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2024

06-24

Filling method of drug pre-filled syringe aseptic filling process

According to the different filling methods of products, pre-filled syringe filling is divided into three types: ordinary filling, nitrogen filling and vacuum filling.

2024

05-16

Causes and solutions of vials broken in freeze-dried

Vial is the main packaging form of sterile powder injection drugs now, and the use is large. At the same time, vacuum freeze drying technology has developed very rapidly in recent years, after nearly ten years of market competition and optimization combination, many vacuum freeze dryer professional manufacturers have been formed. The technical performance of pharmaceutical vacuum freeze dryer has been basically mature, and the corresponding industry standards have also been formulated in China. From the perspective of the actual production problems, since the use of domestic vials, it was found that the problem of broken bottles in the freeze-drying process was relatively prominent, so the relevant departments did a lot of work, starting from the process, equipment, and the quality of vials, and finally solved this long-troubled problem.

2024

04-24

Cleanroom large exhaust equipment room pressure control scheme

In the process of modern manufacturing and scientific research, cleanroom workshop is a common facility to ensure the cleanliness of production and experimental environment, especially for some processes and experiments with high cleanliness and low pollution requirements. HVAC system is the key to ensure the stability and reliability of key environmental parameters such as temperature, humidity and differential pressure in cleanrooms of pharmaceutical factory, and pressure control is a key link of HVAC system. This paper discusses and studies the pressure control of the room where all kinds of large-scale exhaust equipment are located, which is the key and difficult control object of the industry, combining with various schemes of room pressure control.

2024

04-15

7 Basic Items That Need To Be Tested In Cleanrooms

Clean workshop, also known as cleanroom and dust-free workshop, is widely used in pharmaceutical and biological engineering, precision machinery, medical and health, food, electronic materials and other fields. In FED-STD-2, a cleanroom is defined as a room equipped with air filtration, distribution, optimization, construction materials and equipment, in which specific rules and operating procedures are used to control the concentration of airborne particulates to achieve an appropriate level of cleanliness.

2024

04-08

Technology Application of Cleanroom Isolator

The highly-airtight cleanroom isolator is used for protecting the operating environment of high-risk material synthesis, powder feeding in extraction workshop, transfer of wet powder materials in nutsche filter, packaging, crushing, weighing and capping after drying of powder materials, etc. And it is mainly used to protect operators during manual cleaning, and provides OEB5 level of protection.

2024

04-02

How to ensure the sealing performance of vials

Vials are drug sealed containers which are widely used in the pharmaceutical field, generally composed of a bottle, a rubber stopper, and a aluminum cap. There are many factors that affect the sealing performance of vials, for example, whether there is a mechanical and pressure difference between each capping head of the capping machine in the production line, whether the material of the aluminum cap meets the hardness index required, whether the rubber stopper is too soft or hard, whether the angle and thickness of the bottle mouth are reasonably designed, and so on.

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