The high cost of medication errors

Medication errors — many of which result from ineffectively designed or poor-quality labeling — can have severe consequences for patient safety and healthcare outcomes. 

Patient harm

Inaccurate or misleading medication labels can cause patients to receive incorrect dosages or wrong medications, resulting in harm or even death. The Institute of Medicine (IOM) reported that medication errors, including those due to labeling issues, contribute to approximately 7,000 deaths annually in the United States alone.

Increased healthcare costs

Medication errors impose a substantial financial burden on healthcare organizations — approximately $42 billion USD annually or 1% of total global health expenditure, according to World Health Organization estimates.

Loss of patient trust

When patients experience harm due to medication errors caused by ineffective medication labels, it reduces trust in healthcare providers and the medical system, negatively impacting health outcomes and the success of healthcare providers.

Legal and professional repercussions

Healthcare professionals and organizations involved in medication errors may face legal actions, professional disciplinary measures, and damage to their reputations, which can be costly both in the short and long term. 

Creating perfect medication labels is challenging

Medical labels have to be exceptionally multi-functional. They must convey complex information clearly to protect customer safety, endure cold and moisture during storage and shipping, withstand sterilization, and contain tracking and other information mandated by government regulations like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

While standard labels might accomplish one of these goals, they rarely can deliver on all of them. Poor legibility, inadequate adhesives, or materials that fail during cold storage or high humidity can compromise patient safety and lead to costly errors. 

Medical label durability and legibility

Medical facilities are filled with environments that can deteriorate poorly designed labels. Heat, moisture and chemical exposure during sterilization can cause adhesives to fail and label surfaces to wear, reducing or eliminating legibility. Cold storage and its associated moisture can have similarly damaging effects. 

Medication mix-ups

Confusion between medications with similar names — known as look-alike, sound-alike (LASA) errors — is a leading cause of dangerous errors in medical settings and can be exacerbated by poor font choice, confusing label design, and surface degradation that reduces legibility.

Regulatory demands

In addition to patient and safety information, a number of important medication regulations require labels to include tracking elements like bar codes or batch numbers that require variable or on-site printing and must maintain print sharpness in order to be reliably scanned. 

Custom medical labels satisfy all pharmaceutical labeling requirements and then some

Unlike standard labels, custom labels are tailored to meet the unique requirements of medication labels, providing several key advantages:

Enhanced durability and adhesion

Healthcare environments often involve exposure to extreme temperatures, moisture, and chemicals. Custom labels are engineered with specialized materials and adhesives to withstand these harsh conditions, ensuring that they remain intact and legible throughout the product’s lifecycle. 

• Cold and moisture durable adhesives
• Chemical resistant coatings or lamination
• Synthetic liners and facestocks
• Autoclave durable materials

Compliance with regulatory standards

Custom labels can be designed to include all necessary information, such as dosage instructions, expiration dates, and batch numbers, in formats that comply with agencies like the FDA and EMA. 

• Variable batch printing
• Barcodes
• QR codes

Prevention of medication errors

Clear and accurate labeling is vital to prevent medication errors. Custom labels can incorporate features like color coding, highly-legible fonts, barcodes, and QR codes to facilitate quick and accurate identification of medications, thereby reducing the risk of administering the wrong drug or dosage.

• Inkjet, laser, and thermal printing options
• Partial or full printing
• 4-color or black and white
• On-site printing

Sterilization indicators

Custom labels can integrate sterilization indicators providing clear visual confirmation that the sterilization process has been completed.

• Autoclave
• EtO sterilization
• Gamma irradiation 

Improved efficiency

Custom labels can be designed for compatibility with common printing technologies and application processes, streamlining production workflows. 

• Increased traceability
• Variable printing
• Optimized for automatic application

Pro tip >> Learn which printing technology is right for your setting. 

Choosing the right medication label company

Choosing the right label company is essential when it comes to ensuring the safety, compliance, and efficiency of your medication labels. 

CleanMark brings unparalleled expertise and experience in designing and producing medication labels that meet the stringent requirements of the pharmaceutical industry. Our team understands the complexities of regulatory compliance, environmental durability, and operational efficiency, allowing us to deliver solutions that perform flawlessly in your unique environment.

Whether you need labels that can withstand extreme temperatures, integrated sterilization indicators, or enhanced traceability with barcodes and QR codes, CleanMark has the technical know-how and state-of-the-art materials to deliver results. 

Our team of label experts is waiting. Schedule your consultation here. 

References

• “A systematic literature review on strategies to avoid look-alike errors of labels”
• Medication safety for look-alike, sound-alike medicines
• Guideline on the packaging information of medicinal products for human use authorized by the union
• To Err is Human: Building a Safer Health System
• Medication Without Harm

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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.

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What is EtO gas sterilization?

EtO gas sterilization works by exposing products to ethylene oxide gas under controlled conditions of temperature, humidity, and time. The gas penetrates the materials, effectively killing bacteria, viruses, and fungi, making the products safe for use in medical and other critical applications. However, the process must be carefully monitored to ensure all parameters are met and the sterilization is effective.

Challenges in EtO gas sterilization

EtO has a lot of advantages and is an effective way to ensure sterilization. It does, however, have some unique challenges.

Precise control of parameters

The efficacy of EtO sterilization depends on maintaining precise control over a number of parameters, including gas concentration, temperature, humidity, and exposure time.

Safety concerns

Ethylene oxide is a toxic and flammable gas, making safety a top priority. Proper handling and monitoring are essential to protect workers and ensure environmental safety.

Regulatory compliance

Strict regulations govern the use of EtO for sterilization, necessitating thorough documentation and validation of the sterilization process.

The role of EtO indicator labels

Like many sterilization indicator labels, EtO indicator labels are designed to change color when exposed to ethylene oxide gas. These labels serve as a visual confirmation that the sterilization process has taken place. Here’s how they contribute to effective monitoring:

Visual confirmation

The primary function of EtO indicator labels is to provide a clear visual indication that the sterilization process has been completed. The color change is an immediate and easily recognizable sign that the items have been exposed to EtO gas.

Quality assurance

By providing a straightforward method to verify sterilization, these labels enhance quality assurance processes. They help ensure that every item in a batch has been exposed to the sterilization process, reducing the risk of non-sterile items reaching the end user.

Regulatory compliance

Using indicator labels helps meet regulatory requirements for documentation and validation of the sterilization process. The labels can be included in records, providing evidence that the sterilization parameters were achieved.

Ease of use

EtO indicator labels are simple to use and can be easily integrated into existing sterilization workflows. They do not require any special equipment or training, making them appropriate for a wide range of applications.

Chemical mechanism of EtO indicator labels

EtO indicator labels use specialized inks that undergo a distinct chemical reaction upon exposure to ethylene oxide gas. These inks typically contain specific dye compounds that change their molecular structure when they react with EtO, resulting in a visible color change. For instance, a dye used in EtO indicator labels  might transition from purple to green upon sufficient exposure to EtO gas. This reaction is both time and concentration dependent, meaning the color change indicates not only the presence of EtO but also that it has been present in adequate quantities and for a sufficient duration to ensure sterilization.

Types of EtO indicator labels  and sensitivity

EtO indicator labels are classified into different categories, according to ISO 11140 standards, based on their sensitivity and the information they provide. 

Class 1 EtO indicators: These provide a basic pass/fail result, indicating whether the item has been exposed to EtO gas.

Class 2 and higher EtO indicators: These can offer more detailed information, such as exposure to specific sterilization conditions like temperature and humidity.

The sensitivity of these indicators is critical, as they must respond accurately to the presence of EtO gas. Most indicators are designed to react within a specific range of EtO concentration, typically between 200 to 600 mg/L, at controlled temperature and humidity levels, ensuring reliable performance across various sterilization cycles.

Integration with existing labeling systems

One significant advantage of EtO indicator ink is its versatility. This ink can be incorporated into labels that are already in use for asset identification and tracking. This integration allows for a seamless addition of sterilization verification without the need for separate labels, simplifying the process and reducing costs. 

By using custom-engineered labels that combine asset identification and sterilization indicators in a single label, organizations can enhance their efficiency and ensure comprehensive monitoring and tracking throughout the sterilization process.

Best practices for using EtO indicator labels

To maximize the effectiveness of EtO indicator labels, it’s important to follow a few best practices:

Placement

Place the EtOindicator labels in locations where they will be directly exposed to the EtO gas. Ensure that labels are attached to all items or packages that need to be sterilized.

Storage and handling

Store EtO indicator labels in a cool, dry place to maintain their sensitivity and reliability. Handle them with care to avoid any pre-exposure to conditions that might affect their performance.

Interpretation

Train personnel on the correct interpretation of the color change. Ensure that everyone involved in the sterilization process understands what a positive color change looks like and the implications for items that do not show the expected change.

Documentation

Include the use of EtO indicator labels in your sterilization process documentation. Record the presence and condition of labels as part of your routine quality checks.

Ensure safety and efficacy with EtO indicator labels

Effective monitoring of EtO gas sterilization is essential for ensuring the safety and efficacy of sterilized products. EtO indicator labels play a crucial role in this process by providing a clear, visual confirmation that sterilization has occurred. By incorporating these labels into your sterilization workflow, and potentially integrating them with existing asset identification and tracking labels, you can enhance quality assurance, ensure regulatory compliance, and improve the overall safety of your products.

For more information on how to optimize your labels for EtO gas sterilization, schedule a consultation with one of our label engineers.

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Time consuming multi-label autoclave process

As a part of their manufacturing process, Invisible Sentinel stores different types of liquid media inside polypropylene bottles. These bottles (and media within) undergo an autoclave sterilization process. Dominic Falance, director of manufacturing at Invisible Sentinel, wanted to introduce a better way to distinguish the difference between each type of media by integrating a color-coded labeling system to the bottles. After searching online, he found CleanMark and brought his ideas forward so we could bring them to life.

One main challenge that Invisible Sentinel faced was finding a label manufacturer who could produce custom sized labels in small quantities. Also, their existing method for showing proof of sterilization included applying and removing autoclave indicating tape to the bottles in addition to a separate product label.

Dominic preferred to switch to integrated autoclave labels that would serve both functions simultaneously. Each label was to be assigned its own color to specify 12 different types of media. After the autoclave process was complete, the label must be removed but one challenge still remained: how would they be able to distinguish which media was inside each bottle?

Multi-purpose autoclave labels

With Dominic’s idea, CleanMark created a separate outer-ring label, each with a matching color that correlated to the previous autoclave indicating label (see photo). Once the initial label was removed, their manufacturing team could now easily determine the corresponding media.

Dominic’s ideas helped CleanMark’s engineers to select the proper materials needed for each unique label. The outer ring label needed an aggressive permanent adhesive that would last while the autoclave indicating label needed a material-plus-adhesive combination that could be easily removed within three to five days.

What’s more: part of Invisible Sentinel’s manufacturing process involved placing these bottles (and labels) through a vigorous laboratory wash machine cycle. This particular wash cycle would expose the labels to harsh chemicals such as IPA & Lancer-acid. It was critical that CleanMark could produce chemical-resistant autoclave labels that would survive all aspects of this process while maintaining their integrity, legibility, and color.

After a round of free material sampling, Dominic was able to evaluate the performance of CleanMark’s recommended labels on the bottles, through the autoclave sterilization process, and through the lab wash cycle.

“CleanMark was able to help us bring a rough idea to fruition at a very competitive cost. Their expertise with labels made the process very simple as they guided us through everything.”

— Dominic Falance, director of manufacturing at Invisible Sentinel

Custom autoclave labels that save time and resources

With an understanding of Invisible Sentinel’s goals, CleanMark was able to develop a custom labeling system that served several purposes while saving them money. This also simplified their existing process by removing the need for separately applying and removing autoclave indicating tape. Now Invisible Sentinel has a go-to resource that they trust for their label needs.

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Labor-intensive, hand-applied gamma labels

Access Biologicals’ products are filtered and packaged in bottles with technically advanced labels used for branding, compound identification, and sterilization indication. Access Biologicals was experiencing various quality issues related to ink smearing and general material inefficiencies with these labels. Unfortunately, their current supplier couldn’t accommodate correcting these issues on schedule. 

CleanMark connected with Ernie Schrepfer, associate director of quality at Access Biologicals, and after a quick introduction call, presented a way for them to acquire labels in a timely manner but also identified an opportunity to make major changes to the existing label construction, which resulted in a more efficient labeling process.

First, Access Biologicals needed to find a label with better ink properties to enhance the appearance of the company’s logo and brand. Secondly, their product had to include visual proof that it successfully completed a cycle of gamma irradiation for sterility assurance. This process was performed by hand applying a small, circular indicating label to the (already) existing printed label which changes colors to indicate that the bottle had been gamma irradiated. Next, the label adhesive needed to uphold its integrity and remain adhered to the bottles in extreme temperatures below -70°C. Lastly, the printed information on the label needed to survive harsh chemical interaction in order to remain legible.

Gamma labels integrated with cryogenic adhesive

CleanMark utilized their state of the art Flexographic print process with color matching technology to create an exact match of Access Biologicals’ specific shades of blue used for the label. This was paired with a special varnish layer to protect the print from harsh cleaning chemicals, as well. Then, CleanMark’s engineering team identified an alternative way for this label to include the gamma indicating feature without having to apply a secondary gamma dot. 

First, CleanMark’s art department manipulated Access Biologicals’ current label blueprint, which created additional space on the cleanroom label. This additional space allowed room to include a gamma-indicating strip directly onto the label itself and eliminated the need to apply a separate gamma dot. 

This new design caused one side of the label roll to be thicker than the other (due to the addition of the gamma strip). CleanMark’s sampling process was so fast that Access Biologicals was able to implement a minor process change to accommodate this major improvement. This change was accommodated by decreasing the number of labels per roll and changing the way that the rolls were wrapped and handled by the filling group. 

To top it all off, CleanMark used their premium cryogenic adhesive, which withstands negative service temperatures as far down as -196°C!

“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 at Access Biologicals

Integrated gamma labels that are fast to apply

CleanMark’s collaboration with Access Biologicals resulted in a simplified process that no longer required adding a hand-applied gamma dot. Delivery times were cut in half while also improving the overall print quality. Most importantly, Access Biologicals now has a trusted partner that is responsive to its needs and provides the company with solutions that actually work.

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CleanMark approached the company’s manufacturing team with an introduction call and discovered that they needed help improving their process for gamma indicating identification on the growing amount of packages which transported their pipetting devices to their customers.

The company’s existing process for sterile indication was to manually apply a gamma indicator dot label to thousands of pre-printed barcode labels by hand. These labels were later applied to inner boxes for customers as well as outer shelf cartons which store products inside the warehouse. 

Theoretically, this was a working process, but the inconsistency (and sometimes complete lack) of gamma indicator dot placement created confusion when trying to determine which packages had actually completed the sterilization process. This inevitable misplacement combined with the increasing volume of packages was causing timing set-backs on the manufacturing floor but, more importantly, left the end customer with wavering confidence in their products. Without proof, how could they be certain that their products were successfully sterilized?

Cost-saving, automatically applied gamma indicator dots

First, CleanMark engineers identified the proper synthetic label material and adhesive construction to survive the rigorous ASTM packaging requirements for this application. Secondly, CleanMark offered a custom two-in-one label design where the gamma indicating feature was built directly into the label itself. This feature completely eliminated the time-consuming step of hand applying a gamma indicator dot like before. 

Traditional custom gamma indicating labels entail a long indicating strip which runs along the entire border of the label (see image below).

The chemicals and materials used to make these gamma indicating features function and change color correctly can be pricey in volume, especially when large companies consume thousands of labels per day. 

Sensitive to this inconvenience, CleanMark invested in the technology used to produce gamma indicator dots instead of strips, all while using the same automatic application technique. One small auto-applied gamma indicator dot per label compared to thousands of continuous feet of a gamma strip saved a significant amount of material cost in the long run while achieving the same goal.

Gamma indicator dots that save time, resources, and reputation

After gaining a deep understanding of the customer’s goals, CleanMark was able to create a more efficient label that prevented hours of future downtime while increasing peace of mind for the company’s customers. 

This new solution also indirectly saved their executive management team a great deal of unnecessary cost. Ultimately, they received the best of both worlds when acquiring a label that needed to fulfill a vital purpose. Most importantly, their customers could count on them to deliver parts with proof of sterilization — a priceless asset for any life science professional performing critical research.

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