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NCA Verify
Process Validation Challenge Device (PCD)

NCA Verify
Process Validation Challenge Device (PCD)

The Only Device To Monitor The Most Complex Cannulated Instruments & Lumens

(i.e. Dental Handpiece)

The Only Way to Verify the Sterility of Your Dental Handpiece or Cannulated Instruments

All You Need

Is One Indicator Strip Only

For All Instruments In The Autoclave

Overview

 “This is the end all be all of challenge devices – with nothing like it on the market.”

NCA PCD Sterilization Process Challenge Device 

Standards Reference: ANSI/AAMI/ASTM/ISO 11140-4, ISO17665-1, ISO1138-1, EN285 & EN867-5

The NCA PCD Sterilization Monitor is a very small device, about half of the hand’s palm size that could be placed on top of the instruments in the autoclave. It is made and manufactured in Australia, in accordance with AS4187 ref: EN867-5 & AAMI/ISO17665-1.

PCD is an abbreviation that stands for challenge validation process device or challenge process device. This device provides a challenge to the sterilizer/autoclave that is 50 to 100 times greater than the most challenging and complex instruments to sterilize ( e.g. complex cannulated instruments such as the dental handpiece drill). It basically makes it up to 100 times more difficult for the sterilization process to successfully sterilize the NCA PCD, hence it makes it 100 times more difficult for the validation indicators (e.g. Quattro indicator strips) to detect the FOUR sterilization parameters giving you the most accurate reading and evidence of sterility assurance for the peace of mind and protection of patients, staff, and your medical reputation.

NCA PCD provides the quality and robustness needed to cope with the conditions inside the sterilizer. Made from 316L medical-grade metal (Highest medical-grade metal) and 1.5 meter Polytetrafluoroethylene (PTFE) tubing, it provides the greatest challenge for the sterilizer against the most complex cannulated lumens. A special Class 2 indicator (i.e NCA Quattro, NCA Bowie Dick) is placed inside on every cycle and will detect all parameters for sterility assurance. It could also be used with Class 5 integrators and Bio-Spore Test Vials.

The intricately designed NCA Process Validation Challenge Device provides the best monitoring results for the sterility process and can be used both as a Bowie Dick Test, with our special Bowie Dick Indicators, and as a batch control on each run for all benchtop B-Class sterilizers using the Quattro indicators.

The device has a lifespan of 3000 cycles and can serve as a multi-purpose challenge device. It utilises the NCA Quattro indicators on each batch of instruments, to ensure validation on each cycle and acts as a hybrid device by hosting the biological spore test vial for your weekly validation. This places the spore tests through the toughest challenge, which ensures that your sterilizer is functioning to its highest level. 

A New Revolutionary Sterilization Monitoring System

Finally!! 

No more expensive, complex, 

and ineffective biological spore tests*

NCA’s Sterilization Monitoring System consists of the NCA PCD device with the Quattro and NCA Bowie Dick indicators inserted in the device’s barrel.

NO MORE:

Contacting patients from previous weeks if bi-weekly spore test fails

Biological spore test *

Incubation of spore test / biological indicators

Off site lab verification

Instruments quarantine

Weekly tests

Healthcare-associated Infections Outbreaks (HAI)

False pass in beginning of the cycle

IT IS:
 The only technology that validates hollow 

    and cannulated complex instruments

 The only sterilization evidence that

    could be used in a court of law

 Complete protection and peace of mind for each cycle

Instant ultimate validation for every single cycle

 Continuous validation of all the sterilization 

parameters throughout the cycle

HOW IS OUR SYSTEM DIFFERENT?

One vs. several indicators for the whole batch, giving you confidence to use your instruments right away without the need for quarantine (no more integrators and indicators in each bag or tray)

Can be used in every cycle and gives you superior sterility assurance level results when compared to using live spore or biological (BI) integrator tests.

Proactive Autoclave Health: our innovative Bowie Dick Test and advanced superior/unique pouches – which are equipped with pre-failure detection technology in its indicator – will close all loopholes and give you complete sterility assurance all the time, saving you thousands on autoclave repairs or replacements.

24/7 live direct support

NCA Monitoring System Others

Monitors all FOUR critical sterilization parameters, as defined by sterilization standards. (Air Removal*, Temperature, Time, Steam & Pressure)

*Has the most accurate detection of NCG’s down to less than 1ml

 

Responded to single or multiple parameters, but don’t check for all four parameters.

Whether Class 1,3,5,4, or 6, none check for air removal.

Continuous Monitoring Technology
Continues measuring all parameters as the cycle progresses on each stage from start to finish, giving you an accurate true result.
Premature pass result within the first half of the sterilization cycle, giving you an unreliable (false positive result)
Monitors inside cannulated/hollow complex instruments and lumens (such as dental handpieces) and validates sterility. Do not validate sterility of cannulated instruments
Monitors every square inch inside your autoclave and instruments. Only monitors an area of a few square inches, leaving much free space unmonitored.
Scientific evidence accepted in a court of law against infection cases  (a scientific guarantee of sterility) Not enough evidence to stand in a court of law.

* NCA sterilization is by far more accurate than any other sterilization verification test in the market. This includes the synthetic and live bacteria biological indicators or spore tests. Some dental boards and medical facilities might still recommend using a biological test even though it doesn’t provide an accurate evidence of sterility. Until they update their recommendations and guidelines you might still need to do a routine spore test.

Proprietary Technologies

High Accuracy NCG’s Detection

This technology allows the strip indicator to detect volumes of air (non-condensable gases) down to less than 1 ml, which is the volume required to harvest a spore inside a lumen (hollow/cannulated instruments). Those spore sized air and non-condensable gases “NCG’s” pockets, will allow dangerous pathogens to exist.

Some autoclaves/sterilizers have a built-in monitoring system. The built-in monitoring systems for sterilizers/autoclaves are not meant for monitoring instruments, but they only monitor  the sterilizer itself. This means that it monitors to a porous level which requires 150ml of air remaining in the chamber to pass. Only NCA Bowie Dick indicators and the NCA Process Validation Challenge Device (PCD) can detect less than 1ml of air which is what’s required to provide evidence of sterility assurance inside handpieces and other lumens and hollow/cannulated instruments.

Features

  • One-Of-A-Kind Patented Device: This is the only challenge device in the US market that is designed specifically to work with the NCA indicator, which verifies the four critical parameters of sterility (Air Removal, Pressure (Steam), Time, and Temperature).
  • Multi-Purpose-Device: Can be used for multi-purpose testing.
    • Complies with the toughest infection control standards. Ref: AAMI/ANSI, ASTM, ISO11140-4, ISO17665-1, ISO1138-1, EN285 & EN867-5, AS4187
    • Verifies Complex & Hollow Instruments Sterility:  The only device in the US market that verifies sterility for cannulated and hollow instruments and lumens, (e.g. dental handpieces, keyhole surgery tools, laparoscopes, etc.
    • Anywhere In The Autoclave Chamber: Specially designed patented device that verifies every single instrument’s sterility anywhere in the autoclave chamber using one indicator.
      • No Need For Multiple Indicators (Biological or Chemical): One test that gives a complete and comprehensive result for all the instruments in the autoclave.

      Specification

      Sterilization Method Steam
      Device Dimensions

      W 4” x L 6” x H ½” inches 

      (Almost half the size of an average human hand’s palm) 

      Designed to easily fit anywhere in the autoclave even above the instruments.

      Product Use

      Load monitoring/batch control, empty cycle Bowie Dick, spore test. 

      Multi-purpose hybrid device (Could host biological spore and integrator test vials, NCA Qattro indicators, and NCA Bowie Dick Full Cycle indicators for instruments sterilization validation or autoclave functionality tests.)

      Compatibility Hybrid device that  …Modified class II
      Life Span 3000 cycles
      Material

      316L Medical-grade metal

      1.5 meter (Depends on the autoclave size) Polytetrafluoroethylene (PTFE) tubing and indicator attachment mechanism

      Standards Ref. Fully conforms to standards: ANSI/AAMI/ASTM/ISO 11140-4, ISO17665-1, ISO1138-1, EN285 & EN867-5, AS4187

      Specification

      Sterilization Method Steam
      Device Dimensions

      W 4” x L 6” x H ½” inches 

      (Almost half the size of an average human hand’s palm) 

      Designed to easily fit anywhere in the autoclave even above the instruments.

      Product Use

      Load monitoring/batch control, empty cycle Bowie Dick, spore test. 

      Multi-purpose hybrid device (Could host biological spore and integrator test vials, NCA Qattro indicators, and NCA Bowie Dick Full Cycle indicators for instruments sterilization validation or autoclave functionality tests.)

      Compatibility Hybrid device that  …Modified class II
      Life Span 3000 cycles
      Material

      316L Medical-grade metal

      1.5 meter (Depends on the autoclave size) Polytetrafluoroethylene (PTFE) tubing and indicator attachment mechanism

      Standards Ref. Fully conforms to standards: ANSI/AAMI/ASTM/ISO 11140-4, ISO17665-1, ISO1138-1, EN285 & EN867-5, AS4187

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