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Custom sterile labels

Sterile labels configured for your process, equipment, and requirements.

Gamma-sterilized labels for aseptic applications, configured around your printing equipment, packaging, sterile transfer procedures, and qualification needs.

An engineer replies within one business day.

Blue-gloved technician inspecting a labeled vial in a sterile work environment
Cleanroom experience since the 1990sISO 9001:2015 certifiedEngineering and manufacturing in the U.S.
How we help

Common starting points for sterile label projects.

Address a sterile requirementA new sterile supply or aseptic-handling requirement. We help define the label construction, packaging, and documentation needed for evaluation.
Develop a new applicationA new container, product, or workflow. We configure a sterile labeling approach around the process and equipment you already use.
Respond to a process changeChanges to sterilization, transfer, printing, or handling. We review what needs to change and what can remain the same.
Switch sterile label suppliersSupply concerns, inconsistent performance, or qualification needs. We help compare constructions and plan a controlled transition.
Sterile label basics

What are sterile labels?

Sterile labels are specialized identification labels that have been sterilized and packaged to maintain their sterile condition until the package is opened for use in a sterile or aseptic workflow. They are used in pharmaceutical manufacturing, biotechnology, sterile compounding, and other contamination-sensitive applications.

Unlike standard labels, sterile labels must address reliable identification alongside sterile supply, packaging, transfer, printing, and handling. Sterile supply alone does not establish cleanroom compatibility or resistance to additional sterilization.

How CleanMark helps: We offer gamma-sterilized labels in paper-based and cleanroom-compatible constructions, configured around your equipment and application requirements.

Sterile label selection guide

What does your sterile label need to do?

We help align the construction, sterilization approach, printing, and packaging with your process. These are considerations we review with you—not choices you need to make before contacting us.

Support sterile supply and transfer

We help configure sterilization and packaging requirements around how labels enter your controlled process.

Work with your existing equipment

We evaluate printer, ribbon, applicator, roll format, and liner compatibility before recommending a construction.

Maintain identification performance

We account for adhesion, readable text and barcodes, handling, and any exposures after sterilization.

Support qualification and documentation

We clarify specification, sterilization, traceability, and documentation needs for your review process.

Available formats

Labels that fit your equipment and process.

From roll labels to sheets and tags, we configure dimensions, materials, and packaging to work with your existing printers, applicators, and cleanroom procedures.

Die-cut labels on a white plastic coreRoll labelsDie-cut for printing, dispensing, or application.
Continuous label material on a white plastic coreContinuous rollsContinuous media for your printing workflow.
Stack of sheets with die-cut labelsSheetsSheeted labels for manual application.
Cleanroom-compatible identification tagsTagsIdentification without an adhesive label.
Stack of fanfolded cleanroom labelsFanfoldedFolded media for compatible equipment.
Example application · Sterile compounding

A new sterile requirement. An existing labeling line.

A compounding organization needed sterile continuous-roll labels for IV bags and syringes while retaining its existing printers and applicators.

01Sterile continuous-roll supply
02Existing printer and applicator compatibility
03Gamma sterilization and controlled packaging
01 / THE CHALLENGE

Introduce sterile labels without replacing equipment.

The application needed a sterile label supply approach compatible with established printing and application workflows.

02 / CLEANMARK’S APPROACH

Engineer around the existing process.

CleanMark reviewed materials, equipment requirements, packaging, and gamma sterilization as connected design considerations.

03 / THE EVALUATION

Evaluate the complete construction.

The proposed construction would be reviewed against printing, handling, sterile transfer, and qualification requirements.

04 / THE TARGET OUTCOME

A qualification-ready path forward.

The objective was a label tailored to the application with clear evaluation and approval steps—not a claim of completed qualification.

How it works

From application requirements to reliable supply.

We help you define the right label, evaluate its performance, and move into production with a specification built around your process.

01 / DEFINE

Understand your application.

We review your surfaces, operating conditions, and performance requirements to identify a suitable label construction and the next steps for evaluation.

02 / EVALUATE

Test and verify performance.

Evaluate samples through your actual cleaning, handling, and storage conditions. We provide technical data and engineering support to help you assess performance against your requirements.

03 / PRODUCE

Finalize and manufacture.

Once the construction is approved, we confirm specifications, pricing, quantities, packaging, and lead times before manufacturing your labels.

04 / SUPPORT

Maintain consistent performance.

We maintain your approved specification for repeat orders and help evaluate changes to your materials, equipment, or process that could affect label performance.

Sample packs

Evaluate the label in your sterile process.

Screen materials first or request a construction configured for your application. Sterile status, packaging, and documentation are confirmed before samples or prototypes are supplied.

Option 1 · Ready to ship

Product sample

For early material screening: evaluate adhesion, print compatibility, and durability before choosing a configured construction. Product samples are not automatically supplied sterile.

What you can test
  • Adhesion on your actual surfaces
  • Facestock durability against your chemicals and handling
  • Printing on your own printer (not included)
  • Full performance in your process (not included)

Best for: early screening and comparing constructions.

Select product sample →

Your sterile label project

Get the specifications, samples, or pricing you need.

Tell us about your sterile labeling application. Our engineers will help clarify construction, sterilization, packaging, and next steps.

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