是否有必要檢測純化水中的內毒素?
發(fā)布時(shí)間：2024-11-18 瀏覽次數：607
從滿(mǎn)足藥典要求以及成本角度而言，肯定是沒(méi)有必要的。從風(fēng)險角度而言，可以探討一下， 以下是ECA網(wǎng)站關(guān)于這個(gè)話(huà)題的討論。
When planning new purified water (PW) systems, the question arises as part of the risk analysis or later, when drawing up the qualification and sampling plans as to whether endotoxins should be tested for.
當規劃新的純化水(PW)系統時(shí)，當制定確認和取樣計劃時(shí)，作為風(fēng)險分析的一部分或稍后行動(dòng)，關(guān)于是否應該檢測內毒素的問(wèn)題就會(huì )出現。
According to the specifications of the pharmacopoeias (e.g. USP or Ph.Eur.), endotoxin testing is not required for Purified Water. The endotoxin content is not a test parameter in the valid pharmacopoeia monographs for purified water.
根據藥典規范(如USP或EP)，純化水不需要內毒素檢測。在現行的純化水藥典各論中，內毒素含量沒(méi)有作為檢驗參數。（博主注：2020版中國藥典第二部中，純化水各論也未要求檢測內毒素。）
However, if purified water is used as feed water for distillation plants and pure steam generators for the production of WFI (water for injection) or pure steam, it may be useful to test for endotoxins as part of the qualification process. This is due to the fact that distillation systems and pure steam generators - depending on the technology and manufacturer - can only achieve a reduction of 3 to 6 log levels of endotoxins.
但是，如果使用純化水作為蒸餾裝置的給水和用于生產(chǎn)WFI(注射用水)或純蒸汽的純蒸汽發(fā)生器的給水，則作為水系統確認過(guò)程的一部分，內毒素測試可能是有用的。這是由于蒸餾系統和純蒸汽發(fā)生器(取決于技術(shù)和生產(chǎn)商)只能將內毒素降低3到6 log水平。
For the validation of the water system, the performance of the purification process must be proven. This applies to all quality parameters, including the endotoxin content in the WFI. However, such validation is only possible if the initial concentration of a contaminant is known.
為了驗證水系統，必須證明純化水工藝的性能。這適用于所有質(zhì)量參數，包括WFI中的內毒素含量。然而，只有在污染物的初始濃度已知的情況下，這樣的驗證才有可能。
Many operations with PW and WFI systems do not measure endotoxins in PW as part of routine sampling. Instead, endotoxins are measured in the WFI, where there are usually values below the detection limit (<0.06 IU/ml). However, some companies consider these random sample measurements in the WFI to be insufficient. If endotoxin values above the detection limit (0.06 IU/ml) but below the pharmacopoeia limit for WFI (0.25 IU/ml) are occasionally found, it is necessary to analyse the cause as part of the trend evaluation. For this reason, some sites have included the measurement of endotoxins in their sampling plans for PW for information purposes.
許多使用純化水和注射用水系統的操作不將純化水中的內毒素作為常規取樣監測的一部分。通常，內毒素是在注射用水中檢測的，其值通常低于檢測限(<0.06 IU/ml)。然而，一些公司認為注射用水中的這些隨機樣本檢測是不夠的。如果偶爾發(fā)現內毒素值高于檢測限(0.06 IU/ml)，但低于藥典注射用水限值(0.25 IU/ml)，則有必要分析原因，作為趨勢評估的一部分。出于這個(gè)原因，一些工廠(chǎng)在純化水的取樣計劃中包含了內毒素的測量，以提供信息。
PW systems with membrane technology generally have endotoxin levels below the pharmacopoeia limit for WFI (0.25 IU/ml). However, PW systems without membrane technology, especially older, poorly flowingdeionized water systems (with anion and cation exchangers), can have values significantly above the pharmacopoeia limit.
采用膜技術(shù)的純化水系統的內毒素水平通常低于藥典對注射用水的限值(0.25 IU/ml)。然而，沒(méi)有膜技術(shù)的純化水系統，特別是較老的、流動(dòng)性差的去離子水系統(帶有陰離子和陽(yáng)離子交換劑)，其值可能大大超過(guò)藥典限值。
There are also applications of purified water in the biotechnology sector in which endotoxins can play a role, for example in the fermentation process or during purification. In such cases, purified water should also be tested for endotoxins.
純化水在生物技術(shù)領(lǐng)域也有應用，其中內毒素可以發(fā)揮作用，例如在發(fā)酵過(guò)程或凈化過(guò)程中。在這種情況下，純化水也應檢測內毒素。
A 'mini-risk analysis' is recommended here to clarify two questions:
這里建議進(jìn)行“迷你風(fēng)險分析”，以澄清兩個(gè)問(wèn)題:
— What is the purified water used for?
— 純化水是做什么用的?
— In which cases could endotoxins be problematic?
— 在哪些情況下內毒素會(huì )有問(wèn)題?
Based on these answers, the necessity of testing for endotoxins can then be concluded and, if necessary, alarm and limit values as well as specifications for the test interval can be defined.
根據這些答案，可以得出內毒素檢測的必要性，如果有必要，可以定義報警值和限值以及檢測間隔的標準。
文章來(lái)源：環(huán)凱轉載于“藥物微生物檢驗”公眾號，文章來(lái)源于ECA網(wǎng)站；
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