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Sterility Assurance Products

Fort Defiance Industries recommends either of the two options listed below to ensure successful sterilization with each load processed. Option 1 is a combination of Verify™ and 3M products, and Option 2 is the 3M line of products only. Please note: there are no other FDA-Cleared PCDs for a 10-minute pre-vacuum cycle other than the Verify™ LCB035 Reusable Test Pack.

Supports the 4-Minute Exposure Cycles

Option 1: Verify™ Products

LCB035-NC – Reusable Process Challenge Device
PCC065B – Class 5 Chemical Integrator
3M® 1292 – Biological Indicator
Option 2: 3M® Products
1296 – Biological Process Challenge Device
1243 – Class 5 Chemical Integrator
1292 – Biological Indicator
Supports the 10-Minute Exposure Cycles

Option 1: Verify™ Products

LCB035-NC – Reusable Process Challenge Device
4400 – Extended Cycle Tube
3M® 1292 – Biological Indicator
Note: There are no other FDA-Cleared PCDs for a 10-minute pre-vacuum cycle.
Supports the Bowie-Dick Test
3305-NC – Reusable Process Challenge Device
EQC004 – Bowie Dick Test Strip
Option 2: 3M® Products
1233L – Bowie-Dick Test Pack
FDI is a VERIFY®distributor to the United States Department of Defense.

QUICK FACTS:

  • The Verify™ LCB035 is cleared by the FDA for a 10-minute 270°F pre-vacuum cycle
  • The Verify™ LCB035 PCD can be used with a 4-minute cycle (without the SteriScan 4400 extended cycle tube)
  • The Verify™ LCB035 can be used to run air removal tests using the Bowie Dick Test Strip
  • The Verify™ LCB035 can be used in up to 200 cycles before replacement
  • The Verify™ LCB035 reusable test pack and associated test strips are compact, reducing storage and space requirements
  • With the Verify™ LCB035 system, users save approximately 35% in sterility assurance material costs per load and 30% cost savings per air removal (Bowie-Dick) test