Validex PCD Tech Sheet - Mesa Labs
Validex PCD Tech Sheet - Mesa Labs
Validex PCD Tech Sheet - Mesa Labs
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<strong>Validex</strong> <strong>PCD</strong> - <strong>Tech</strong> <strong>Sheet</strong><br />
<strong>Validex</strong> <strong>PCD</strong> - <strong>Tech</strong> <strong>Sheet</strong><br />
<strong>PCD</strong> for use externally on pallets processed in EtO Sterilization<br />
<strong>Mesa</strong>’s <strong>Validex</strong> <strong>PCD</strong> (Process Challenge Device) is intended for use externally on pallets processed<br />
in Ethylene Oxide sterilization.<br />
• Validation and routine monitoring of Ethylene Oxide sterilization cycles<br />
• Four different EO resistances available<br />
• Contains the EZTest ® Gas self-contained biological indicator<br />
<strong>Validex</strong> consists of an EZTest ® EO SCBI packaged in a pouch that can be directly attached to<br />
the outside of a pallet or package to be sterilized. Four different packaging configurations are<br />
available that offer four different resistances to Ethylene Oxide sterilization (see page 2). <strong>Validex</strong><br />
<strong>PCD</strong> is available in each of the four different resistances or all together in a Validation Set.<br />
Process: Ethylene Oxide<br />
Spores: B. atrophaeus<br />
Population: 10 6<br />
Incubation Time: 48 hours<br />
Incubation Temperature: 35 - 39°C<br />
Shelf Life: 24 months<br />
Peel off to attach <strong>PCD</strong> Attached to Box Write in load information Cut to remove BI<br />
Reorder #s for EZTest ® Self-contained<br />
Type 7 PC7EZG/6 100 units<br />
Type 6 PC6EZG/6 100 units<br />
Type 4 PC4EZG/6 100 units<br />
Type 2 PC2EZG/6 100 units<br />
<strong>Mesa</strong> Laboratories, Inc.<br />
www.<strong>Mesa</strong><strong>Labs</strong>.com<br />
BIsales@mesalabs.com<br />
Validation Set<br />
A series of four <strong>PCD</strong>s resistances are assembled in a validation set. Each <strong>PCD</strong> type<br />
has been calibrated to impede the penetration of ethylene oxide gas and moisture at<br />
a defined rate, ranging from a lower challenge on one end (Type 7), up through and<br />
ending with a significant challenge on the other end (Type 2). Using this range of available<br />
<strong>PCD</strong>s externally attached to the pallet during validation, the user selects the <strong>PCD</strong><br />
that represents the configuration that is equal to or greater than the resistance of the<br />
product challenge imbedded in the load. This <strong>PCD</strong> would then be used externally as a<br />
routine monitor.<br />
Validation Set (PCVEZG/6) is packaged 31 per box (30 test cards and one for control). Each card has four<br />
pouches affixed, one of each type (i.e. 2, 4, 6, & 7).<br />
<strong>Mesa</strong><strong>Labs</strong><br />
Rev. 5.29.2012
<strong>Validex</strong> <strong>PCD</strong> - <strong>Tech</strong> <strong>Sheet</strong><br />
<strong>Validex</strong> <strong>PCD</strong> - <strong>Tech</strong> <strong>Sheet</strong><br />
<strong>PCD</strong> for use externally on pallets processed in EtO Sterilization<br />
The graph below illustrates a typical survivor curve of BIs in the <strong>PCD</strong>s exposed in an ethylene oxide resistometer.<br />
The black curve on the far left represents a “naked” BI, while the remaining four curves represent the<br />
same BI packaged in each of the four different <strong>PCD</strong> resistance types. The actual biological indicator lethality<br />
values appear in Tables I and II (below).<br />
Survivor Curve of BIs, Naked and in Four <strong>PCD</strong> types Exposed in an Ethylene Oxide Resistometer<br />
Table I<br />
Plateau Length<br />
D-value<br />
(Minutes) 600mg/l, 54°C, 60+/- 10% RH<br />
Type 7 30 13.0 0.9801<br />
Type 6 60 16.9 0.9844<br />
Type 4 90 30.3 0.9866<br />
Type 2 90 40.5 0.8971<br />
Sample<br />
Identification<br />
Coefficient of Determiniation<br />
(r 2 )<br />
Sample<br />
Identification<br />
Table II<br />
Kill Time Exposure<br />
# Negative Units / Total Units<br />
Type 7 125.0 minutes 20/20<br />
Type 6 180.0 minutes 20/20<br />
Type 4 275.0 minutes 20/20<br />
Type 2 315.0 mintues (estimated) NA<br />
<strong>Validex</strong> <strong>PCD</strong> complies with the global industry standard ISO 14161:2000 “Sterilization of health care products –<br />
Biological Indicators – Guidance for the selection, use, and interpretation of results”.<br />
Individual <strong>PCD</strong>s packaged 100 units per box. Validation sets packaged 31 per box (30 test units and one control<br />
set).<br />
<strong>Mesa</strong> Laboratories, Inc.<br />
www.<strong>Mesa</strong><strong>Labs</strong>.com<br />
BIsales@mesalabs.com<br />
<strong>Mesa</strong><strong>Labs</strong>
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