PCD-A-E1 Test Strip with Chemical Indicator

The PCD-A-E1 is a precision-engineered test strip designed for use in the Helix-PCD system to monitor and control Ethylene Oxide (EO) sterilization processes. This chemical indicator ensures accurate verification of sterilization efficacy under specific conditions, offering peace of mind for industries where sterilization is critical.

Key Usage Parameters

Sterilisation Conditions:

• Duration: 240 minutes
• Temperature: 54°C
• EO Concentration: 600 mg/L
• Relative Humidity: 60% RH

Conformance to Standards:

• Quality Management: ISO 13485:2016 / NS-EN ISO 13485:2016
• Chemical Indicator Classification: ISO 11140-1:2014

Product Classification and Authorization

• Risk Classification: Class 1 (low-risk product)
• Authorized by: ANMAT (PM-1614-4)

Product Features

Indicator Type: Type 2 Chemical Indicator

Size: Individual strip dimensions 76 x 6 mm, with sheets measuring 80 x 98.5 mm.

Colour Change:

• Initial Color: Light Blue
• Final Color: Green (Successful sterilization)

Heavy Metals: 100% toxic heavy metals free

Adhesive Properties: Self-adhesive varnished strip with indicator ink for secure application.

Performance Validation

• The 4-bar system indicates successful sterilization when all bars change to green.
• Any deviation in bar colour highlights potential equipment malfunctions.

Environmental and Storage Specifications

• Manufacturing Conditions: Temperature 15-30°C, Humidity 30-80% RH
• Storage Conditions: Temperature 10-30°C, Humidity 30-80% RH, protected from direct light.
• Transport Requirements: Product must be transported in closed and reinforced boxes to prevent damage.

Shelf Life and Packaging

Shelf Life: 5 years from the date of manufacture.

Packaging: Sheets of 10 units, totaling 250 strips per pack.

• Includes detailed product description, regulatory classification, storage conditions, and batch details.

Labelling Information

• Each pack includes critical data:

• Product code, intended use, batch number, manufacture/expiration dates, and barcode/datamatrix code.

Target Markets

Industries: Healthcare, Food, Pharmaceutical, and Medical sectors.

Precautions

• Do not store near sterilizing agents.
• Avoid exposure to Steam, Dry Heat, Formaldehyde, or sterilization methods other than EO.
• Reuse the sterilizer only after confirming the correct color change.

Important Notes

Follow the product’s instructions thoroughly before use.

The PCD-A-E1 ensures precision, reliability, and compliance for your sterilization processes, making it an essential tool for effective infection control.