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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