ISO Class 7

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.

Our controlled environment ensures that air quality, temperature and humidity are highly regulated by an air locked gowning area, protecting sensitive materials and components from dust contamination and other impurities that can compromise component integrity. Our ISO Class 7 cleanroom environment meets industry standard specifications in the manufacturing of contaminant free composite components. At Total Clean Air, we provide cleanrooms by ISO class, as well as additional cleanroom accessories to guarantee superior air quality and particle filtering.

Modular Cleanroom Benefits

  • Modular Construction
  • Quick Assembly Time
  • Versatility
  • Reconfiguration
  • Airflow Control
  • Inexpensive Modifications

ISO 7 Cleanroom (Class 10, 000) Explained

Most cleanrooms fall into the class 6, 7, or 8 categories. This is because a cleanroom may be rated ISO 6 at rest, but at ISO 7 during operation. An ISO 7 zone has 30 to 60 air changes per hour. Before an ISO 7 cleanroom is installed, an ISO 8 airlock or gowning room is set up prior to entering the ISO 7 room.

The classification of an ISO 7 cleanroom can be carried out when the room is:

  • As built
  • At rest
  • Operational

To comply with performance requirements, the as-built empty room should be tested and benchmarked, followed by testing and documentation of the at-rest and operational states. If contamination in the at-rest or operational states is not compliant, corrective steps need to be taken. These steps can range from examining the production process and number of workers in the cleanroom, to testing the room’s air flow performance.

Cleanroom Design, Build & Validation

  • Budgeting and planning
  • Engineering, design & layout
  • Airflow and filtration design
  • Construction and Installation
  • Full Certification of our product
  • Industry-specific equipment installation
  • Validation

Considerations for ISO Class 7 Cleanrooms

There are many determining factors involved in choosing a cleanroom classification and every industry has a default standard to start with. In medical device packaging for instance, the default classification is ISO 7 (or a class 10,000) cleanroom.

Some of the things to bear in mind when going for an ISO 7 cleanroom are:

  • 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.

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.

For areas where hydrogen peroxide is used as a disinfectant or bio-decontamination agent, the use of special insulation and surfaces of epoxy laminated resins intertwined at high pressure (HPL) or the use of stainless steel needs to be considered. Some best practices for cleaning and disinfecting pharmacy cleanrooms include:

  • Always clean from cleanest to dirtiest and from top to bottom.
  • Choose non-shedding, non-linting single-use cleanroom wipes.
  • Use slightly overlapping, unidirectional strokes rather than circular motions.
  • Replace used wipes often.
  • Isolated cleaning tools, mops, and buckets should be dedicated to each room or area.
  • Disinfectant dwell time is critical, therefore, consult the product label for the appropriate contact time.

Total Clean Air for a Guaranteed Secure Environment for Your Critical Processes

At Total Clean Air, your contamination control requirements are our priority. Our world-class hard-walled ISO Class 7 certified cleanroom ensure the quality and sterility of your controlled environment. Our team will work with you to review the basics of selection, and all applicable cleanroom industry requirements.

Our services are ISO 14001, ISO 9001 and OHSAS 18001 accredited. Are you ready to start a project with us? Give us a call today.

phillip.godden
Phillip Godden

Phillip Godden is the Founder & Chief/Executive Officer at Total Clean Air.

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