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Special requirements for LVP production

Final sterilizing large volume parenteral means the package above 50ml, which is abbreviated LVP. The vessels' types are bottle or bag and the materials of vessel are glasses, poly-ethylene, poly-propylene, poly-chloroethylene and compound-film etc.

2.1  Special requirements of production

2.1.1  For the products enter human body directly, complete measure should be adopted to ensure the safety such as prevention of contamination from particle, microbe and pyrogen during production.

2.1.2  All the important equipments including sterilizing equipment, filtering system, air-cleaning system and water system should be approved. The repair and maintenance should follow the standard operation regulation, and the supervision procedure should be performed.

2.1.3  The cleaning regulation of all drug-touching equipments such as package material, tool, preparation tank and piping should be validated.

2.1.4  Any new producing process' effect should be validated and re-validated in certain period. When important changes are performed, such validation procedures are also required.

2.1.5  The sterilizing effect for various kinds of bacteria should be proved, and re-proved

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