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嘉峪檢測網 2025-04-01 20:35
滅菌/消毒過程中，例如，VHP消毒，指示劑出現陽性，一定是失敗了嗎？我們參考USP1221.11和PDA TR51，其中提及流氓 Bl，即BI出現出乎意料的陽性，可能會發(fā)生在經過認證的生物指示劑批次中。如果檢測到陽性生物指示劑，并且已經排除了所有可能的物理參數原因，則有可能是生物指示劑本身的可變性原因。使用重復樣品（指同一位置放置多個相同指示劑）可以減輕生物指示劑陽性的影響。
Addressing Anomalous Bl Results
處理異常的 Bl 結果
Any indicator system that relies on living organisms is liable to variation. The organisms themselves are inherently variable (genotypic factors) and are affected by external factors which lead to phenotypic Variation.
任何依賴于活體微生物的指示系統(tǒng)都容易發(fā)生變化。微生物本身本質上是可變的（基因因素），并受到導致表型變異的外部因素的影響。
The Bl represents an integration of several biological, chemical, and physical factors, and it is inappropriate to make comparisons with simpler systems such as chemical indicating strips or temperature sensors, The Bl cannot be calibrated and is not a calibration device.
Bl 代表生物、化學和物理因素的綜合，不宜與化學指示劑或溫度傳感器等更簡單的系統(tǒng)進行比較，Bl 無法校準，也不是校準設備。
Rogue Bls (unexpected survivors) may occur in batches of certified Bls. In the event positive Bls are detected and all the cycle's physical parameters have been eliminated as possible causes, then it is necessary to investigate the basis of the variability of the Bls themselves. The impact of positive Bls may be mitigated by using duplicates (43).
流氓 Bl（出乎意料的陽性）可能會發(fā)生在經過認證的生物指示劑批次中。如果檢測到陽性生物指示劑，并且已經排除了所有可能的物理參數原因，則有必要調查生物指示劑本身的可變性原因。使用重復樣品（指同一位置放置多個相同指示劑）可以減輕生物指示劑陽性的影響 。
Investigation of Anomalous Results
異常結果的調查
lf the process fails, an investigation should be conducted. This investigation may include, but is not limited to, the following:
如果過程失敗，則應進行調查。這項調查可能包括但不限于以下內容：
confirmation of cycle parameters
確認循環(huán)參數
review of the certificate of conformity supplied with the Bls and the results of in house test data
審查生物指示劑隨附的COA和內部測試數據的結果
review of process records for compliance with relevant SOPs
審查程序記錄是否符合相關 SOP
review of the certificate of conformity supplied with the sporicidal agent
審查殺孢子劑隨附的COA
review of equipment calibration data
審查設備校準數據
review of maintenance records
審查維護記錄
review of trends from previous cycles
審查前幾次滅菌的趨勢
review of temperature and chemical indicator data
審查溫度和化學指示劑數據
Then, if necessary, further modes of investigation should be pursued, including：
然后，如有必要，應采取進一步的調查方式，包括：
re-running the cycle using a different lot of Bls
使用其他批次的Bl重新運行循環(huán)
usage of duplicate or triplicate Bls in the same location
在同一位置使用雙重或三重Bl
The investigation should also take into account previous cycles and a history of the site where the Bl failed as well as those of adjacent and similar sites. One investigational approach is to expose multiple Bls at the problem site(s) and determine the number of survivors. One hundred percent survival may indicate a change in cycle conditions; occasional or sporadic survival may indicate an issue involving variation in the Bls' resistance.
調查還應考慮以前的周期和 Bl 失敗位置的歷史以及相鄰和相似位置的歷史。一種研究方法是在問題位置身上放置多個Bl 并確定陽性的數量。100% 陽性可能表明該循環(huán)條件發(fā)生了變化；偶爾或散發(fā)的陽性可能表明存在涉及 Bl 抗性變化的問題。
If the assessment method used to verify the specified kill level shows occasional random positive growth that is not repeated in the same test position, then it may be possible to argue that the results are due to rogue Bls. Ongoing random positives are an indication that the cycle is not robust and requires further investigation.
如果用于確認指定殺滅水平的評估方法顯示偶爾的隨機陽性生長，并且在同一測試位置沒有重復，那么有可能認為結果是由于流氓 Bl造成的。持續(xù)的隨機陽性表明該周期不穩(wěn)健，需要進一步調查。
Current industrial experience indicates that occasional positive Bls occur even in well defined cycles. Such rogue results may not be indicative of a failed cycle. Appropriate statistical methods may be used to support the acceptance of such rogue results in both primary validation and revalidation programs.
目前的工業(yè)經驗表明，即使在明確的周期中，偶爾也會發(fā)生陽性 Bl。這種流氓結果可能并不表示循環(huán)失敗。可以使用適當的統(tǒng)計方法來支持在主要驗證和重新驗證計劃中接受此類流氓結果。
Table-Factors That May Affect the Performance of Biological Indicators
可能影響生物指示劑性能的因素
Variation in the inoculum loaded on to the carriers (volume and spore count)
載體上的接種物的變化（體積和孢子數）
Purity of the inoculum on the carrier
載體上接種物的純度
Genotypic variability amongst the spore population
孢子種群中的基因型變異性
Aggregation of spores
孢子聚集
Presence of cel/media debris in the inoculum
接種物中細胞/介質殘骸的存在
Orientation of carrier within primary package
內包裝中載體的方向
Surface characteristics of the carrier
載體的表面特性
Handling of naked (i.e.., no packaging) Bls (aseptically, gloved hands, UAF Hood to avoid addition of oils or dirt that will occlude the inoculum)
BI（即拆開包裝后）的處理（無菌操作、戴手套、UAF層流罩以避免添加會影響接種物的油或污垢）
Composition of the primary packing material (when this is not removed during the cycle)
內包裝材料（循環(huán)期間未去除）的成分
Storage conditions used for the Bis
BI的儲存條件
Equilibrium relative humidity of the spores on the carrier immediately prior to exposure to stress
載體上的孢子在暴露于壓力之前的平衡相對濕度
Method used to release spores from carriers when carrying out spore counts
進行孢子計數時用于從載體中釋放孢子的方法
Age of the Bis
BI的新鮮度
Retention of sterilant gases by the spore coat, carrier materials and primary packaging (and subsequent outgassing)
滅菌氣體在孢子涂層、載體材料和內包裝上的殘留
Time between exposure and recovery of the Bls
從暴露到Bls回收之間的時間
Composition of the recovery medium, including the presence of substances that may stimulate/inhibit the germination and subsequent outgrowth of injured spores
回收培養(yǎng)基的組成，包括可能刺激/抑制受傷孢子發(fā)芽和隨后生長的物質的存在
Table 2 Manufacturing Issues That May Affect Bacterial Spore Resistance to Physical and Chemical Stresses
表 2 可能影響細菌孢子物理和化學抵抗力的制造問題
Genetic complement-species/strain variation (Genotypic variability)
遺傳互補—物種/品系變異（基因型變異）
Composition of growth/sporulation medium (e.g., variation in concentration of divalent cations especially Mn++and Ca++)
生長/產孢培養(yǎng)基的組成（例如，二價陽離子，尤其是 Mn++ 和 Ca++ 濃度的變化）
Temperature of sporulation
產孢溫度
Growth limiting nutrient during sporulation
孢子形成過程中限制生長的營養(yǎng)物質
Age of the spore
孢子的年齡
Temperature at which spore suspensions are stored and temperature fluctuations
孢子懸浮液的儲存溫度和溫度波動
pH of the suspending medium
懸浮介質的 pH 值
Chemical composition of the suspending medium
懸浮介質的化學成分
來源：Internet
