CD16 Multivariable Process Indicator

The CD16 Multivariable Process Indicator is a Type 4 chemical indicator specifically designed for monitoring Ethylene Oxide (EO) sterilization processes. It provides reliable and precise performance, ensuring compliance with strict sterilization standards.

Key Features

Multivariable Process Indicator:

Monitors EO sterilization processes under specified conditions.

Conditions:

• 600 mg/l EO, RH 60%, 30 °C, 30 minutes.
• 600 mg/l EO, RH 60%, 54 °C, 20 minutes.

Chemical Indicator Type:

• Type 4, as per ISO 11140-1 standards.
• Double punched card strips printed with indicator ink.
• Initial color: Purple/brown.
• Final color: Green.
• 100% Toxic Heavy Metal free.

Regulatory Compliance

Quality Management System Standards:

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

ISO 11140-1:2014.

Authorizations:

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

• FDA 510(k) K191021.

Classification:

Class 1 (ANMAT).

Usage Guidelines

Intended Use:

Designed for monitoring EO sterilization processes.

Precautions:

• Do not store near sterilizing agents.
• Avoid exposure to Steam or Dry Heat sterilization processes.
• Refrain from reusing the sterilizer until the indicator changes to the final color as specified.

Additional Instructions:

Read the product’s instructions for use thoroughly before operation.

Specifications

Dimensions: 200 x 15 mm.

Environmental Conditions:

Manufacturing: T15-30 °C, RH 30-80%.

Storage: T10-30 °C, RH 30-80%, avoid direct light.

Transport: Adhere to storage conditions during transport. Use closed, reinforced boxes to prevent damage.

Shelf Life: 5 years.

Packaging and Labelling

Packaging:

• 250 strips per aluminum foil bag.
• Includes product description, instructions for use, storage conditions, and manufacturer information.

Labelling:

• Product code and description.
• Process intended for use.
• Classification according to regulation.
• Color change information.
• Product presentation.
• Batch number and expiration date.
• Barcode and datamatrix code.

Target Markets

The CD16 Multivariable Process Indicator is suitable for the following industries:

• Healthcare.
• Food.
• Pharmaceutical.
• Medical.

Important Information

Instructions: Ensure thorough understanding of the product’s usage instructions.

Precautions:

• Do not store the product near sterilizing agents.
• Ensure proper storage and transport conditions.
• Use exclusively for Ethylene Oxide sterilization.

Infection Control Division

This product is part of the Infection Control Division’s Chemical Indicators range, offering a high-performance solution for monitoring EO sterilization processes.