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ISO 7 and ISO 8 Clean rooms are part of the ISO
14644-1 classification system, which defines cleanroom environments based on the
concentration of airborne particles. These classes are typically used in
industries where cleanliness is essential but not as critical as higher classes
like ISO 5 or ISO 6. Understanding these classifications helps ensure the right
level of cleanliness for processes such as pharmaceutical manufacturing,
electronics assembly, and food production.
ISO 7 Clean room
A ISO 7 clean room meets ISO 7 standards, which allows up to 352,000 particles per cubic meter of air (measured at 0.5 micronsor larger). This level of cleanliness is commonly found in environments where contamination control is necessary but the highest standards are not required. ISO 7 modular clean rooms are typically used for less sensitive manufacturing processes, such as certain stages of drug production or assembly of non-critical electronic components.
ISO 8 Clean Room
ISO 8 clean rooms are less stringent than ISO 7, meeting ISO 8 standards. These clean rooms permit up to 3.5 million particles per cubic meter of air (measured at **0.5 microns
or larger). They are used in environments where contamination control is still important but not critical. Industries such as food packaging, medical device manufacturing, and some areas of pharmaceutical production may use ISO 8 Clean rooms.
Key Features of ISO 7 and 8 Clean Rooms
Both ISO 7 and ISO 8 clean rooms have similar characteristics, though they differ in particle contamination levels. Their designs prioritize air filtration and airflow control, but ISO 7 has stricter requirements for particle concentration compared to ISO 8.
Filtration: Both classes use HEPA
filters, but ISO 7 typically requires higher efficiency in particle removal.
Airflow:
ISO 7 Clean rooms generally have higher air exchange rates to maintain cleanliness.
Control Procedures:
Gowning and cleanliness protocols in both classes are less strict compared to higher-class rooms (e.g., ISO 5).
Applications of ISO 7 and 8 Clean Rooms
ISO 7 and 8 modular clean rooms are commonly found in various industries where environmental cleanliness is important but not to the extent required for aseptic or sterile production.
ISO 7 applications:
Pharmaceutical manufacturing, biotechnology, precision manufacturing
ISO 8 applications:
Food processing, medical device assembly, general industrial production
Differences Between ISO 7 and ISO 8 Clean Rooms
While both ISO 7 and ISO 8 are suitable for less critical environments, the difference lies mainly in the allowable concentration of airborne particles. ISO 7 has stricter limits, making it more suitable for sensitive applications like pharmaceuticals, whereas ISO 8 is designed for environments where cleanliness is controlled but less critical.
Particle Count:
ISO 7 allows up to 352,000 particles per cubic meter, while ISO 8 permits up to 3.5 million particles per cubic meter.
Applications:
ISO 7 is used for more critical processes (e.g., pharmaceuticals), while ISO 8 is used for less sensitive operations (e.g., food packaging).
Relevant Standards and Guidelines
ISO 14644-1:Defines CleanRoom Classifications based on particle concentration, including ISO 7 and ISO 8 standards.
- ISO 14644-2:Specifies monitoring and maintenance procedures for cleanrooms.
Federal Standard 209E:Older U.S. standard for cleanroom classification, now largely replaced by ISO 14644, but still referenced for classes like Class 100, Class 1000, etc.
EU GMP Annex 1:European guidelines for cleanroom standards in the pharmaceutical industry, aligning with ISO classifications.
Understanding the difference between ISO 7 and ISO 8 clean rooms helps industries choose the appropriate environment for their manufacturing processes, ensuring product quality while maintaining cost-efficiency.
Clean Room Standard
A clean room standard defines the acceptable levels of airborne particles and other environmental factors such as temperature, humidity, and airflow, in order to provide an uncontaminated workspace. These standards are vital for industries that require a contaminant-free environment for manufacturing or research.
What is Clean Room Standard?
Modular clean room standards, typically classified by ISO (International Organization for Standardization), define the maximum allowable concentration of airborne particles in a clean room. These classifications range from ISO1 (the cleanest) to ISO9 (the least clean). For example, a ISO 7 clean room allows up to 352,000 particles per cubic meter for particles sized 0.5 microns.
ISO 7 Cleanrooms Standard
ISO7 clean rooms allow a maximum particle count of 352,000 particles per cubic meter for 0.5-micron particles.
ISO 8 Cleanrooms Standard
ISO8 clean rooms allow a maximum of 3,520,000 particles per cubic meter for 0.5-micron particles.
Clean Room Specifications
The specifications of clean rooms are defined by various factors, including airflow, particle count, temperature, humidity, and pressure. ISO 7 and ISO 8 clean rooms are designed to accommodate specific levels of contamination, and their operational efficiency is dictated by strict standards to ensure optimal performance.
ISO 7 Clean Room Specifications:
Maximum allowable particles (0.5 microns): 352,000 per cubic meter
Air cleanliness: Requires continuous air filtration, typically using HEPA filters
Airflow velocity: 0.45 to 0.54 m/s for efficient particulate removal
Temperature and humidity: Usually set between 18-22°C and 30-60% RH
ISO 8 Clean Room Specifications:
Maximum allowable particles (0.5 microns): 3,520,000 per cubic meter
Air cleanliness: HEPA filters are required
Airflow velocity: 0.45 to 0.54 m/s for consistent air circulation
Temperature and humidity: Typically between 18-22°C and 30-60% RH
Cleanroom Design
1. ISO 7 Clean Room Design:
ISO 7 clean room design typically incorporates high-efficiency particulate air (HEPA) filtration systems to maintain the required level of air cleanliness. The room must be airtight to prevent contamination from the external environment. Proper airflow design is crucial, including laminar flow and clean air distribution systems. The room is usually equipped with positive pressure to ensure that no contaminants enter. Proper material selection for wall, floor, and ceiling finishes is essential to minimize particle generation.
2. ISO 8 Clean Room Design:
ISO 8 clean rooms are designed with a focus on contamination control at a slightly lower level than ISO 7. Similar to ISO 7, HEPA filters are used, but the room may tolerate a higher particle count. The design typically includes a clean air distribution system and positive pressure. The layout is structured to minimize the risk of contamination and maximize airflow efficiency. Unlike ISO 7, ISO 8 may not require as stringent airflow and ventilation systems, though these still play a critical role in maintaining cleanliness.
Cleaning Requirements
Cleaning requirements for clean rooms vary according to the class of cleanliness. These requirements are crucial to maintain the environment's integrity and minimize particle accumulation.
1. ISO 7 Clean Room Cleaning Requirements:
For ISO 7 clean rooms, cleaning protocols are strict, requiring frequent cleaning of surfaces, equipment, and floors using cleaning agents that do not contribute to particulate contamination. Cleaners must be filtered and non-volatile. Surfaces should be wiped with lint-free materials to avoid particle buildup.
2. ISO 8 Clean Room Cleaning Requirements:
ISO 8 clean rooms require routine cleaning, but the frequency can be lower compared to ISO 7. Surfaces should be wiped regularly with HEPA-filtered vacuums and lint-free wipes. It’s important to use cleaning agents that are non-volatile and non-reactive to avoid contamination.
Air Change Rates
Air change rates are a critical parameter in maintaining clean room standards. The higher the air change rate, the more effective the room is at removing particulate matter from the air, ensuring the room remains within the required cleanliness levels.
1. ISO 7 Clean Room Air Change Rates:
ISO 7 clean rooms typically require 30 to 60 air changes per hour (ACH). This ensures the air is constantly refreshed to maintain the low particle count. The rate depends on factors such as room size and activity level.
2. ISO 8 Clean Room Air Change Rates:
ISO 8 clean rooms generally require around 20 to 40 air changes per hour. While lower than ISO 7, this rate is still sufficient to maintain air cleanliness standards, as long as the filters are maintained and the room's airflow is well-distributed.
Relevant Domestic and International Standards:
iso 14644-1: This standard defines the classification of air cleanliness in clean rooms and controlled environments.
FS 209E: A former standard used to classify clean rooms, now largely replaced by ISO 14644-1 but still referenced in some regions.
GMP Guidelines (Good Manufacturing Practice): These regulations are often applied to pharmaceutical clean rooms to ensure the highest hygiene standards.
FDA 21 CFR Part 820: Sets the requirements for the design and operation of clean rooms in medical device manufacturing.
summary
By adhering to these standards and specifications, industries can ensure that their clean rooms meet the necessary requirements for maintaining product quality and safety in sensitive manufacturing environments.
