Prime factors
Porex takes a look at factors affecting molecular test results in polymeric consumables
Technological advancements of analytical instrumentation platforms coupled with demand for higher sensitivity in lab-on-a-chip based applications for the molecular diagnostics marketplace have led to a critical requirement for significant improvement in the degree of cleanliness of plastic consumables. Other motivating factors, including a preference towards single use disposable products for many lab-on-a-chip platforms, are also accelerating research into analysis of plastic resins used to manufacture these devices.
Compelling negative effects on assays due to plastic consumables have been identified by researchers in a number of diverse applications including cell culture, immunoassays, and PCR-based protocols among others (1-4). These negative effects are further magnified when using high surface area plastic consumables such as depth filters, as well as by a general trend towards using smaller volumes of sample and reagents. Leachables and extractables (L&E) can affect assays and patient safety by potentially causing toxicity, carcinogenicity, immunogenicity, oxidation, aggregation and decreased stability over the shelf life of the product.
Identifying and quantifying leachables and extractables that are found in commonly used laboratory plastics and the effects of the contaminants on various assays is an increasingly important part of workflow development. In light of recent technological advancements and market requirements, Porex has initiated a Certified Pure Porex Program to qualify porous polymeric materials via a stringent program of various analytical, clinical and life science testing procedures. Porex advanced porous polymers were tested by means of Pyrolysis Gas Chromatography Mass Spectroscopy (PYMS), Proton Induced X-ray Emission (PIXE) and Liquid Chromatography Mass Spectroscopy (LCMS) for heavy metal contamination, polymeric components and other organic compounds. Additional testing for hemolysis and cytotoxicity was performed using ISO 10993-5 MRM and modified ASTM F 756-08 GLP compliant methodologies.
Porex certified pure materials were found to have virtually no material additives, contaminants or heavy metals that cause interferences in clinical and laboratory testing. These materials were verified to be non-cytotoxic and non-hemolytic via independent testing labs. Porex Certified Pure materials have 99.9% Bacterial Aerosol Filtration Efficiency (BFE) as tested by ASTM F21012 methodology. To our knowledge, this is the first extensive qualification program for porous polymeric materials that fills a critical gap in the progression of developing standardized methodologies in the analysis of leachables and extractables in plastic consumables.
1. http://www.pqri.org/
2. Equipment. Code of Federal Regulations, Title 21, Volume 4, Subchapter C, Part 211, Subpart D. US Food and Drug Administration: Rockville, MD, 1 April 2010.
3. Biological Products: General. Code of Federal Regulations, Title 21, Volume 7, Subchapter F, Part 600. US Food and Drug Administration: Rockville, MD, 1 April 2010.
4. Drug Product Containers and Closures. Code of Federal Regulations, Title 21, Volume 4, Subchapter C, Part 211, Subpart E, Section 211.94. US Food and Drug Administration: Rockville, MD, 1 April 2010.
5. CDER/CBER. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. US Food and Drug Administration: Rockville, MD, 1999; www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070551.pdf
6. Definitions. Code of Federal Regulations, Title 21, Volume 7, Subchapter F, Part 600, Subpart A, Section 600.3. US Food and Drug Administration: Rockville, MD, 1 April 2010.