Injection sterile clean workshop project

Injection sterile clean pharmaceutical cleanroom project

Injection is a sterile preparation, which should not only be produced in accordance with the production process, but also be strictly managed in accordance with GMP to ensure quality and safety; ampoules belong to the second-class packaging material, which should be washed and used after removing the outer packaging. The water should be fresh water for injection, commonly used...

Text label: sterile plant engineering, clean plant engineering, injection clean plant

Injection sterile clean pharmaceutical cleanroom project

Injection is a sterile preparation, which should not only be produced in accordance with the production process, but also be strictly managed in accordance with GMP to ensure quality and safety; ampoules belong to the second-class packaging material, which should be washed and used after removing the outer packaging. The water should be fresh water for injection. The commonly used washing methods include pressurized jet air-water washing method and ultrasonic washing method. The ultrasonic washing method is a combination of ultrasonic washing and air-water jet washing, which has high cleaning cleanliness. , fast speed and so on. Pressurized jet air and water to wash hair, use pressurized, filtered purified water and filtered compressed air to alternately spray into the ampoule through the needle for washing, the washing sequence is generally air→water→air→water→air, rinse 4 -8 times, the last washing should be water for injection filtered by the microporous membrane; the equipment used in this method is the air-water jet ampoule washing unit, which is mainly composed of water supply system, compressed air and its filtration system, washing bottle It is composed of three parts, including the machine, which is suitable for the washing of curved neck ampoules and large ampoules, and the air-water washing program is automatically completed.

Ultrasonic washing method, the interface between the ultrasonic wave propagating in the liquid and the ampoule in contact with the ampoule is in a state of severe ultrasonic vibration, and the dirt on the inner and outer surfaces of the ampoule is impacted and peeled off, so as to achieve the purpose of cleaning the ampoule, and its washing efficiency and effect are ideal; Using the principle of combining jet air-water washing technology and ultrasonic cleaning technology, a continuous rotary ultrasonic bottle washing machine is made. The equipment is rotated by the needle drum to wash the ampoules. Each washing cycle is bottle feeding → water filling → ultrasonic washing → purified water washing. →Purge with compressed air →Wash with water for injection →Purge with compressed air →Out of bottle; the needle drum rotates continuously, and the ampoule washing cycle is carried out, which realizes the function of large-scale processing of ampoules, meets the technical requirements of GMP production, and is automatic electrical control. After washing the ampoules, they are generally dried in an oven at 120-140 °C. The ampoules containing aseptic operation or low-temperature sterilization must be dried and sterilized at 180 °C for 1.5H. In mass production, tunnel-type dry heat sterilizers are often used. The equipment is mainly composed of two parts: infrared emission device and ampoule automatic transmission device. The ampoules pass through the tunnel in sequence: the preheating section, where the temperature is at 100 °C, to evaporate most of the water; the high temperature sterilization section, where the temperature can reach over 350 °C to kill microorganisms; the cooling section, where the temperature is about 100 °C, the ampoules leave the tunnel ; The sterilized ampoule storage cabinet should be protected by purified air, and the storage time of ampoules should not exceed 24H. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for sterile workshops and clean workshops.

Filtering operation is one of the important steps in the preparation of injections, and it is the key to ensure the clarity of the finished product. There are two filtration mechanisms, one is sieving protection, that is, the particles larger than the filter gap are all trapped on the surface of the filtration medium , the other is that the particles are trapped in the deep layer of the filter, such as deep filter such as vertical melting glass bucket; commonly used filters: vertical melting glass filter, plate and frame filter, titanium filter, sand filter rod, microporous filter membrane; microporous filter membrane It can be used for sterilization filtration, especially for some heat-labile products, commonly used 0.22μm or 0.45μm filter membrane for sterile filtration, and microporous filter membrane is also used for sterility test. The filling and sealing of the injection is the last process in the container, and it is also the most important process in the production. After the injection is filtered, it should be filled and sealed immediately after passing the inspection to avoid pollution. Its quality is directly determined by the environment and filling of the filling area. It is determined by the sealing equipment; the potting area is the key part of the entire injection production workshop, and a high cleanliness should be maintained in accordance with GMP regulations to ensure the cleanliness of the potting environment. At the same time, the rational design and correct use of the potting equipment will directly affect the injection products. quality.

The injection after filling and sealing should be sterilized immediately. Generally, the injection should not exceed 12 hours from preparation to sterilization. It is necessary to maintain the stability of the injection and make the finished product meet the requirements of complete sterility. These sterilization methods are used in combination. For thermally unstable products, injections produced under better sterilization conditions, generally 1-5ML ampoules can be sterilized by circulating steam at 100°C for 30min, and 10-20ML ampoules can be sterilized at 100°C. The sterilization temperature and time can be adjusted appropriately according to the specific situation; for heat-stable products, autoclaving can also be used for sterilization.

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Further dialogue of PHARMA between the approaches, the chapter concludes, could lead to actionable advice on more robust policies that drive both structural change and competitiveness upgrading.