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1、Unit 13 Sterile Products Sterile Products Sterile products are dosage forms of therapeutic agents that are free of viable microorganisms. Principally，these include parenteral， ophthalmic， irrigating preparations. Of these, and parenteral products are unique among dosage forms of drugs because they a
2、re injected through the skin or mucous membranes into internal body compartment. Thus，because they have circumvented the highly efficient first line of body defense，the skin and mucous membranes，they must be free from microbial contamination and from toxic components as well as possess an exceptiona
3、lly high level of purity. All components and processes involved in the preparation of these products must be selected and designed to eliminate，as much as possible，contamination of all types，whether of physical，chemical，or microbiologic origin. Preparations for the eye, though not introduced into in
4、ternal body cavities，are placed in contact with tissues that are very sensitive to contamination. Therefore，similar standards are required for ophthalmic preparations). Irrigating solutions are now also required to meet the same standards as parenteral solutions because during an irrigation procedur
5、e，substantial amounts of these solutions can enter the bloodstream directly through open blood vessels of wounds or abraded mucous membranes. Therefore，the characteristics and standards presented in this chapter for the production of large-volume parenteral solutions apply equally to irrigating solu
6、tions. Sterile products are most frequently solutions or suspensions，but may even be solid pellets for tissue implantation. The control of a process to minimize contamination for a small quantity of such a product can be achieved with relative ease. As the quantity of product increases，the problems
7、of controlling the process to prevent contamination multiply. Therefore，the preparation of sterile products has become a highly specialized area in pharmaceutical processing. The standards established，the attitude of personnel，and the process control must be of a 第第 13 单元单元 无菌产品无菌产品 无菌产品无菌产品 无菌产品是不含
8、微生物活体 的治疗剂剂型，其主要包括非肠 道用的、眼用的和冲洗用的制剂。 这之中，非肠道用产品在药物剂 型当中是（较为）特别的因为它 们是通过皮肤和黏膜被注射到人 体内部的。这样，由于它们进入 了高效率的人体第一道免疫防线 皮肤和黏膜， （所以）它们 必须没有微生物感染和有毒成分， 同时又（必须）具有特别高的纯 度。这些产品的制备过程中涉及 到的所有组分和（工艺）流程都 必须经过选择和设计以尽可能地 消除各种类型的污染，无论是来 自物理的、化学的，还是微生物 的。 眼用制剂尽管没有被引入到 内部体腔，但它仍与对污染（物） 敏感的组织有接触，因此，对眼 用制剂也要求（与非肠道用制剂） 类似的标准
9、。 冲洗液现在也要求满足和非 肠道用溶液一样的标准，因为在 冲洗过程中，大量的冲洗液都可 以通过敞开的血管伤口或者擦伤 的黏膜组织直接进入到血液。因 此，本章中描述的有关非肠道用 溶液大批量生产的特点和标准， 对于冲洗液同样适用。 无菌产品通常是溶液或者悬浮液， 但甚至也可以是用于组织对端植 入的固体药丸。对于少量的这种 产品，使其污染降到最低的工艺 控制可以相对容易地实现。 （但） 随着产品量的增加，控制工艺流 程从而防止污染的困难也会增加。 因而，无菌产品的制备已经成为 药品加工里一个高度专业化的领 域。制定的标准、人员的态度和 工艺流程的控制都必须有着优秀 的水平。superior le
10、vel. Vehicles By far the most frequently employed vehicle for sterile products is water，since it is the vehicle for all natural body fluids. The superior quality required for such use is described in the monograph on Water for Injection in the USP. Requirements may be even more stringent for some pr
11、oducts，however. One of the most inclusive tests for the quality of water is the total solids content，a gravimetric evaluation of the dissociated and undissociated organic and inorganic substances present in the water. However，a less time- consuming test，the electrolytic measurement of conductivity o
12、f the water，is the one most frequently used. Instantaneous measurements can be obtained by immersing electrodes in the water and measuring the specific conductance, a measurement that depends on the ionic content of the water. The conductance may be expressed by the meter scale as conductivity in mi
13、cromhos ，resistance in megohms , or ionic content as parts per million (ppm) of sodium chloride. The validity of this measurement as an indication of the purity of the water is inferential in that methods of producing high-purity water，such as distillation and reverse osmosis，can be expected to remo
14、ve undissociated substances along with those that are dissociated. Undissociated substances such as pyrogens，however，could be present in the absence of ions and not be disclosed by the test. Therefore，for contaminants other than ions，additional tests should be performed. Additional tests for quality
15、 of Water for Injection with permitted limits are described in the USP monographs. When comparing the total solids permitted for Water for Injection with that for Sterile Water for Injection，one will note that considerably higher values are permitted for Sterile Water for Injection. This is necessar
16、y because the latter product has been sterilized，usually by a thermal method，in a container that has dissolved to some extent in the water. Therefore， the solids content will be greater than for the nonsterilized product. On the other hand，the 10 ppm total solids officially permitted for Water for Injection may be much too high when used as the vehicle for many products. In practice, Water for Injection normall
