A cleanroom’s primary objective is to provide an ultra-clean environment where sensitive manufacturing and testing processes can be carried out without contamination. Cleanrooms are used across a range of industries, from pharmaceuticals to semiconductors, where even the smallest amount of contamination can result in compromised product quality, failed batches, costly recalls, and regulatory issues.
Cleanrooms are classified based on the number and size of particles allowed per cubic meter of air. These classifications range from ISO 1 to ISO 9, with ISO 1 being the most stringent. The semiconductor, microelectronics, pharmaceutical, and medical device industries often require the highest cleanroom standards, where contamination can lead to severe operational disruptions.
While many contaminants, such as dust or airborne particles, are well understood, there are less obvious but equally harmful sources that can threaten the integrity of a cleanroom. Below we explore five hidden sources of contamination.
1. Human Activity: The Most Common Contamination Source
Human presence in cleanrooms is one of the leading causes of contamination. Every person entering a cleanroom, regardless of how well-gowned they are, sheds particles such as skin cells, hair, and bodily fluids. Even when wearing cleanroom-approved garments, improperly worn or maintained apparel can still allow particles to escape. Tears, worn-out fabrics, or incorrectly sealed cuffs can release these particles into the cleanroom environment, leading to contamination that compromises production.
A study on cleanroom contamination showed that about 30-40% of contamination is linked to human activity. In industries like pharmaceuticals or semiconductors, a small particle from a human source could cause product defects or even entire batch failures. The cost of these failures can be enormous, leading to both financial losses and damage to a company’s reputation.
Mitigation Strategies
- Certified Cleanroom Garments: Always use garments that meet cleanroom standards. Regular inspections of clothing for signs of wear and tear can help identify contamination risks before they become a problem.
- Proper Gowning Procedures: Implement strict gowning protocols to ensure that personnel fully cover themselves, including gloves, face masks, hoods, and shoe covers. Employees should be trained regularly to ensure compliance.
- Frequent Garment Changes: Cleanroom garments should be changed frequently, depending on the level of contamination risk. For high-grade cleanrooms, a fresh gown should be worn for each entry.
- Seal Cuffs and Gaps: Cleanroom cuff sealing tapes, specifically designed for use in clean environments, can help minimize particle release through garment openings.
For example, in a semiconductor manufacturing facility, a minor tear in a cleanroom worker’s garment went unnoticed. This allowed microscopic particles to enter the cleanroom, resulting in defective microchips. The loss was significant, causing the company to halt production and recall an entire batch of products.
2. Labels and Tapes: A Surprising Source of Contamination
Labels and tapes used in cleanrooms are often overlooked as potential contamination risks. Traditional labels and tapes are often made from paper or other materials that are prone to shedding particles, which can compromise cleanroom air quality. Additionally, adhesives used in these products can outgas or leave behind sticky residues, further contaminating the environment.
Paper-based labels and tapes tend to shed tiny fibers, and their adhesives can emit volatile organic compounds (VOCs) that degrade the cleanroom atmosphere. In semiconductor and pharmaceutical industries, this type of contamination can lead to chemical contamination that may ruin entire batches of sensitive products.
Mitigation Strategies
- Use Cleanroom-Certified Labels and Tapes: Opt for labels and tapes specifically designed for cleanroom environments. These products are made from synthetic materials that do not shed particles and have adhesives that do not outgas.
- Plastic Cores: Many tapes are wound on cardboard cores, which can shed fibers into the cleanroom. Use tapes with plastic cores to reduce the risk of particulation.
- Double-Bag Packaging: Tapes and labels should be packaged in double-bagged, cleanroom-compatible packaging to prevent contamination from outside sources.
For example, a pharmaceutical company found that outgassing from labels used on drug packaging caused chemical contamination, compromising the quality of a large batch of medication. The company had to recall the batch, resulting in lost revenue and regulatory scrutiny.
3. Process Tools: Necessary but Risky
Every piece of equipment brought into a cleanroom poses a contamination risk. While essential to manufacturing processes, tools can generate particulates, gases, and volatile organic compounds (VOCs), which can compromise cleanroom standards. Even tools that appear clean can release particles during use, making it crucial to implement stringent monitoring protocols.
During operation, process tools can emit solid particles, volatiles, or gases that can contaminate sensitive products. In industries such as medical devices or microelectronics, this can lead to device failures or expensive rework.
Mitigation Strategies
- Inspection and Cleaning: Before installation, all tools should be thoroughly inspected and cleaned. After installation, they should be regularly cleaned and maintained to prevent contamination during use.
- Continuous Monitoring: Monitoring tools for VOC emissions and particulation during use is essential. Implementing in-line filtration systems can help reduce the release of particulates and gases.
- Regular Maintenance Plans: Tools should have a scheduled maintenance routine, and staff should be trained to identify potential contamination sources from worn-out components or residue buildup.
For example, a medical device manufacturer discovered that contaminated medical devices used in open-heart surgery caused severe infections in patients which has led to a class-action lawsuit.
4. Raw Materials and Consumables: Hidden Contaminants
Raw materials and consumables, such as gloves, masks, and cleaning mats, can introduce contaminants into the cleanroom if they are not properly handled. Contamination can come from the packaging materials themselves or from improper handling practices, leading to the transfer of particles or microorganisms into the cleanroom.
The Risks
Materials brought into the cleanroom can introduce particulates or microbes, especially if they are handled improperly or not sufficiently cleaned before entry. Cross-contamination can also occur when materials are used across multiple processes.
Mitigation Strategies
- Pre-Clean All Materials: All materials entering the cleanroom should be cleaned to the appropriate standard. This includes packaging, raw materials, and consumables.
- Double-Bagging: All consumables should be double-bagged to prevent outside contaminants from entering the cleanroom during transport and storage.
- Controlled Handling Protocols: Staff should be trained in proper handling techniques to prevent cross-contamination, and dedicated areas for unbagging and handling materials should be implemented.
For example, a biotech company learned that improperly cleaned packaging materials had introduced bacteria into a critical drug manufacturing process, delaying production and jeopardizing an upcoming product launch.
5. Cleaning Products: Not All Are Created Equal
Cleaning products are an essential part of maintaining cleanroom standards, but not all cleaning supplies are appropriate for use in such controlled environments. Many household and industrial cleaners can leave behind residues, particulates, or even harmful gases that compromise cleanroom air quality.
The Risks
Using improper cleaning products can introduce more contaminants than they remove. For example, particulate-laden wipes or mops can shed fibers, and cleaning solutions can outgas harmful chemicals, leading to contamination issues in industries that require ultra-clean environments.
Mitigation Strategies
- Use Cleanroom-Specific Cleaning Products: Ensure that all cleaning supplies, including wipes, mops, and cleaning solutions, are designed specifically for cleanroom use. These products should minimize shedding and outgassing.
- Certified Vacuums: Use vacuums with filtration systems that meet or exceed the cleanroom’s classification. Improper vacuums can recirculate contaminants back into the environment.
- Surface-Specific Solutions: Different cleaning products are designed for different surfaces. For example, floor cleaners may not be suitable for counters or equipment surfaces, and using the wrong product could lead to chemical contamination.
Example
A microelectronics company saw a 15% increase in defective components due to improper cleaning procedures. After switching to cleanroom-approved cleaning supplies, they were able to significantly reduce contamination levels and improve production yields.
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In summary, hidden sources of contamination in cleanrooms can wreak havoc on production processes, leading to costly recalls, regulatory fines, and damage to brand reputation.
To ensure your facility operates at the highest level of cleanliness partner with SourceONE to implement proper protocols and using certified materials.
Contact us now for tailored cleanroom solutions that meet the stringent demands of your industry. Call us at (408) 437-3046 or complete our Contact Us form and we will reach out to you.