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Information on NAMSA Chemical Indicators and Related Products
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NAMSA range of Chemical Process Indicators (CPIs), Chemical Indicators and Indicator Tapes are manufactured with NAMSA’s Eco Friendly Indicating Inks and meet performance specifications as outlined in ISO 11140-1 Sterilization of Health Care Products.  NAMSA's CPI's and Indicator Tapes provide a fast and consistent visual check to determine whether an item has been exposed to a sterilisation process.

NAMSA's range of Chemical Indicators, Integrators and Emulators manufactured with a tear resistant lamination protection. Their new and innovative indicators demonstrate exceptional performance and are customised for the most widely utilised sterilisation processes.

Shelf Life and Storage Considerations - All Chemical Indicator Types: These products have a 24 months shelf life and are stored at room temperature. The shelf life is based on the date the indicating ink is applied to the substrate. After exposure to a sterilisation process, the colour change remains stable when stored correctly.
Chemical Indicators
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Product Type Product Description
Chemical Process Indicators (CPI)
NAMSA Chemical Process Indicators
Indicator Tapes
NAMSA Indicator Tape
Go to NAMSA websiteNAMSA's Class 1 Chemical Process Indicators are suitable for application by hand or Meto gun on shipping cartons or individual packages. The label colour indicates at a glance whether or not the product has gone through the sterilisation process.

Examples: Below is table containing examples of the available formats for the Chemical Process Indicator labels. A number of other formats are also available as standard products:
 
Sterilisation Process: 13mm Circles METO Labels Preprinted 13mm Circles
Gamma or E-beam 5,000/roll 1,000/roll 5,000/roll
Ethylene Oxide 5,000/roll 1,500/roll 5,000/roll
Steam 5,000/roll Custom Label Custom Label
Steam - Formaldehyde 5,000/roll Custom Label Custom Label
Vapourised H2O2 Custom Label Custom Label 5,000/roll
Dry Heat 1,000/roll Custom Label Custom Label
Depyrogenation 500/roll Custom Label Custom Label
 
 Colour Transistions of Standard CPI's:
Sterilisation Process Exposure Conditions Unexposed1 Exposed1
Gamma Radiation >10kGy    
Gamma Radiation >3kGy    
Ethylene Oxide2 600mg/L    
Steam3 121°C    
Steam - Formaldehyde 70°C, 1mol/L    
Vapourised H2O24 6mg/L    
Dry Heat5 <250°C    
Depyrogenation6 <180°C    
Note 1: Pre-exposure colour and post-exposure colour for the conditions specified. Indicative colours only as actual colours may vary from those shown.
Note 2: 54°C, 60% RH, 20 minutes
Note 3: Saturated Steam 121°C, 3 minutes
Note 4: Minimum 6mg/L, 6 minutes at 50°C
Note 5: 30 minutes at 250°C
Note 6: Dry heat for 10 minutes at 160°C
 
Go to NAMSA websiteNAMSA's Indicator Tapes are made of strong crepe-embossed paper with a pressure sensitive adhesive. They adhere to paper, paper/plastic, woven, treated woven and non-woven wraps. The adhesive allows for secure seals yet is easy to remove. They are manufactured with NAMSA’s Eco Friendly Inks making them one of the most environmentally friendly and most consistently performing tapes on the market. Designed to aid in distinguishing processed from unprocessed loads.
 
The following Indicator Tapes are available:
Sterilisation Process Indicator Class Colour Change
Steam 4 Green to Orange
Ethylene Oxide 1 Yellow to Dark Green
Vapourised H2O2 1 Red to Yellow
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Chemical Indicators, Integrators and Emulators
Go to NAMSA websiteNAMSA has introduced a new generation of Chemical Indicators, Integrators and Emulators manufactured with NAMSA’s Eco Friendly Indicating Ink technology and tear resistant lamination protection. These indicators demonstrate exceptional performance and are customised for the most widely utilised sterilisation processes. NAMSA evaluates the performance of every lot of Chemical Indicators, Integrators and Emulators using state of the art equipment to ensure consistent and reliable performance.
  Lead & latex free
  Permanent colour change
  Long shelf life of 24 months
  Each shipment includes a Certificate of Conformance for assurance of product quality and performance
  Room temperature storage (15°C to 30°C)
 
The following Chemical Indicators, Integrators and Emulators are available:
Sterilisation Process Indicator Class Exposure Conditions
Steam 4 121°C for 30 minutes (gravity cycle) or 134°C for 2.5 minutes (pre-vacuum cycle)
Steam 5 121°C for 16.5 minutes or 134°C for 3.5 minutes or 135°C for 3 minutes (all pre-vacuum cycles). Note: Industrial use only
Steam 6 121°C for 10 minutes, 121°C for 15 minutes or 134°C for 3.5 minutes (all pre-vacuum cycles). Note: Industrial use only
Ethylene Oxide 4 54°C, 600mg/L 60%RH for 20 minutes
Vapourised H2O2 1 54°C, 2.3mg/L
Dry Heat 4 160°C for 40 minutes
Formaldehyde 4 70°C, 1mol/L for 15 minutes
 
Bowie & Dick Test
Go to NAMSA websiteNAMSA Bowie & Dick Test are used to monitore steam sterilisation processes using autoclaves. The Bowie & Dick Test Pack consists of a series of steam penetration (air removal) barriers in the center of which is a chemical indicator sheet. The test pack should be placed into an empty autoclave chamber and put through the recommended autoclave cycle of 121°C for 15 miutes or 134°C for 3 to 3.5 minutes.

These can be used to qualify a newly installed autoclave or following a major repair, but are generally used to monitor performance changes in air removal and steam quality during routine use.
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CPI Custom Labels
Go to NAMSA websiteNAMSA's Custom Chemical Process Indicator labels are a convenient, cost-effective option for manufacturers who wish to combine a sterilisation indicator with an existing label. These custom indicators can be any size or shape, in roll or sheet formats, and are designed for application directly to an existing label, pouch, carton, or other container as required. NAMSA currently manufactures custom labels for leading companies in the medical device, garments, food and packaging industries.
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