Autoclave tape guarantees safety in high-sensitivity industries like pharma and biotech

In industries like pharmaceuticals, medical devices, BioTech, and life sciences, where patient safety is on the line — and where recalls and noncompliance can jeopardize companys’ financial health — maintaining sterility is essential. That means not just knowing that something went into and out of the autoclave. It means knowing that the autoclaving process actually worked. One of the more efficient ways to get that level of certainty is with autoclave tape.  

What is autoclave tape?

At the most basic level, autoclave tape (also sometimes called autoclave indicator tape or autoclave sterilization tape) is a pressure-, time-, and heat-sensitive adhesive tape used to indicate whether items have been exposed to the proper sterilization conditions in an autoclave. 

Similar to other sterilization indicators (like gamma labels or dots and EtO indicator labels), autoclave  indicator tape changes color or displays markings when subjected to the factors that result in successful sterilization, providing a visual confirmation that the sterilization process has been completed successfully. It’s worth noting that this same technology is also used in autoclave indicator labels and dots. 

The science behind autoclave tape

Autoclave indicator tape is designed with a sophisticated blend of materials and chemicals that enable the user to visibly confirm whether an item has been exposed to the appropriate combination of heat, pressure, and time to be properly sterilized. Because of the accuracy  required of autoclave tape, precise manufacturing processes must be used in its production. 

Here’s a detailed look at how this technology works:

Heat sensitivity and chemical indicators

At the core of autoclave indicator tape’s functionality is the use of chemical indicators that are sensitive to heat and pressure. Indicator ink reacts to the specific heat and pressure levels encountered during autoclaving, typically between 121°C and 134°C for a sustained period, usually 15 to 30 minutes.

The indicator ink contains heat-sensitive chemical compounds, often made from organic compounds like lead carbonate, copper oxide, or other similar agents. These chemicals are chosen for their ability to undergo a visible chemical change when exposed to the appropriate sterilization conditions. 

For example, they may decompose or oxidize when the tape reaches the necessary combination of temperature and pressure, leading to a distinct color change, often from white or light yellow to dark brown or black. This reaction is irreversible, providing a permanent visual record that the sterilization process has been completed.

Time, temperature, and pressure

The functionality of autoclave tape is closely tied to the precise combination of time, temperature, and pressure that autoclaving requires. For sterilization to be effective, steam must penetrate the load to kill bacteria, viruses, spores, and other contaminants. Autoclave indicator tape is designed to react only when all three parameters — time, temperature, and pressure — are met.

• Temperature: Autoclave indicator ink is specifically engineered to respond only when the autoclave reaches the target temperature range.
• Pressure: Autoclave tape is pressure-sensitive to ensure that merely heating an item (without the necessary pressure for sterilization) won’t trigger the indicator.
• Time: Autoclave cycles require a sustained period of exposure to achieve complete sterilization. Autoclave indicator tape is designed not to react immediately but only after it has been exposed to these conditions for the appropriate duration.

How to ensure you choose the right autoclave tape for your use case

Autoclave tape can be beneficial in a broad range of industries, but it’s especially important in industries where sterility and particle elimination can mean the difference between business success and failure, or even worse, endangering patient safety.

All autoclave tape is not created equal. Off the shelf autoclave indicator tape likely doesn’t have all the features you’ll need to make it work efficiently and reliably in your unique environment and processes. Custom autoclave indicator tape ensures you have a solution that’s tailored to your unique environment and operational processes.

Ready to learn which autoclave tape features you should be paying attention to in your industry? Read on.

Autoclave tape in semiconductor manufacturing

In industries like semiconductor manufacturing, where environments aren’t just sterile, but clean, autoclave tape not only has to perform its primary function but also meet cleanroom particulate parameters and be ESD controlling. 

Autoclave tape for pharmaceutical and medical device manufacturing

For highly regulated industries like pharma, medical device manufacturing, BioTech, and life sciences, autoclave indicator tape is a powerful tool in proving compliance. This holds true both in research and manufacturing processes and also with packaging. Take, for instance, sterile packaging for injectable drugs, vaccines, or biologics, where proof of proper sterilization is critical for meeting FDA and GMP (Good Manufacturing Practices) standards.

Autoclave tape in the food and beverage industry

In food and beverage processing, autoclave sterilization tape is key for hygiene and safety — and it must withstand harsh chemicals and cold temperatures during processing and storage. Custom tapes designed to withstand cold storage, chemical exposure, and abrasion ensure items are contamination-free.

By using custom-designed autoclave tape, companies in these sectors can not only streamline their sterilization processes but also improve traceability and compliance with regulatory requirements. These tapes provide a visual, customizable method to ensure proper sterilization while enhancing operational efficiency and ensuring product safety across industries.

Designing the perfect customized autoclave tape

So. You know you need a solution that reliably indicates autoclave sterilization. You know tape is the right form factor. You know you need it to do some other stuff besides simply indicating sterility. Where do you go from here? 

First, find a good label partner, like CleanMark, to do the heavy lifting for you. We have label engineers experienced in a broad range of high-tech sectors who will work with you to understand your use case and design a custom label that fits your unique needs. Below are just a few of the factors they’ll consider.

Adhesive 

Autoclave tape can only do its sterility indicating job if it stays where it’s supposed to be. That means choosing an adhesive that sticks for the intended period of time (permanent, removable, or repositionable) to the type of surface you’ll be using and can withstand environmental stressors like extreme temperature, chemical exposure, moisture, or abrasion. 

The adhesive typically used is pressure-sensitive and designed to adhere securely during the sterilization process while maintaining its stickiness after autoclaving, ensuring the tape doesn’t lose its position during sterilization or leave residue when removed. Moreover, the adhesive and tape must be formulated to resist moisture because the steam used in autoclaving could otherwise cause ordinary adhesives to soften or fail. 

Durability

Again, autoclave tape is only helpful if it doesn’t disintegrate. That means it has to be engineered to not only indicate autoclave sterilization success but withstand the extreme conditions inside an autoclave. Autoclave tape backing material is usually made from high-density crepe paper or other heat-resistant fibers that can endure exposure to high temperatures without degrading. 

Custom indicator systems

In customized autoclave sterilization tape designs, additional indicator features may be included. For instance, some autoclave tapes incorporate multiple indicators that illustrate successful autoclave sterilization and also exposure to ethylene oxide (EtO) or gamma radiation.

Ensuring reliability and accuracy

Whichever features your autoclave indicator tape has, it of must also meet international standards such as ISO 11140-1, which defines performance criteria for sterilization indicators. The standard ensures that the color change is easily discernible and that the tape reacts only when specific sterilization parameters are met, avoiding false positives. 

The next step is easy — set up a consultation with one of CleanMark’s label experts! They’re waiting to hear from you.