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Sunday , October , 22 2017

Things To Consider When Planning a Cleanroom


Contact a ISO 17025 accredited 3rd party cleanroom Certification Agency to discuss your specific requirements as they have the experience from a service providers perspective that will save you $$$ on the front end and frustration once you are in operation. They also know experienced design firms and contractors that understand cleanrooms.

A few questions to ask your design team

1. Will the HEPA filters need to be challenged for certification.

2. Are the HEPA filter installers trained on installing the HEPA filters properly.

3. What is the right sealant to be used for sealing wall/ceiling penetrations.

4. Will you need a  Pass-Thru or Air Shower.

5. Will the flooring be conductive or non conductive.

6. Will you be using a Central Vacuuming System or a Portable HEPA Vacuum.

7. DO NOT skimp on the size of the Gown Room.

8. Where are you going to store the custodial equipment and supplies.

9. Where are you going to store the extra garments.

 

 

 

The Value of an On-Going Monitoring Program

Keeping your cleanroom and laminar flow bench operating at optimum efficiency is essential. This means having an active On-Going Monitoring Program (OGMP) in place, either by internal personnel or utilizing your Certification Agency on a more regular basis.

There are many good reasons for this program to be implemented, the main on being, is that you do not want any surprises when your cleanroom or bench certification comes due.

Rooms and benches are certfiied either Semi-Annual or Annually and it is usually assumed that everything is working fine between these visits. In most cases, it is.

To insure that, you should consider:

1. Check pre-filters on all air handling systems on a weekly basis, either visibly or via the use of a calibrated pressure differential gage. Change these filters as applicable, not on a time use basis.

2. Check and record daily, Room Pressure (see ISO 14644-4:2001 pages 14 & 15 for recommendations). This is the first line of defense in making sure all is in proper working order. If pressures are not as per design specification, this indicates an immediate problem, therefore doing this daily is paramount.

3. Check and record daily, Room Temperature and Humidity readings. A minute swing in either of these readings may negatively impact your product.

4. Check and record daily, Non-Viable particle counts at work elevation in areas of concern. this will provide you with a trending pattern of your room for benchmarking.

5. It is every persons responsibility that enter the clenroom to visually check all wall, ceiling surfaces for any unsealed penetrations. These penetrations are to be seal with approved sealant by the proper personnel. Remember the cleanroom is a sealed vessel with registers that can be regulated to maintain room pressurization.

6. Check and record daily, all Laminar Flow bench pressure differential gages to note Hepa filter differential pressure. This will also indicate that all cabinet fans are in operation. If there is no pressure differential gage in the Laminar Flow Bench, there should be readily accessible ports to measure the Hepa filter pressure differential.

With this program in place, in conjunction with good personnel disciplines and housekeeping protocol, you will be guaranteeing yourself that there will be no surprises at the last minute, thus keeping your cleanroom and or Laminar Flow bench operating at optimum efficiency.

Develop a "Process of Occupancy" For Your Cleanroom

The development of a Documented Process of Occupancy (DPO) is an inexpensive insurance policy for future troubleshooting investigations, possible audits by clients and remodeling/upgrade considerations.

  • While installing the Hepa filters in the ceiling matrix, obtain the serial number of each Hepa filter and the placement of same in the ceiling matrix and record it on the “As -Built” Drawings. This information is to be provided the Air Balancing Firm and the Certification Agency for their reports.
  • Make sure that the wall/ceiling angle on the cleanroom side and all penetrations in the walls and ceiling are sealed with the approved sealant that is compatible with your process.
  • Develop a set of “As - Built” Drawings at the completion of the construction process by your installation contractor for your files that will accompany the original set of design drawings and specifications.
  • After the Air Balancing is complete, keep the air handling system in operation during the precision cleaning of the cleanroom and prior to the certification.
  • After the room has been cleaned, schedule the room to be certified in an “As-Built” mode of operation at 0.5 microns after a 24 hour purge time.
  • After the room has been certified in the “As-Built” mode of operation, clean all equipment you will be installing in the cleanroom in the buffer area designated for this disciplines outside the cleanroom prior to installation in the cleanroom.
  • At the completion of the “As-Built” certification process and prior to the Certification Team leaving your site, have a debriefing meeting with them to discuss their findings and get their opinion on how you can better enhance your cleanroom.
  • Move all equipment into the cleanroom.
  • Clean the equipment again.
  • Clean the cleanroom again. Let it purge for 24 hours.
  • Turn on all operating equipment.
  • Have the room certified again in an “At-Rest” mode of operation at 0.5 Microns.
  • The next certification will be in an "Operational" mode.
"RKI is your Single Source For Cleanroom Services"

R. Kraft, Inc
129 Shorecliff Dr. 
Rochester, NY 14612
United States of America

Tel: (585) 621-6946
Email: info@cleanroomservices.com


Let our 40 yrs of cleanroom experience

(Certification, Troubleshooting, Performance Appraisals, Training Seminars, Design Assistance from a Service Provides viewpoint, Construction/Project Management)
assist you in achieving and operating a cost effective cleanroom facility.


ISO/IEC 17025 Accredited For The Testing/Certification of Clean rooms and Laminar Flow Devices.

NAISC CODES

    236210 - 238220 - 611430 

           

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