Liquid preparation systemThe design and installation of should follow the general principle of "should be able to avoid pollution, cross contamination, confusion, and errors to the greatest extent possible, and be easy to clean, operate, and maintain". According to the principles of "compliance, easy operation and maintenance, cleanliness and aesthetics", the design, installation, and verification should be carried out based on the production processes and URS of different pharmaceutical companies.

For sterile injection solutions, the following aspects should be considered:

One is sterility. Injection is a sterile drug injected into the human body, which requires strict requirements for production environment, raw material quality, process conditions, and cleaning and sterilization. Therefore, the sterility of the system is the first element;

The second is the control of insoluble particles, which needs to fully consider the four major sources of pollution caused by insoluble particles and take corresponding prevention and control measures; (Four major sources of pollution: 1. Public utility systems, including nitrogen, air, etc.),

Gas, injection water, clean steam, and air conditioning; 2. Process material system, including raw materials, solvents, disinfectants for environmental and equipment surface disinfection, etc; 3. Tools and equipment pipeline system; 4. Operating system, including the operator's clothing, gloves, and the setting position of the operator's operating surface. The third is the uniformity and stability of product physical and chemical indicators. A good design should consider strict control over the production process, and adopt advanced self-control measures for important process parameters to achieve the uniformity of product physical and chemical indicators.

Based on years of engineering experience in injection design, construction, commissioning, and verification at Jiadun Corporation, the installation of injection pipelines generally requires attention to the following points:

Try to use cold drawn ports and NA interfaces on the mixing tank to meet cleaning needs

All tanks with top mixing are equipped with two cleaning balls to avoid leaving blind spots during cleaning.

To ensure measurement accuracy, it is best to equip on-site quality inspection with weighing modules or differential pressure level gauges.

All mixing motors are equipped with frequency converters to meet the requirements of material mixing speed.

The material preparation and transportation process should be completed in the same room as much as possible to avoid cross flow of personnel.

As much as possible, connect the inlet pipes of the distribution tank in series to reduce the number of tank interfaces and facilitate equipment cleaning.

Gas should be imported through respirators as much as possible to reduce the risk of pollution.

Minimize the connection pipes and valves between various devices as much as possible to facilitate use and cleaning.

When there are multiple pipeline branches, the conversion plate mode is used to facilitate pipeline cleaning and avoid the formation of blind spots. Reduce pipeline connections.

The selection of filters follows the principle of step-by-step improvement, which ensures the filtration requirements of the solution and avoids filter clogging.

Add temperature detection to all low points of equipment and filter sterilization, and install condensate discharge valve groups and pipelines.

All sterilization filters achieve online sterilization.

Perform CIP and SIP according to the principles of segmented cleaning and segmented sterilization.

The CIP cleaning circuit is equipped with a conductivity meter to detect the conductivity of the cleaning return water.

The temperature control system during the dispensing process is automatic to meet the temperature requirements of the dispensing.