Sterilization indicators

CleanMark sterilization indicator labels visually confirm that an item has been exposed to a sterilization process by changing color or displaying text. In contrast, CleanMark sterile labels are themselves sterilized and designed for use in aseptic environments. While both support regulatory compliance, sterilization indicator labels ensure proper processing, whereas sterile labels maintain cleanliness in critical environments.

When selecting a CleanMark sterilization indicator label, consider:

– Sterilization method compatibility: CleanMark offers labels for steam (autoclave), gamma radiation, and ethylene oxide (EtO) sterilization. Surface adhesion: CleanMark labels are designed to adhere to materials such as plastic, metal, and glass, even under extreme conditions.
– Regulatory compliance: Our indicator inks meet ISO 11140-1:2014 standards, making them suitable for BioTech, pharmaceutical, and medical device manufacturing.
– Tracking elements: CleanMark can incorporate barcodes, lot numbers, and text-based indicators to enhance traceability.

CleanMark specializes in customizing labels for your unique environment and processes. Learn more about our customization process here.

Yes! CleanMark sterilization indicator labels are designed for direct application to pouches, wraps, and containers used in sterilization cycles. Our labels remain securely affixed and legible throughout the process, ensuring clear visibility of sterilization status.

No, CleanMark sterilization indicator labels confirm exposure to sterilization conditions, not sterility itself. To validate sterility, additional bioburden testing or biological indicators should be used. However, our labels provide clear, visual confirmation that items have gone through the sterilization process.

Yes! CleanMark offers custom sterilization indicator labels with barcodes, QR codes, lot numbers, and text-based process indicators. This customization helps with traceability, batch tracking, and regulatory compliance, ensuring full process documentation.

Yes, CleanMark sterilization indicator labels are engineered to withstand high temperatures, pressure, moisture, and chemical exposure during sterilization processes. Our autoclave indicator labels resist steam and heat, while EtO and gamma indicator labels maintain integrity through gas exposure and radiation sterilization. The labels remain legible, securely adhered, and resistant to smudging even in extreme conditions.

Yes, CleanMark’s sterilization indicator labels are ideal for high-throughput sterilization processes. Our labels are available in custom roll formats or sheets, making them compatible with both manual and automated application systems for large-scale operations.

Yes, CleanMark offers custom sterilization indicator labels that can combine sterilization confirmation with identification features, such as barcodes, lot numbers, expiration dates, and instructions. This dual-purpose functionality helps streamline workflows and reduces the need for multiple labels on sterilized items.

Yes! CleanMark sterilization indicator labels are designed with high-performance adhesives that allow them to conform to curved, flexible, and irregular surfaces, such as vials, syringes, tubing, and medical instruments. If you need a label for a specific surface or application, our team can help select the best material and adhesive combination for your needs.