1；容器，用具处理

1； Cleaning of container and utensil

1.1; soak the vials with clean water for an hour, and then clean them with 500 Ultrasound for 10 minutes. Next, clean the vials three times with pure water (you can also use injecting water or bacteriostatics water on the condition of sterility and none heat source, similarly hereinafter). Then, place the vials upside down on the tray and cap them and put them under the condition of 180℃ for two hours. At last, store and cool them in the sterilized cabinet, opening the ultraviolet lamp

1,1；西林瓶用清水浸泡1hr，超声500W清洗10min，用纯水（无菌无热源，可以用注射水或抑菌水代替，下同）冲洗3次，倒置于托盘，加盖，T180℃2hr干烤灭菌灭热源，在无菌柜中开紫外灯存放冷却备用。

1.2; soak Butyl Rubber Stoppers with 95%Alc for 12 hours and then clean them three times with pure water, 15minutes with 500 Ultrasound. Next, wrap them loosely with for layers of gauze which have been clean with pure water. Then use 115℃vapor to sterilize them for 30 minutes. At last, store and cool them in the sterilized cabinet, opening the ultraviolet lamp

1,2；丁基胶塞用95%Alc浸泡12hr，用纯水洗三遍，超声500W清洗15min，用纯水冲洗3遍。用纯水洗净的四层纱布很松地包裹丁基胶塞，115℃蒸汽灭菌半hr，在无菌柜中开紫外灯存放冷却备用。，

1.3；Use pure water to clean the filling head three times, then clean with 500 Ultrasound for 15 minutes, and again clean three times with pure water. Then put it in the clean tip box. Next, use 115℃vapor to sterilize them for 30 minutes. At last, store and cool them in the sterilized cabinet, opening the ultraviolet lamp

1,3；灌装枪头纯水洗三遍，超声500W清洗15min，用纯水冲洗3遍。放到洁净的枪头盒中，115℃蒸汽灭菌半hr，在无菌柜中开紫外灯存放冷却备用。

1.4; store the transfer liquid gun in the sterilized cabinet, opening the ultraviolet lamp

1,4；移液枪在无菌柜中开紫外灯存放备用

1.5; install ultrafilter. First, clean it with 0.5mol NaOH for 10minutes and then clean it until it reach pH7 with pure water. At last, store it in the sterilized cabinet, opening the ultraviolet lamp

1,5；超滤器安装，用0.5mol清洗10min，用纯水冲洗到pH7，无菌柜中开紫外灯存放备用

2；配制；

2; Preparing

2,1；取原料和纯水，手、原料和纯水容器用75%Alc消毒，

2.1; disinfect hands, material and container of pure water with 75%Alc

2,2；以原料中的HGH计算，1g加纯水300ml，摇匀至液体澄清

2.2; add 300ml pure water in 1g raw material, shake until it become transparent.

2,3；用100KD超滤膜过滤,

2.3; filtrate it with 100KD ultrafiltration membrane

3；分装

3; sub dividing

3,1；用移液枪灌装，每瓶1ml。

3.1;filling vials with above transparent liquid by the transfer liquid gun, 1ml/vial.

3,2；压胶塞（留出真空口）

3.2; pressure the stoppers (set aside vacuum mouth)

4：预冷冻

4; prepare for freezing

4,1；将分装完毕的产品，置≤-18℃冷冻3小时。

4.1; place the above vials  under the temperature -18℃ for three hours

5；冷冻干燥

5; lyophilization

5,1；将预冷冻的产品放到冻干机的冷肼，盖上冷肼盖，-45度冷冻4hr.

5.1; place those above vials on the Cold hydrazine of the freeze dryer, and then cover cold hydrazine, freeze them under the temperature -45℃ for 4 hours

5,2；将产品移入冻干架，盖上钟罩。

5.2; place the products on the freeze frame and cover with bell jar.

5,3；开真空显示，开真空机，手压钟罩1min

5.3; open the vacuum pump and press the button to show the data of vacuum, then press the bell jar with hands for one minutes

5,4；冷冻干燥24-30hr，环境温度20-25℃.

5.4; lyophilize the products for 24 to 30 hours; the temperature should be controlled around 20 to 25℃

6；压胶塞

6; press the stoppers

6,1；冻干结束后，旋转压盖手柄，压紧胶塞。

6.1; after the lyophilization, spin the hand shank of the capper to clamp the stopper to vial.

6,2；插入破真空管，破真空。

6.2; insert vacuum breaker to make vacuum

6,3；旋松压盖手柄，移去钟罩，出料

6.3; loose the hand shank and remove bell jar

7；压铝塑盖

7; press aluminum plastic cap

7,1；用75%Alc消毒胶塞表面

7.1; disinfect the surface of stoppers with75%Alc

7,2；盖上紫外消毒0.5hr的洁净铝塑盖

7.2; cover the stoppers with aluminum plastic caps that have been disinfected by ultraviolet for 30 minutes

7,3；用压盖机压盖

7.3; use gland machine to gland the caps

7,4；检查是否压紧，用干净白布檫净产品表面，包装。

7.4; exam whether the caps have been gland closely and then use clean white choth to clean the outerside of the vials and package.

Note: the steps in red can be omitted if the procedure is under the condition of sterilization and there is not any particle impurity mixed in during the procedure.

注，红色字体，如在操作过程可以保证无菌和无颗粒性杂质混入，可以省略。