ISO 4 and Class 10 Certifications for Ultra-Cleanrooms
ISO 4 cleanroom standards, also known as Class 10 cleanrooms, represent some of the highest standards of cleanliness in controlled environments. These ultra-clean spaces are essential in industries such as pharmaceuticals, semiconductor manufacturing, and biotechnology, where even the slightest contamination can compromise product quality and safety.
Overview of ISO 4 Cleanroom Standards
ISO 4 cleanroom standards are defined by the ISO 14644-1 standard, which specifies that it allows no more than 10,000 particles measuring 0.1 micrometers or larger per cubic meter of air. This classification corresponds to a Class 10 cleanroom under the former Federal Standard 209E, which permits a maximum of 10 particles with a size of ≥0.5 micrometers per cubic foot. Such stringent requirements ensure that these environments maintain exceptionally low levels of contamination.
Key Features and Requirements
Air Quality Control:
- ISO 4 cleanrooms require high air exchange rates, typically between 300 to 540 air changes per hour.
- The use of ULPA filters (Ultra-Low Penetration Air) ensures high filtration efficiency, removing at least 99.9995% of airborne particles as small as 0.12 micrometers.
Environmental Controls:
- Environmental factors such as temperature and humidity are meticulously controlled to align with specific application needs.
- High air velocity is maintained to facilitate effective particle removal and ensure cleanliness.
Design Considerations:
- Surfaces within the cleanroom must be smooth, non-porous, and easy to clean to prevent particle accumulation.
- Flooring materials are often resinous for durability and ease of maintenance.
Essential Equipment:
- Dynamic pass boxes, fan filter units, air showers, airlocks, and air handling units (AHUs) are commonly employed in an ISO 4 cleanroom setup.
- Additional equipment may include laminar airflow units and decontamination chambers depending on specific operational needs.
Applications of ISO 4 Cleanrooms
ISO 4 cleanrooms are critical in various fields:
- Pharmaceutical Manufacturing: Ensuring sterile conditions for drug formulation and filling processes.
- Semiconductor Manufacturing: Maintaining the integrity of microelectronic components during production.
- Biotechnology Research: Supporting sensitive experiments that require controlled environments free from contaminants.
DrStemCellsThailand‘s Anti-Aging and Regenerative Medicine Center of Thailand‘s Commitment to Cleanroom Standards
At DrStemCellsThailand‘s Anti-Aging and Regenerative Medicine Center of Thailand, we adhere to ISO 4 and Class 10 cleanroom standards to ensure the highest levels of safety and efficacy in our Cellular Therapy, Stem Cells and regenerative medicine practices. Our commitment includes:
- Stringent Environmental Controls: We maintain rigorous air quality standards with advanced filtration systems to ensure a contaminant-free environment for all procedures.
- Comprehensive Training for Staff: Our team is trained in cleanroom protocols to minimize contamination risks during patient treatments.
- Regular Monitoring and Maintenance: Continuous monitoring of environmental conditions ensures compliance with ISO standards, allowing us to provide safe and effective treatments.
- State-of-the-Art Facilities: Our facilities are designed with the latest technology to support ultra-clean environments necessary for advanced regenerative therapies.
By integrating ISO 4 and Class 10 standards into our operations, we aim to provide our patients with the safest and most effective regenerative medicine solutions available.
Consult with Our Team of Experts Now!
References
- ISO 4 (Class 10) Cleanroom Wipes – Blue Thunder Technologies. https://bluethundertechnologies.com/iso-4-class-10-cleanroom-wipes/
- What are the Requirements for an ISO 4 Cleanroom? – Allied Cleanrooms. https://alliedcleanrooms.com/iso-4-cleanroom-requirements/
- Class 10 Clean Room Testing Requirements – Clean Room Manufacturer in China. https://www.isocleanroomchina.com/class-10-clean-room/
- ISO 4 Class 10 Cleanroom Design and Build – AdvanceTEC LLC. https://www.advancetecllc.com/classifications/iso-4-class-10-cleanroom-classification
- The Different Cleanroom Types (ISO 1 to ISO 9) – CSI Testing. https://csitesting.com/the-different-cleanroom-types-iso-1-to-iso-9/
