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Frequently Asked Question - Cleanroom Section
 
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Pharma ,Cleanroom Glossary of Terms


   Cleanroom Entrance Zones   Cleanroom Entrance Zones

1.  If a crossover bench is available, it should be crossed over now. This bench is used to demarcate the slightly soiled changing-zone from the cleaner entrance zone, and allows cleanroom footwear (overshoes or overboots) to be correctly put on.

2.  Personnel should sit on the bench. One leg should be raised, the cleanroom footwear put on, the leg transferred over the bench and placed on the floor of the entrance zone. Then the other leg should be raised, the cleanroom footwear put on and the leg taken over the bench. While still sitting on the bench, the legs of the cleanroom garment and the footwear should be adjusted for comfort and security. Personnel should now stand up.

3.  If required, protective goggles can be put on. These are used not only for safety reasons but to prevent eyelashes and eyebrow hair falling onto the product.

4. The garments should be checked in a full-length mirror to see that they are worn correctly. Check that the hood is tucked in and there are no gaps between it and the coverall (or gown). Check that no hair can be seen.

5. If donning gloves have been used they can be dispensed with now. They can, however, be kept on and a pair of clean working gloves put on top. Two pairs of gloves can be used as a precaution against punctures, although sensitivity of touch is lost.

6.  If deemed necessary, the hands can again be washed. Gloves can also be washed. In a biocleanroom it is beneficial to decontaminate the hands by applying an alcohol solution containing a skin disinfectant. Apart from being more efficient, the use of an alcohol solution overcomes the problem of having a washhand basin in the room, with its attendant risk of microbial growth.

7.  Low particle (and if required, sterile) working gloves should now be put on, without the outside of them becoming contaminated. In some cleanrooms this task is left until the personnel is within the production cleanroom. If they are latex gloves, which are wrapped in pairs with the cuffs rolled back (in the style used by surgeons), then the gloves can be put on without being contaminated. In this case, the first glove is taken out of the exposed package by gripping the fold of the rolled-over cuff with the one hand and inserting the other hand into it. Two fingers of the gloved hand are then passed under the rolled-over cuff of the second glove and it is lifted from the package. The hand is then put into the second glove, the fingers being slotted into the correct fingers of the glove, and the cuff lifted over the cuff of the cleanroom garment. It is now possible to pull back the cuff of the first glove, making sure that it is completely over the garment's cuff.

8.  Most cleanroom gloves are not packed in a way that will allow gloves to be put on without contaminating the glove surface. These gloves must be gripped at the edge of the cuff and put on in a similar way to that described above. Gloves packed in pairs will be contaminated less than those packed in 50s or 100s, as it is difficult to remove a glove from a large pack without contaminating those that are left. If considered necessary, the gloves can now be washed or disinfected.

9.  Personnel may now proceed into the cleanroom. This may be over a cleanroom mat.