~Suzhou Pharma Small Class~

Ⅰ、 Cleaning and sterilization of clean room

1. Clean room cleaning shall generally be carried out after the completion of production process; If it is necessary to clean before production, the process production can only be started after the start-up time of the purification air conditioning system meets the cleaning requirements. In order to prevent cross contamination, the cleaning facilities in the clean workshop should be dedicated according to the product characteristics, process requirements and cleanliness levels.

Cleaning tools generally adopt centralized fixed and portable mobile vacuum cleaning equipment. If the above conditions are not met, you can also use materials that do not shed fibers, such as mercerized towels and nylon cloth, to wipe, generally once or several times a day.

The workbench and tools are generally cleaned once a day; The walls and floors of the 10-1000 level plant are generally cleaned once a week, and the 10000-100000 level plant is cleaned once a month. The purified air conditioning system should be cleaned once or twice a year, and entrusted to special cleaning personnel.

2. Clean room sterilization

For biological clean rooms, in addition to controlling the number of biological or non-biological particles in the air sent into the clean room, the surfaces of indoor appliances, floors, walls, wallboards, etc. should also be disinfected. Air cleaning technology cannot kill bacteria. Disinfection and sterilization measures must be taken in the operation and management of biological clean room to reduce the survival and reproduction of microorganisms in the clean room.

At present, the traditional sterilization methods are ultraviolet sterilization, medicament sterilization, heating sterilization and ozone sterilization. They have good safety and reliability and are most widely used.

In addition, the whole sterilized clean room should be in a circulation state through the air supply and return duct, and the machine should be turned on every day for air sterilization for 1-1.5 hours; If it is necessary to disinfect the walls, floors and equipment of the clean room, it will take about 2 hours.

Ⅱ、 Equipment management

1. Anti-pollution management of process equipment

During the production process of production process equipment, or the operation error will cause the increase of indoor dust emission; According to the situation of 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 process and equipment

2. The air conditioning system device is the main equipment to ensure the cleanliness level of indoor air, including various filters, clean workbench, laminar flow hood, air shower room, transfer window, air conditioning device, etc. Their normal maintenance and regular inspection are important conditions to ensure the cleanliness of the clean room.

Ⅲ、 Management of office facilities

According to the needs of clean room maintenance, do a good job in daily maintenance, regular inspection and specified testing and certification of water, electricity and gas supply systems, communication, safety alarm devices, etc.

Ⅳ、 Management of equipment and personal safety

Record the operation status and relevant parameters of various equipment as required, record and analyze the regular inspection, maintenance and cleaning status, and pay special attention to the regular inspection of the integrity of rotating parts, communication and safety alarm devices and automatic devices.

Regularly inspect and calibrate various testing and measuring instruments and meters to ensure the accuracy and reliability of measurement control. Operators shall strictly implement relevant management requirements and regulations to ensure the safety of operators.

                 

   

                 

                 

Suzhou Pharma Machinery Co.,Ltd.

2023/02/06

Alice