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Transfer Disinfection Validation

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Better bioburden reduction when vial caps opened before alcohol spray ... Operational procedures showed transfer of up to 9 cfu/vial into critical work zones ... – PowerPoint PPT presentation

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Title: Transfer Disinfection Validation


1
Transfer Disinfection Validation
  • Sarah Hiom
  • Cardiff and Vale NHS Trust

2
Aseptic PreparationIsolator Technology
3
Transfer into controlled work zone
? High contamination risk ? Disinfection (70
alcohol)
4
Validation of Disinfection Transfer
  • Current methods
  • Swabs/Contact plates
  • Lack sensitivity
  • Not appropriate for assessing disinfection

5
Aim
  • To develop and validate an accurate in house
    disinfection assessment method
  • To use this method to benchmark contamination
    levels and compare disinfection transfer
    procedures in pilot sites across Wales

6
Method
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Validate new method
  • Background count
  • Effect of residual alcohol on recovery rates
  • Determining recovery

13
Recovery
  • S.epidermidis stock culture 55cfu/100µl

Contact Plate 40 Swab 20
14
Sampling Concept
15
Benchmark Contamination Levels
  • 50ml glass vial
  • Batch (6) stored in unit for 5 days
  • Bioburden determined after each disinfection
    point during transfer to critical work zone (n ?
    5)

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18
Pilot conclusions
  • Novel sensitive method to assess disinfection
    transfers
  • Spray wipe transfer methods significantly
    better at reducing bioburden than spray only
    procedures (Plt0.1)
  • Better bioburden reduction when vial caps opened
    before alcohol spray disinfection transfers
    (Plt0.1)
  • Operational procedures showed transfer of up to 9
    cfu/vial into critical work zones

19
  • Action limits?

20
Bioburden (cfu/item)
21
Action Limits
  • for transfer disinfection procedures to pass
    this validation test, results are expected to
    demonstrate no greater than two colony forming
    units from each item sampled within the critical
    work zone.

SteriVal Technical Information Sheet 3.3
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