ISO 5 cleanrooms, also known as class 100 cleanrooms, are controlled environments used in industries where particulate contamination control is critical. They provide a clean space where the concentration of airborne particles is tightly controlled and monitored. But what exactly are ISO 5 cleanrooms used for and why are they needed?
What is an ISO 5 Cleanroom?
ISO 5 cleanrooms refer to cleanroom facilities that meet the ISO 14644-1 class 5 air cleanliness standard. This international standard defines the maximum concentration limits of particles per volume of air at specific particle sizes. For an ISO 5 cleanroom:
- There must be no more than 3,520 particles of 0.1 μm or larger per cubic meter of air
- No more than 352 particles of 0.2 μm or larger per cubic meter
- No more than 83 particles of 0.3 μm or larger per cubic meter
- And just 10 particles of 0.5 μm or larger per cubic meter
To achieve these stringent particulate concentration limits, ISO 5 cleanrooms use high-efficiency particulate air (HEPA) filters, specialized air handling systems, strict protocols for gowning and cleaning, and constant monitoring. Air is continuously circulated through the HEPA filters to remove particles and keep contaminants in check.
Applications of ISO 5 Cleanrooms
The ultra-low particulate levels in ISO 5 cleanrooms make them essential for industries and processes where tiny particles or airborne contaminants can ruin products, experiments, or processes. Some of the main applications and uses of ISO 5 cleanrooms are:
Microelectronics Manufacturing
The microelectronics industry widely relies on ISO 5 cleanrooms during the manufacturing of semiconductor chips and other precision components. Airborne particles can critically affect the fabrication, etching, and other micro-scale processes involved in chip-making. A speck of dust that is invisible to the naked eye can ruin an intricate circuit pattern on a semiconductor wafer. ISO 5 cleanrooms provide the clean environment needed for flawless manufacturing.
Pharmaceutical Production
Stringent cleanroom protocols are followed in the production of pharmaceutical drugs, especially injectable or intravenous medications. An ISO 5 cleanroom is standard for the aseptic preparation of injectable drugs and fills. The highly controlled environment minimizes risks of particulate or microbiological contamination that can be hazardous to patients.
Medical Device Assembly
The manufacture of sensitive medical devices like implants, catheters, surgical equipment etc. involves ISO 5 cleanroom processes. Particle contamination can impair the functionality of such devices or introduce infection risks when used in medical procedures. Cleanroom protocols are thus critical.
Scientific Research
Cleanroom facilities allow researchers to precisely control experimental conditions for repeatable and verifiable results. ISO 5 cleanrooms are used when nanoscale materials or processes are being studied, where even tiny airborne particles can influence outcomes. Universities, government labs and R&D centers use ISO 5 cleanrooms for fields like nanotechnology, stem cell research, microfluidics, optics etc.
Aerospace Applications
In the production of spacecraft, satellites, optical systems and other sensitive aerospace systems, ISO 5 cleanrooms maintain cleanliness throughout assembly and testing. Airborne particles can degrade sensitive aerospace components or coat mirrors and optical surfaces, impacting performance.
Hazardous Material Handling
When working with toxic, radioactive or biologically hazardous materials, ISO 5 cleanrooms with filtration systems confine the particles and prevent exposure. Cleanroom clothing and protocols also prevent hazardous particles from spreading outside the containment area.
Cleanroom Garments in ISO 5 Facilities
Personnel working inside ISO 5 cleanrooms wear specialized garments to minimize shedding of skin cells, hair, microbes and other particles from the body. Cleanroom apparel requirements for ISO 5 include:
- Coveralls – Full-body coveralls made of low particle-shedding fabrics like polyester or nylon are worn over street clothes to prevent contamination.
- Shoe Covers – Foot covers worn over regular shoes prevent dirt and particles from shoes from spreading inside.
- Head Covers – Hair nets and hoods cover the head and hair.
- Face Masks – Face masks prevent expulsion of particles while breathing.
- Gloves – Lint-free gloves are worn to keep hands and fingers clean.
Donning clean garments minimizes contamination from personnel. Hand washing and cleaning protocols must be strictly followed before entering ISO 5 areas. Beards or other facial hair that interfere with masks are prohibited.
Maintaining ISO 5 Cleanroom Conditions
Achieving ISO 5 air cleanliness levels involves careful maintenance and monitoring of cleanroom parameters. Some of the ways ISO 5 conditions are maintained are:
- Air filtration – HEPA filters continuously clean circulated air to remove particles down to 0.3 microns.
- Positive pressurization – Cleanrooms are kept at a higher pressure than surrounding areas to prevent influx of unfiltered air.
- Air conditioning – Precisely controlled temperature and humidity conditions are maintained.
- Gowning procedures – Personnel entering the cleanroom follow gowning protocols to limit contamination.
- Surface cleaning – Strict surface disinfection of floors, work surfaces and tools controls contamination.
- Monitoring – Particle counters continuously monitor particulate levels
Access to ISO 5 cleanrooms is restricted. Materials or equipment brought inside need to be thoroughly cleaned. Maintaining ISO 5 air cleanliness takes consistent diligence and vigilance.
Cleanroom Construction Features
ISO 5 cleanrooms are purpose-built facilities with specialized design, layout and materials to facilitate clean conditions. Some important cleanroom construction features include:
- Airtight walls, floors and ceilings made of smooth non-shedding materials
- Integrated HEPA filtration system with adequate air changes per hour
- Separate gowning rooms for garment changing
- Airlocks and interlocking doors to maintain cleanroom pressurization
- Seamless surfaces for easy cleaning
- No exposed fabric, carpet or other particle-shedding materials
- Mechanisms for transferring materials/equipment into the cleanroom
Careful planning goes into the layout and construction of ISO 5 cleanrooms. Facilities are designed to maintain ISO 5 particle counts, prevent contamination, and enable smooth material and personnel flows.
ISO 5 Cleanroom Certification
After construction, cleanrooms must undergo rigorous certification and testing to verify adherence to ISO 5 specifications. Some important aspects of the certification process include:
- HEPA filter system validation using particle count and visualization tests
- Airflow pattern analysis using smoke studies
- Particle count testing at rest and in operation for all particle sizes from 0.1 to 5 microns
- Negative and positive pressure testing of lobby doors and connections
- Checking for air leaks in construction materials and seals
- Assessing performance of lighting, utilities, monitoring systems etc.
Annual re-certification is necessary to ensure the cleanroom continues to deliver ISO 5 level performance. Unscheduled particle count testing is also conducted during routine cleanroom operation.
Common ISO 5 Cleanroom Uses
Here are some examples of processes and products that involve ISO 5 cleanroom environments:
| Industry | ISO 5 Cleanroom Uses |
|---|---|
| Microelectronics | Semiconductor fabrication, chip processing, LCD panel manufacturing |
| Pharmaceuticals | Aseptic filling of injectable drugs, sterile medical solutions |
| Medical Devices | Manufacturing of implants, catheters, surgical tools |
| Scientific Research | Nanomaterial synthesis, microfluidics, optics, space telescope assembly |
| Aerospace | Aircraft and spacecraft assembly, manufacture of guidance systems, sensors |
The highly controlled environment in ISO 5 cleanrooms makes them indispensable across industries where microscopic contaminants can be detrimental.
ISO Class 5 Cleanroom Guidelines
For personnel working in ISO 5 cleanrooms, the following protocols and hygiene practices must be strictly followed:
- Wear only approved cleanroom garments with hair/beard covers inside work areas
- Remove any jewellery, cosmetics, perfume that can shed particles
- Avoid rapid movements that can kick up dust
- Keep cleanroom floors, workbenches and equipment meticulously clean
- Use only vacuum cleaners approved for cleanroom use
- Follow restrictions on materials allowed inside cleanrooms
- Pass through air showers when entering or exiting gowning rooms
- Wash hands vigorously before gowning and entering cleanrooms
- Report any protocol violations or cleanliness issues immediately
Maintaining discipline and adhering to contamination control procedures is vital in ISO 5 cleanrooms. Even minor lapses can undo all the rigorous filtration and cleaning processes.
Conclusion
ISO 5 cleanrooms provide an ultraclean environment that is essential for many critical industrial processes and advanced research. The extremely low particulate concentrations allow precision manufacturing, sterile production conditions, and experiments sensitive to contamination. While expensive to construct and operate, ISO 5 cleanrooms deliver value across technology sectors by enabling defects-free production, reliable R&D, and verifiable scientific results.
