CD30 Multi-variable Chemical Indicator

The CD30 Multi-variable Chemical Indicator is a reliable solution for monitoring Dry Heat sterilization processes, designed to ensure safety, compliance, and efficiency in the healthcare, food, pharmaceutical, and medical industries.

Usage

Specifically engineered for Dry Heat sterilization processes.

Conditions:

• 160 ºC for 40 minutes
• 180 ºC for 20 minutes

Applicable Regulations

Designed under ISO 13485:2016/NS-EN ISO 13485:2016 Quality Management Systems standards.

Complies with ISO 11140-1:2014.

Product Classification: Class 1 (according to risk).

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

Key Features

• Type: Type 4 Multi-variable Chemical Indicator.
• Material: Strips printed with indicator ink.
• Dimensions: 105 x 18 mm.

Colour Change:

• Initial colour: Dark blue

• Final colour: Brown
• Environmental Impact: Free from toxic heavy metals.

Conditions for Use

Manufacture:

Temperature: 15-30 ºC

Relative Humidity: 30-80%

Storage:

Temperature: 10-30 ºC

Relative Humidity: 30-80%

Keep out of direct light.

Transport:

Follow storage conditions.

Use reinforced packaging to prevent damage.

Durability

Shelf Life: 5 years.

Packaging Details

• Available in 250 or 500 strips per aluminium foil bag.
• Packaging includes product descriptions, instructions, storage conditions, and manufacturer details.

Labelling Information

On the Product Bag:

• Product code and description
• Intended process
• Usage conditions
• Classification
• Colour change details
• Batch number, manufacture date, expiration date
• Barcode and datamatrix.

Target Markets

• Healthcare
• Food Industry
• Pharmaceutical Industry
• Medical Industry

Precautions

• Store away from sterilizing agents.
• Do not expose to Steam, EO, or sterilization processes other than Dry Heat.
• Only reuse the sterilizer once the indicator has changed to the specified colour.
• Read and follow product instructions thoroughly before use.