PMID- 7658360
OWN - NLM
STAT- MEDLINE
DCOM- 19951002
LR  - 20190711
IS  - 0022-3549 (Print)
IS  - 0022-3549 (Linking)
VI  - 84
IP  - 5
DP  - 1995 May
TI  - Interlaboratory comparison of analytical methods for residual ethylene oxide at 
      low concentration levels in medical device materials.
PG  - 647-55
AB  - An interlaboratory comparison of two extraction methods and one thermal 
      desorption test method for the quantification of ethylene oxide (EO) by gas 
      chromatography in two common medical device materials, high density polyethylene 
      (HDPE) and plasticized polyvinyl chloride (PVC), was conducted by 15 
      laboratories. The three procedures included extraction with water, extraction 
      with acetone, and headspace gas analysis, respectively. Materials were processed 
      through an industrial EO cycle and aerated for various periods to achieve target 
      levels of a low (5 micrograms/g), medium (10 micrograms/g), and high (25 
      micrograms/g) residual determination following extraction or thermal desorption. 
      The results of this study, using only the data from the laboratories that did not 
      deviate from the procedure, showed that the average estimated total coefficient 
      of variation ranged from 3.63 to 12.42% for the three different methods. Each of 
      the methods is suitable for use as a reference test method for determining 
      residual EO in polymeric materials in the concentration range 2.8-42.3 
      micrograms/g.
FAU - Lao, N T
AU  - Lao NT
AD  - U.S. Food and Drug Administration, Center for Devices and Radiological Health, 
      Office of Science and Technology, Rockville, MD 20852, USA.
FAU - Lu, H T
AU  - Lu HT
FAU - Rego, A
AU  - Rego A
FAU - Kosakowski, R H
AU  - Kosakowski RH
FAU - Burgess, D J
AU  - Burgess DJ
FAU - Hume, R D
AU  - Hume RD
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - United States
TA  - J Pharm Sci
JT  - Journal of pharmaceutical sciences
JID - 2985195R
RN  - 0 (Polyethylenes)
RN  - 059QF0KO0R (Water)
RN  - 1364PS73AF (Acetone)
RN  - 9002-86-2 (Polyvinyl Chloride)
RN  - JJH7GNN18P (Ethylene Oxide)
SB  - IM
MH  - Acetone
MH  - Chromatography, Gas/*methods
MH  - Equipment Safety
MH  - Equipment and Supplies/*standards
MH  - Ethylene Oxide/*analysis
MH  - Polyethylenes/chemistry
MH  - Polyvinyl Chloride/chemistry
MH  - Sterilization/*standards
MH  - Water
EDAT- 1995/05/01 00:00
MHDA- 1995/05/01 00:01
CRDT- 1995/05/01 00:00
PHST- 1995/05/01 00:00 [pubmed]
PHST- 1995/05/01 00:01 [medline]
PHST- 1995/05/01 00:00 [entrez]
AID - S0022-3549(15)49795-3 [pii]
AID - 10.1002/jps.2600840524 [doi]
PST - ppublish
SO  - J Pharm Sci. 1995 May;84(5):647-55. doi: 10.1002/jps.2600840524.