Medical Device Clean Rooms

Article provided by: Pacific Environmental Technologies, Inc.

Medical Device Clean Rooms

Pacific Environmental Technologies, Inc. (PETI) has a track record of excellence in the area of producing the best-customized cleanroom solutions when compared to the rest of the market. This level of professional technical skills can be noticed with the services rendered to some of the well-renowned companies across the world such as AMPHASTAR PHARMACEUTICAL, INC. where we contacted to help provide a complete design and turn-key construction of the cleanroom manufacturing facility. Another company that has enjoyed our services is BROOKS AUTOMATION in which we assisted in Cleanroom medical devices turnkey design and construction of an IC FAB EQUIPMENT MANUFACTURING & TESTING FACILITY which included improvement in the area of tenant comfort among other areas. Other companies that we have also been of service to include DIGILENS, INC. where we helped set up an IC PILOT PLANT FOR WAVEGUIDE TECHNOLOGY, HEMACARE INC. which we helped set up a BLOOD ANTIBODY PROCESS FACILITY and INTERNATIONAL MEDICAL SYSTEMS which we helped set up a PHARMACEUTICAL MANUFACTURING FACILITY are among the list of satisfied clients who have enjoyed the top quality cleanroom design and installation for medical devices services.

Why cleanroom manufacturing matters for medical devices?

Medical devices over the years have become more detailed and specialized which has led the medical device manufacturers requiring cleanroom manufacturing with the purpose of maintaining a higher degree of sterility and cleanliness. The controlled environment of a cleanroom ensures that dust and other particles don't contaminate the environment as well as plastics that would make up various parts of medical devices.

Cleanrooms are controlled by Air changing equipment's which can serve as a means of clearing out all exposed particles before they get the chance to settle.

The importance of cleanroom manufacturing also assists in the field of food production as FDA requirements states the possibility of environmental factors affecting product quality and the need for environmental controlling measures to be taken which is where cleanrooms can come in.

Classification of Medical device cleanrooms.

The FDA does not set forth any Medical device cleanroom classification, but regardless a number of factors play a role in the classification of cleanrooms with each industry having its default standards. In the medical device packaging field, the default classification is ISO 7.

We at PETI take into account all factors:

  1. Source contamination.
  2. Size of particles filtered out.
  3. The amount of air needed in circulation for contamination to be removed.

Which plays a major role in the classification of cleanrooms but in the case of companies who need to adhere to specific cleanroom design standards, we ensure to keep our clients well informed on all possibilities of meeting up to cleanliness standards, depending on the environmental conditions of their target region.

we understand the importance of these factors and pay clear attention to them in classifying what standards are required for your medical device cleanroom no matter the field of operation you have in mind.

We understand the importance of the cleanroom process and would really appreciate the opportunity to be of service to you. If you have some questions or require any of our services, kindly request a quote us for a free estimate.

Medical Device Clean Rooms
Pacific Environmental Technologies, Inc.

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