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Special requirements for production

1.1  Special requirements for production

Final Sterilizing SVP is mean the volume capacity below 50ml and adopting humid-heat method to sterilize. Except normal physical and chemical characteristics, the items of bacteria, pyrogen, clarity degree and PH value should meet the requirement of code. The special requirements are following:

Special requirements for production :

1.1.1  The materials, solutions and adjuvant should be according to the injection standard.

1.1.2  During the process of preparation and filling, should prevent the microbe's contamination. Prepared liquid drug should be filled and sterilized in time to ensure the products without bacteria and pyrogen.

1.1.3  Producing line should be in the code-confirming sanitary environment. In addition, the material of worker's clothing involving the process of fine-cleaning, preparation and filling should be dustless and without fiber falling.

1.1.4The PH value of drug liquid is probable changed during the pre/after sterilizing or storage period. In the preparation process, the PH value range should be setup and the method of adjusting should be regulated.

1.1.5Injection's stability is poor, so extra attention should be paid to the quality-affecting factors such as water, plant-oil, water-hating solvent, vessel and inert-gases during the manufacture process.



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