Bienvenue à Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.

info@marya.cn

Marya

Actualités de l'entreprise

Informations sur l'industrie

Daily Maintenance and Operation Management of Cleanroom

2022-04-12

Original

Marya

In order to maintain the cleanliness of the air in the clean room, the relevant maintenance regulations are strictly implemented to prevent the generation, retention and reproduction of dust particles and microorganisms in the clean room,and to ensure the safety of equipment and personnel. 

In order to maintain the cleanliness of the air in the clean room, the relevant maintenance regulations are strictly implemented to prevent the generation, retention and reproduction of dust particles and microorganisms in the clean room,and to ensure the safety of equipment and personnel. 


                                                           


     1. Management of entering and leaving the clean room
(1) Personnel entering the clean room should be strictly required to implement the personal purification system,route and sequence. When exiting the clean room, follow the above order and route,and it is not allowed to bring clean supplies into the hall.
(2) If there is a air shower room, it can only enter the clean room after blowing and showering according to the regulations.At the same time, in strict accordance with the specifications and usage requirements of the air shower, the number of people entering the air shower is controlled each time, and it is not allowed to forcibly shut down the running fan or power
(3) In order not to interfere with the clean airflow pattern in the room,no items should be placed on the upstream side of the work area, and no items should be stacked near the air return port; no items should be blocked or stacked under the air supply orifice, and the production operation should be performed on the clean workbench or upstream of the airflow.
(4) Items unrelated to production and prone to dust production into clean rooms are not allowed.
(5) Smoking, eating and non-productive activities in clean rooms are strictly prohibited.
(6) Before entering the clean room, the personal items must be put into the designated cabinet, remove the makeup and decoration, and put on the designated clean clothes and shoes.
(7) When wearing a hat, the hair should be completely covered, and the shoe cover should tightly wrap the hem of the trousers around the shoe cover.
(8) When taking off clean work clothes, it is necessary to avoid the work clothes from touching the ground, tables and other items.Generally, the work clothes should be removed from the bottom to the top,and stored in the cabinet or hung in the specified place.
(9) When exiting the clean room, it is not allowed to take off the clean work clothes before the changing area;if you enter room after taking off the work clothes, you still need to follow the prescribed order for entering the clean room.
(10) When exiting the clean room, it is allowed to enter the replacement area without going through an air shower.

2. Operation personnel management of the clean room
(1)Hands are the medium of cross-contamination. Operators need to wash their hands when entering the clean room, and do not touch high-purity products and high-purity packaging materials with their hands. Drug production operators also need to be disinfected.
(2) The following personnel are not allowed to enter the clean room:patients with colds, coughs,eczema and other diseases; those who do not wash off cosmetics, nail polish and clean work clothes as required;operators should wash their hair,change clothes and cut their nails frequently.
(3) When working in a clean room, operators should move lightly,strictly implement operating procedures,do not make large movements that are easy to generate dust, do not drag their feet, and do not do unnecessary movements;they are not allowed to wear clean work clothes to go to the toilet.
(4) In the clean room, gloves should be worn as required,without showing wrists,and gloves should be changed frequently.
(5) Relevant training and education should be carried out for personnel entering the clean room: master the characteristics, structure and general knowledge of cleaning technology of the clean room, personnel purification procedures and material purification route requirements, the use and cleaning requirements of clean work clothes, cleaning and disinfection of the clean room,clean room safety facilities and safety management regulations.
(6) Clean work clothes should be made of fabrics that produce less dust and are antistatic.Generally, class 10000 to 100000 clean rooms are used in one piece. It is best to use disposable clean shoe covers, and clean shoes are required to be washable. Generally, when people wearing clean clothes walk, the number of particles emitted on the surface is 40-60 times less than that of people wearing ordinary clothes, so this point is very important for the maintenance and management of high-cleanliness workshops.
(7) Clean work clothes must be managed by special personnel, regularly inspected and cleaned. Generally cleaned once a week,usually after 50 to 100 cleanings, it should be checked to determine whether it is scrapped.
(8) The “5S”operation in the clean room needs to ensure the timeliness and continuity, and the on-site management personnel perform regionalized positioning management.

3. Cleaning and sterilization of clean rooms
The cleaning of the clean room generally must be carried out after the production process; if it is necessary to clean before production, the process production should be carried out after the clean air-conditioning system has been turned on and the operating time has reached the cleanliness requirements.
In addition, the entire sterilized clean room should be in a circulating state through the return air duct, and air sterilization should be done for 1-1.5 hours every day.It takes about 2 hours to disinfect and sterilize surfaces such as clean room walls, floors, and equipment.

4. Device management
The production of anti-pollution management will increase the amount of indoor dust when the production process or operational errors occurs. In response to these pollution sources, it is necessary to formulate corresponding management measures and necessary countermeasures, so it is necessary to strictly implement the management system of processes and equipment.
The air-conditioning system device is the main equipment to ensure the cleanliness level of indoor air, including various filters, clean workbenches, laminar flow hoods, air showers, transfer windows, air-conditioning devices, etc. Their normal maintenance and regular inspection are important conditions to ensure  cleanliness. The specific requirements are shown in the following table:

Device name

Management project

Management content

Instrumentation

Test requirements

1.Filter
  1. Cleanliness
  2. Air Duc
  3. Airflow rat
  4. Indoor and outdoor static pressure difference.

Clean room fixed-point monitoring scanning test and gasket leak detection.

Dust particle counter.
Wind velocity indicator.

Differential pressure meter.

According to clean room regulations.

2. Primary filter
Medium filter
  1. Contaminate
  2. Air volum
  3. Static pressure difference

Clean room fixed-point monitoring.
Visual test
Standard assay.

Air meter.

Differential pressure meter.

Timing, continuity

3. Clean bench.

Clean room.
  1. Cleanliness
  2. Air volum
  3. Airflow rat
  4. Vibratio
  5. Calorific valu
  6. Illuminance

The high-efficiency filter comprehensively scans and tests for leaks, and each unit measures 5 points.

Visual.
Touch.

Dust particle counter.

Corpuscular counter.

Air meter.
Differential pressure meter.

Illuminometer

Determined according to production process requirements.

4. Air blower
  1. Voltage, curren
  2. Levels of leash loosenin
  3. Motor rotatio
  4. Noise, hea
  5. Air blower impeller balance

Fixed-point monitoring.

Visual.

Visual.

Voltmeter.

Amperemeter.

Tachometer.

Dynamic balancer.

Daily timing.

Dynamic balance from March-June.

5. Control instruments, control valves,etc.

1.Induction action

2. Recorder action
3. Pen point
4. Record paper

Standard value correction for given value change test.
Using manual test.

Sensor cleanig, especially the temperature sensor, and the shaft part should be finely inspected.

Visual.

Standard hanging temperature, hygrometer, galvanometer and other related standard instruments.

The action is scheduled every day, and the correction are carried out according to the regulations.