Clean Room Design Consultants |ISO 14644 | Clean Room Regulations

Clean Room Design Consultants ISO 14644 https://www.operonstrategist.com/clean-room-designconsultant/

As a Clean Room Design consultants, we provide expertise clean room design solution to medical device manufacturers. Clean Room helps in establishing & maintaining an environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.

What is Clean Room? “A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure are controlled as necessary.� - ISO 14644-1 Clean Room is the facility ordinarily utilized as a part of specialized industrial production or scientific research. For that, clean room design is under the expertise is more important.

Clean Room Design: Presence of unwanted air particles may adversely affect the performance and safety of a product and hence Medical Device manufacturers are advised to manufacture under classified areas.

Clean rooms of different sizes and complexity are designed to maintain low levels of air particles as per the ISO 13485, ISO 14644 Clean Room Design Standards.

ď‚´ As a medical device Clean Room Design Consultant, we Operon Strategist help in designing the medical device clean room as per the desired levels of air quality.

ď‚´ In addition, of controlling the air particle count, environmental factors such as humidity, temperature, and pressure are also considered while designing a clean room.

Clean Room Regulations – ISO 14644 To manufacture the clean room ISO class system provides an industry-wide standard that is ISO 14644 it’s the clean room standard for cleanliness and particles counts.

ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in clean rooms and clean zones; and separative devices as defined in ISO 14644-7.

What is this ISO 14644-1:2015 standard about?

This standard is all about improving quality control in an environment by the limited presence of sub-micron particles within the clean room. It gives guidelines related to air cleanliness, looking specifically at particle concentration.

The ISO 14644-1:2015 standard is applicable for?  Clean room facility users, testers, consultants  Vendors of clean room technology components such as air filters, safety cabinets  Healthcare operators/hospitals/clinics  Healthcare design and build/research and development  Healthcare manufacturing, including pharmaceutical and medical devices

 Life sciences research and microelectronics and biomedical technology

 Micro-mechanical industries

 Nanotechnology industries  Optics  Aerospace

Why is this ISO 14644-1:2015 standard necessary? ď‚´ It focuses on the definition of air cleanliness by particle number concentration and gives the updated classification procedures specified to achieve this. ď‚´ This latest revision reflects recent advances in airborne particle counting science and the improved statistical rigour of cleanliness classifications for clean rooms and clean devices.

Changes in the ISO 14644-1:2015 from the previous? ď‚´ The 2015 revision takes into account improved industry knowledge and a reconsideration of the levels of statistical confidence that can be practically achieved during clean room and clear air device classification.

Changes include:

ď‚´ Amendments to the method of evaluation of data collected from airborne particle counting

ď‚´ The basic ISO cleanliness classes 1 to 9 do not fundamentally change, but the classification process requires the adoption of a revised protocol for every clean room or clean air device ď‚´ The revised standards also include updated references to normative and supporting standards

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