Biological Quality Testing
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.
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
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.
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.
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.
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).
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