Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products

References

1. 1.↵
   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.
2. 2.↵
   Guideline on Plastic Immediate Packaging Materials. European Medicines Agency. CPMP/QWWP/4359/03. EMEA/CVMP/205/04. 5/19/05.
3. 3.↵
   Guidance for Industry. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products. Chemistry, Manufacturing, and Controls Documentation. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, October, 1998.
4. 4.↵
   Guidance for Industry. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing and Controls Documentation. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, July, 2002.
5. 5.↵
   Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. PQRI Leachables and Extractables Working Group, September 9, 2006, available at http://www.pqri.org/pdfs/LE-Recommendations-to-FDA-09-29-06.pdf.
6. 6.↵
   Experimental Protocol for Qualitative Controlled Extraction Studies on Material Test Articles Representative of Prefilled Syringe (PFS) and Small Volume Parenteral (SVP) Container Closure Systems. PQRI Parenteral and Ophthalmic Drug Products Leachables and Extractables Working Group, December 9, 2009. Available at http://www.pqri.org/commworking/minutes/pdfs/dptc/podpwg/Addl/PODP_Protocol_PhI.pdf.
7. 7.↵
   1. Grob K.,
   2. Grob G.,
   3. Grob K.

   Testing capillary gas chromatographic columns. J. Chromatogr. 1981, 219 (1), 13–20.

   OpenUrl
8. 8.↵
   1. Jenke D.

   Experimental Protocol for Qualitative Controlled Extraction Studies on Material Test Articles Representative of Prefilled Syringe (PFS) and Small Volume Parenteral (SVP) Container Closure Systems: Extraction Methods and Analytical Testing Procedures. PQRI Workshop on Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products (PODP), February 22–23, 2011; available at http://www.pqri.org/workshops/PODP11/pdfs/posters/Experimental_Protocol_1.pdf.
9. 9.↵
   Chapter 730 Plasma Spectrochemistry. In The United States Pharmacopeia, USP 34; The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2010; pp 299–304.
10. 10.↵
    1. Jenke D. R.

    Extractable/Leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA Journal of Pharm. Sci. and Technol. 2002, 56(6), 332–371. See also Jenke, D.R. Extractable substances from plastic materials used in solution contact applications, An updated review. PDA J. Pharm. Sci. Technol. 2006, 60(3), 191–207.

    OpenUrl
11. 11.↵
    1. Ulsaker G. A.,
    2. Korsnes R. M.

    Determination of cyclohexanone in intravenous solutions stored in PVC bags by gas chromatography. Analyst 1977, 102 (1220), 882–883.

    OpenUrlCrossRefPubMed
12. 12.↵
    1. Ulsaker G. A.,
    2. Hoem R. M.

    Determination by gas chromatography-single-ion monitoring mass spectrometry of phthalate contaminants in intravenous solutions stored in PVC bags. Analyst 1978, 103(1231), 1080–1083.

    OpenUrlPubMed
13. 13.↵
    1. Arbin A.,
    2. Ostelius J.

    Determination by electron-capture gas chromatography of mono- and di-(2-ethylhexyl) phthalate in intravenous solutions stored in poly (vinyl chloride) bags. J. Chromatogr., A 1980, 193 (3), 405–412.

    OpenUrl
14. 14.↵
    1. Ching N. P. H.,
    2. Jham G. N.,
    3. Subbarayan C.,
    4. Grossi G.,
    5. Hicks R.,
    6. Nealson T. F.

    Gas chromatographic quantitation of two plasticizers contaminating intravenous fluids stored in plastic containers. J. Chromatogr. 1981, 225 (1), 196–210.

    OpenUrlPubMed
15. 15.↵
    1. Arbin A.,
    2. Ostelius J.,
    3. Callmer K.,
    4. Sroka J.,
    5. Hanninen K.,
    6. Axelsson A.

    Migration of chemicals from soft PVC bags into intravenous solutions. Acta Pharm. Seuc. 1983, 3, 20–33.

    OpenUrl
16. 16.↵
    1. Ulsaker G.,
    2. Teien G.

    Determination of 9,10-epoxystearate ester in intravenous solutions stored in poly (vinyl chloride) bags, using gas chromatography-single ion monitoring mass spectrometry. Analyst 1984, 109 (7), 967–968.

    OpenUrlCrossRefPubMed
17. 17.↵
    1. Srivastava S. P.,
    2. Saxena A. K.,
    3. Seth P. K.

    Migration of di-(2-ethylhexyl) phthalate (DEHP) from plastic containers used for packaging of infusion solutions. Indian J. Pharm Sci. 1985, July/August, 156–158.
18. 18.↵
    1. Arbin A.,
    2. Jacobsson S.,
    3. Hanninen K.,
    4. Hagman A.,
    5. Ostelius J.

    Studies on the contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC diode array techniques. Int. J. Pharm. 1986, 28 (2), 211–218.

    OpenUrl
19. 19.↵
    1. Snell R. P.

    Capillary GC analysis of compounds leached into parenteral solutions packaged in plastic bags. J. Chromatogr. Sci. 1989, 27 (9), 524–528.

    OpenUrlAbstract/FREE Full Text
20. 20.↵
    1. Chawla A. S.,
    2. Hinberg I.

    Leaching of plasticizers from and surface characterization of PVC blood platelet bags. Biomater. Artif. Cells Immobilization Biotechnol. 1991, 19 (4), 761–783.

    OpenUrlPubMed
21. 21.↵
    1. Wright D. W.,
    2. Mahler K. O.,
    3. Davis J.

    The application of multidimensional GC techniques to the analysis of sub-ppb levels of vinyl chloride monomer in polyvinylchloride. J. Chromatogr. Sci. 1992, 30 (8), 291–295.

    OpenUrlAbstract/FREE Full Text
22. 22.↵
    1. Ulsaker G. A.,
    2. Teien G.

    Identification of caprolactam as a potential contaminant in parenteral solutions stored in overwrapped PVC bags. J. Pharm. Biomed. Anal. 1992, 10 (1), 77–80.

    OpenUrlPubMed
23. 23.↵
    1. Khaliq M. A.,
    2. Alam M. S.,
    3. Srivastava S. P.

    Implications of physico-chemical factors on the migration of phthalate esters from tubing commonly used for oral/nasal feeding. Bull. Environ. Contam. Toxicol. 1992, 48 (4), 572–578.

    OpenUrlPubMedWeb of Science
24. 24.↵
    1. Snell R. P.

    Solid-phase extraction and liquid chromatographic determination of monophthalates and phthalide extracted from solution administration sets. J. AOAC Int. 1993, 76 (3), 531–534.

    OpenUrlPubMed
25. 25.↵
    1. Snell R. P.

    Gas chromatographic determination of cyclohexanone leached from hemodialysis tubing. J. AOAC Int. 1993, 76 (5), 1127–1132.

    OpenUrlPubMed
26. 26.↵
    1. Pearson S. D.,
    2. Trissel L. A.

    Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am. J. Health-Syst. Pharm. 1993, 50 (5), 1405–1409.

    OpenUrlAbstract
27. 27.↵
    1. Mass B.,
    2. Huber C.,
    3. Kramer I.

    Plasticizer extraction of Taxol®-infusion solution from various infusion devices. Pharm. World Sci. 1996, 18 (2), 78–82.

    OpenUrlPubMed
28. 28.↵
    1. Hanawa T. E.,
    2. Muramatsu E.,
    3. Asakawa K.,
    4. Suzuki M.,
    5. Tanaka M.,
    6. Kawano K.,
    7. Seki T.,
    8. Juni K.,
    9. Kakajima S.

    Investigation of the release behavior of diethylhexyl phthalate from polyvinyl-chloride tubing for intravenous administration. Int. J. Pharm. 2000, 210 (1), 109–115.

    OpenUrlCrossRefPubMedWeb of Science
29. 29.↵
    1. Loff S.,
    2. Subotic U.,
    3. Reinicke F.,
    4. Wischmann H.,
    5. Brade J.

    Extraction of di-ethylhexyl-phthalate from perfusion lines of various material, length and brand by lipid emulsion. J. Pediatr. Gastroenterol. Nutr. 2004, 39 (4), 341–345.

    OpenUrlCrossRefPubMedWeb of Science
30. 30.↵
    1. Hill S. S.,
    2. Shaw B. R.,
    3. Wu A. H. B.

    Plasticizers, antioxidants, and other contaminants found in air delivered by PVC tubing used in respiratory therapy. Biomed. Chromatogr. 2003, 17 (4), 250–262.

    OpenUrlCrossRefPubMedWeb of Science
31. 31.↵
    1. Loff S.,
    2. Kabs F.,
    3. Subotic U.,
    4. Schaible T.,
    5. Reinecke F.,
    6. Langbein M.

    Kinetics of diethylhexyl-phthalate extraction from polyvinylchloride-infusion lines. J. Paren. Enteren. Nutr. 2002, 65 (5), 305–309.

    OpenUrl
32. 32.↵
    1. Nakamura Y.,
    2. Nakazawa K.,
    3. Ohmori S.,
    4. Kawano K.,
    5. Shin'ichirou N.,
    6. Kitada M.

    Investigation of the involvement of a surfactant in the leaching of diethylhexyl phthalate from administration sets. Iryo Yakugaku 2004, 30, 180–184.

    OpenUrl
33. 33.↵
    1. Schoff H. W.,
    2. Rahman M.,
    3. Brazel C. S.

    Leaching and migration resistance of phosphonium-based ionic liquids as PVC plasticizers: comparative study of traditional phthalate and citrate plasticizers with ionic liquids. Polymer Preprints 2004, 45, 295–296.

    OpenUrl
34. 34.↵
    1. Wang Q.,
    2. Storm B. K.

    Migration of additives from poly(vinyl chloride) (PVC) tubes into aqueous media. Macromol. Symp. 2005, 225, 191–203.

    OpenUrl
35. 35.↵
    1. Masucci P.,
    2. Moffat M. I.

    The diffusion of phenol and tricresol through rubber. J. Pharm. Sci. 1923, 12, 117–120.

    OpenUrl
36. 36.↵
    1. McGuire G.,
    2. Falk K. G.

    The disappearance of phenols and cresols added to “biological products” on standing. J. Lab. Clin. Med. 1937, 22, 641–645.

    OpenUrl
37. 37.↵
    1. Wiener S.

    The interference of rubber with the bacteriostatic action of thiomersalate. J. Pharm. and Pharmacol. 1955, 7 (2), 118–125.

    OpenUrl
38. 38.↵
    1. Berry H.

    Pharmaceutical aspects of glass and rubber. J. Pharm. Pharmacol. 1953, 5 (12), 1008–1017.

    OpenUrlPubMed
39. 39.↵
    1. Wing W. T.

    An examination of rubber used as a closure for containers of injectable solutions. III. The effect of chemical composition of the rubber mix on phenol and chlorocresol absorption. J. Pharm. Pharmacol. 1956, 8 (10), 738–744.

    OpenUrlPubMed
40. 40.↵
    1. Lachman L.,
    2. Weinstein S.,
    3. Hopkins G.,
    4. Slack S.,
    5. Eisman P.,
    6. Copper J.

    Stability of antibacterial preservatives in parenteral solutions. I. Factors influencing the loss of antimicrobial agents from solutions in rubber-stoppered containers. J. Pharm. Sci. 1962, 51 (3), 224–232.

    OpenUrlPubMed
41. 41.↵
    1. Reznek S.

    Rubber closures for containers of parenteral solutions. I. The effect of temperature and pH on the rate of leaching of zinc salts from rubber closures in contact with (acid) solutions. J. Am. Pharm. Assoc. 1953, 42 (5), 288–291.

    OpenUrl
42. 42.↵
    1. Milosovich G,
    2. Mattocks A. M.

    Haze formation of rubber closures for injections. J. Am. Pharm. Assoc. 1957, 46 (6), 377–381.

    OpenUrl
43. 43.↵
    1. Inchiosa M. A. Jr..

    Water-soluble extractives of disposable syringes; nature and significance. J. Pharm. Sci. 1965, 54 (9), 1379–1381.

    OpenUrlPubMed
44. 44.↵
    1. Capper K. R.

    Interaction of rubber with medicaments. J. Mondial de Pharmacie 1966, 9 (4), 305–315.

    OpenUrl
45. 45.↵
    1. Lachman L.,
    2. Pauli W. A.,
    3. Sheth P. B.,
    4. Pagliery M.

    Lined and unlined rubber stoppers for multiple-dose vial solutions. II. Effect of Teflon lining on preservative sorption and leaching of extractives. J. Pharm. Sci. 1966, 55 (9), 962–966.

    OpenUrlPubMed
46. 46.↵
    1. Petersen M. C.,
    2. Vine J.,
    3. Ashley J. J.,
    4. Nation R. L.

    Leaching of 2-(2-hydroethylmercapto)benzothiazole into contents of disposable syringes. J. Pharm. Sci. 1981, 70 (10), 1139–1143.

    OpenUrlPubMed
47. 47.↵
    1. Danielson J. W.,
    2. Oxborrow J. S.,
    3. Placencia A. M.

    Quantitative determination of chemicals leached from rubber stoppers into parenteral solutions. J. Paren. Sci. Technol. 1984, 38 (3), 90–93.

    OpenUrl
48. 48.↵
    1. Reepmeyer J. C.,
    2. Juhl Y. H.

    Contamination of injectable solutions with 2-mercaptobenzothiazole leached from rubber closures. J. Pharm. Sci. 1983, 72 (11), 1302–1305.

    OpenUrlPubMed
49. 49.↵
    1. Salmona G.,
    2. Assaf A.,
    3. Gayte-Sorbier A.,
    4. Airaudo C. B.

    Mass spectral identification of benzothiazole derivatives leached into injections by disposable syringes. Biomed. Mass Spectrometry 1984, 11 (9), 450–454.

    OpenUrl
50. 50.↵
    1. Jaehnke R. W. O.,
    2. Joerg R. G.

    Interaction of rubber closures with powders for parenteral administration. J. Paren. Sci. Technol. 1990, 44 (5), 282–288.

    OpenUrl
51. 51.↵
    1. Jaehnke R.W.O.,
    2. Linde H.,
    3. Mosandl A.,
    4. Kreuter J.

    Contaimination of injectable powders by volatile hydrocarbons from rubber stoppers. The C-13-oligomer and determination of its structure. Acta Pharm. Technol. 1990, 36 (3), 139–148.

    OpenUrl
52. 52.↵
    1. Danielson J. W.

    Toxicity potential of compounds found in parenteral solutions with rubber stoppers. J. Paren. Sci. Technol. 1992, 46 (2), 43–47.

    OpenUrl
53. 53.↵
    1. Norwood D. L.,
    2. Prime D.,
    3. Downey D. P,
    4. Creasey J.,
    5. Sethi S. K.,
    6. Haywood P.

    Analysis of polycyclic aromatic hydrocarbons in metered dose inhaler drug formulations by isotope dilution gas chromatography/mass spectrometry. J. Pharm. Biomed. Anal. 1995, 13 (3), 293–304.

    OpenUrlCrossRefPubMedWeb of Science
54. 54.↵
    1. Paskiet D. M.

    Strategy for determining extractables from rubber packaging materials in drug products. PDA J. Pharm. Sci. Technol. 1997, 51 (6), 248–251.

    OpenUrlAbstract/FREE Full Text
55. 55.↵
    1. Zhang F.,
    2. Chang A.,
    3. Karaisz K.,
    4. Feng R.,
    5. Cai J.

    Structural identification of extractables from rubber closures used for pre-filled semisolid drug applicator by chromatography, mass spectrometry and organic synthesis. J. Pharm. Biomed. Anal. 2004, 34 (5), 841–849.

    OpenUrlPubMed
56. 57.↵
    1. Xiao B.,
    2. Gozo S. K.,
    3. Herz L.

    Development and validation of LC methods for the determination of potential extractables from elastomeric stoppers in the presence of a complex surfactant vehicle used in the preparation of parenteral drug products J. Pharm. Biomed. Anal. 2007, 43 (2), 558–565.

    OpenUrlPubMed
57. 58.↵
    1. Bergendorff O.,
    2. Persson C.,
    3. Luedtke A.,
    4. Hansson C.

    Chemical changes in rubber allergens during vulcanization. Contact Dermatitis. 2007, 57 (3), 152–157.

    OpenUrlPubMed
58. 59.↵
    1. Norwood D.,
    2. Ruberto M.,
    3. DeGrazio F.L.,
    4. Castner J.,
    5. Wong W.K.,
    6. Jenke D.

    Extractables and leachables from rubber materials used in pharmaceutical systems. Rubber & Polymer News 2009, June 29, 15–19.
59. 60.↵
    1. Sharma B.,
    2. Bader F.,
    3. Templeman T.,
    4. Lisi P.,
    5. Ryan M.,
    6. Heavner G. A.

    Technical investigations into the cause of the increased incidence of antibody-mediated pure red cell aplasia associated with EPREX®. Eur. J. Hosp. Pharm. 2004, 5, 86–91.

    OpenUrl
60. 61.↵
    1. Boven K.,
    2. Knight J.,
    3. Bader F.,
    4. Rossert J.,
    5. Eckardt K.,
    6. Casadevail N.

    Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. Nephr. Dialy. Trans. 2005, 20 (Suppl. 3), ii33–ii40.

    OpenUrl
61. 62.↵
    1. Pang J.,
    2. Blanc T.,
    3. Brown J.,
    4. Labrenz S.,
    5. Villalobos A.,
    6. Depaolis A.,
    7. Gunturi S.,
    8. Grossman S.,
    9. Lisi P.,
    10. Heavner G. A.

    Recognition and identification of UV-absorbing leachables in EPREX pre-filled syringes: an unexpected occurrence at a formulation–component interface. PDA J. Pharm. Sci. Technol. 2007, 61 (6), 423–432.

    OpenUrlAbstract/FREE Full Text
62. 63.↵
    1. Jenke D. R.

    Compatability of Pharmaceutical Products and Contact Materials—Safety Considerations Associated with Extractables and Leachables; Wiley: New York, 2009.
63. 64.↵
    1. Wong W. K.

    Impact of elastomer extractables in pharmaceutical stoppers and seals, material supplier perspective. Rubber World 2009, 240 (3), 20 – 29.

    OpenUrl
64. 65.↵
    3.1.5. Polyethylene with Additives for Containers for Parenteral Preparations and for Ophthalmic Preparations. In the European Pharmacopoeia, 7th ed.; Council of Europe: Strasburg, France, 2010; pp 338–341.
65. 66.↵
    1. Jagnandan I.,
    2. Dunn H.,
    3. Ambrosio J.,
    4. Gilbert S.G.

    Isolation and identification of 3,3',5,5'-tetrabis (tertbutyl) stilbenequinone from polyethylene closures containing titanium dioxide and butylated hydroxytoluene. J. Pharm. Sci. 1979, 68 (7), 916–917.

    OpenUrlCrossRefPubMed
66. 67.↵
    1. Goydan R.,
    2. Schwope A. D.,
    3. Reid R. C.,
    4. Cramer G.

    High-temperature migration of antioxidants from polyolefins. Food Additives and Contaiminants 1990, 7 (3), 323–337.

    OpenUrl
67. 68.↵
    1. Vom Bruck C.,
    2. Rudolph F. B.,
    3. Figge K.,
    4. Eckert W. R.

    Application of diffusion theory to migration of plastics components into packaged goods: Survey of recent migration studies. Food Cosmet. Toxicol. 1979, 17, 153–157.

    OpenUrlPubMed
68. 69.↵
    1. Azuma K.,
    2. Tanaka Y.,
    3. Tsundo 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, 2003–2008.

    OpenUrl
69. 70.↵
    1. Azuma K.,
    2. Tanaka Y.,
    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
70. 71.↵
    1. Demertzis P.G.,
    2. Franz R.,
    3. Welle F.

    The effects of gamma irradiation on compositional changes in plastic packaging films. Packaging Technol. Sci. 1999, 12 (3), 119–130.

    OpenUrl
71. 72.↵
    1. Schwope A. D.,
    2. Till D. E.,
    3. Ehntholt D. J.,
    4. Sidman K. R.,
    5. Whelan R. H.,
    6. Schwartz P. S.,
    7. Reid R. C.

    Migration of BHT and Irganox 1010 from low-density polyethylene (LDPE) to foods and food-simulating liquids. Food Chem. Toxicol. 1987, 25 (4), 317–326.

    OpenUrlCrossRefPubMedWeb of Science
72. 73.↵
    1. Helmroth I. E.,
    2. Bekhuis H. A. M.,
    3. Linssen J. P. H.,
    4. Dekker M.

    Direct measurement of additive migration from low-density polyethylene as a function of space and time. J. Appl. Poly. Sci. 2002, 86 (12), 3185–3190.

    OpenUrl
73. 74.↵
    1. Welle F.

    Migration of radiolysis products from radiation-sterilized plastics. Pharmazeutische Industrie 2005, 67, 970–972.

    OpenUrl
74. 75.↵
    1. Arias M.,
    2. Penichet I.,
    3. Ysambertt F.,
    4. Bauza R.,
    5. Zougagh M.,
    6. Rios A.

    Fast supercritical fluid extraction of low- and high-density polyethylene additives: comparison with conventional reflux and soxhlet extraction. J. Supercritical Fluids 2009, 50 (1), 22–28.

    OpenUrl
75. 76.↵
    1. Akapo S. O.,
    2. McCrea C. M.

    SPME-GC determination of potential volatile organic leachables in aqueous-based pharmaceutical formulations packaged in overwrapped LDPE vials. J. Pharm. Biomed. Anal. 2008, 47 (3), 526–534.

    OpenUrlPubMed
76. 77.↵
    1. Haishima Y.,
    2. Hayashi Y.,
    3. Yagami T.,
    4. Nakamura A.

    Elution of bisphenol-A from hemodialyzers of polycarbonate and polysulfone resins. J. Biomed. Res. 2001, 58 (2), 209–215.

    OpenUrl
77. 78.↵
    1. Sajiki J.,
    2. Yonekubo J.

    Degradation of bisphenol-A (BPA) in the presence of reactive oxygen species and its acccleration by lipids and sodium chloride. Chemosphere 2002, 46 (2), 345–354.

    OpenUrlPubMed
78. 79.↵
    1. Sajiki J.,
    2. Yonekubo J.

    Leaching of bisphenol-A from polycarbonate plastic to water containing amino acids and its degradation by radical oxygen species. Chemosphere 2004, 55 (6), 861–867.

    OpenUrlPubMed
79. 80.↵
    1. Sajili J.,
    2. Yonekubo J.

    Leaching of bisphenol A (BPA) to seawater from polycarbonate plastic and its degradation by reactive oxygen species. Chemosphere 2003, 51 (1), 55–62.

    OpenUrlPubMed
80. 81.↵
    1. Chang C. M.,
    2. Chou C. C,
    3. Lee M. R.

    Determining leaching of Bisphenol A from plastic containers by solid-phase microextraction and gas chromatography-mass spectrometry. Anal. Chim. Acta, 2005, 539 (1), 41–47.

    OpenUrl
81. 82.↵
    1. Cao X.,
    2. Corriveau J.

    Migration of Bisphenol A from polycarbonate baby and water bottles into water under severe conditions. J. Agric. Food Chem. 2008, 56 (15), 6378–6381.

    OpenUrlCrossRefPubMedWeb of Science
82. 83.↵
    1. Jakobs A.

    Topas Cyclic-Olefin Copolymer—Advances in Pharma Packaging and Pre-Fillable Drug Delivery Systems. In Medical Polymers 2000; 14th International Conference, Vienna, Austria, September, 2000.
83. 84.↵
    1. Grimm M.

    Cyclic Olefin Copolymer (COC): An Innovative Transparent Plastic Material for Applications in Medical and Diagnostic. In Medical Polymers 2006; 5th International Conference Focusing on Polymers used in the Medical Industry, Cologne, Germany, June, 2006.
84. 85.↵
    1. Shah D.,
    2. Cronin J.,
    3. Chacko M.,
    4. Gillum A.

    Impact of formulation and processing parameters on silicone extraction from cyclic olefin copolymer (COC) syringes. PDA J. Pharm. Sci. Technol, 2011, 65 (2), 109–115.

    OpenUrlAbstract/FREE Full Text
85. 86.↵
    1. Jenke D.,
    2. Odufu A.,
    3. Couch T.,
    4. Chacko M.,
    5. Strathmann S.,
    6. Edgcomb E.

    Evaluation of the general solution compatibility of polymer materials used in medical devices such as syringes. PDA J. Pharm. Sci. Technol. 2012, 66 (3), 286–306.

    OpenUrlAbstract/FREE Full Text