Chemical Indicator for Helix-PCD Systems – PCD-A-E1

Reliable EO Sterilization Process Monitoring

The PCD-A-E1 Chemical Indicator is specifically designed for use in Helix-PCD systems to control Ethylene Oxide (EO) sterilization processes under the conditions of 240 minutes at 54°C, EO 600 mg/l, and 60% RH.

Manufactured under ISO 13485:2016 Quality Management System standards and compliant with ISO 11140-1:2014, this Type 2 Chemical Indicator offers dependable verification for healthcare, pharmaceutical, food, and medical industries.

Key Features

• Precise EO Sterilization Monitoring – Ensures process control for EO sterilizers.
• Clear Visual Results – Light blue to green colour change for easy interpretation.
• High-Quality Design – Self-adhesive varnished strips printed with indicator ink.
• User-Friendly Format – Each sheet contains 10 strips (size: 76 × 6 mm per strip; sheet size: 80 × 98.5 mm).
• Safe & Eco-Friendly – 100% free from toxic heavy metals.
• Long Shelf Life – 5 years under recommended storage conditions.

Result Interpretation

• Successful Cycle: All 4 bars change to the final green colour – sterilizer is functioning properly.
• Cycle Failure: Any bar remains a different colour – indicates possible equipment malfunction.

Storage & Handling

• Temperature: 10–30°C | Humidity: 30–80% | Keep out of direct light.
• Do not store near sterilizing agents.
• Only for use with EO sterilization; not compatible with steam, dry heat, or formaldehyde.

Precautions

• Do not store the product near sterilizing agents.
• Do not expose this product to steam, dry heat, formaldehyde, or any sterilization process other than EO.
• Do not reuse the sterilizer until the chemical indicator’s colour change matches the final reference colour.

Packaging

• 250 strips in sheets of 10.
• Clearly labelled with product details, usage process, classification, storage instructions, batch number, manufacturing and expiry date, barcode, and datamatrix code.

Applications

Trusted across hospitals, pharmaceutical manufacturing units, medical device production, and food industries for ensuring EO sterilization efficiency.