- Good Manufacturing Practice (GMP): Regulations that ensure pharmaceutical products are consistently produced and controlled according to quality standards.
- ISO 14644-1: Specifies the maximum allowable concentration of particles in the air and outlines testing and monitoring procedures to ensure air cleanliness in cleanrooms and controlled environments.
- United States Pharmacopeia (USP): Provides standards and guidelines for pharmaceutical products, including requirements for cleanroom operations.
- European Medicines Agency (EMA): Provides regulations for pharmaceutical manufacturing within the European Union, including requirements for cleanroom operations.
- Food and Drug Administration (FDA): Provides regulations for pharmaceutical and biotech manufacturing in the United States, including requirements for cleanroom operations.
Cleanrooms can be certified by a third party in many ways. Some common options include:
- Particle counting: Measures airborne particle concentration using particle counters.
- Airflow velocity measurement: Measures airflow velocity using an anemometer or similar device.
- Smoke studies: Introduces smoke to observe airflow movement and design.
- Pressure differential measurement: Measures pressure differential to ensure proper isolation from outside contamination.
- Microbial sampling: Tests for presence of microorganisms to ensure cleanroom is free from contamination.
To maintain the standard of this certification, a cleanroom should be checked – at 6 month intervals for ISO 5 and 12 month intervals for ISO 6 and above – using the same or similar methods to the certification process.
- Use of appropriate personal protective equipment (PPE)
- Establishment and maintenance of a cleanroom environment that adheres to standards and regulations
- Implementation of proper cleaning and disinfection procedures
- Proper handling and storage of materials and equipment
- Proper cleanroom balancing to maintain positive cascading pressure (from the main cleanroom to the anterooms then to the outside)
- Regular monitoring and testing of the cleanroom environment to ensure continued compliance and minimize the risk of contamination.
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ICS is a top-tier cleanroom supplier that specializes in creating intentional and customized designs to meet clients' specific needs within industry-leading timeframes. All our cleanrooms are fully certified by third-party organizations, ensuring the highest standards of cleanliness and quality. With six decades of experience in cleanroom construction, we have won notable awards, including the Department of Energy's Small Business of the Year.
Frequently asked questions
In the pharmaceutical industry, cleanrooms are used to manufacture medications, vaccines, and other pharmaceutical products that require a sterile environment to prevent contamination. Cleanrooms are also used to manufacture medical devices and to conduct research and development on new drugs.
In the biotech industry, cleanrooms are used for the production of biologics such as vaccines, gene therapies, and monoclonal antibodies. These products require a sterile environment to prevent contamination and maintain product purity. Cleanrooms are also used in the biotech industry for cell culture, fermentation, and other manufacturing processes.
- Barrier Isolators (Soft-Wall Cleanrooms): These are small-scale cleanrooms that are designed to prevent contamination of sensitive materials, such as vaccines and other biologics.
- Hard-Wall Cleanroom Suites: These are multiple connected cleanrooms that allow for the manufacture of different products in different environments while maintaining the integrity of the overall production process.
- Mobile Cleanrooms: These are cleanrooms that can be transported to different locations and used for temporary production needs, such as during a drug shortage, emergency response, or facility manufacturing.
Each type of cleanroom is designed to meet specific requirements and is equipped with specialized equipment, materials, and procedures to maintain the cleanliness and sterility of the environment.
Choosing the right cleanroom for your needs involves a careful assessment of several factors related to your production process and requirements. Here are some key considerations to keep in mind when selecting a cleanroom:
- Level of Cleanliness: Choose a cleanroom that meets the required standards for your industry and products.
- Size and Configuration: Select a cleanroom that accommodates the scale of your operations, personnel, and equipment. Cleanroom size (cubic volume) will also impact the HVAC requirements, which will have an effect on the efficiency of the cleanroom.
- Airflow and Filtration: Ensure the cleanroom has the required airflow rate and filtration system for maintaining a clean environment.
- Environmental Controls: Consider the environmental controls needed to maintain a stable and controlled environment, including temperature, humidity, and pressure.
- Equipment and Material Compatibility: Ensure the cleanroom is compatible with the equipment and materials used in your production process.
- Compliance Requirements: Choose a cleanroom that meets all applicable regulatory requirements and industry standards.
- Maintenance and Operation Costs: Consider the ongoing maintenance and operation costs of the cleanroom to ensure it fits within your budget.
The classification of a pharmaceutical cleanroom by the FDA is based on the air cleanliness level and is determined by the number of particles present in the air per cubic meter. The FDA classifies cleanrooms using the International Organization for Standardization (ISO) standards for air cleanliness.
The ISO classification system ranges from ISO Class 1 to ISO Class 9, with ISO Class 1 being the cleanest and ISO Class 9 being the least clean. The FDA has established guidelines for the use of cleanrooms in pharmaceutical manufacturing, which includes recommendations for the appropriate ISO classification for different stages of the manufacturing process.
The ISO standard for cleanrooms used in the pharmaceutical industry is ISO 14644. This standard sets out requirements for the classification of air cleanliness levels in cleanrooms and associated controlled environments.
ISO 14644 provides a system of classifications based on the number and size of particles present in the air. The classifications range from ISO Class 1, which is the cleanest, to ISO Class 9, which is the least clean. The standard also specifies the testing methods and procedures that should be used to determine the cleanliness level of a cleanroom.
- ISO Class 6-8 Cleanrooms: These cleanrooms are designed to control the levels of airborne particles and are commonly used for the production of drugs and biologics.
- ISO Class 3-5 Cleanrooms: These cleanrooms are used for the production of non-sterile products that require a high level of cleanliness, or sterile/aseptic, extremely clean applications that are nearly free of organics.
- ISO Class 1-2 Cleanrooms: A limited number of these cleanrooms exist globally. These are the most stringent type of cleanroom and are used in the production of advanced biotech products such as gene and cell therapies.