GMP Standard Cleanroom System Workshop Cleanliness LevelⅡ

Blowing and potting technique

The blowing and sealing equipment used for the production of non-final sterilized products should be equipped with A Class A air shower, the personnel should be dressed in accordance with the style of A/B class clean area, and the equipment should be installed in at least a Class C clean area environment. Under static conditions, the suspended particles and microorganisms in this environment should meet the standard, and under dynamic conditions, the microorganisms in this environment should meet the standard.

The blowing and sealing equipment used to produce the final sterilized product should be installed in a Class D clean area environment at a minimum.

Due to the particularity of the blowing and sealing technology, special attention should be paid to the design and validation of the equipment, the verification of online cleaning and sterilization and the reproducibility of the results, the clean area environment in which the equipment is located, the training and dressing of the operators, and the operation in the key areas of the equipment, including the aseptic assembly of the equipment before the filling begins.

Personnel

The number of people in the clean area should be strictly controlled, and inspection and supervision should be carried out outside the clean area of aseptic production as far as possible.

All personnel working in clean areas (including cleaners and equipment maintenance workers) should be regularly trained to ensure that the handling of sterile drugs meets the requirements. Training should include basic knowledge of hygiene and microbiology. Untrained external personnel (such as external construction personnel or maintenance personnel) should be given special detailed guidance and supervision when they need to enter the clean area during production.

Personnel engaged in animal tissue processing or personnel engaged in microbial culture unrelated to current production are generally not allowed to enter the sterile drug production area, and when unavoidable, the relevant personnel purification operating procedures should be strictly implemented.

Employees engaged in the production of sterile products should always report any abnormal conditions that may lead to contamination, including the type and extent of contamination. Appropriate action should be taken by designated personnel when an employee's health condition may lead to an increased risk of microbial contamination.

Dressing and washing of hands should be done in accordance with operating procedures to minimize contamination of or introduction of contaminants into clean areas.

The work clothes and their quality should be adapted to the requirements of the production operation and the clean room cleanliness levels, and the style and way of wearing should be able to meet the requirements of protecting products and personnel. The dress code for each clean area is as follows: Class D clean area: Hair, beard and other related parts should be covered. Appropriate work clothes and shoes or shoe covers should be worn. Appropriate measures should be taken to avoid contaminants brought outside the clean area. Class C clean area: Hair, beard and other relevant parts should be covered, and masks should be worn. Jumpsuits that can be tightened at the wrist or overalls that are separated should be worn and appropriate shoes or shoe covers should be worn. Clothing should not shed fibers or particles. Level A/B clean areas: All hair, beard and other relevant areas should be fully covered with a hood, tucked into the collar, a mask should be worn to prevent droplets, and protective eyewear should be worn if necessary. Rubber or plastic gloves that have been sterilized and are free of particulate matter (such as talc) should be worn, and foot gloves that have been sterilized or sterilized should be worn, with pant legs tucked into the foot cover and cuffs tucked into the glove. The overalls should be sterilized overalls that do not shed fibers or particles and can retain particles emitted by the body.

Personal clothing may not be brought into the changing rooms leading to Class B or C clean areas. Every employee entering A/B clean area, should change sterile work clothes; Or at least once per shift, but the feasibility of this method should be demonstrated by monitoring results. Gloves should be disinfected frequently during operation, and masks and gloves should be replaced if necessary.

The cleaning and treatment of the cleanroom clothes used in the clean area should be able to ensure that it does not carry pollutants and will not pollute the clean area. The cleaning and sterilization of work clothes should be carried out in accordance with the relevant operating procedures, and the laundry room is best set separately.

To be continued...

Suzhou Pharma Machinery Co.,Ltd.

2024/06/03

Tia