There are a large number of technological processes in pharmaceutical factories that involve storage and preparation. For example: the storage of purified water is used in the purified water storage tank, the storage of water for injection is used in the storage tank of water for injection (distilled water storage tank), the storage and preparation of medicinal liquid is used in the temporary storage tank, the preparation tank and so on. Understand the common practices and special requirements of these systems and provide customers with support services in the design, manufacture, installation, testing and validation of process vessels.

According to the special requirements of bioengineering equipment, the process vessel should have a good structure to meet the requirements of pharmacy and hygiene. The general requirements for water storage containers are to prevent the formation of biofilms, reduce corrosion, and facilitate the disinfection of storage tanks with chemicals; the storage tanks should be sealed and the inner surface should be smooth to facilitate thermal and chemical disinfection and prevent biofilms. form. Install a 0.2um hydrophobic ventilation filter (respirator), there can be no dead angle, and the shape of the tank conforms to the GMP design.

1. The requirements for the pipeline distribution system are:

1. The inner wall of 316L stainless steel pipe is electro-polished for passivation treatment; the interior of the pipe is polished (minimum 150 grit, 180 grit or electro-polishing is recommended)

2. The pipeline is automatically welded by TIG argon arc welding, the welding part is polished, and the inner wall is smooth; or the sanitary chuck is used for segmental connection;

3. The valve adopts sanitary grade stainless steel polytetraethylene diaphragm valve, connected with sanitary chuck; the installation position of each valve is convenient for operation and maintenance.

4. The pipeline has a certain inclination to facilitate the removal of stored water; the pipeline has a necessary slope, and there is a drain port to drain the purified water in the pipeline; the pipeline design should have no excessively long stagnation points, in line with 3D rules, There is no dead angle, and the length of the "blind pipe" section at the valve at the point of use shall not be greater than 6 times the pipe diameter for the heating system and 4 times the pipe diameter for the cooling system.

5. The pipeline is arranged in a cycle, and the return water flows into the storage tank. The connection method can be connected in parallel or in series, and the series connection method is better. The fluid maintains a certain flow velocity, greater than 2m/s.

6. The pipeline is sterilized with clean steam, and the sterilization temperature is 121℃. All inner surfaces can withstand hot water greater than or equal to 82 degrees or steam at 121 degrees Celsius without dismantling and washing. Capable of flushing to all valves, including relief valves.

2. Cleaning, passivation and disinfection of pipelines

After the purified water pipeline is installed, the cleaning, passivation and disinfection are carried out. The process includes purified water pre-rinsing, lye circulating cleaning, purified water rinsing, passivation, purified water rinsing, discharge, disinfection (ozone water or pure steam purging), and final Flush until the resistivity of the water at each outlet point matches that of purified water.

3. GMP verification service for purified water equipment system

Provide system commissioning and verification services in accordance with ISPE guidance, provide standard management procedures SMP and standard operating procedures SOP, provide design qualification (DQ), installation qualification (IQ) and operation qualification (OQ) program preparation and implementation, provide performance confirmation (PQ) program writing. Among them, many customers have passed FDA, EMEA, TGA and other foreign certifications, and have established good long-term cooperative relations.