PCD-A-3.5Y Chemical Indicator for use in Helix-PCD system

The PCD-A-3.5Y is a Type 2 Chemical Indicator specifically designed for use in the Helix-PCD system, ensuring secure load release during steam sterilization processes. This product complies with stringent quality and safety standards, making it suitable for critical applications in healthcare, food, pharmaceutical, and medical industries.

Usage

• Designed for Helix-PCD systems to ensure secure load release.

• Operating conditions: 3.5 minutes at 134 °C.

Applicable Regulation

• ISO 13485:2016/NS-EN ISO 13485:2016.

• ISO 11140-1:2014.

• Authorization: ANMAT (Argentinean National Administration of Drugs, Food, and Medical Devices) PM-1614-4.

• Classification: Class 1, according to risk (ANMAT).

Product Characteristics

• Indicator Type: Type 2 Chemical Indicator.

• Material: Self-adhesive varnished strip printed with indicator ink.

Size:

• Individual strip: 76 x 6 mm.

• Sheet size: 80 x 98.5 mm (10 strips per sheet).

Colour Change:

• Initial colour: Yellow.

• Final colour: Dark brown or black.

Metal-Free: 100% toxic heavy metal-free.

Performance Notes:

• Successful sterilization is indicated by the 4 bars on the strip changing to the final colour.
• If any bars do not change colour, the sterilization cycle is considered unsuccessful, and the load cannot be released as sterile.

Environmental Conditions During Manufacture

• Temperature: 15-30 °C.

• Relative Humidity: 30-80%.

Storage and Transport

Storage Conditions:

• Temperature: 10-30 °C.

• Relative Humidity: 30-80%.

• Keep out of direct light.

Transport Conditions:

• Follow storage conditions.

• Transport in closed and strengthened boxes to prevent damage.

• The product poses no health risk during transport.

Shelf Life

5 years from the date of manufacture.

Packing Information

Packaging:

• 250 strips in sheets of 10 units.

• Includes product description, classification, storage conditions, and manufacturer information on the label.

Labelling:

• Product code.

• Intended use process.

• Presentation details.

• Colour change indicators.

• Batch number.

• Manufacture and expiration dates.

• Barcode and DataMatrix code.

Target Markets

• Healthcare.
• Food industry.
• Pharmaceutical industry.
• Medical device manufacturing.

Precautions

• Read product instructions thoroughly before use.
• Do not store the product near sterilizing agents.
• Avoid exposing the product to EO, Dry Heat, Formaldehyde, or any sterilization process other than Steam.
• Do not reuse the sterilizer until the chemical indicator shows the final colour change as indicated in the product instructions.