09-02-2013, 03:51 PM
ASEPTIC AND STERILIZATION PROCESS CONTROL
ASEPTIC AND STERILIZATION .pptx (Size: 104.15 KB / Downloads: 30)
STERILIZATION PROCESS CONTROL
General considerations
The production of sterile preparations should be carried out in clean areas,entry to which should be through airlocks for personnel and/or for equipment and materials
The various operations of component preparation ,product preparation, filling and sterilization should be carried out in separate areas within a clean area.Manufacturing operations are divided here into two categories: first, those where the product is terminally sterilized, and second, those which are conducted at some or all stages.
QUALITY CONTROL
(a) for products that have been filled aseptically, samples should include containers filled at the beginning and end of the batch and after any significant interruption of work;
(b) for products that have been heat sterilized in their final containers, consideration should be given to taking samples from that part of the load that is potentially the coolest.
The sterility of the finished product is ensured by validation of the sterilization cycle in the case of terminally sterilized products, and by “media-fills” runs for aseptically processed products.
For injectable products, the water for injection and the intermediate and finished products should be monitored for endotoxins, using an established pharmacopoeial method.
Aseptic preparation
Components after washing should be handled in at least a grade D environment.The handling of sterile starting materials and components should be done in a grade A environment with a grade B background.
The preparation of solutions which are to be sterile filtered during the process should be done in a grade C environment; if not sterile filtered, the preparation of materials and products should be done in a grade A environment with a grade B background.
STERILIZATION
Whenever possible, products intended to be sterile should preferably be terminally sterilized by heat in their final container.
Sterilization can be achieved by the use of moist or dry heat, by irradiation with ionizing radiation (but not with ultraviolet radiation unless the process is thoroughly validated), by ethylene oxide (or other suitable gaseous sterilizing agents) or by filtration with subsequent aseptic filling of sterile final containers.
The microbiological contamination of starting materials should be minimal, and their bioburden should be monitored before sterilization.