In short: Bo Yikang has been committed to the development of freeze drying technology. In the process of long-term customer service, it was found that the majority of freeze dryers use customers to understand the mechanism of freeze-drying, and how to explore and optimize the freeze-drying process of products should not be known. In order to solve the above problems, we will collect and freeze the technical data to help users who are using lyophilization or are planning to use lyophilization for dry preservation.

This product uses azithromycin sterile freeze-dried powder injection, which must be >600 azithromycin per mg titer according to dry product. The operation process is as follows: unit raw material - weighing - compounding - sterilization filtration - filling - semi-plugging - freeze drying - rolling cover - lamp inspection.

This product is cleaned and sterilized from the vial to the filling. The dispensing agent is carried out in a local 100-level clean room. The disinfection of the rubber plug and the aluminum-plastic cover is carried out in the sterilizer. When used, it is used in the 10,000-class clean area. Operate in a hundred-level environment. After filling, half-plugging is carried out. After filling a tray, the ferrules are immediately sent to the Bokang Kang Pilot 10-15T dryer for lyophilization. After lyophilization, the tampon is pressed, the cabinet is sent to the rolling cover, the lamp is inspected, and the label is attached. We will thoroughly test the three batches of products according to the Pharmacopoeia, fully comply with the requirements of the Pharmacopoeia and report them as GMP product certification products. The trial production process is as follows:

1. When the prepared azithromycin powder injection solution is to be sterilized and filtered, several complicated processes of coarse filtration and fine filtration are eliminated, and several different pore size membranes are overlapped, and the whole process is completed once, and the sterilization is achieved. The effect is that the filter has much less damage caused by several times of filtration, and the liquid is clear and transparent and has no hair spots, which meets GMP requirements.

2. Use stainless steel stoppers. After the product is lyophilized, when the vacuum plug is sealed in the drying box, in order to be free from the limitation of the number of products, a stainless steel stopper can be placed on each shelf, so that different specifications of the product can be similarly sealed and sealed. The product vials are not crushed.

3. In the case of a small container and a large amount of lyophilized product, it is impossible to use the double water sample method and the vacuum pressure recovery method to determine when the lyophilization is finished. The water for injection can be lyophilized together with the product, and sublimated according to the water for injection. Once completed, the end time of the product freeze-drying can be determined.

4. In the freeze-drying process, the vacuum is adjusted by the Bokang Pilot10-15T freeze dryer itself and controlled at 8-13Pa, while most of the time the vacuum pump does not run, the whole time can be shortened by 6-8 hours. In the initial stage of lyophilization, the vacuum pump is usually stopped once every 30 minutes, 5-7 minutes each time, but the vacuum pump runs once every 2-3 hours after lyophilization, and the time is about 5 minutes, saving energy (hydropower) and machinery. The wear and tear improves the quality of the product and reduces the cost.

5. When some product solutions are frozen, due to the large evaporation area, the bottle mouth is small, and it is not possible to use the semi-plugged lyophilized. It is only necessary to open the bottle mouth and freeze it. After the lyophilization, the product bottle is taken out and the butyl group is manually aseptically operated. The rubber stopper is placed on the bottle mouth, and it is placed naturally, and then it is sent to the dry box of the freeze-drying machine which can be automatically pressed and vacuumed for 2 hours. When the vacuum degree is controlled at about 40 Pa, the automatic pressure plug is sealed, and after the box is discharged, High-frequency spark vacuum detector, bottle-by-bottle detection, the vacuum rate is as high as 99.5%.

6. When using the Bokang Pilot10-15T freeze dryer to pre-freeze the product, the layer can be pre-cooled first, and the loading temperature can be set when loading a larger amount of vials. This will allow the temperature of the vials of all layers to be uniform and reduce temperature differences. According to the pre-freezing process, the product can be pre-frozen through the 2-3 stage pre-freezing process, which is beneficial to the freeze-drying effect of the azithromycin freeze-dried powder injection, and is also the key to the successful lyophilization of the azithromycin freeze-dried powder.

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