Injection preparation system

Injection preparation system

In drug production, it is crucial to eliminate cross contamination of active ingredients, foreign substances, insoluble particles, and reduce or eliminate microbial and pyrogen contamination of injections to ensure product quality and safety; In the production process of injection materials, the cleaning methods of the material system can be divided into three modes: manual, semi-automatic, and fully automatic.

1. Manual cleaning mode: such as manually disassembling filters, filter elements, hoses, etc., they must be disassembled and cleaned to ensure cleaning effectiveness; This is an unstable processing method, and reproducibility and effectiveness cannot be guaranteed. The quality risk level is "high".

2. Semi automatic cleaning mode: using ultrasonic technology to clean filters and other accessories; It belongs to a relatively stable processing method, with basic assurance of reproducibility and effectiveness, and a quality risk level of "medium".

3. Fully automatic cleaning mode: using a human-machine interface, information exchange, and functional contact or mutual influence to achieve a fixed process or program to complete the operation of batching equipment or systems; By utilizing CIP/SIP technology, the following basic conditions are met: washing solution name and concentration, temperature, flow rate, and time to achieve cleaning objectives; It belongs to a stable processing method, with guaranteed reproducibility and effectiveness, and a low quality risk level.

Injection preparation systemDevelopment trend:

With the continuous improvement of drug quality risk control, the risk control of ingredient systems has reached a necessary level of implementation. It is necessary to eliminate the previous manual cleaning mode and semi-automatic cleaning mode to reduce the harm of human errors to products. Therefore, in the sterile preparation production material system, reliable online CIP/SIP functions should be added to reduce or remove the substances remaining in the production equipment from the previous batch of production to a level that will not affect the quality and safety of the next batch of products. This can effectively remove the organic matter required for microbial reproduction

CIP characteristics and selection of cleaning agents

1. Characteristics of Conventional Cleaning Agents:

The "Residual Solvent Guidelines" classify solvents into three levels, with clear requirements for their use and residual limits. Cleaning agents should have the advantages of: * equipment, dissolution of residues, and easy removal by themselves; Chemical cleaning agents can be selected based on the nature, dosage, water quality, mechanical material, cleaning method, and cost of the dirt.

Generally, it has the following characteristics:

(1) Easily soluble in water, not easy to produce foam, and the reaction with salt in water should be as low as possible.

(2) Strong wetting ability, * equipment.

(3) Good cleaning effect on pollutants and minimal environmental pollution.

(4) Low water consumption, low cost, and no safety hazards to the human body.

2. Selection of Conventional Cleaning Agents:

Cleaning agents used in pharmaceutical production, such as water, purified water, injection water, acids, alkalis, fungicides, etc; It is very important to choose the correct cleaning agent based on the product process conditions. Here are a few common cleaning agents and their application scope:

(1) Water is a conventional cleaning agent that can dissolve and dilute highly polar inorganic and organic substances.

(2) Acidic cleaning agents are mainly composed of nitric acid, phosphoric acid, citric acid, etc. Acidic cleaning agents can remove stubborn dirt that alkaline detergents cannot remove, such as inorganic acids, calcium salts, etc.

(3) Alkaline cleaning agents are mainly composed of sodium hydroxide, sodium bicarbonate, etc. Alkaline cleaning agents have good solubility for organic matter and good emulsifying properties at high temperatures.

(4) Fungicides are mainly composed of high-temperature hot water, hydrogen peroxide, peracetic acid, etc. They have a killing effect on microorganisms and bacteria.

3. Cleaning method design:

Based on the production process, design process modes such as coarse washing, circulation, and fine washing, define cleaning program control, monitor system cleaning effect parameters in real time, and meet process requirements; Prevent contamination of other systems during the cleaning process.