoresis to confirm molecular integrity.
Ultra low metal products offered by Labcon are qualified to have less than one part per billion of the applicable elements using Inductively Coupled Plasma (ICP) testing.
Some very sensitive procedures, such as enzyme tests and PCR or DNA/RNA purification can be fouled unless they use disposable plastics that are free from the additives di-(2-hydroxyethyl) methyldodecylammonium (DiHEMDA) and 9-octadecenamide (oleamide). Labcon uses only resins that are free of these contaminants.
Labcon is compliant with Directive 2002/95/EC. No Labcon product contains any of the six banned substances: lead, mercury, cadmium, hexavalent chromium, poly-brominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE), in quantities exceeding maximum concentration values.
Labcon product contains resins made with tallow-based additives derived from bovine material. These materials originate in BSE/TSE free countries including the United States, Canada and Mexico. These additives are processed to eliminate any presence of hazards. All of these conditions exceed the European Union standards as listed in the 22nd Commission Directive 98/16/EC of March 5th, 1998; as annexed to council Directive 76/768/EEC.
REACH is a European Union regulation that addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Labcon products are not produced with, and do not contain any Substances of Very High Concern (SVHC).