Sterile Labels

Safe and Hygienic Labeling in Sterile Environments

Sterile labels indicate that items and products have been sterilized and are free of viable microorganisms. Sterilization eradicates all microbial life forms, including bacteria, viruses, and fungi, from a product or item to ensure its cleanliness and safety. Sterile labels serve several purposes, including:

Identification: Sterile labels identify items that have undergone process sterilization. They include listing the sterilization technique, the date of sterilization, and other relevant details.
Sterility Assurance: These labels provide visual confirmation that a product or item is sterile and safe for use. They help healthcare professionals, laboratory personnel, and other stakeholders rapidly identify sterile items and mitigate contamination or infection risks.
Regulatory compliance: In heavily regulated industries such as healthcare and pharmaceuticals, sterile labels play a crucial role in maintaining compliance set by regulatory bodies, including the FDA and ISO.

In sterile environments, safe and hygienic identification is essential. Our sterile labels offer exceptional performance, ensuring reliable identification and adherence to strict cleanliness standards. Explore our wide range of sterile labels and how they can elevate your sterile processes.

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Best Practices Guide

Product Resources

Product Features Flyer for Sterile Labels

Sterile Label Features

Particle-flow controlled - Cleaned, slit, rewound, and packaged in a Class 100 cleanroom
Odor controlled - made with low outgassing adhesives
Waterproof - label will not lift or tear apart when submerged under water
Smudge resistant - will remain legible when wet or when written with permanent marker
Tear free - removes from high and low surface energy surfaces easily without ripping apart
Residue free - labels remove cleanly from surfaces
Regulation Compliance - Can be configured to fit any GHS, OSHA, GMP, or FDA labeling requirements and standards
≥99.9999% (6-Log reduction) bioburden reduction of labels post irradiation sterilization

Custom Made Sterile Labels

Our sterile labels are fully customizable to satisfy a wide range of technical requirements. We are here to understand your needs end-to-end to develop a complete label construction unique to your application.

Adhesive Grade

Pick from permanent, semi-removable, and removable adhesives

Construction Type

Available in rolls or sheets, piggyback, and label set constructions

Topcoat Finish

Choose from a variety of matte, gloss, and semi-gloss topcoat selections

Sterile Indicating

Utilize chemical indicators that fit your sterilization processing method

Material Selection

Select from multiple forms of premium facestocks, plastic cores, and liners

Form Factor

Die cut and tailor your labels to fit practically any dimension or containers, products, and packaging

Printing Capabilites

Labels can be fully printed, partially printed, blank, or hand writeable

Surface Resistance

Utilize chemical indicators that fit your sterilization processing method

Printing Options

Compatible with thermal transfer, direct thermal, inkjet, and standard laser printers

Find The Right Sterile Labels

In order to find sterile labels that perform and properly satisfy your quality standards, it is important to partner with a label expert familiar with a wide array of controlled environment applications. Our team has extensive experience working with companies involved with advanced research and manufacturing. We can work in tandem with your technical team to design, prototype and manufacture sterile labels that are engineered for your application. Our aim is to make this quick and easy for you.

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Label features

Particle-flow controlled - Cleaned, slit, rewound, and packaged in a Class 100 cleanroom
Odor controlled - made with low outgassing adhesives
Waterproof - label will not lift or tear apart when submerged under water
Smudge resistant - will remain legible when wet or when written with permanent marker
Tear free - removes from high and low surface energy surfaces easily without ripping apart
Residue free - labels remove cleanly from surfaces
Regulation Compliance - Can be configured to fit any GHS, OSHA, GMP, or FDA labeling requirements and standards
≥99.9999% (6-Log reduction) bioburden reduction of labels post irradiation sterilization

Applications of sterile labels

Healthcare and Hospitals: Sterile labels have extensive use in healthcare settings for labeling sterile medical supplies, including surgical instruments, dressings, syringes, and catheters. These labels help ensure proper identification and prevent cross-contamination.
Pharmaceutical Manufacturing: Sterile labels find application in pharmaceutical manufacturing facilities for labeling sterile medications, vials, ampoules, and intravenous (IV) bags. These labels provide important information regarding product identification, dosage, and expiration dates.
Laboratory and Research Facilities: Sterile labels are crucial in laboratories and research facilities for labeling sterile containers, test tubes, Petri dishes, and other laboratory equipment. These labels help maintain sterility and prevent contamination of sensitive samples.
Biotechnology and Life Sciences: Biotechnology and life sciences industries utilize sterile labels for labeling sterile cell culture flasks, cryogenic storage containers, and bioreactors. These labels ensure proper identification and tracking of sterile materials.
Food Processing and Packaging: Sterile labels find application in food processing and packaging facilities for labeling sterile food products, such as pre-packaged salads, ready-to-eat meals, and medical-grade sterilized food items. These labels assure product safety and integrity.
Cleanrooms and Controlled Environments: Sterile labels are used in cleanroom environments, including semiconductor manufacturing, electronics, and aerospace industries, for labeling sterile components, tools, and equipment. These labels assist in maintaining sterility and preventing contamination.
Dental and Orthodontic Practices: Dental and orthodontic practices deploy sterile labels for labeling sterile dental instruments, implants, and orthodontic appliances. These labels ensure proper identification and adherence to sterilization protocols.
Veterinary Medicine: Sterile labels find application in veterinary clinics and research facilities for labeling sterile surgical instruments, syringes, and implants used in veterinary procedures. These labels help ensure proper identification and prevent cross-contamination.
Cosmetics and Personal Care: Sterile labels are used in the cosmetics and personal care industry for labeling sterile products, such as contact lens solutions, sterile wipes, and sterile skincare products. These labels provide information about sterility and usage instructions.

Design considerations

Sterilization Compatibility: Sterile labels should be compatible with various sterilization methods, such as steam autoclaving, gamma irradiation, ethylene oxide (EtO) sterilization, or hydrogen peroxide vapor sterilization. Choosing labels that can withstand the specific sterilization method used in your facility is essential without compromising their adhesive properties or legibility.
Material Selection: Selecting the suitable label material is crucial for sterile labeling. Common materials used for sterile labels include polyester, polyimide, or other synthetic materials known for their durability and resistance to sterilization processes and cleaning agents. The chosen material should withstand sterilization without degrading, fading, or compromising label adhesion.
Adhesive Properties: The adhesive on sterile labels should be strong enough to ensure secure attachment to various surfaces, including medical devices, vials, containers, or packaging. The adhesive should maintain effectiveness even when exposed to sterilization methods, temperature fluctuations, or moisture.
Cleanliness and Particle Generation: Sterile labels should have low particle generation and resist shedding particles or fibers. The design should minimize the risks of introducing contaminants into the sterile environment. Labels with low particle generation help maintain the cleanliness and integrity of the sterile environment.
Legibility and Printability: Clear and readable identification is vital for sterile labeling. Labels should provide a smooth surface allowing high-quality printing of important information such as lot numbers, expiration dates, barcodes, or regulatory symbols. Crisp printing ensures easy identification and efficient data capture.
Compliance with Regulations: Sterile labels should meet industry and regulatory requirements, such as FDA regulations or ISO standards. Ensuring the labels used in sterile environments comply with the guidelines to maintain compliance and traceability is paramount.

Frequently asked questions

What is the difference between cleanroom labels and sterile labels?

Cleanroom labels are processed in environments that tightly regulate the amount of particulate matter exposed to the label surface. Sterile labels take this one step further by eradicating all microorganisms post-cleanroom processing.

How are cleanroom labels converted to sterile labels?

Each cleanroom label post-processing batch is irradiated with gamma radiation to sterilize the labels.

What is the difference between cleanroom labels and cleanroom tags?

Cleanroom tags are adhesive-free labels attached to the item of choice by hanging or tying.

What options are available for label adhesives?

We have multiple adhesive options ranging from high tack and peel strength permanent adhesion for sticky labels to easy-to-remove labels for those that wish to reuse their product post-labeling.

What label would you recommend for easy peel-off so I do not have to spend extra time washing off adhesive residue?

Our ultra-removable label is particularly suitable for customers who want to avoid additional washing cycles due to residue left by the label. These labels also do not leave behind the phantom ring often seen post-peeling.

Do you support GHS (Global Harmonized System) and GMP (Good Manufacturing Practices) label printing requirements for cleanrooms?

Yes, we are capable of preprinting labels in any format you need. We will work with you to ensure that you fully comply with GHS cleanroom standards.

How do you support cleanroom label identification requirements, asset tracking, back chain of custody (provenance) tracing, and general label inventory?

We can support you in several ways. We can customize any design you need to fit virtually any packaging. We can print barcodes, UPCs, and QR codes. This can be combined with any templates to make tracking and identification easier.

What type of printers are your cleanroom labels compatible with or commonly used?

Labels are used with various thermal printers (direct or thermal transfer) and inkjet printers, including DYMO 4XL, the Zebra GK420, Rollo Thermal Label Printer, Epson Colorworks, etc.

What type of products and items can you produce labels to fit?

We can create labels that are fit for use for an extensive architecture of materials, including:
Cleanroom bags (HDPE, LDPE, ESD, Nylon, etc.)
1. Pipes and tubing
2. Circuit boards
3. Cables and wires
4. Corrugated cardboard boxes
5. Glassware (scintillation vials, beakers, graduated cylinders, flask, etc.)
6. Plasticware

What is bioburden reduction?

Often expressed in terms of base log x, bioburden reduction is any activity or function designed to eradicate any microorganisms to reduce microorganism levels on or in an item of interest. For sterile applications, this value must remain at log 6 or 99.9999% removal of bioburden for a specified amount of time to be considered sterile.

What Our Customers Say

"The CleanMark team was informative about the different materials and print processes. They were able to quickly get me samples to test as well as pre-production proofs to verify label size, orientation and color. They fulfilled on their promise to decrease my delivery time while improving print quality."

— Ernie Schrepfer, Associate Director of Quality Access Biologicals