Process Challenge Devices® (PCD®)

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    Process Challenge Devices® (PCD®)

PCD EZTest EZG6 SCBI
PCD-EZTest-EZG6-SCBI-002
PCD-EZTest-EZG6-SCBI-003
PCD EZTest EZG6 SCBI PCD-EZTest-EZG6-SCBI-002 PCD-EZTest-EZG6-SCBI-003

Process Challenge Devices® (PCD®) certified to ISO 13485 quality systems for medical devices. Available across 6 resistance types, these PCDs ensure success of terminal sterilization cycles of medical devices, and can be used for both validation and routine monitoring of EO sterilization cycles.

Each PCD combines specific biological indicators with proprietary barrier pouches to achieve consistent, validated resistance levels for ethylene oxide (EO) sterilization, plus one specialized option for hydrogen peroxide (H₂O₂) sterilization.

Why choose Mesa Labs PCDs?

  • Each PCD has a defined resistance value, with all components resistance tested using an ISO 18472 compliant resistometer, ensuring complete confidence in every PCD. 
  • Manufactured under an ISO 13485 certified quality system
  • Helps to achieve compliance with ISO 11135.
  • Patented packaging of a variety of B. atrophaeus biological indicators (BI) to match your process.
  • Broad resistance levels and BI types to meet different cycle configurations.
  • Faster turnaround with self-contained biological indicators (SCBI).
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Selecting the correct resistance level

Not sure which PCD® is right for your cycle? Mesa’s PCD Selection Set includes four of the most common resistance configurations in one kit, helping you quickly determine the correct match.

Products
Technical Specifications
Document Downloads

Products

Nominal D Values by PCD Type and BI Configuration

PCD Bare Strip or Disc Strip in Glassine SCBI
PCD Type 3 3min 4min 5min
PCD Type 5 4min 5min 13min
PCD Type 7 9min 14min 26min
PCD Type 6 12min 17min 35min
PCD Type 4 21min 32min 50min
PCD Type 2 28min 37min 58min

 

Type 2 (Most Resistance)

PCD® 2.1 Mesa BI Disc, 1-10006mm (D-Value: 28)

PCD® 2.12 Mesa BI Strip, SGMG/6 (D-Value: 28)

PCD® 2.13 Mesa EZTest EZG/6 SCBI (D-Value: 58)

PCD® 2.2 Steris BI Spore Strip, NA005 (D-Value: 28)

PCD® 2.5 Mesa BI Spore Strip in glassine, SGMG/6 (D-Value: 37)

PCD® 2.6 3M Attest™ 1264-S SCBI (D-Value: 58)

PCD® 2.7 Steris BI Spore Strip in glassine, NA005 (D-Value: 37)

PCD® 2.9 3M Attest™ 1294-S RRBI (D-Value: 58)

 

Type 3 (Least Resistance)

PCD® 3.13 Mesa EZTest EZG/6 SCBI (D-Value: 3)

PCD® 3.2 Steris BI Spore Strip, NA 005 (D-Value: 3)

PCD® 3.5 Mesa BI Spore Strip in Glassine, SGMG/6 (D-Value: 4)

PCD® 3.6 3M Attest™ 1264-S SCBI (D-Value: 5)

PCD® 3.9 3M Attest™ 1294-S RRBI (D-Value: 5)

 

Type 4 (Medium Resistance)

PCD® 4.1 Mesa BI Disc, 1-10006mm (D-Value: 21)

PCD® 4.13 Mesa EZTest EZG/6 SCBI (D-Value: 50)

PCD® 4.2 Steris BI Spore Strip, NA005 (D-Value: 21)

PCD® 4.5 Mesa BI Spore Strip in Glassine, SGMG/6 (D-Value: 32)

PCD® 4.6 3M Attest™ 1264-S SCBI (D-Value: 50)

PCD® 4.7 Steris BI Spore Strip in Glassine, NA005 (D-Value: 32)

PCD® 4.9 3M Attest™ 1294-S RRBI (D-Value: 50)

 

Type 5 (Low Resistance)

PCD® 5.1 Mesa BI Disc, 1-10006mm (D-Value: 4)

PCD® 5.13 Mesa EZTest EZG/6 SCBI (D-Value: 13)

PCD® 5.2 Steris BI Spore Strip, NA005 (D-Value: 4)

PCD® 5.5 Mesa BI Spore Strip in Glassine, SGMG/6 (D-Value: 5)

PCD® 5.62 3M Attest™ 1264-S SCBI (D-Value: 13)

PCD® 5.92 3M Attest™ 1294-S RRBI (D-Value: 13)

 

Type 6 (Medium Resistance)

PCD® 6.1 Mesa BI Disc, 1-10006mm (D-Value: 12)

PCD® 6.13 Mesa EZTest EZG/6 SCBI (D-Value: 35)

PCD® 6.2 Steris BI Spore Strip, NA005 (D-Value: 12)

PCD® 6.5 Mesa BI Spore Strip in Glassine, SGMG/6 (D-Value: 17)

PCD® 6.6 3M Attest™ 1264-S SCBI (D-Value: 35)

PCD® 6.7 Steris BI Spore Strip in Glassine, NA005 (D-Value: 17)

PCD® 6.9 3M Attest™ 1294-S RRBI (D-Value: 35)

 

Type 7 (Medium Resistance)

PCD® 7.1 Mesa BI Disc, 1-10006mm (D-Value: 9)

PCD® 7.13 Mesa EZTest EZG/6 SCBI (D-Value: 26)

PCD® 7.2 Steris BI strip, NA005 (D-Value: 9)

PCD® 7.5 Mesa BI Spore Strip in Glassine, SGMG/6 (D-Value: 14)

PCD® 7.6 3M Attest™ 1264-S SCBI (D-Value: 26)

PCD® 7.7 Steris BI Spore Strip in Glassine, NA 005 (D-Value: 14)

PCD® 7.9 3M Attest™ 1294-S RRBI (D-Value: 26)

 

Type 8

PCD® 8.13 Mesa EZTest EZH/6 SCBI H2O2 Cycles

Technical Specifications

Product Label: Polyolefin plastic with removable pressure sensitive test tube label.

Mounting Card: PVC plastic with a pressure sensitive adhesive strip for external mounting on sterilizer load boxes.

Packaging: Corrugated shippers with appropriate cushioning for damage-free transport

Documentation Package (Every Lot):

  • Certificate of Quality Conformance
  • BI manufacturer's Certificate of Analysis
  • Traceability to ISO certified laboratory testing
  • Fraction Negative method validation data

Regulatory Compliance:

  • Manufactured under ISO-13485 certified quality system
  • BIER vessel confirmation for all D-value claims
  • Validation guideline reference for implementation

Storage and Handling:

  • Expiry based on BI manufacturer's certificate
  • Environmental conditions per BI specifications
  • Protective packaging prevents contamination and damage

Document Downloads

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