Optimization of a novel headspace-solid-phase microextraction-gas chromatographic method by means of a Doehlert uniform shell design for the analysis of trace level ethylene oxide residuals in sterilized medical devices

Biomedical Chromatography

Volumn 23, Issue 6, 2009, Pages 647-657

  DiCicco, Michael P ^a   Lang, Bridget ^a   Harper, Thomas I ^a  

^a JOHNSON AND JOHNSON   (United States)

Author keywords

Doehlert design; Ethylene oxide (EtO); Headspace solid phase microextraction gas chromatography (HS SPME GC); Medical devices; Optimization; Sterilization

Indexed keywords

BIOMEDICAL EQUIPMENT; CHROMATOGRAPHIC ANALYSIS; ETHYLENE; EXTRACTION; STENTS; TRACE ANALYSIS;

CHROMATOGRAPHIC METHODS; DOEHLERT DESIGN; ETHYLENE OXIDE; ETHYLENE OXIDES; HEAD-SPACE SOLID-PHASE MICROEXTRACTION; HEADSPACE SOLID PHASE MICROEXTRACTION; HEADSPACE-SOLID-PHASE MICROEXTRACTION-GAS CHROMATOGRAPHY; MEDICAL DEVICES; OPTIMISATIONS; TRACE LEVEL;

GAS CHROMATOGRAPHY;

ETHYLENE OXIDE; DISINFECTANT AGENT; DRUG DERIVATIVE;

ARTICLE; CONTROLLED STUDY; DESORPTION; DRUG ELUTING STENT; GAS CHROMATOGRAPHY; HEAT TREATMENT; INSTRUMENT STERILIZATION; PROCESS OPTIMIZATION; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SOLID PHASE MICROEXTRACTION; TEMPERATURE; METHODOLOGY; VALIDATION STUDY;

CHROMATOGRAPHY, GAS; DISINFECTANTS; DRUG-ELUTING STENTS; ETHYLENE OXIDE; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SOLID PHASE MICROEXTRACTION; STERILIZATION; TEMPERATURE;

EID: 67651214390     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.1170     Document Type: Article

References (42)

1. AAMI. Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. AAMI/ANSI/ISO Document 10993-7:1995. AAMI: Arlington, VA, 1995.
2. Aguilar C, Peñalver A, Pocurull E, Ferré J, Borrull F and Marcé RM. Optimization of solid-phase microextraction conditions using a response surface methodology to determine organochlorine pesticides in water by gas chromatography and electron-capture detection. Journal of Chromatography A 1999; 844: 425-432.
3. Alegretti AP, Thiesen FV and Maciel GP. Analytical method for evaluation of exposure to benzene, toluene, xylene in blood by gas chromatography preceded by solid phase microextraction. Journal of Chromatography B 2004; 809: 183-187.
4. Alkalde TK, Peralba MCR, Zini CA and Caramão EB. Quantitative analysis of benzene, toluene and xylenes in urine by means of headspace solid-phase microextraction. Journal of Chromatography A 2004; 1027: 37-40.
5. Altaki MS, Santos FJ and Galceran MT. Analysis of furan in foods by headspace solid-phase microextraction-gas chromatography-ion trap mass spectrometry. Journal of Chromatography A 2007; 1146: 103-109.
6. Antoniou CV, Koukouraki EE and Diamadopoulos E. Determination of chlorinated volatile organic compounds in water and municipal wastewater using headspace-solid phase microextraction-gas chromatography. Journal of Chromatography A 2006; 1132: 310-314.
7. Araujo P, Couillard F, Leirnes E, Ask K, Bøkevoll A and Frøyland L. Experimental design considerations in quantification experiments by using the internal standard technique: cholesterol determination by gas chromatography as a case study. Journal of Chromatography A 2006; 1121: 99-105.
8. Ayoub K, Harris L and Thompson B. Determination of low-level ethylene oxide by using solid-phase microextraction and gas chromatography. Journal of AOAC International 2002; 85: 1205-1209.
9. Delinsky AD, Bruckner JV and Bartlett MG. A review of analytical methods for the determination of trichloroethylene and its major metabolites chloral hydrate, trichloroacetic acid and dichloroacetic acid. Biomedical Chromatography 2005; 19: 617-639.
10. Doehlert DH. Uniform shell designs. Applied Statistics 1970; 19: 231-239.
11. Dron J, Garcia R and Millán E. Optimization of headspace solid-phase microextraction by means of an experimental design for the determination of methyl tert.-butyl ether in water by gas chromatography-flame ionization detection. Journal of Chromatography A 2002; 963: 259-264.
12. Ferreira SLC, dos Santos WNL, Quintella CM, Neto BB and Bosque-Sendra JM. Doehlert matrix: a chemometric tool for analytical chemistry - review. Talanta 2004; 63: 1061-1067.
13. Ferreira SLC, Bruns RE, da Silva EGP, dos Santos WNL, Quintella CM, David JM, de Andrade JB, Breitkreitz MC, Jardim ICSF and Neto BB. Statistical designs and response surface techniques for the optimization of chromatographic systems. Journal of Chromatography A 2007; 1158: 2-14.
14. Flanagan RJ, Morgan PE, Spencer EP and Whelpton R. Micro-extraction techniques in analytical toxicology: short review. Biomedical Chromatography 2006; 20: 530-538.
15. González AG and Herrador MA. A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles. Trends in Analytical Chemistry 2007; 26: 227-238.
16. Gramiccioni L, Milana MR and Di Marzio S. A head-space gas-chromatographic method for the determination of traces of ethylene oxide in sterilized medical devices. Microchemical Journal 1985; 32: 89-93.
17. Harper T, Cushinotto L, Blaszko N, Arinaga J, Davis F, Cummins C and DiCicco M. Round-robin evaluation of a solid-phase microextraction-gas chromatographic method for reliable determination of trace level ethylene oxide in sterilized medical devices. Biomedical Chromatography 2008; 22: 136-148.
18. Hu Y and Massart DL. Uniform shell designs for optimization in reversed-phase liquid chromatography. Journal of Chromatography 1989; 485: 311-323.
19. Huber L. Validation and Quantification in Analytical Laboratories. Interpharm Press: East Englewood, CO, 1998.
20. International Conference on Harmonization (ICH). Harmonized Tripartite Guideline Q2A; Text on Validation of Analytical Procedures - ICH Technical Requirements for Registration of Pharmaceuticals for Human Use, 1994.
21. International Conference on Harmonization (ICH). Harmonized Tripartite Guideline Q2B; Validation of Analytical Procedures: Methodology - ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996.
22. Kolb B and Ettre LS. Static Headspace-Gas Chromatography, Theory and Practice. Wiley-VCH: New York, 1997.
23. Li N and Zou J. Determination of impurities in industrial caprolactam produced from toluene by SPME and GC-MS. Journal of Applied Polymer Science 2006; 100: 3141-3144.
24. Liu Y, Muralidhara S, Bruckner JV and Bartlett MG. Determination of trichloroethylene in biological samples by headspace solid-phase microextraction gas chromatography/mass spectrometry. Journal of Chromatography B 2008; 863: 26-35.
25. Markelov M and Guzowski JP. Matrix independent headspace gas chromatographic analysis. This full evaporation technique. Analytica Chimica Acta 1993; 2: 235-245.
26. Marlowe DE, Lao NT, Eaton AR, Page BFJ and Lao CS. Interlaboratory comparison of analytical methods for residual ethylene oxide in medical device materials. Journal of Pharmaceutical Science 1987; 76: 333-337.
27. Mathurin J-C, de Ceaurriz J, Audran M, Krafft M-P. Detection of perfluorocarbons in blood by headspace solid-phase microextraction combined with gas chromatography/mass spectrometry. Biomedical Chromatography 2001; 15: 443-451.
28. Matisová E, Medved'ová M, Vraniaková J and Šimon P. Optimisation of solid-phase microextraction of volatiles. Journal of Chromatography A 2002; 960: 159-164.
29. Mestres M, Sala C, Martí MP, Busto O and Guasch J. Headspace solidphase microextraction of sulphides and disulphides using carboxen-polydimethylsiloxane fibers in the analysis of wine aroma. Journal of Chromatography A 1999a; 835: 137-144.
30. Mestres M, Martí MP, Busto O and Guasch J. Simultaneous analysis of thiols, sulphides and disulphides in wine aroma by headspace solid-phase microextraction-gas chromatography. Journal of Chromatography A 1999b; 849: 293-297.
31. Navalón A, Prieto A, Araujo L and Vílchez JL. Determination of oxadiazon residues by headspace solid-phase microextraction and gas chromatography-mass spectrometry. Journal of Chromatography A 2002a; 946: 239-245.
32. Navalón A, Prieto A, Araujo L and Vílchez JL. Determination of pyrimethanil and kresoxim-methyl in green groceries by headspace solid-phase microextraction and gas chromatography-mass spectrometry. Journal of Chromatography A 2002b; 975: 355-360.
33. Pawliszyn J. New directions in sample preparation for analysis of organic compounds. Trends in Analytical Chemistry 1995; 14: 113-122.
34. Pawliszyn J. Solid-Phase Microextraction, Theory and Practice. Wiley-VCH: New York, 1997.
35. Pizarro C, Pérez-del-Notario N and González-Sáiz JM. Optimization of a headspace solid-phase microextraction with on-fiber derivatisation method for the direct determination of haloanisoles and halophenols in wine. Journal of Chromatography A 2007; 1143: 26-35.
36. Sandra P, David F and Szücs R. Some applications of state-of-the-art capillary gas chromatography in the pharmaceutical industry. Trends in Analytical Chemistry 2002; 21(9-10): 662-671.
37. Tak V, Kanaujia PK, Pardasani D, Kumar R, Srivastava RK, Gupta AK and Dubey DK. Application of Doehlert design in optimizing the determination of degraded products of nerve agents by ion-pair liquid chromatography electrospray ionization tandem mass spectrometry. Journal of Chromatography A 2007; 1161: 198-206.
38. Tranchida PQ, Presti ML, Costa R, Dugo P, Dugo G and Mondello L. High-throughput analysis of bergamot essential oil by fast solid-phase microextraction-capillary gas chromatography-flame ionization detection. Journal of Chromatography A 2006; 1103: 162-165.
39. Tsai SW and Wu KK. Determination of ethylene oxide by solid-phase microextraction device with on-fiber derivatization. Journal of Chromatography A 2003; 991: 1-11.
40. Tsai SW, Tsai ST, Wang VS and Lai JS. Laboratory and field validations of a solid-phase microextraction device for the determination of ethylene oxide. Journal of Chromatography A 2004; 1026: 25-30.
41. United States Food and Drug Administration (USFDA). Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, FDA, 2001.
42. Waters Corp. A Guide to Analytical Method Validation. Available at: https://www.waters.com/webassets/cms/library/docs/720001826en.pdf (accessed August 2008).