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Pressure Management: Ensure that the areas surrounding the cleanroom have lower pressure compared to the cleanroom itself.
Airlock Rooms: Install airlock rooms before entering the cleanroom to minimize contamination.
Separate Change Rooms: Provide separate change rooms for male and female workers. These rooms serve not only for changing clothes but also as buffer zones between the cleanroom and contaminated areas.
Airlock Door Management: Ensure the previous airlock door is completely closed before entering the next airlock. Always open and close doors slowly to minimize air disturbance. Never leave doors open.
Air Showers: Utilize air showers to reduce particle entry during human movement.
Window Management: Close existing windows permanently to prevent cross-contamination.
Flooring: Install smooth, scratch-resistant flooring with skirting to facilitate cleaning.
Coving: Install coving at corners to prevent dust accumulation and ease cleaning.
Restricted Access: Treat the cleanroom as a restricted area, allowing only authorized personnel to enter during operation.
Prohibited Items: Do not allow paper products or cotton buds inside the cleanroom.
Footwear Protocol: All personnel must remove their shoes and socks before entering the cleanroom and step on the wet/tacky mat appropriately.
Cleanroom Garments: Ensure that all personnel and visitors wear cleanroom garments when entering. Store cleanroom garments properly in a laminar airflow storage cabinet.
Personal Items: Prohibit the carrying of personal items such as pencils, pens, or handkerchiefs into the cleanroom.
Health Restrictions: Do not allow individuals with skin ailments or coughs to enter the cleanroom.
Communication: Avoid talking inside the cleanroom.
Cleaning Procedures: Use liquid detergents for cleaning the cleanroom. Cleaning should be done slowly, and personnel must wear cleanroom garments during the process.
Cleaning Equipment: Avoid using blowing equipment inside or near the cleanroom. Instead, use vacuuming equipment for cleaning.
Material Movement: Minimize the movement of materials to and from the cleanroom.
Handling Materials: Use forceps rather than hands to handle materials inside the cleanroom.
Particle Emission: Be aware that a sitting person emits over 100,000 particles, a moving person emits over one million particles, and a walking person emits up to five million particles of 0.5 micron size.
Air Classification and Maximum Concentration Limits (Particles/m³)
Class | Particle Size (µm) | Static (At Rest) | Dynamic (In Operation) |
0.5 µm | 5 µm | 0.5 µm | |
Class A | 3500 | 0 | 3500 |
Class B | 3500 | 0 | 35000 |
Class C | 350000 | 2000 | 3500000 |
Class D | 350000 | 20000 | NOT DEFINED |
Particle Concentration Limits by Cleanroom Class
| Class Name | ≥0.1µm | ≥0.2µm | ≥0.3µm | ≥0.5µm | ≥5µm |
|---|---|---|---|---|---|
| Volume Units | Volume Units | Volume Units | Volume Units | Volume Units | |
| SI (m³) | English (ft³) | SI (m³) | English (ft³) | SI (m³) | |
| M1 | 350 | 9.91 | 75.7 | 2.14 | 30.9 |
| M1.5 | 1240 | 35.0 | 265 | 7.50 | 106 |
| M2 | 3500 | 99.1 | 757 | 21.4 | 309 |
| M2.5 | 12400 | 350 | 2650 | 75.0 | 1060 |
| M3 | 35000 | 991 | 7570 | 214 | 3090 |
| M3.5 | – | – | 26500 | 750 | 10600 |
| M4 | – | – | 75700 | 2140 | 30900 |
| M4.5 | – | – | – | – | – |
| M5 | – | – | – | – | – |
| M5.5 | 10000 | – | – | – | – |
| M6 | – | – | – | – | – |
| M6.5 | 100000 | – | – | – | – |
| M7 | – | – | – | – | – |
Maximum Concentration Limits (Particles/m³ of Air)
| ISO Class | ≥0.1µm | ≥0.2µm | ≥0.3µm | ≥0.5µm | ≥1µm | ≥5.0µm |
|---|---|---|---|---|---|---|
| ISO Class 1 | 10 | 2 | – | – | – | – |
| ISO Class 2 | 100 | 24 | 10 | 4 | – | – |
| ISO Class 3 | 1000 | 237 | 102 | 35 | 8 | – |
| ISO Class 4 | 10000 | 2370 | 1020 | 352 | 83 | – |
| ISO Class 5 | 100000 | 23700 | 10200 | 3520 | 832 | 29 |
| ISO Class 6 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 |
| ISO Class 7 | – | – | – | 352000 | 83200 | 2930 |
| ISO Class 8 | – | – | – | 3520000 | 832000 | 29300 |
| ISO Class 9 | – | – | – | 35200000 | 8320000 | 293000 |
– Indicates no limit specified for that particle size.
Class 1: Primarily used in the microelectronics industry for manufacturing integrated circuits requiring submicron resolution. This class ensures extremely low particle counts, suitable for high-precision tasks.
Class 10: Commonly used in the semiconductor industry, particularly where bandwidths below 2 micrometers are involved. It maintains a high level of cleanliness necessary for sensitive semiconductor manufacturing processes.
Class 100: Known for its critical cleanliness, this class is often mistakenly referred to as a “sterile” room. It is used in environments requiring extremely low levels of bacteria and particles. Common applications include aseptic pharmaceutical manufacturing, integrated circuit production, and in medical settings for isolating patients with severe bacterial sensitivities, such as after bone marrow transplants.
Class 1000: Typically used in high-quality optics production, mounting and testing of aircraft gyroscopes, and assembling high-precision miniature bearings. This class balances cleanliness with practical industry requirements.
Class 10000: Suitable for mounting hydraulic and pneumatic equipment, and occasionally used in the food and beverage industry. It is also frequently employed in pharmaceutical manufacturing to ensure adequate cleanliness while accommodating broader applications.
Class 100000: Applied across various industries including optical products, large electronic systems assembly, hydraulic and pneumatic systems, and the food and beverage sector. It is also used within the pharmaceutical industry for less stringent cleanliness needs.
ISO 14644-1: Classification of Air Cleanliness
This standard outlines the classification of air cleanliness in cleanrooms and controlled environments based solely on the concentration of airborne particles. It does not address the physical, chemical, radiological, or viable nature of airborne particles.
ISO 14644-2: Specification for Testing and Monitoring to Prove Continued Compliance
This part specifies requirements for periodic testing and monitoring of cleanrooms and controlled environments to ensure ongoing compliance with ISO 14644-1 and its designated cleanliness class.
ISO 14644-3: Metrology and Test Methods
This standard details the methods and techniques for characterizing and monitoring various parameters in cleanrooms and other controlled environments.
ISO 14644-4: Design, Construction, and Start-up
This standard provides guidelines for the design, construction, and initial operation of cleanrooms and controlled environments.
ISO 14644-5: Cleanroom Operations
This standard specifies the basic operational requirements for cleanrooms and controlled environments, aimed at those planning to work in such settings.
ISO 14698-1: General Principles
This standard describes the principles and methodologies for assessing and controlling bio-contamination in cleanroom environments. It facilitates reproducible monitoring of bio-contamination and helps in selecting appropriate protective measures.
ISO 14698-2: Evaluation and Interpretation of Bio-contamination Data
This part outlines the principles and methods for evaluating microbiological data related to bio-contamination. It includes guidelines for interpreting data from sampling and assessing risks based on the selected system.
ISO 14698-3: Methodology for Measuring Efficiency
This standard focuses on the efficiency of processes such as rinsing, cleaning, and disinfection. It describes methods for measuring the effectiveness of these processes on wet, soiled surfaces where microorganisms may be present, including the formation of bio-films.
| Class of Cleanroom | Airflow Type | Average Velocity (ft/min) | Air Changes/hr |
|---|---|---|---|
| ISO 8 (100,000) | N/M | 1-8 | 5-48 |
| ISO 7 (10,000) | N/M | 10-15 | 60-90 |
| ISO 6 (1,000) | N/M | 25-40 | 150-240 |
| ISO 5 (100) | U/N/M | 40-80 | 240-480 |
| ISO 4 (10) | U | 50-90 | 300-540 |
| ISO 3 (1) | U | 60-90 | 360-540 |
| Better Than ISO 3 | U | 60-100 | 360-600 |
Air Changes per hour Calculation:
Air Changes/hr = Average airflow velocity (ft/min) × Room area (ft²) × 60 min/hr / Room volume (ft³)
Flow Types:
| Filter Class | Overall Value Efficiency (%) | Overall Value Penetration (%) | Leak Test Efficiency (%) | Leak Test Penetration (%) |
|---|---|---|---|---|
| H 10 | 85 | 15 | – | – |
| H 11 | 95 | 5 | – | – |
| H 12 | 99.5 | 0.5 | – | – |
| H 13 | 99.95 | 0.05 | 99.75 | 0.25 |
| H 14 | 99.995 | 0.005 | 99.975 | 0.025 |
| U 15 | 99.9995 | 0.0005 | 99.9975 | 0.0025 |
| U 16 | 99.99995 | 0.00005 | 99.99975 | 0.00025 |
| U 17 | 99.999995 | 0.000005 | 99.9999 | 0.0001 |
| Test Parameter | Class | Maximum Time Interval |
|---|---|---|
| Particle Counting | ≤ ISO 5 | 6 months |
| > ISO 5 | 12 months | |
| Airflow Velocity or Volume | All Classes | 12 months |
| Air Pressure Difference | All Classes | 12 months |
| Installed Filter Leakage | All Classes | 24 months* |
| Airflow Visualization | All Classes | 24 months* |
| Recovery | All Classes | 24 months* |
| Containment Leakage | All Classes | 24 months* |
*Suggested time interval.
| Hazard | Route | Control Methods | Monitoring Methods |
|---|---|---|---|
| Supply Air | Airborne | Air filters | Filter integrity test |
| Areas Adjacent to the Cleanroom | Airborne, Contact | Overpressure; air movement control; Cleanroom mats | Room pressure differential; Mat inspection |
| Various Airborne Dispersions | Airborne | Ventilation | Air supply rate or velocity; Counts of airborne particles and micro-organisms |
| Floors, Walls, and Other Surfaces | Contact | Cleaning (and disinfection, where required) | Surface counting of particles and micro-organisms |
| People | Airborne, Contact | Cleanroom garments; Gloves | Surface counts; Inspection for tears; Particle penetration testing; Inspection for punctures |
| Machines | Airborne, Contact | Ventilation; Design of machine cleaning or disinfection | Air extract rates and airflow patterns; Surface contamination |
| Raw Materials | Mainly Contact | Control of manufacturing; Cleaning or filtration; Sterilization | Particle and bacterial counts within or on the materials; Filtration systems; Sterilization system |
| Containers and Packaging | Mainly Contact | Control of composition and manufacturing environment; Sterilization | Particles and microbial counts on surface; Sterilization systems |
Legend:
| Apparel Type | ISO 7 & 8 (100K & 10K) | ISO 6 (1000) | ISO 5 (100) | ISO 4 & 3 (10 & 1) |
|---|---|---|---|---|
| Frock | R | AS | AS (NR*) | NR |
| 2 Piece Suit | AS | AS | AS | AS |
| Coverall | AS | R | R | R |
| Shoe Cover | R | AS | AS (NR*) | NR |
| Boot | AS | R | R | R |
| Special Footwear | AS | AS | AS | AS |
| Hair Cover | R | R | R | R |
| Hood | AS | AS | R | R |
| Facial Cover | AS | AS | R | R |
| Powered Headgear | AS | AS | AS | AS |
| Woven Gloves | AS | AS | AS | NR |
| Barrier Gloves | AS | AS | AS | R |
| Inner Suit | AS | AS | AS | R |
Legend:
| Apparel Type | ISO Class 7 (10,000) | ISO Class 6 & 5 (1,000 & 100) | ISO Class 4 & 3 (10 & 1) |
|---|---|---|---|
| Frock | NR | NR | NR |
| 2 Piece Suit | NR | NR | NR |
| Coverall | R | R | R |
| Shoe Cover | NR | NR | NR |
| Boot | R | R | R |
| Special Footwear | AS | AS | AS |
| Hair Cover (Bouffant) | R | R | R |
| Hood | AS | R | R |
| Facial Cover | R** | R** | R** |
| Powered Headgear | AS | AS | AS |
| Woven Gloves | NR | NR | NR |
| Barrier Gloves | R | R | R |
| Inner Suit | AS | AS | R |
Legend:
| Class of Room | ISO 7 & 8 (Class 1000 & 100,000) | ISO 6 (Class 1000) | ISO 5 (Class 100) | ISO 4 (Class 10) | ISO 3 (Class 1) |
|---|---|---|---|---|---|
| Frequency | 2 per week | 2 to 3 per week | Daily | Per entry to 2 per day | On each entry |
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