Pharma & Cleanrooms: Low-VOC, Low-Residue Tapes That Pass the Swab Test

Controlled cleanroom environments must be kept clear of all potential contaminants. That includes avoiding tapes that could release particulates or gas into the air or leave residue on surfaces. To maintain a safe, responsible cleanroom environment consistent with regulatory requirements, cleanrooms must use low-residue, sterile area tape that doesn't compromise sterility or introduce extractables.

Tape Jungle is a leading provider of ISO cleanroom tape. We offer a range of low-residue, low-outgassing, and medical-grade tape options perfect for a range of cleanroom situations.

What 'Cleanroom Appropriate' Means: VOCs, Outgassing, and Residue Basics

Cleanroom appropriate tapes are specifically engineered to be residue-free and release minimal particles or gasses into the environment. Tape-related contamination can lead to dangerous microbial growth and interfere with cleanroom operations. The most common types of tape contamination in sterile areas are:

Volatile Organic Compounds (VOCs): VOCs are harmful gases some adhesives emit, and they can contaminate cleanroom samples and harm workers' health.
Outgassing: Outgassing occurs when gases or small particles are released by tape adhesive or backing material, contaminating cleanroom air and surfaces.
Adhesive Transfer: Adhesive transfer occurs when tape adhesive remains on the surface after the tape is removed, creating a sticky surface for potential contamination.

Common tapes often leave adhesive smears or shed fibers, especially when exposed to temperature extremes and harsh chemicals common in cleanrooms. In some cases, tapes may damage underlying material when removed, delaminating surfaces and creating potential pockets of contamination.

Cleanroom Standards and Compliance Framework

To address these problems, federal and international standards organizations have established classifications and certifications for specific cleanroom applications. Organizations use cleanrooms for everything from pharmaceutical development to electronic equipment manufacturing, so regulatory standards can vary widely.

Standards for cleanroom-compliant tapes define requirements and limitations, such as tape materials and permitted levels of particulate offgassing.

ISO 14644

The International Organization for Standardization (ISO) provides worldwide standards for cleanroom safety under ISO 14644. This standard specifically addresses air cleanliness, outlining airborne particle concentration limits and filtration requirements.

Under ISO regulations, cleanrooms are classified from 1-9, with ISO 1 being the cleanest to ISO 9 being the least clean. ISO 1 facilities have the lowest allowable particle count, and are typically used for nanotechnology and other highly sensitive manufacturing. Most medical and pharmaceutical manufacturing operations range from ISO 5 for internal medical devices to ISO 8 for less sensitive external medical equipment.

GMP Annex 1

International standards for Good Manufacturing Practices in pharmaceuticals are outlined under GMP Annex 1. These regulations specifically identify good practices for cleanroom manufacturing of sterile medicinal products, including appropriate tape and adhesive materials.

GMP cleanroom requirements are divided into four grades (A, B, C, and D). Grade A has the most stringent standards, and Grade D the least. Like ISO regulations, these standards are based on allowable particle limits in pharmaceutical manufacturing operations. Grade A is equivalent to ISO 5, and is used for aseptic pharmaceutical filling and packaging. Grade B is equivalent to ISO 7 and Grades C and D correlate to ISO 8.

In addition to these international standards, the US Food and Drug Administration (FDA) maintains guidance and regulations for safe medical and pharmaceutical manufacturing practices. At Tape Jungle, we offer tapes consistent with cleanroom standards across numerous industries. We can help you determine which tapes are appropriate for your operation.

Tape Families That Perform Best in Pharma and Cleanrooms

The ideal tape for your cleanroom will vary depending on the application and operating conditions. The best performing tapes for cleanroom environments include the following.

Polyimide Tape (Silicone Adhesive)

Polyimide tape with a silicone adhesive is an electrical grade Kapton™ alternative ideal for use in elevated temperatures. It consists of a high-performance polyimide film with a low-outgassing silicone adhesive that leaves minimal residue when removed. This tape withstands high sanitization temperatures and harsh chemicals without losing adhesion.

Polyester Splicing and Masking Tapes

Polyester splicing tape is a thin polyester film with pre-cured silicone or acrylic adhesive that is resistant to cleaning chemicals and high temperatures. We recommend silicone adhesive for clean removal and optimal temperature resistance. However, it's important to check that your silicone adhesive is appropriate for cleanroom use.

For pharmaceutical operations, consider pharma masking tape with specialized chemical-resistant hold for medical-grade operations.

Specialty Low-VOC Labeling and Identification Tapes

Labeling and identification tapes are an unexpected source of contamination in sterile environments. Look for specialty low-outgassing tapes like polyethylene tape to color-code items, label equipment, and mark lines on countertops and equipment surfaces.

Controlled-Environment Floor and Safety Tapes

In non-critical Grade C and D rooms, the regulations for particle limits and surface contamination are much more relaxed. Tapes for these areas should still be low-residue and low-VOC. Choose a heavy duty vinyl or polyethylene film tape with acrylic adhesive for floor markings and safety labels.

Pharma & cleanrooms, low-VOC, low-residue tapes that pass the swab test.

The Swab Test: A Practical On-Site Method To Validate Tape

Thorough testing is crucial to ensure cleanroom-compliant tape. Before you apply a new tape to your cleanroom, perform a swab test to make sure it's appropriate for your facility. Most cleanrooms use a 70% concentration of isopropyl alcohol (IPA) in the form of wipes or swabs.

Put on gloves and clean them with a 70% IPA solution.
Wipe down the area where you plan to apply the tape using 70% IPA.
Apply the tape once the area is completely dry.
Remove the tape from the surface.
Moisten a sterile swab with 70% IPA.
Swab the area horizontally from the top left corner of the testing area.
Swipe the swab horizontally, turning it 180° with each pass. The strokes should overlap slightly.
Turn the swab to repeat the process using parallel vertical strokes from the top left corner of the test area.
Repeat the process again with diagonal parallel overlapping strokes, so you have sterilized the entire surface.
Allow the surface to air dry naturally.

Send the tape to a laboratory to test for adhesive residue and VOCs. During the test, watch the tape for loss of adhesion or discoloration that could indicate poor compatibility with sterilization processes.

Visual Assessment

In addition to the alcohol test, it's a good idea to visually assess tape residue. Look for streaks or smears of residual adhesive after removal. If there are filaments, particles, or adhesive still stuck to the surface, the tape is not appropriate for a sterile cleanroom environment.

Document your assessment by noting the tape lot number and taking photos of the tape before, during, and after swabbing. Write down your observations for quality assurance.

You can also gauge some particulate release from the tape or cardboard core by pulling the tape away from the core in bright light. Floating particles indicate a potential contamination issue. Alternatively, you can take a tape lift sample and compare particles microscopically.

Application-by-Application Recommendations

Although cleanroom tape must meet stringent standards, not all tapes work for all situations. Use this quick guide to determine the right tape for your application:

Equipment masking near sterilization or heat: Polyimide Kapton™ Alternative Tape provides strong adhesion with exceptional heat and chemical resistance.
Cable ID, fixtures, temp marking: Polyester with silicone adhesive is a low-VOC, low-residue tape with excellent hold in harsh cleanroom conditions.
Aisle demarcation and equipment zones: Cleanroom tape with low-VOC can ensure clear directions and safety markings on flooring and equipment without unnecessary offgassing or particulate release.
Temporary bonding or process labeling: Low-residue splicing tapes are low-profile polyester films perfect for line marking and color-coded labeling.

Best Practices for Cleanroom Tape Use and Storage

Even the highest quality cleanroom tape can show reduced performance with improper tape practices. If stored improperly, tape can collect dust and other particulate matter that can compromise your cleanroom. Environmental factors like temperature and humidity also affect how tape behaves in your cleanroom environment.

You can avoid tape degradation by storing rolls properly in airtight containers to minimize exposure to UV radiation and temperature fluctuations. Keep them in a dry environment to prevent adhesives from breaking down due to humidity in the air. Leave tape in the package until you are ready to use it, and make sure to wipe down the edges of any exposed tape with alcohol before applying.

Replace rolls as soon as they show signs of yellowing, edge lifting, or drying. If you notice performance issues, it's better to replace the tape than to keep using bad tape that can harm your operation.

Partner With Tape Jungle for Contamination Control and Operational Reliability

Cleanroom tape selection is about controlling contamination and ensuring reliability in harsh cleanroom conditions. At Tape Jungle, we understand the stringent requirements necessary for safe cleanroom operations. We offer sample testing and validation support to help you identify the right tape for your needs.

Start the process today by ordering samples of our polyester, low-VOC, and polyimide tape to test for your cleanroom operation. Or contact us to discuss your specific cleanroom tape needs.