Purification procedures for personnel entering Class 10,000 (10,000) clean rooms

Purpose

To establish the purification and operation procedures for operators entering the Class 10,000 clean room (area) to ensure the cleanliness and hygiene of the Class 10,000 clean room (area).

Scope

Applicable to all personnel entering the Class 10,000 clean room (area).

Responsibilities

Operators, workshop managers, and maintenance personnel are responsible for the implementation of this procedure, and QA is responsible for supervising the implementation of the procedure.

(Figure 1: Class 10,000 clean room)

Procedures

1. Entry procedures

After entering the general area procedures, personnel enter the Class 10,000 clean area according to the following procedures to change shoes → [take off the general area work clothes and wash hands] → put on clean work clothes → [hand disinfection room and hand disinfection] → enter the Class 10,000 clean room (area).

1.1 Changing shoes

When entering the Class 10,000 clean room (area) changing shoe room, sit outside the shoe changing cabinet, take off the general production area work shoes, put them neatly into the outer compartment of the shoe cabinet, turn 180 degrees to take out the Class 10,000 clean room (area) work shoes and change them on the inside of the shoe cabinet, and enter the changing room.

1.2 Take off the work clothes of the production area

In the locker room, take off the work clothes of the production area and put them in the storage cabinet.

1.3 Wash hands

1.3.1 Go to the wash basin and push the purified water switch with your wrist, stretch your hands to let the water wet your hands to 5cm from the wrist. After your hands touch the detergent, rub them against each other to make the palms, backs of hands, fingers and skin 5cm above the wrists evenly filled with a lot of foam and clean each finger and finger, remove the grease in the palms, remove the dirt on the nails.

1.3.2 Push the purified water switch with your wrist, stretch your hands under the faucet, let the purified water rinse your hands, and rub your hands against each other to make them free of foam, until your hands are no longer greasy.

1.3.3 After checking that your hands are clean with your eyes, push the purified water switch with your wrist to turn it off.

1.3.4 Place your hands about 8-10cm below the electric hand dryer to turn it on automatically, and flip your palms up and down until they are dry.

1.4 Wearing class 10000 clean work clothes

1.4.1 Arrive at the door of the clean clothes room, use your elbow to unlock the door, push the door open and enter immediately, and close the door.

1.4.2 Arrive at the locker and take out your clean work clothes from the storage bag in the locker. Put on your work hat from top to bottom (do not expose your hair), then put on your clean work clothes, zip up, tighten your collar and wrists, wear a mask, and close the door.

1.4.3 Go to the dressing mirror to check whether your hair is exposed and whether the mask covers your mouth and nose. The work clothes should be tucked into the trouser legs, and the trouser legs should be tucked into the foot covers.

1.4.4 Complete the dressing and dressing procedure, arrive at the door of the hand disinfection room, use your elbow to unlock the door, enter the hand disinfection room and close the door.

(Figure 2: Personnel entering the clean room)

1.5 Hand disinfection

Before reaching the hand disinfector, reach under the hand disinfector to start it automatically, turn your hands and stay for 30 seconds to let 75% ethanol spray evenly on your hands.

1.6 Entering the 10000-level clean room (area)

Use your elbow to push open the door of the clean area corridor, immediately enter the clean area corridor and close the door, open the door of each operating room according to the work position and enter, and close the door immediately.

2. Wear gloves 

Wear gloves when directly contacting drug production, and do not allow manual operation. If it is unavoidable, wipe and disinfect with 75% ethanol immediately.

3. Procedure for leaving the 10,000-level clean room (area)

Change clothes in the reverse order when entering, change work clothes and work shoes and put them in the work clothes recycling container respectively, and send them to the work clothes cleaning room before leaving the workshop.