SOP on Guidelines: – Working in B-Lactam Rooms

1.0 Introduction:   A clean room is defined as a specially isolated environment strictly controlled with respect to airborne particles, temperature, humidity, air pressure, air flow, air motion, and lighting. Clean rooms can be classified by the type of air filtration used.

During and after the manufacture of products in these areas special precautions and procedures are essential because of the dangers of contamination Operators working in clean areas and their clothing could become a source of contamination if they do not pay attention to matters of hygiene and cleanliness and the right habits of working. The following guidelines deal with the additional precautions necessary for personnel involved in the manufacture of products in clean rooms.

2.1. Staff with open wounds, rashes, boils or any other skin ailment must not be permitted to work in clean areas.

2.2. Staff suffering from upper respiratory tract infections, colds, coughs, hay fever etc. must not be allowed to work in clean areas.

2.3. Periodic health checks for the aforementioned conditions should be done.

3.1. The number of persons working in clean areas should be kept to the minimum practicable. As far as possible, inspection and control procedures should be conducted from outside these areas.

3.2. Staff should not move about unnecessarily in clean areas because movement increases particulate and bacterial shedding.

3.3. Persons engaged in maintenance work or process adjustment or rectification of minor faults to equipment must observe the same precautions and hygienic standards as production personnel.

4.0 Protective clothing 

4.1. Staff working in clean areas should change into special garments include head and footwear.

4.2. Edges of the garments should be sealed and the garments should have no external pockets and unnecessary tucks or belts.

4.3. Clean area garments should shed virtually no fibers or particulate matter and should retain particles shed by the body. The cloths should be cleaned in such a way that they do not gather contaminants which can latter be shed while working.

4.4. Fresh & clean garments should be worn each time a person enters a clean area. The garments should be restricted for use only in the relevant clean areas.

4.5. Clean areas garments should be stored and handled after cleaning in such a manner as to minimize microbial contamination and the accumulation of particulate matter.

5.1 Gowning Procedure 

5.1.1. Remove factory foot wear outside in the first change room.

5.1.2. Enter the first change room.

5.2.1. Clean the hands with the antiseptic solution.

5.2.2. Wear the clean foot wear.

5.2.3. Enter second change room.

5.3.1. Open the Locker and take out the clean dress.

5.3.2. Wear the clean dress on the factory uniform.

5.3.3. Next wear the clean headgear and booties.

5.3.4. Enter the production area.

5.4.1. Open the door and enter the room.

Note: Authorized production staff, hired cleaning staff and any person specifically authorized to enter the production area, must follow these instructions.