Modular 0.3 Micron 0.5µM Iso 7 Clean Room Class 10000 GMP

Product Specification

ISO 14644-1 Standard Iso 7 Modular Clean Room, Class 10000 Clean Rooms

ISO 7 is one of the most common classes of cleanrooms. The cleanroom classification standard ISO 14644-1 requires specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. For ISO 7, particles smaller than 0.5 microns are not taken into consideration. Total Clean Air is the leading expert in the design and fabrication of critical environment applications. We offer a complete range of equipment, furnishing and supplies for ISO 7 cleanrooms.

Some Considerations when going for an ISO 7 cleanroom:

High Efficiency Penetration Air (HEPA) Filtration is 99.99% efficient at 0.3 micron and should be considered when looking to achieve ISO class 7.

Softwall and Hardwall cleanroom constructions are both effective at achieving the environment required for ISO class 7.

If organisations are working towards GMP grades, monobloc is the most effective solution, as it can accommodate required features such as interlocked doors and coved floors.

ISO Clаѕѕ 7 cleanrooms ѕhоuld also have a Changing Atrium for gowning which is set apart from the main working area. This reduces contaminants from entering the clean area.

ISO 7 Cleanroom Applications

ISO 7 clean rooms provide air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot and a minimum of 60 air changes per hour. Industries that utilize ISO 7 cleanrooms include:

Medical device manufacturing

Electronics manufacturing

Pharmaceutical compounding

Laboratories

Aerospace product development

How to Determine the Correct Cleanroom Classification Based on Your Needs?

A typical cleanroom is designed to keep outside contaminants and particles at a minimum based on the ISO clean room standards. Once fully built and operational, an isolated cleanroom is free from outside particles and contamination. However, the two things that can introduce particles and contamination into your cleanroom are people and processes.

Classification for cleanrooms ranges from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. The lower the ISO class the more stringent the requirements for keeping particles and contamination to the acceptable levels of the room class.

As an example, Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot. The chart below provides an explanation of the differences between our clean room classes.

Sanitation Guidelines For Class 7 Cleanrooms

ISO Class 7 cleanrooms are designed to minimise airborne contamination from contacting critical sites. Care must be taken to maintain the cleanliness of the room. There are minimal cleaning requirements for a typical Class 7 room.

The most critical element to consider is the material used for the surface that will be in direct contact with the room’s inner environment. It is important to know the cleaning and sanitation methods that will be employed and to select the finishes accordingly. For example, for a washing area where pressurised water is used daily, partition surfaces in stainless steel can be justified.

About anlaitech Clean rooms:

anlaitech Cleanrooms has been building modular clean rooms and environmental enclosures for over 30 years. Based out of California and Tennessee, our facilities provide coverage for coast-to-coast shipments.

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We specialize in Class 10 to Class 100,000 (ISO 4 – ISO 8) cleanrooms that are used for some of the following activities: environmental test chambers, pharmaceutical storage rooms, temperature controlled rooms, bio-safety laboratories, pharmaceutical research laboratories, stem cell research laboratories, server control rooms, organic chemistry laboratories, laser rooms, microbiology laboratories, dry rooms and more.

We offer a complete turnkey solution that begins with building to your exact specifications and seeing your project through until completion. Our non-invasive modular construction process involves the manufacturing of your clean room in a factory, resulting in short lead times and a minimal amount of on-site construction contamination. Our modular clean rooms are reusable, reconfigurable and environmentally friendly which will minimize your carbon footprint.