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Sterile labels

Tired of sterilizing labels in house? CleanMark’s custom sterile labels take the risk and effort out of labeling in regulated aseptic environments.

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Sterile labels increase productivity in sensitive environments

Labels are small but essential elements of operations. They facilitate tracking, control quality, prove compliance, and ensure consistency in your processes. They can also be a source of contamination. CleanMark sterile labels get you all the benefits with none of the risks. 

Processed in a clean environment

Our state-of-the-art cleanroom processing facility and double bagging reduce contamination.  

Sterilized with gamma irradiation

Deep-penetrating gamma irradiation ensures our sterile labels are free of microorganisms so your sensitive environments are protected.

No bacteria-attracting adhesive residue

Our sterile labels stay put when they’re supposed to and remove cleanly when designed to do so — so you’re never left with a sticky surface that attracts contaminants.

Durability in harsh lab environments

CleanMark’s sterile labels are durable against a range of challenging environmental conditions, ensuring no contaminating particles are shed.

Explore our full range of sterile labels

STERILe LABELS AND STERILIZATION INDICATORS

Autoclave indicator labels

Easy-to-read results based on steam, temperature, and time

ETO indicator labels

Color change under pressure, exposure, temperature and duration consistent with sterilization 

Gamma indicator labels

Color change under irradiation dose process consistent with sterilization 

Image of two people looking at samples that could be labeled with sterile labels

There’s more to a label than sterility

The best labels don’t just perform one function — they’re a constellation of features that allow the label to function perfectly in your unique environment and processes.  CleanMark has the expertise to ensure  your label has the right combination of features to perform flawlessly.

Let us design the perfect sterile labels for you

What sets CleanMark apart from other label producers is our expertise and level of service. Our label experts work with you to understand the exact parameters of your operational needs and then design a label that meets every one of them — even if we have to invent something new to make it happen.

Looking for more information about labeling technology and applications?

Explore case studies, articles, guides and more in our extensive library of labeling resources. 

September 18, 2025

Optimizing lab labels for high-performance aseptic operations: hybrid sterile + cleanroom-compatible labels

Key takeaways High-tech fields like medical device manufacturing and pharma depend on aseptic areas and cleanrooms that are built for precision, but many still rely on lab labels that fall …
January 30, 2025

Medication labels: why customization matters

Inadequate medication labels are a leading cause of preventable harm in healthcare. Custom medical labels are the answer.
November 7, 2024

What is the ISO standard for implantable medical device labeling requirements?

What’s the ISO standard for implantable medical device labeling requirements? Read on to learn which requirements your label needs to satisfy.

Have more questions? We have answers!

Read on for answers to our customers’ most common questions.

How do CleanMark sterile labels differ from sterilization indicator labels?
How are your sterile labels packaged to maintain sterility?
Can your sterile labels be customized?
What sterilization methods are used for the labels?
What documentation will I receive?
Are there specific storage requirements for sterile labels?
How long do your sterile labels stay sterile?
Can your sterile labels be used on different types of surfaces?
What should I do if I need a sterility certificate for regulatory purposes?
What quality control measures are in place to ensure the labels meet sterility standards?
Can CleanMark match a label I already use?
What’s the typical lead time?
Can I use them in a cleanroom?

Gloss

Provides a shiny, gloss finish — not recommended for QR and bar codes

Matte

Matte finish — great for detailed images and text that require high print clarity

Laminated

Versatile technique to provide added protection to printing, change label stiffness, or modify label gloss

EtO

Contains EtO‑sensitive ink that visibly and permanently shifts color once proper ethylene oxide gas exposure conditions have been met

Gamma

An indicator chemical compound irreversibly changes color when exposed to a validated dose of gamma radiation, offering fast visual confirmation of sterilization

Autoclave

Heat‑sensitive ink permanently changes color once the required steam temperature and dwell time have been achieved in an autoclave cycle

QR code

Only select if CleanMark will print the QR code during production

Bar code

Only select if CleanMark will print the bar code during production

Serial number

Only select if CleanMark will print the serial number during production

100% pre-printed

CleanMark prints the entire label, including any variable data like bar codes or serial numbers

Partially pre-printed

CleanMark prints static info but leaves space for handwritten or on-site printing of variable or time-dependent data

Blank

Label is completely blank upon delivery

Direct thermal

Uses heat-sensitive film and a heated print head to create images without ink or ribbons

Thermal transfer

Transfers ink from a ribbon onto the label using heat for long-lasting, durable prints

Ink jet

Sprays tiny droplets of ink directly onto the label surface for full-color, high-resolution prints

Laser

Uses a laser beam and toner to produce crisp, smudge-resistant labels with sharp detail

Handwritten

Labels are manually marked using a pen or marker, offering maximum flexibility but limited consistency

Yes

Not appropriate for machine application

Paper

Affordable, efficient option that accepts ink well. Great for cardboard label application. Not appropriate for cleanrooms.

Polyamide (nylon)

Good option for garments and screen printing

Polyimide

Cleanroom compatible option perfect for electronics and other high heat applications

Polyester

Versatile facestock perfect for high-heat and chemical exposure contexts.

Polycarbonate

Stiffer facestock that can be printed or extruded in a variety of colors. Great for nameplates.

BOPP (biaxially oriented polypropylene)

Versatile, affordable option with high flexibility and direct thermal options.

Polyethelene

Absorbs color ink well and has high flexibility for adhering to tightly curved surfaces like vials and syringes

Permanent

Remains firmly adhered throughout the intended lifecycle, then can be removed after use residue free

Removable

Designed for easy, residue-free removal after a short to medium lifecycle

Repositionable

Designed to be repositioned during lifecycle — perfect for tracking labels that must move from a component or product to a documentation sheet

Synthetic (clear)

Best for gap sensing printers

Synthetic (colors)

Best for printers that require opaque liners or where clear liner would be a safety issue, such as warehouses, labs, and shipping facilities

Paper

Available in a variety of thicknesses — not suitable for cleanrooms

Paper

Not suitable for cleanrooms

Plastic

Color options available

Glass

Glass

Metal

Metal

Plastic

Plastic

Cardboard

Cardboard

Flat

Includes flat surfaces of all sizes

Curved

Includes vials, beakers, syringes, and any other non-flat surface

Chemical resistant

Remain adhered and legible through exposure to cleaning and other chemicals

Heat resistant

Resist yellowing and discoloration, remaining adhered and legible through heat-intensive processes (100C - 250C)

Freezer

Designed to remain legible and adhered at both freezer (-80C - 0C) and ambient temperatures

Cryogenic

Firm, cold-specific adhesive ensures reliable performance at ultra-low temps (-196C to -86C) and around tight curves, like vials and syringes.

Dry ice

Use flexible materials and adhesive that remain secure and legible when moved in and out of dry ice conditions (-86C to -70C)

Refrigerator

Designed to remain legible and adhered at both refrigerator (0C - 20C) and ambient temperatures with a high degree of moisture resistance

Autoclave durable

Ultra-durable labels that withstands the moisture, temperature (121C or higher), and pressure of the autclave process and can be designed for residue-free removal

Abrasion resistant

Withstand the rigors of shipping and other high-abrasion environments without smearing, degrading, or peeling

UV resistant

Reliable adhesion and legibility through prolonged outdoor exposure

Moisture resistant

Moisture-resistant adhesives and synthetic label materials ensure reliable adhesion and legibility in humid or wet conditions.

Cleanroom labels

CleanMark can produce clean labels up to ISO 5 cleanroom standards. We process labels in our own cleanroom and are ISO 9001:2015 certified. Cleanroom labels are double bagged.

Sterile labels

CleanMark's sterile labels are gamma irradiated after packing. Optional sterility validation testing is available.

Hand applied

Designed for fast, easy hand application

Machine applied

Labels can be customized for your specific label applicator machine

Roll

Labels are wound on a roll

Fanfold

Flat sheets of labels

Labels

3 in.

1.5 in.

1 in.

3/4 in.

Square / rectangle

Circle

Irregular

Width (in.)

Height (in.)

Diameter (in.)

1

2

3

4

5

6