Are your labels contaminating your aseptic environment?

In the fast-paced corridors of a pharmaceutical research facility, maintaining an aseptic environment is paramount. Even minor contamination can compromise product safety, research integrity, or patient health. And that contamination can sneak in where you least suspect it — like a seemingly innocuous little label. 

There are two primary ways that a label can compromise an aseptic environment: by being a direct source of contamination or by compromising processes that guard against other sources of contamination. 

How labels can directly contaminate an aseptic environment

Let’s start with direct contamination risks. There are a number of different ways in which a label itself can become a source of contamination.

Particle shedding

When a label isn’t sufficiently durable to withstand the harsh conditions often present in laboratory aseptic environments, the label can degrade and begin shedding particles. This could occur due to mechanical abrasion, chemical exposure, or other environmental factors like humidity or extreme heat or cold temperatures. 

Particles shed from labels can carry bacteria, fungi, or other microorganisms into the aseptic environment. As these particles become airborne, they can settle on sterile surfaces, equipment, or even directly onto pharmaceutical products. This can introduce microbes into areas that need to remain sterile, increasing the risk of contamination in products like injectable drugs or sterile medical equipment.

Stray particles can also stick to gloves or other protective gear and then transfer to previously sterile surfaces or items during routine handling. This type of cross-contamination can be difficult to detect but has serious implications, as even a small microbial load can multiply quickly in the right conditions, jeopardizing product safety.

Adhesive residue

One often-overlooked source of contamination is adhesive residue left behind by labels. Sticky residues can trap and harbor microorganisms, creating localized pockets of contamination. These residues provide a surface where microbes can attach and multiply. Once microorganisms are present on the residue, they can be transferred to sterile surfaces, equipment, or products during handling, introducing contamination into the environment.

This risk is heightened by the fact that adhesive residue can be difficult to clean effectively with routine disinfection protocols. The adhesive can form a film that protects the microorganisms from the effects of sterilizing agents. As a result, surfaces that appear clean may still harbor microbial contamination, which can then be transferred to sterile products or packaging, compromising their safety.

Residue can also adhere to gloves, tools, or other items used within the aseptic environment. When personnel handle these items, the sticky residue, along with any trapped microbes, can be transferred to sterile materials or equipment. This risk of cross-contamination makes adhesive residue a serious concern in environments where maintaining sterility is critical.

Microbial passengers

Materials that have not been pre-treated or engineered specifically for sterility can harbor microbial contaminants right from the start, meaning that they may carry bacteria, fungi, or other microorganisms when they are first introduced into an aseptic environment. These microbes could come from various sources during the production, handling, and transportation of the label materials. For example, during the manufacturing process, materials might be exposed to airborne dust, moisture, or human handling, all of which can introduce microorganisms that might remain on the surface of the label.

Without specific sterilization treatments, such as gamma irradiation, ethylene oxide exposure (EtO), or autoclaving, these microbes remain viable on the materials. When these non-sterile materials are then used in an aseptic environment, they introduce a risk that microorganisms could transfer from the labels onto sterile surfaces or products. This risk is especially significant in environments where even a small microbial load could jeopardize the sterility of medical devices, pharmaceuticals, or research samples.

In an environment where the goal is to maintain near-complete freedom from microorganisms, even a single untreated label can become a source of significant contamination, undermining the stringent efforts to maintain sterility throughout the production or research process. 

How labels can indirectly contaminate an aseptic environment

Then there’s indirect contamination. In an aseptic environment, clear and reliable labeling is essential for ensuring proper handling, storage, and tracking of sterile items. Labels that become illegible due to exposure to chemicals, moisture, or extreme temperatures may lose important information, such as sterilization dates or batch numbers. This lack of traceability can result in the mishandling of contaminated items or failure to identify compromised batches, leading to potential contamination risks throughout the production or research process.

Imagine, for example, a medical device company that needs to autoclave various device components. These components are labeled with a serial number and sterilization date. If the label on which this information is kept degrades, then unsterilized components could accidentally be moved forward into the production process, jeopardizing patient safety and leading to expensive recalls (like this one).

Sterile, durable labels protect your aseptic environment

The answer to both of these risks is to use sterile labels that are custom-engineered to meet the unique durability requirements of your aseptic environment. 

Sterile labels

Sterile labels are meticulously prepared for use in aseptic environments through specialized manufacturing and sterilization processes. These labels are produced in controlled conditions to minimize the risk of contamination and are then subjected to rigorous sterilization method to eliminate any remaining microorganisms. The sterilization process ensures that the labels are free from bacteria, fungi, and other contaminants before they reach the aseptic environment.

Mechanical durability

Labels intended for use in aseptic environments meet stringent standards of mechanical durability to ensure that the labels remain intact without tearing, fading, or peeling when exposed to physical stress, such as application, removal, or repeated handling. This durability ensures that critical information remains legible and prevents particle shedding or adhesive residue that contribute to contamination.

Chemical resistance

Chemical resistance is essential for labels in aseptic environments. They often must withstand harsh cleaning agents and disinfectants like hydrogen peroxide, ethanol, isopropyl alcohol, and bleach-based solutions. Chemically resistant labels are designed to maintain their adhesion and legibility despite repeated exposure to these aggressive cleaners. 

Autoclave durability

Autoclaves are commonly used to sterilize equipment and materials in aseptic environments. They reach temperatures of 121°C (250°F) or higher and use pressure and steam to effectively eliminate microbial life. Autoclave-durable labels are specially engineered to resist these high temperatures and pressures without degrading or peeling, ensuring that they remain securely attached to surfaces throughout the entire sterilization cycle. This durability is crucial for maintaining traceability and compliance, as it ensures that labels remain intact and readable even after multiple sterilization cycles. 

Extreme cold resistance

Labels used in aseptic environments often need to withstand extreme cold, especially in settings where products are stored or transported at sub-zero temperatures, such as cryogenic storage or deep freezers. Extreme cold resistance ensures that labels maintain their adhesion, flexibility, and legibility even when exposed to temperatures as low as -196°C, which is common in cryogenic environments. 

Engineering the perfect label for your aseptic environment

The only person who knows exactly what a label needs to withstand in your particular aseptic environment is — you! That’s why it’s essential to use a custom-engineered label designed with an labeling partner experienced with aseptic environments. 

CleanMark works with our customers to understand every nuance of their environmental and use needs and then we engineer a high-performance, cost-effective label that will safeguard your sensitive environments and perform seamlessly in your operational processes.

And, we stay with you longterm to ensure that your labels are always optimized. Let us show you what a difference custom labels can make. Schedule a consultation with one of our label engineers.