Clean room production management system for radiopharmaceutical production plants

1. Preparation before production

a. Before production personnel enter the Clean air production plant for drug placement, they should carefully wipe the floor, desktop, control cabinet and other dusty places with a wet clean cloth;

b. Turn on the air purification system to purify the air: turn on the ultraviolet light to sterilize the dust for at least 1 hour'

c. After the air purification system has been running for at least 1 hour, production personnel can Enter the clean room for drug placement production.

d. After careful cleaning, the necessary items for production enter the production site through the logistics port;

e. Before entering the clean room, production personnel must wear clean room special work clothes and work shoes, and wear masks. The clean room work clothes must cover all hair, beards and feet, an

d the mouth must cover the mouth and nose to prevent human body shed objects from being blown away by the wind. Only after taking a shower can you enter the clean room to work;

f. Production personnel entering the clean room are not allowed to wear makeup or accessories, and should take a bath, change clothes, get a haircut (no long hair or beard), cut nails, and maintain good personal hygiene habits; patients with infectious diseases, skin diseases, and wounds on the body surface are not allowed to enter the clean room to engage in the production of drug placement.

g. After entering the clean room, production personnel should first check whether the temperature, humidity, and pressure difference between rooms with different cleanliness meet the production requirements, and make records. If they meet the requirements, they can only carry out drug placement production. If the temperature, humidity, and pressure difference between rooms with different cleanliness do not meet the requirements, they should be reported in time, and the production of drug placement can only be carried out after taking appropriate measures to eliminate the fault.

(Figure 1: Radiopharmaceutical production plant)

2. Requirements for clean room working status during production

a. During the production of drug release, the air purification system must be in operation;

b. During the production of drug release, the doors between the clean room and the non-clean room, the wind and shower doors, and the doors between different cleanliness levels must always be closed. When production personnel enter and exit these doors, they must close them at any time and tightly.

c. When production personnel enter the clean room to work, they can turn off the ultraviolet light to prevent ultraviolet damage;

d. Except for production personnel who must enter the clean room for production needs, other non-production personnel are not allowed to enter the clean room without permission. If there is something, they can contact by phone. Non-production personnel who are allowed to enter the clean room must also wear special work clothes and work shoes for the clean area and wear masks like production personnel;

e. During the production of drug release, production personnel should reduce walking and movement as much as possible to prevent the generation or fall of human dust.

(Figure 2: Clean room work requirements)

3. Requirements for clean room status after production

a. Clean the clean room used and put all items in order.

b. Clean the items used in the production site and register the items left in the production site and taken out of the production site. Non-production items and personal items shall not be stored in the clean room. Waste in production shall be handled or taken out of the clean room in a timely manner.

c. Turn off the power supply and lighting used in the clean room.

d. Close all doors of the clean room, and lock them if they need to be locked.

e. Turn off the air purification system and keep operation records.

(Figure 3: Clean room environment requirements)

4. Precautions

a. Smoking, drinking water, and eating are strictly prohibited in the clean room.

b. Fighting, crazy play, and loud noises are strictly prohibited in the clean room.

c. Clean It is forbidden to use work clothes and work shoes for cleanrooms in non-cleanrooms: It is forbidden to wear your own clothes to enter the cleanroom.

d. All doors from entering the clean dressing room to entering the cleanroom must be closed and closed tightly to prevent insects and mice from entering the cleanroom;

e. Cigarette butts, paper scraps and other debris shall not be thrown around in the drug production plant (including the delivery room, bathroom, dressing room and the outside yard);

f. No debris shall be piled in the dressing room (including the top of the locker)

g. Clothes used in the cleanroom area shall not be changed in other places outside the clean dressing room, and the locker door shall be closed at all times

h. Do not open or close the door while wearing gloves to prevent the door handle from being contaminated by radioactivity.

5. Requirements for outsiders to visit the clean room

When our department leaders receive requests from other departments to bring outsiders to visit the clean room production line, they must first verify with the general manager whether they know or agree with the outsider's visit. If the general manager does not know or does not agree to the visit, our department leaders must refuse the visit: If the general manager knows or agrees to the outsider's visit, our department leaders will notify the relevant team leaders to open the door and the team leaders will explain, but the explanation cannot involve production process secrets: When outsiders take photos or sketch the equipment on the production line, the team leaders must refuse to allow the outsider to visit. The leader and the accompanying personnel must stop it. 

Before entering the clean room for a visit, outsiders must wear clean room-specific work clothes and work shoes in the designated dressing room, and can enter the clean room for a visit after passing through the air shower door. When other departments ask the team leader to bring outsiders to visit the clean room production line, the team leader must refuse their visit and report to the leader of our department. If outsiders do not change into clean room-specific work clothes and work shoes, the team leader has the right to refuse their visit.

(Figure 4: Visitors visiting the clean room)

6. Rewards and punishments

For those who violate the above regulations, a fine of 50 yuan per person will be imposed, and the fine will be used as the activity fund of our department. After verification, the fine will be awarded to the informant who exposes and reports violations of the above regulations.