Validation of Clean Room Pass Boxes
(A) Clean Room: A Clean Room is an area in which the quantity and size of air- borne particles are controlled in order to limit contamination. A Clean Room is constructed and operated in a manner to control the introduction, generation and retention of contaminates inside the space.
(B) Pass Boxes: Pass Boxes are cubical boxes that are used to transfer material from one area to another area.
(C) Need of developing Pass Boxes- Pass Boxes are designed to aid in transfer of material without much personnel movement in Clean Rooms.
(D) Difference between Dynamic Pass Box AND Static Pass Box:
(E) Test for the Validation of Cleanliness for Pass Boxes:
Following Validation test should be performed during installation and specified pre- defined frequency:
- Air Flow System:
- Air Flow should be Uni-directional air flow system.
2. HEPA Filter Integrity Test:
- Required Apparatus for performing test: The name of the apparatus is:
- Aerosol Photometer.
- Criteria for Acceptance: Leakage rate should not be more than 0.01%.
- Procedure for Operating the Apparatus:
- Integrity checking of filters should be carried out by using Calibrated Photometer.
- Following apparatus should be used while performing integrity testing of filters.
- An Aerosol Photometer having threshold senstivity below 10 microgram/ liter for 0.3 μ particles of aerosolized by Poly Alfa Olefin (PAO) and a sampling rate of 1 Cubic Feet Per Minute ( CFM). Set up the Aerosol generator and fill the DOP/ PAO liquid to minimum ½ of its capacity.
- NON- Viable Particular Count Test:
- Required Apparatus for performing test: The name of the apparatus is:
- Discrete Particular Counter.
- Criteria for Acceptance: The average particle concentration at each of the particle measuring location should fall below the mentioned class limit:
| Grade | Maximum permitted number of particles/ m3 equal to or greater than the tabulated size. | |||
| At Rest | In Operation | |||
| 0.5 μm | 5.0 μm | 0.5 μm | 5.0 μm | |
| A | 3,520 | 20 | 3,520 | 20 |
| B | 3,520 | 29 | 3,520 | 29 |
| C | 3520, 000 | 2,900 | 3520, 000 | 2,900 |
| D | 3,520, 000 | 29,000 | Not Defined | Not Defined |
Procedure for particulate count recovery test:
- Required Apparatus for performing test: The name of the apparatus is:
- Discrete particulate counter.
- Criteria for Acceptance: The process should not take more than 15 minutes to return contaminated condition of clean room to the specified clean room condition. In accordance with ISO 14644-3; the average particle concentration at each of the particle measuring location should fall below the mentioned class limit:
| Grade | Maximum permitted number of particles/ m3 equal to or greater than the tabulated size. | |||
| At Rest | In Operation | |||
| 0.5 μm | 5.0 μm | 0.5 μm | 5.0 μm | |
| A | 3,520 | 20 | 3,520 | 20 |
| B | 3,520 | 29 | 3,520 | 29 |
| C | 3520, 000 | 2,900 | 3520, 000 | 2,900 |
| D | 3,520, 000 | 29,000 | Not Defined | Not Defined |
- Viable Particulate Count Test:
- Recommended limits should be followed for microbiological monitoring of clean areas during operation and are mentioned below:
| Recommended Limits for MICROBIAL CONCENTRATION (a) | ||||
| Grade | Air Samples Cfu/ m3 |
Settle Plates (diam. 90 mm), cfu/4 hours (b) |
Contact Plates (diam. 55 mm), cfu/ plate |
Glove print 5 fingers cfu/ glove |
| A | < 1 | < 1 | < 1 | < 1 |
| B | 10 | 5 | 5 | 5 |
| C | 100 | 50 | 25 | – |
| D | 200 | 100 | 50 | – |
Notes:
- Is indicating for Average Values.
- Is indicating for single settle plates which are exposed for less than 4 hours.
Reliable alert and action limits should be set for the results of particulate and microbiological monitoring. If limits are exceeded from the above mentioned values while performing operating procedures then corrective actions must be taken.
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