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Recent technological advancements of analytical instrumentation platforms coupled with demand for higher sensitivity in many life science applications have led to a critical need for significant improvement in the cleanliness of plastic consumables. Other motivating factors including a preference towards single use disposable products for many laboratory techniques, 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 different markets including cell culture, microfluidics, PCR-based protocols among others.(1-4) These negative effects are further magnified when using high surface area plastic consumables such as depth filters. Leachables and extractables (L&E) can affect assays and patient safety by 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. Efforts to develop exhaustive L&E programs have been made for various industries including orally inhaled and nasal drug products as well as the packaging market.5 Numerous regulations by the FDA further emphasis the importance of having control and understanding of L&E for various products.
Various analytical, clinical and life science testing procedures were employed to test and qualify porous polymeric materials including, but not limited to, PYMS, PIXE, and 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.
Extensive third party testing of Certified Pure Porex Materials from Porex Corporation has shown no cytotoxicity or hemocompatibility concerns as measured using ISO 10993-5 MRM and modified ASTM F 756-08 GLP compliant methodologies. LC/MS analysis of Certified Pure Porex samples showed a very low level of a single quaternary amine which was identified as an antistatic agent. This agent was subsequently removed from use in production.
Competitor A sample results showed significant levels of various molecular weight amines and quaternary amines. A large peak that was identified as hydrogen methyl sulfate was also observed in negative ESI ionization mode. Competitor B sample results revealed the presence of several acids including benzoic, nitric, C15H22O, Palmitic, and Stearic acid.
PYMS analysis measured no detectable organic chemical components in the Certified Pure Porex samples. Competitor A results detected Stearic and Palmitic acids. A distinct peak was seen for hydrocarbon oil, resembling polyethylene in its fragmentation. This is commonly seen as a plasticizer. Competitor B results detected a presence of Dibutylphenol and Stearic acid. PIXE analysis revealed much lower levels of elemental contamination across the spectrum in Certified Pure Porex components than competitive samples.
These combined results highlight the importance of selecting and utilizing clean resins in manufacturing of porous plastics commonly used in laboratory and diagnostics consumables. Tight control over manufacturing conditions to ensure no additional additives are introduced during processing is essential. A thorough understanding of the chemistry involved in an assay is vital for manufacturers developing an appropriate L&E program for specific product lines.
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Systematic Analysis of Leachables and Extractables in Clinical Polymeric Consumables
References
1. G. Reid McDonald, Alan L. Hudson, Susan M. J. Dunn, Haitao You, Glen B. Baker, Randy M. Whittal, Jonathan W. Martin, Amitabh Jha, Dale E. Edmondson, Andrew Holt “Bioactive Contaminants Leach from Disposable Laboratory Plasticware.” Science, 2008. 322, 917.
2. John Watson, Emily B. Greenough, John E. Leet, Michael J. Ford, Dieter M Drexler, James V. Belcastro, John J. Herbst, Moneesh Chatterjee, Marlyn Banks “Extraction, Identification, and Functional Characterization of a Bioactive Substance From Automated Compound-Handling Plastic Tips.” J Biomol Screen 2009, 14(5): 566-572
3. L. Kevin Lewis, Michael H. Robson, Yelena Vecherkina, Chang Li, Gary W. Beall “Interference with Spectrophotometric analysis of nucleic acids and proteins by leaching of chemicals from plastic tubes.” BioTechniques 48:297-302.
4. Andrew Holt, Janna L. Kozuska, G. Reid McDonald “Bioactive Leachates from Lab Plastics” G.I.T. Laboratory Journal, 2010.
