During the production process, the sterility of the cell freeze solution can be ensured by:

First, raw material control

Choose sterile raw materials:

Ensure that all raw materials used in the production of the cell freeze, such as solvents, protectants, additives, etc., are sterile. Source raw materials from reliable suppliers and require relevant quality reports and sterility certificates.

Carry out strict incoming inspection of raw materials, including appearance inspection, microorganism, etc., to ensure that raw materials meet sterility requirements.

Storage of raw materials:

Raw materials should be stored in a sterile, dry, cool environment to avoid contamination. Use airtight containers to store raw materials to prevent airborne microorganisms from entering.

Clean the raw material storage area regularly to keep the environment sterile.

2. Production environment control

Clean workshop:

The production of cell freeze should be carried out in a clean workshop, and the clean workshop should meet the corresponding cleanliness standards. For example, the use of class 100,000 or higher grade clean workshop, to ensure that the air of microorganisms and dust particles content is very low.

Regular maintenance of the clean workshop to ensure that the cleanliness meets the requirements.

Air purification system:

The air purification system is installed to filter and purify the air entering the clean workshop. The air purification system should include primary filters, medium filters and filters that can effectively remove microorganisms and dust particles from the air.

Maintain the air purification system regularly and replace the filter to ensure its normal operation.

Personnel and Material Management:

Personnel entering the clean workshop should wear sterile work clothes, masks, hats, etc., and go through strict hand-washing procedures. Restrict the entry and exit of personnel to reduce the pollution of the production environment.

Materials should be cleaned and treated before entering the clean workshop, in aseptic packaging or through a transfer window. Avoid microorganisms brought into the material.

3. Production process control

Sterility:

In the production process, aseptic norms should be strictly observed, and personnel should be trained and familiar with aseptic technology. Use sterile tools and equipment and avoid direct contact with products.

Clean the production equipment regularly to ensure that there is no microbial residue on the surface of the equipment.

Process monitoring:

A number of monitoring points are set up in the production process to carry out microorganisms in key links. For example, sampling of raw material mixing, filling and other links to find potential pollution problems in a timely manner.

Rapid microbial methods, such as ATP bioluminescence and microbial culture, are used to ensure the accuracy and timeliness of the results.

Terminal:

For some products that cannot be guaranteed sterility through sterility, a terminal approach can be considered. For example, the product is treated by methods such as damp heat and irradiation.

When carrying out the terminal, appropriate parameters should be selected to ensure that the quality of the product is not affected at the same time.

4. Quality control and

Quality control system:

Establish a perfect quality control system, and strictly control the quality of each link in the production process. Develop quality standards and procedures to ensure that products meet aseptic requirements.

Periodically audit and improve the quality control system to improve product quality and sterility assurance level.

Microorganism:

Microorganisms, including mycoplasma, performed on the production of cell freeze. A variety of methods, such as culture, PCR, enzyme-linked immunosorbent assay, were used to ensure the accuracy of the results.