As industries increasingly rely on cleanroom environments for producing high-quality products, maintaining and cleaning these spaces to the highest possible standards has become more critical than ever. However, achieving effective results is only possible with a well-trained workforce.

Employee training plays a crucial role in ensuring that cleanrooms are cleaned and maintained to the required standards, preventing contamination, reducing risks, and ensuring regulatory compliance.

Cleanroom Classifications

Cleanrooms are classified by how clean the air is. Singapore is using ISO 14644-1 cleanroom classification standards, requiring specific particle count measurements and calculations to classify a cleanroom or clean area’s cleanliness level. The classes are based on the maximum allowable number of airborne particles per cubic metre of air. Here are the different classes:

1. ISO Class 1 is the cleanest class of cleanroom, mostly used in electronics and life sciences industries requiring nanotechnology or ultra-fine particulate processing. It has a maximum of 10-micron particles of size 0.1 or larger per cubic metre of air.
2. ISO Class 2 has a maximum of 100 particles of microns measuring 0.1 or larger per cubic metre of air. These cleanrooms are used for applications like microelectronics manufacturing and some kinds of medical device manufacturing.
3. ISO Class 3 has a maximum of 1,000 particles of microns measuring 0.1 or larger per cubic metre of air. These cleanrooms are used for applications such as pharmaceutical manufacturing and some types of medical device manufacturing.
4. ISO Class 4 has a maximum of 10,000 particles of size 0.1 microns or larger per cubic metre of air. They are used for applications like electronics manufacturing, thin-film materials, displays, and optics.
5. ISO Class 5 is used in the biotechnology and pharmaceutical industry, specifically cell culture, microbiology research, and DNA/RNA amplification. It has a maximum of 100,000 particles measuring 0.1 microns or larger per cubic metre of air.
6. ISO Class 6 has a maximum of 1,000,000 particles of size 0.1 microns or larger per cubic metre of air. They are still considered high-performance cleanroom systems because their air quality is suitable for preparing particulate medical devices, sensitive products, and non-sterile or some terminally sterilised products.
7. ISO Class 7 cleanrooms serve as primary manufacturing environments or secondary containment rooms to support gowning, staging, or cleaning and processing stations. This class has a maximum of 3.52 million particles measuring 0.5 microns per cubic metre of air.
8. ISO Class 8 has a maximum of 35.2 million particles measuring 0.5 microns per cubic metre of air. ISO Class 8 cleanrooms are enough for numerous manufacturing processes, such as packaging, powder handling, storage of packaged goods, OEM assembly, and localised process containment/isolation.

Risks of inadequate cleanroom cleaning and maintenance

Regular cleanroom cleaning and maintenance are essential to guarantee the quality and safety of products manufactured in it. Such neglect would risk the product and people working within this space.

Recognise the following risks so you can be fully aware of what to do and avoid:

1. The number one risk is contamination. Cleanrooms are designed to regulate and minimise the number of airborne particles (in microns) and contaminants. Do not compromise the integrity of the product being manufactured/tested, as it may result in pricey product recalls and potential harm to consumers.
2. If you fail to clean and maintain the cleanroom, the product may malfunction, especially those sensitive to contamination (like microelectronics and pharmaceuticals).
3. The health and safety of workers within the cleanroom are also compromised, potentially causing illness and infection. This risk is significant for cleanrooms serving as a manufacturing space for medical devices and pharmaceuticals.
4. When a cleanroom is poorly maintained, it may lead to reduced efficiency and productivity. Say, your cleanroom is contaminated due to negligence in sanitation. It can cause delays in manufacturing processes and result in lost time and revenue. The workers may have to spend additional time containing and cleaning up contaminants, which could have been used in actual production.
5. You may also face compliance issues (e.g., fines, legal action, and damage to reputation) because cleanrooms must meet the stringent standards and guidelines set so they can legally operate.

Thus, it is imperative to keep your staff trained so that everyone is fully knowledgeable of the things to do and when to do them.

Cleanroom cleaning & maintenance training

The first and foremost training aspect must focus on familiarising employees with the protocol and regulations of their cleanroom. If you say you already did it, it would be best to remind them of rules that are often neglected, including new ISO standards (if there are any) and other updated guidelines. It is critical that they should be aware of company-specific procedures like gowning procedures, disinfection protocols, and airlock requirements.

The second training aspect should revolve around the proper cleaning techniques and tools needed for maintaining a cleanroom, including information on the appropriate cleaning agents and disinfectants, how to use and implement these tools and techniques properly, and correct handling and disposal of cleaning supplies and waste.

Workers within this engineered space must also be trained on the correct use of personal protective equipment. From the start, they should understand the appropriate PPE to be worn for a specific task and the proper PPE donning and doffing process to avoid contamination. They should also be trained to respond quickly and systematically and have adequate knowledge of emergency procedures, including evacuation, spill cleanup, and other safety protocols.

Finally, employees should be trained in record-keeping and documentation of cleaning activities, equipment calibration, and possible incidents and deviations. By considering all these in drafting the cleanroom cleaning and maintenance training program for employees, you can reduce the risk of product contamination and maintain a safe work environment for all personnel.

Best practices in cleanroom cleaning and maintenance

The following are best practices you can adopt for cleanroom cleaning and maintenance.

They are concise and straightforward.

1. Establish and strictly follow a cleaning schedule.
2. Use colour-coded cleaning tools.
3. Follow the recommended gowning procedures.
4. Monitor and maintain ideal environmental conditions.
5. Conduct regular equipment maintenance.

Strictly follow all these practices so that your cleanroom adheres to the highest cleanliness and employee safety standards.

Conclusion

Do not compromise personnel safety and product quality and start proactively addressing the risks presented above. Consider investing in training and retraining, as continuing education keeps up with the fast-paced changes and innovations in the industry. Work hand-in-hand with a cleanroom cleaning company to guarantee that your cleanroom is fully compliant with the standards and want to minimise these risks. Only the experts can tell what is clean for a cleanroom.

If you are in need of cleanroom cleaning services in Singapore, consider partnering with Day&Night Services. Get in touch with us for answers to your inquiries.