The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete

References

1. 1.↵
   1. Ball D. J.,
   2. Norwood D. L.,
   3. Stults C. L. M.,
   4. Nagao L. M.

   1. Paskiet D.,
   2. Lippert E. L.,
   3. Mitchell B. D.,
   4. Zurbriggen D.

   Inorganic Leachables. In Leachables and Extractables Handbook, Ball D. J., Norwood D. L., Stults C. L. M., Nagao L. M., Eds.; Wiley: Hoboken, NJ, 2012; pp 549–571.
2. 2.↵
   1. Jenke D.

   Compatibility of Pharmaceutical Solutions and Contact Materials; Safety Considerations Associated with Extractables and Leachables; Wiley: New York, 2009. See, for example, pp 140–142.
3. 3.↵
   Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, May 1999.
4. 4.↵
   Guideline on Plastic Immediate Packaging Materials. European Medicines Agency. CPMP/QWWP/4359/03. EMEA/CVMP/205/04. 5/19/05.
5. 5.↵
   ANSI/AAMI BE3:2006. Biological evaluation of medical devices—Part 18: Chemical characterization of materials. AAMI: Arlington, VA, March 21, 2006.
6. 6.↵
   Product Quality Research Institute (PQRI) Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products; Product Quality Research Institute: Arlington, VA, 2006; available at http://www.pqri.org/pfds/LE-Recommendations-to-FDA-09-29-06.pdf. See, for example, pp 108–117.
7. 7.↵
   1. Martin J.,
   2. Fitzgerald R.,
   3. Pothier N.,
   4. Ding W.

   Recommendations for Testing and Evaluation of Extractables from Single-Use Process Equipment; Bio-Process Systems Alliance: Washington, DC, 2006. See, for example, pp 13–17.
8. 8.↵
   1. Tribon V.,
   2. Creasey J.

   Measuring potential leachables in single-use assemblies using total organic carbon (TOC) analysis. Am. Pharm. Rev. 2013, 16 (3), 18–26.

   OpenUrl
9. 9.↵
   Chapter <643> Total Organic Carbon. In USP 36/NF 31; United Sates Pharmacopeial Convention: Rockville, MD, 2013; p 276.
10. 10.↵
    1. Jenke D.,
    2. Poss M. P.,
    3. Sadain S.,
    4. Story J.,
    5. Smith W.,
    6. Reiber D.

    Identification of caprolactam oligomers and related compounds in aqueous extracts of Nylon-6. J. Appl. Poly. Sci. 2005, 95 (5), 1262–1274.

    OpenUrl
11. 11.↵
    1. Nashed-Samuel Y.,
    2. Torraca G.,
    3. Liu D.,
    4. Fujimori K.,
    5. Zhang Z.,
    6. Wen Z.,
    7. Lee H.

    Identification of an extraneous black particle in a glass syringe: extractables and leachables case study. PDA J. Pharm. Sci. Technol. 2010, 64 (3), 242–248.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    1. Yu X.,
    2. Zdravkovic S.,
    3. Wood D.,
    4. Li C.,
    5. Cheng Y.,
    6. Ding X.

    A new approach to threshold evaluation and quantitation of unknown extractables and leachables using HPLC/CAD. Drug Del. Technol. 2009, 9 (3), 50–55.

    OpenUrl
13. 13.↵
    1. Azuma K.,
    2. Hirata T.,
    3. Tsunoda H.,
    4. Ishitani T.,
    5. Tanaka Y.

    Identification of volatiles from low density polyethylene film irradiated with an electron beam. Agric. Biol. Chem. 1983, 47 (4), 855–860.

    OpenUrl
14. 14.↵
    1. Azuma K.,
    2. Tanaka Y.,
    3. Tsunoda H.,
    4. Hirata T.,
    5. Ishitani T.

    Effects of film variety on the amounts of carboxylic acids from electron beam irradiated polyethylene film. Agric. Biol. Chem. 1984, 48 (8), 2003–2008.

    OpenUrl
15. 15.↵
    1. Buchalla R.,
    2. Boess C.,
    3. Bogl K. W.

    Characterization of volatile radiolysis products in radiation-sterilized plastics by thermal desorption-gas chromatography-mass spectrometry; screening of six medical plastics. Rad. Phys. Chem. 1999, 56 (3), 353–367.

    OpenUrl
16. 16.↵
    1. Buchalla R.,
    2. Boess C.,
    3. Bogl K. W.

    Analysis of volatile radiolysis products in gamma-irradiated LDPE and polypropylene films by thermal desorption-gas chromatography-mass spectrometry. Appl. Rad. Isotopes 2000, 52 (2), 251–269.

    OpenUrl
17. 17.↵
    1. Chytiri S.,
    2. Goulas A. E.,
    3. Badeka A.,
    4. Riganakos K. A.,
    5. Kontominas M. G.

    Volatile and non-volatile radiolysis products in irradiated multilayer coextruded food-packaging films containing a buried layer of recycled low-density polyethylene. Food Addit. Contam. 2005, 22 (12), 1264–1273.

    OpenUrlPubMed
18. 18.↵
    1. Kao Y. H.,
    2. Bender J.,
    3. Hagewiesche A.,
    4. Wong P.,
    5. Huang Y.,
    6. Vanderlaan M.

    Characterization of filter extractables by proton NMR spectroscopy: studies on intact filters with process buffers. PDA J. Pharm. Sci. Technol. 2001, 55 (5), 268–277.

    OpenUrlAbstract/FREE Full Text
19. 19.↵
    1. Huang M.,
    2. Horwitz T. S.,
    3. Zweiben C.,
    4. Singh S. K.

    Impact of extractables/leachables from filters on stability of protein formulations. J. Pharm. Sci. 2011, 100 (11), 4617–4630.

    OpenUrlPubMed