【正文】 and inorganicsubstances present in the ，a lesstimeconsuming test，the electrolytic measurement ofconductivity of the water，is the one most frequently measurements can be obtained by immersingelectrodes in the water and measuring the specificconductance, a measurement that depends on the ioniccontent of the conductance may be expressed bythe meter scale as conductivity in micromhos，resistance inmegohms , or ionic content as parts per million(ppm)ofsodium validity of this measurement as anindication of the purity of the water is inferential in thatmethods of producing highpurity water，such as distillationand reverse osmosis，can be expected to removeundissociated substances along with those that are substances such as pyrogens，however，could be present in the absence of ions and not bedisclosed by the ，for contaminants other thanions，additional tests should be tests for quality of Water for Injection withpermitted limits are described in the USP paring the total solids permitted for Water forInjection with that for Sterile Water for Injection，one willnote that considerably higher values are permitted for SterileWater for is necessary because the latterproduct has been sterilized，usually by a thermal method，ina container that has dissolved to some extent in the ，the solids content will be greater than for thenonsterilized the other hand，the 10 ppm totalsolids officially permitted for Water for Injection may bemuch too high when used as the vehicle for many practice, Water for Injection normally should not have aconductivity of more than 1 micromho(1 megohm，approximately ppm NaCl).溶媒 到目前為止，最常被用于無菌產(chǎn)品的溶媒就是水，因為水（也）是所有自然體液的溶媒。因而，無菌產(chǎn)品的制備已經(jīng)成為藥品加工里一個高度專業(yè)化的領(lǐng)域。對于少量的這種產(chǎn)品，使其污染降到最低的工藝控制可以相對容易地實(shí)現(xiàn)。因此，本章中描述的有關(guān)非腸道用溶液大批量生產(chǎn)的特點(diǎn)和標(biāo)準(zhǔn)，對于沖洗液同樣適用。眼用制劑盡管沒有被引入到內(nèi)部體腔，但它仍與對污染（物）敏感的組織有接觸，因此，對眼用制劑也要求（與非腸道用制劑）類似的標(biāo)準(zhǔn)。這樣，由于它們進(jìn)入了高效率的人體第一道免疫防線——皮膚和黏膜，（所以）它們必須沒有微生物感染和有毒成分，同時又（必須）具有特別高的純度。第二篇：制藥工程專業(yè)英語 Unit 13 課文翻譯Unit 13Sterile ProductsSterile ProductsSterile products are dosage forms of therapeutic agents that are free of viable ，these include parenteral，ophthalmic，irrigating these, and parenteral products are unique among dosage forms of drugs because they are injected through the skin or mucous membranes into internal body ，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 ponents as well as possess an exceptionally high level of ponents 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 for the eye, though not introduced into internal body cavities，are placed in contact with tissues that are very sensitive to ，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 procedure，substantial amounts of these solutions can enter the bloodstream directly through open blood vessels of wounds or abraded mucous ，the characteristics and standards presented in this chapter for the production of largevolume parenteral solutions apply equally to irrigating products are most frequently solutions or suspensions，but may even be solid pellets for tissue control of a process to minimize contamination for a small quantity of such a product can be achieved with relative the quantity of product increases，the problems of controlling the process to prevent contamination ，the preparation of sterile products has bee a highly specialized area in pharmaceutical standards established，the attitude of personnel，and the process control must be of a第13 單元 無菌產(chǎn)品 無菌產(chǎn)品 無菌產(chǎn)品是不含微生物活體的治療劑劑型，其主要包括非腸道用的、眼用的和沖洗用的制劑。的分布可能是“一刀切”的費(fèi)用可轉(zhuǎn)移到一定的工資項目，可能會產(chǎn)生更有利的承包商的現(xiàn)金流。承包商會，當(dāng)然，必須支付這些項目。這些物品可能是必不可少的交付項目，但不這樣做，對自己帶來任何價值的項目。有些業(yè)主sirrtply不支付動員，聲稱不提高項目本身的價值僅僅存在幾件裝備或一些臨時建筑物。對于exrample，動員可以是一個大的