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A cleanroom is a controlled environment where pollutants such as dust, microbes and airborne particles are kept within strict limits. Sectors that operate cleanrooms include semiconductor manufacturing, pharmaceuticals, biotechnology, medical devices, electronics, aerospace, optics, and laser technologies. These environments require stringent contamination control to maintain optimal operational performance, and that’s where specialized cleanroom cleaning services play a vital role.
Cleanroom Classification
ISO 14644-1 Standard was widely adopted in replacing Federal Standard 209E in 1999 in Europe and in 2001 in the United States. Despite its official discontinuation, Federal Standard 209E remains widely referenced due to familiarity among practitioners.
The ISO 14644-1 Standard outlines nine classes of cleanrooms, ranging from ISO Class 1 (the cleanest) to ISO Class 9 (the room air). Each class imposes limits on airborne particulate levels, which directly impacts cleaning methods, frequency, and the equipment allowed within the cleanroom. Cleanroom cleanliness is classified based on the number and size of dust particles permitted per cubic meter (m3).
Table 1: ISO 14644-1 Cleanroom Classification
Rules and Regulations in Cleanroom Environments
Operating in a cleanroom environment requires adherence to strict procedures to minimize contamination.
1. Controlled Access and Gowning Procedures
Only authorized and trained personnel are allowed access to cleanrooms. Workers must wear cleanroom garments such as coveralls, hoods, gloves, shoe covers, and face masks based on the cleanroom’s ISO classification. These garments reduce the risk of human-borne contamination such as skin flakes, hair, or respiratory droplets.
Table 2: Minimum Apparel Requirement in Cleanroom
2. Air Filtration and HVAC Systems
Cleanrooms use High-Efficiency ParticulateAir (HEPA) or Ultra-Low Penetration Air (ULPA) filters to control airborne particles. The HVAC systems are designed to maintain positive pressure (or negative, depending on application), temperature, and humidity, ensuring that contaminated air doesn't enter from adjacent spaces.
3. Proper Cleaning Protocols
Cleaning in a cleanroom is a meticulous process. Surfaces must be wiped down with lint-free wipes and approved cleaning agents, using specific wiping techniques to trap and remove particles rather than disperse them. Mops, buckets, and tools must be cleanroom-compatible —non-shedding and autoclavable or sterilized.
4. Monitoring and Validation
Particle counts are regularly monitored through air samplers and surface swabs. Cleaning activities are documented meticulously to ensure traceability and compliance. Facilities must undergo validation to meet industry-specific standards.
5. Behavioural Protocols
Personnel must minimize movement, talking, and unnecessary activity, as these can generate particles. Personal items like jewellery, cosmetics, or mobile phones are prohibited inside cleanrooms.
6. Zoning and Segregation
Cleanrooms often follow a unidirectional workflow and zoning system, separating high-risk and low-risk areas to control contamination flow. Equipment, materials, and personnel movement are strictly managed to prevent cross-contamination.
Maclean’s Expertise in Cleanroom Cleaning Services
At Maclean, we specialise in cleanroom dust control cleaning services in sectors including semiconductors, medical devices, microelectronics, and pharmaceuticals. we understand the importance of dust control and strict compliance in cleanroom environments.
Maclean adheres to ISO 14644-1 and Federal Standard 209E, ensuring full compliance with regulatory requirements. What sets us apart is our comprehensive cleanroom training. The cleanroom service crew undergo training on cleanroom protocols, gowning techniques, equipment handling, and safety procedures. We also partner with clients to optimize their contamination control strategy, helping them pass audits, extend equipment lifespan, and ensure product quality. Refresher training is conducted periodically to ensure ongoing compliance and readiness for audits or inspections.
With our expert team and specialized training programs, Maclean helps clients maintain operational excellence and meet the highest quality and safety standards. Contact us at enquire@maclean.com.my or WhatsApp 019-292 1105 to learn more about our cleanroom dust control cleaning services.
References:
ISO.(2015). ISO 14644-1:2015.
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