?ISPE發(fā)布了新的清潔驗證指南——《ISPE基準(zhǔn)指南：清潔驗證生命周期–應(yīng)用，方法和控制 ;（ISPE Baseline Guide: Cleaning Validation Lifecycle: Applications, Methods, and Controls） ;》

8.2 TestMethod Assessment for Bioburden and Endotoxin

生物負(fù)荷和內(nèi)毒素的檢測方法評估

8.2.1 Swab Recovery Method Assessment

擦拭回收率方法評估

The recovery study results should beassessed by the QC laboratory when reviewing cleaning validation and routinemicrobiological data. If the recovery results are low, then an RCF should be applied to the final test results to ;compensate for sampling method limitations and to determine if the acceptance criteria weremet.

在審查清潔驗證和常規(guī)微生物數(shù)據(jù)時，應(yīng)由QC實驗室對回收試驗結(jié)果進(jìn)行評估。如果回收率低，則應(yīng)在最終試驗結(jié)果中使用回收校正因子RCF，以補(bǔ)償取樣方法的局限性，并確定是否滿足接受標(biāo)準(zhǔn)。

Appendix 4 describes a standard swabtest method assessment based on “A Novel Improved Bioburden Recovery MethodUsing Swabbing Technique” [108]. For standard bioburden recovery, afterswabbing is complete typically the swab is either streaked onto an agar mediumor transferred into a liquid medium, vortexed for about 30 s and then the liquid sample preparation is tested by pour-plate or membrane filtration method[37].

附錄4描述了基于“使用拭子技術(shù)的新型改進(jìn)生物負(fù)荷回收方法”的標(biāo)準(zhǔn)擦拭方法評估[108]。對于標(biāo)準(zhǔn)的生物負(fù)荷回收，擦拭完成后，通常將拭子劃到瓊脂培養(yǎng)基上或轉(zhuǎn)移到液體培養(yǎng)基中，渦旋約30秒，然后通過傾倒平板或薄膜過濾法測試制備好的液體樣品[37]。

Appendices 4 and 5 describe themethods for collecting and extracting microorganisms from swab material. Usinga commercial swab kit is recommended for this study. There are many differentcommercially available swabs that can be used, especially for surface sampling.Most swab wetting solutions contain an emulsification and neutralizing bufferto neutralize cleaning agents that may inhibit microbial growth. Theemulsification solution extracts the ;microorganismsfrom the swab material and disperses them into the solution. This allows therecovery of any ;microorganismsexposed to specific cleaning agents

附錄4和5描述了從棉簽材料中收集和提取微生物的方法。該研究建議使用商用棉簽。有許多不同的商用棉簽可以使用，特別是表面取樣。大多數(shù)擦拭用潤濕溶液有乳化和中和緩沖液，以中和可能抑制微生物生長的清潔劑。有乳化作用的溶液從棉簽材料中提取微生物并分散到溶液中。這樣就可以回收暴露到特定清潔劑中的任何微生物。

It should be noted that typicalrecovery specifications applied to chemical cleaning validation are not appliedto microbiological recovery. For bioburden limits, a 50% recovery isoutstanding; usually recoveries obtained are around 5%–20%, with some companiesstating only “growth” as the recovery requirement. The bioburden recoveryresults for some materials (porous) can even be less. However, the methoddescribed in this Guide should assist in getting recovery rates greater than50%.

應(yīng)注意，通常用于化學(xué)清潔驗證的回收率標(biāo)準(zhǔn)不適用于微生物回收。對于生物負(fù)荷限度，50%的回收率已經(jīng)是很好的了；通常回收率在5%-20%左右，有些公司只將“生長”作為回收要求。對于某些材料（多孔材料）的生物負(fù)荷回收結(jié)果甚至可能更少。然而，本指南中描述的方法應(yīng)有助于使回收率大于50%。

Consider that there is one factoraffecting these recoveries that is normally not an issue in chemical cleaning ;validation: the survival of the microorganisms.

考慮到有一個因素會影響這些回收率，這在化學(xué)清潔驗證中通常不是一個問題：即微生物的存活率。