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 Steriscan 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 SteriScan 3305 Reusable Test Pack.

Option 1: SteriScan® Products Option 2: 3M® Products

Supports the 4-Minute Exposure Cycles

3305-NC-Reusable-Process-Challenge-Device

3305-NC – Reusable Process Challenge Device

 

1100-Class-5-Chemical-Integrator

1100 – Class 5 Chemical Integrator

 

3M-1292
3M® 1292 – Biological Indicator

3M1296-Biological-Process-Challenge-Device

1296 – Biological Process Challenge Device

 

3M-class-5

1243 – Class 5 Chemical Integrator

 

3M-1292
1292 – Biological Indicator

Supports the 10-Minute Exposure Cycles

3305-NC-Reusable-Process-Challenge-Device

3305-NC – Reusable Process Challenge Device

 

4400 Extended Cycle Tube

4400 – Extended Cycle Tube

 

3M-1292
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

3305-NC – Reusable Process Challenge Device

 

5500-Bowie-Dick-Test-Strip
5500 – Bowie Dick Test Strip

3M-BD
1233L – Bowie-Dick Test Pack

FDI is a SteriScan® distributor to the United States Department of Defense.

 

Quick Facts:

  • The SteriScan 3305 is cleared by the FDA for a 10-minute 270°F pre-vacuum cycle
  • The SteriScan 3305 PCD can be used with a 4-minute cycle (without the SteriScan 4400 extended cycle tube)
  • The SteriScan 3305 can be used to run air removal tests using the Bowie Dick Test Strip
  • The SteriScan 3305 can be used in up to 200 cycles before replacement
  • The SteriScan 3305 reusable test pack and associated test strips are compact, reducing storage and space requirements
  • With the SteriScan PCD system, users save approximately 35% in sterility assurance material costs per load and 30% cost savings per air removal (Bowie-Dick) test