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嘉峪檢測(cè)網(wǎng) 2022-07-28 21:53
Consideration 1 Choosing the right sterilisation cycle to implement
注意事項(xiàng) 1：選擇正確的滅菌周期
There are three basic types of sterilisation cycles. Choose the right one according to the type of goods to be sterilised:
有三種基本類型的滅菌周期。根據(jù)待滅菌物質(zhì)的類型進(jìn)行選擇。
Hard Goods (Vacuum)
堅(jiān)硬裝載（真空）
Suitable for items that are easy to sterilise, because air removal and steam penetration are highly effective on these items. e.g., open glassware and large diameter piping
適用于那些易于滅菌的物質(zhì)，因?yàn)榭諝馇宄驼羝┩笇?duì)這些物質(zhì)是高度有效的。例如：敞開的玻璃器皿和大口徑的管道
A typical hard goods cycle may draw one vacuum prior to introducing steam to reach the desired sterilisation temperature.
典型的堅(jiān)硬物品滅菌循環(huán)在通入蒸汽達(dá)到設(shè)定滅菌溫度前需要達(dá)到一個(gè)真空度。
Wrapped Goods (Vacuum)
包裹物品（真空）
Utilized for items that are difficult to sterilise, because air removal and steam penetration are harder to achieve on these items than on hard goods.
用于滅菌困難的物品，因?yàn)楹蛨?jiān)硬品比起來(lái)空氣清除和蒸汽穿透更難實(shí)現(xiàn)。
e.g., empty bottles (glass or plastic) with lids, gowns, long hoses/tubes, vent filters, portable vessels with small inlet/outlet ports
例如，有蓋子的空瓶（玻璃或塑料），潔凈服，長(zhǎng)軟管/管子，抽氣過濾器，進(jìn)/出口小的便攜式容器。
A typical wrapped goods cycle may draw three or more vacuums prior to reaching sterilisation. A post-sterilisation vacuum draws the steam from the load items.
一個(gè)典型的包裹品滅菌循環(huán)在滅菌前至少進(jìn)行 3 次抽真空。滅菌后通過真空將負(fù)載中的蒸汽抽走。
Liquids (Non-vacuum)
液體（非真空）
Items that contain liquids generally cannot have a deep vacuum pulled or the liquid will be drawn out of them. Autoclave cycles for liquids generally heat up and cool down without a vacuum. Steam, introduced into the top of the chamber, displaces the air. The air is pushed to the bottom of the chamber and is removed.
一般含有液體的物品不能有大的真空度，否則液體會(huì)溢出。針對(duì)液體來(lái)說高壓滅菌鍋循環(huán)是在沒有真空度的情況下加熱和冷卻。蒸汽進(jìn)入腔室頂部置換空氣，空氣推入腔室的底部并排出。
The steps involved in choosing the right sterilisation cycle.
選擇正確滅菌循環(huán)的步驟：
Consideration 2 Which load configurations to use?
注意事項(xiàng) 2：使用哪一種負(fù)載配置
A variable to consider is whether to use fixed load or variable load configurations. There’s a trade-off here between validation effort and operational flexibility – do you want to validate a wide range of load configurations to increase Production’s flexibility in loading the autoclave? Here are some typical load configurations to consider:
需要考慮的一個(gè)因素是選擇固定裝載還是可變的裝載。在驗(yàn)證和操作靈活性之間需要一個(gè)權(quán)衡- 你是否驗(yàn)證最大最小裝載以增加生產(chǎn)的靈活性？下面是需要考慮的一些典型裝載模式：
A fixed load/fixed position configuration means that any load to be sterilised will be placed inside the chamber in exactly the same way for every processing run. A diagram of the load configuration should appear in the Standard Operating Procedure (SOP) so that operators can reproduce the load for every processing run. This situation requires the fewest validation runs (3), but offers no flexibility in load configurations.
固定裝載/固定位置模式 意味著, 任何待滅菌裝載將以完全相同的方式放置在室內(nèi)。在標(biāo)準(zhǔn)作業(yè)流程（SOP）中應(yīng)有負(fù)載配置的圖表，因此操作者可以在腦海中再現(xiàn)每一個(gè)運(yùn)行過程的負(fù)載。這種情況要求最少的驗(yàn)證運(yùn)行（3），但負(fù)載配置沒有靈活性。
A fixed load/variable position configuration means that the location of the load items in the autoclave can vary. Only a list of the items that can be in a load is required for the SOP. The validation runs must demonstrate positional equivalence by rotating the items from location to location during the test runs. If positional equivalence is proven after three validation runs, then you can stop. A fixed load/variable position configuration gives operators flexibility in loading the autoclave. This saves time when loading large loads of numerous items of different types.
固定負(fù)載/可變位置模式 指負(fù)載在高壓滅菌器內(nèi)的位置是可變的。在 SOP 中只需一個(gè)負(fù)載列表。在測(cè)試運(yùn)行過程中，驗(yàn)證運(yùn)行應(yīng)通過輪換負(fù)荷物品逐個(gè)位置論證不同位置的等效性。如果經(jīng)過 3 個(gè)run的驗(yàn)證證明了位置的等效性那就可以停止。固定負(fù)載/可變位置的模式給操作者操作高壓滅菌器時(shí)帶來(lái)靈活性。針對(duì)包含不同物品的大負(fù)載來(lái)說，這樣可以節(jié)省時(shí)間。
A variable load configuration means that different combinations of items and/or numbers of any item(s) can be placed into the chamber. The validation runs must demonstrate that the cycle is adequate for both a maximum and minimum load configuration. The minimum load tests are done with only one item in the autoclave, that item being the load item demonstrated as being the most difficult to sterilise .
可變負(fù)載配置 指腔室內(nèi)物品種類和/或數(shù)量不固定。驗(yàn)證運(yùn)行時(shí)必須表明此循環(huán)周期可以滿足最大和最小兩個(gè)負(fù)載模式。最小負(fù)載測(cè)試高壓滅菌器腔室一個(gè)物品，必須證明其是最難滅菌的一個(gè)物品。
Consideration 3 Choosing the right Control for liquid cycles
注意事項(xiàng) 3：選擇合適的液體循環(huán)監(jiān)控裝置
The choice of the Control used when sterilising liquids determines whether the load you are sterilising will pass all the acceptance criteria.
液體滅菌時(shí)所選的監(jiān)控決定了待滅菌的負(fù)載能否通過接收標(biāo)準(zhǔn)。
More than one liquid Control may be needed to validate all the different types of bottles and liquids requiring sterilisation. Consider the following when choosing the Control for liquid cycles:
需要不止一個(gè)液體監(jiān)控裝置以證明不同類型的瓶子和液體能滿足滅菌要求。選擇液體循環(huán)監(jiān)控裝置時(shí)需考慮以下因素：
The size of the bottle and its fill volume – the larger the bottle and the greater its volume, the harder it is to sterilise.
瓶子的大小和填充量-瓶子越大其體積越大，就越難滅菌。
The thickness of the glass –thicker glass is more difficult to sterilise than thinner glass.
玻璃的厚度，厚玻璃比薄玻璃難滅菌
The viscosity of the liquid – the greater the viscosity, the slower the heat-up time, and the harder it is to sterilise.
液體的粘度 – 粘度越大傳熱越慢，就越難滅菌。
The liquid Control will ideally be the one that is the most difficult to sterilise (worst-case) and will be located at the coldest spot in the chamber (lower level near the front door or directly above the drain).
理想情況下，液體監(jiān)控裝置所在應(yīng)是最難滅菌的（最壞情況），放置在腔室內(nèi)最冷點(diǎn)（靠近前門或在排水口正上方）。
Don’t be tempted to use a Control that is dramatically different from the composition of the load. If the liquid Control takes too long to reach the sterilisation temperature, then the protein composition of the media in the rest of the load (which may have exceeded the desired temperature by the time the Control reaches the sterilisation temperature) may be denatured.
不要試圖使用與待滅菌裝載完全不通過的液體監(jiān)控裝置，如果液體控制需要很長(zhǎng)時(shí)間來(lái)達(dá)到滅菌溫度，則負(fù)載其他位置中的蛋白質(zhì)可能會(huì)變性（在監(jiān)控裝置到達(dá)滅菌溫度的過程中，可能已經(jīng)超出所要求的溫度）。
If in doubt, perform preliminary studies using different liquid Controls to obtain information on the load's heat-up times and F0-values.
不要對(duì)不同組分的負(fù)載嘗試控制，如果液體控制需要很長(zhǎng)時(shí)間還達(dá)不到滅菌溫度，則負(fù)載介質(zhì)中的蛋白質(zhì)將會(huì)變性（這可能已經(jīng)超出了控制的時(shí)候達(dá)到殺菌所需的溫度）。
The number of validation runs required for different types of liquids and bottles can be reduced by grouping liquids with similar viscosities, bottle sizes and fill volumes. Each liquid Control will have a unique maximum and minimum load configuration associated with it.
可以根據(jù)相似粘度，瓶子大小和填充量大小進(jìn)行分組，減少不同類型的液體和瓶子所需驗(yàn)證測(cè)試的次數(shù)。每個(gè)液體控制將有一個(gè)與之相關(guān)的最大和最小負(fù)載配置。
Use procedural controls to ensure that the choice of liquid, bottle size and fill volume used for each Control, and its location in the chamber, are maintained during the validation runs and subsequent processing runs.
使用程序化的控制，以確保每個(gè)液體控制所使用的液體、瓶子體積、填充量，及其在腔室內(nèi)的位置，在驗(yàn)證期間和后續(xù)操作過程中保持一致。
Consideration 4 Determining which load items are the most difficult to sterilise and which location(s) within the items represents the worst-case conditions
注意事項(xiàng) 4：確定哪些裝載物品是最難滅菌的和哪些位置最能代表滅菌的最差情況
With a large load containing a wide variety of different types of items, the number of possible test locations within items seems to approach infinity. It also can be difficult to get the thermocouple and indicators (BI & CI) into the item without affecting the item’s ability to be sterilised and/or ruining the item (a concern with expensive items).
由于負(fù)載包含很多不同類型物品，需要檢測(cè)的位置似乎很多。在不影響物品滅菌能力或破壞物品（關(guān)注貴重物品）的情況下，將熱電偶和指示劑（BI 與 CI）放入物品中也是非常困難的。
We must evaluate each item on a case-by-case basis and determine how to best challenge the item. Often the item must be sealed somehow to return it to a state that represents equivalency with respect to steam penetration.
我們必須逐個(gè)逐個(gè)評(píng)估每個(gè)物品，確定最佳挑戰(zhàn)方式。通常,物品必須以某種方式密封,以確保其蒸汽滲透狀態(tài)不變。
Some examples:
舉例：
Q. What is the most difficult point to sterilise in a hose of uniform diameter?
問：一個(gè)直徑均一的軟管內(nèi)哪一點(diǎn)最難滅菌？
A. In the centre of the length of hose.
答：在軟管長(zhǎng)度的中心。
Q. How do you get a 3 m length of thermocouple into the middle of a 20 m hose?
問：如何將一個(gè) 3 米長(zhǎng)的熱電偶插入 20 米的軟管中間？
A. By cutting a slot in the middle of the hose and inserting the thermocouple through the slot, making sure to seal the slot with silicon. If you don’t seal it, you will not be challenging the hose properly. Alternatively, get two 10 m lengths of hose (if available) and join them with a connector, after inserting the thermocouple through the connector. Using this method doesn’t ruin a 20 m length of hose.
答：在軟管中間刻一插槽，熱電偶沿著插槽插入軟管，確保用硅膠將插槽密封，如果你沒有密封，則不能挑戰(zhàn)軟管?；蛘撸瑢蓚€(gè) 10 米的軟管（如有）插入熱電偶后用連接器將其連接，用這種方法則不用破壞 20 米長(zhǎng)的管子。
Q. What is the worst-case location within a bottle, flask or cylinder?
問：瓶子、錐形瓶和柱形瓶那個(gè)位置最難滅菌？
A. In the centre near the bottom (but not touching the floor).
答：在靠近底部的中間（但不接觸底面）。
Q. How do you hold a thermocouple in position inside a sealed bottle?
問：如何保持熱電偶在一個(gè)密封瓶子里的位置？
A. Choose a piece of Silastic tubing with an internal diameter (ID) that is narrow enough to hold the thermocouple probe without letting it slip through. Drill a hole in the bottle's lid the same size as the outer diameter (OD) of the tubing. Push the tubing through the hole, into the bottle. Now push the probe into the tubing. Slide the probe through the tubing until it reaches the desired position in the bottle. Make sure it is not touching the wall of the bottle. For bottles with rubber stoppers, make a small hole in the centre of the stopper, sufficient to push the thermocouple through.
答：選擇一個(gè)內(nèi)徑與熱電偶探頭相近的硅橡膠管件套住它以確保不會(huì)滑落。在瓶蓋上鉆一個(gè)和管子外徑一樣大的孔。通過孔將管子插入瓶中。將探頭推入管子中，推動(dòng)探頭直至到達(dá)瓶子中所需位置。確保它不會(huì)觸碰瓶壁。對(duì)于橡膠瓶塞的瓶子，在篩子中間鉆一個(gè)小孔，足以使熱電偶通過。
Consideration 5 Wired temperature thermocouples are cumbersome and don’t always give accurate data
注意事項(xiàng) 5：有線熱電偶較復(fù)雜，且并非總是提供準(zhǔn)確的數(shù)據(jù)
The list below highlights some considerations when using wired thermocouples:
下面重點(diǎn)介紹一些使用熱電偶傳感器時(shí)的注意事項(xiàng)：
Some loss of steam (leakage) will occur when the wire's outer plastic protector has been cut and air or steam can pass through it. This may result in a failed leak test.
當(dāng)導(dǎo)線的外層塑料保護(hù)膜被切割并且有空氣或蒸汽通過，就會(huì)發(fā)生一些蒸汽損耗（泄漏），可能會(huì)導(dǎo)致泄漏測(cè)試失敗。
Validator thermocouples inside the chamber will draw condensate and will need a slice/cut made in their outer protective layer, to ensure that any fluid is released. If condensate passes through the wires and into the electronics, the thermocouples will be destroyed.
在腔室內(nèi)的熱電偶會(huì)吸冷凝水，需要在腔室外部將熱電偶保護(hù)層切開以將冷凝水釋放。如冷凝水通過熱電偶流到驗(yàn)證儀電子元件，熱電偶將損壞。
The thermocouple may be difficult to place into the item without adversely affecting the item’s ability to be sterilised and/or ruining the item (a concern with expensive items).
熱電偶可能難以在不影響物品滅菌和/或破壞物品 (貴重物品)的情況下，放入物品中。
Wires can get caught (and be damaged) under the autoclave's wheels when moving loads into and out of the chamber.
當(dāng)進(jìn)料或出料時(shí)熱電偶可能被高壓滅菌器的輪子卡?。úp壞）
It is difficult to place wires inside sealed bottles without (i) touching the inside wall, and (ii) compromising the bottle’s ability to be sterilised.
將熱電偶裝在密封瓶里并且不碰到內(nèi)壁是很難做到的，并且降低瓶子的無(wú)菌程度。
You may be limited by the number of wires you can place through the autoclave's inlet.
你可能會(huì)受限于高溫滅菌器進(jìn)口的導(dǎo)線數(shù)量。
The resistance of the thermocouple in some locations in the chamber can change, leading to inaccurate and/or unreliable data even though the pre/post calibration verifications meet specifications.
即使前/后校準(zhǔn)確認(rèn)符合標(biāo)準(zhǔn)，某些位置熱電偶電阻也會(huì)發(fā)生變化，從而導(dǎo)致數(shù)據(jù)不準(zhǔn)確和/或不可靠。
Case Study
示例
This example looks at nine thermocouples placed into a loaded chamber. They were evenly spaced from one another at the top, middle and bottom levels and at the front, centre and rear of the chamber.
此示例包含裝載腔室內(nèi)的9個(gè)熱電偶。他們均勻分布在頂部，中部和底部，以及前、中、后部。
The study used wired thermocouples in a loaded chamber for a 40-minute cycle at 121.1 °C. The chamber's maximum pressure of 2.16 bar (at any time) was equivalent to 122.7 °C. One probe (top front LHS) constantly reached temperatures between 123.3 °C and 123.5 °C. All other probes were within the required limit of 120.1 °C +2 °C/-1 °C at temperatures from 122.4 °C to 122.7 °C.
該研究使用有線熱電偶用于測(cè)試 121.1℃ 40 分鐘的負(fù)載腔體 。內(nèi)室最大壓力 2.16bar（在任何時(shí)間）相當(dāng)于 122.7℃。一個(gè)探頭（頂部前左）溫度持續(xù)維持在123.3 °C - 123.5 °C之間。所有其他探頭則在規(guī)定溫度范圍120.1℃ +2 ° C/-1 ° C內(nèi)，在122.4 ° C 至 122.7 ° C 之間
The temperature differential started during heat-up and remained during the sterilisation and post vacuum cooling phases. The Equipment Engineer and the Manufacturer agreed that the temperature reading at this position was inaccurate and unreliable. The thermocouple reading was inconsistent with the steam pressure indication and the other thermocouple readings. Consequently, no useful data were collected at that point.
溫度偏差開始于加熱階段，并在滅菌和真空冷卻階段仍然存在。該設(shè)備工程師和制造商一致認(rèn)為，在這個(gè)點(diǎn)的溫度讀數(shù)是不準(zhǔn)確和不可靠的。熱電偶讀數(shù)與蒸汽壓力讀數(shù)以及其他熱電偶讀數(shù)不一致。因此，在這一點(diǎn)沒有任何有用的數(shù)據(jù)。
Consideration 6 Determining the acceptance criteria
注意事項(xiàng) 6：確定接受標(biāo)準(zhǔn)
An example:
一個(gè)例子：
You run your validation studies, only to realise that you cannot meet one of the acceptance criteria. But, was it really needed in the first place?
當(dāng)您運(yùn)行驗(yàn)證測(cè)試時(shí)，您只認(rèn)識(shí)到能不能達(dá)到接受標(biāo)準(zhǔn)。但是，是不是真的需要擺在首位？
It’s important to understand the aim of the autoclave cycle and what its parameters are. For example, is it for sterilisation or decontamination? Is the load heat sensitive, or can it be subjected to an overkill cycle? Is it a porous load (hard/wrapped goods), or is it a liquid?
重要的是要了解滅菌柜的周期及其參數(shù)。例如，是用于滅菌還是降低負(fù)荷？負(fù)載是熱敏感的嗎？還是可以承受過度滅菌？是多孔裝載（堅(jiān)硬/包裹的物品）嗎？，還是液體？
Most Validation departments have a Standard Operating Procedure (SOP) detailing the validation requirements for sterilisation processes. Included in that is a complete list of all the acceptance criteria.
大多數(shù)驗(yàn)證部門有標(biāo)準(zhǔn)操作程序（SOP）詳細(xì)說明滅菌工藝驗(yàn)證的要求。列出所有接受標(biāo)準(zhǔn)的完整清單。
Each phase of the autoclave cycle is likely to have different acceptance criteria:
滅菌柜不同階段的循環(huán)周期存在不同的遵循標(biāo)準(zhǔn)：
Phase I – Heat distribution (empty chamber)
第一階段 - 熱分布（空載）
Phase II – Heat distribution (loaded)
第二階段 - 熱分布（裝載）
Phase III – Heat distribution (loaded) cold spot determination within
第三階段 - 熱分布（裝載）內(nèi)部冷點(diǎn)測(cè)定
Phase IV – Heat penetration
第四階段 - 熱穿透
There may also be different requirements for Phases III and IV if you are sterilising liquids (non-vacuum) vs. porous items (vacuum), e.g., F0 > 15 at the end of sterilisation (liquids only).
對(duì)于滅菌液體（非真空）和多孔裝載（真空），第三階段和第四階段可能存在不同的要求，例如滅菌結(jié)束時(shí) F0>15（只針對(duì)液體）。
Typical acceptance criteria are as follows:
典型的接受標(biāo)準(zhǔn)如下：
All porous cycles require min SAL 10-6 at the end of sterilisation. All porous items are subject to at least one post-vacuum cycle which removes steam from the chamber (Phases III & IV).
所有多孔裝載程序要求結(jié)束時(shí)SAL≤10-6。所有多孔物品至少進(jìn)行一次后真空循環(huán)以消除滅菌腔室內(nèi)的蒸汽（階段三和四）。
All liquid cycles require a min SAL 10-6 and a min F0 > 15 at the end of the cycle, because they do not use vacuum and are subject to natural cooling?(Phases III & IV).
所有液體循環(huán)周期要求SAL≤ 10-6，并且F0 > 15，因?yàn)樗鼈儾皇褂谜婵?，并自然冷卻（階段三和四）。
Throughout the sterilisation phase all temperatures are within a 3 °C range (Phases II, III & IV)?, e.g., 121.1 °C -1 °C/+2 °C.
在整個(gè)滅菌階段所有的溫度都在 3 ° C 的變化范圍內(nèi)（階段二，三和四）例如，121.1 ° C -1℃/+2 ° C
Throughout the sterilisation phase all temperatures in the chamber are within 1.0 °C of the chamber's mean temperature (Phase II).
在整個(gè)滅菌階段，滅菌柜各探頭溫度在平均溫度±1.0 ℃范圍內(nèi)，（階段二）。
The steam's temperature corresponds to its vapour pressure (Phases II, III & IV).4
蒸汽的溫度與其蒸氣壓力相適應(yīng)（階段 II，III 及 IV）。
Timed measurements are to be controlled to an accuracy of ±1%.?
時(shí)間計(jì)時(shí)控制在±1%的精度范圍內(nèi)（階段 II，III 及 IV）。
Required pre-certification and post-certification of the data logger ensures that the temperature measurement system is accurate to within ±0.5 °C.
驗(yàn)證前和驗(yàn)證后溫度測(cè)量系統(tǒng)的準(zhǔn)確度在± 0.5℃的范圍內(nèi)。
The load is visually dry at the end of the cycle (porous cycles only).
滅菌結(jié)束時(shí)裝載目測(cè)干燥（只針對(duì)多孔裝載）。
All autoclaved Biological Indicators (BIs) are negative and the control is positive following incubation (Phase IV).
所有生物指示劑培養(yǎng)結(jié)果陰性，陽(yáng)性對(duì)照陽(yáng)性（階段IV）。
Consideration 7 Adequately documenting the validation test runs
注意事項(xiàng) 7：充分記錄驗(yàn)證測(cè)試
Documenting what was done during the validation test runs is all about knowing what needs to be documented and how to present it. This documentation must be clear, consistent between runs and transparent, and must conform to all GMP requirements. It must be complete and must include the following items:
記錄驗(yàn)證測(cè)試期間進(jìn)行的工作,就是了解需要記錄的內(nèi)容以及如何記錄它。記錄清晰、一致和一目了然,并且必須符合所有 GMP 要求。它必須是完整的,并且必須包括以下項(xiàng)目:
a diagram showing the location of all load items within the autoclave chamber
顯示高壓滅菌腔室內(nèi)所有裝載物品位置的圖表
the precise location/number of each thermocouple, BI and CI within each item
各熱電偶、BI、CI的數(shù)目和精確位置
the printout from the data recorder
數(shù)據(jù)記錄器（熱電偶）打印輸出
the printout or chart from the autoclave
從滅菌器打印或輸出圖表
the time the sterilisation period began and finished (per the data recorder time)
滅菌周期起始和結(jié)束（根據(jù)數(shù)據(jù)記錄器的時(shí)間）
the time difference between the autoclave controller and the validation temperature monitoring device
高壓滅菌柜控制器和溫度驗(yàn)證儀的時(shí)間差
the results of each BI and CI
各生物指示劑和化學(xué)指示劑的結(jié)果
Label each document with the equipment ID, load description, date, test run number and cycle start/end time.
每個(gè)記錄分別標(biāo)明設(shè)備 ID、負(fù)載說明、日期、測(cè)試編號(hào)和循環(huán)開始/結(jié)束時(shí)間。
If you fail to generate good documentation while conducting the validation test runs, you will not be able to analyse the data when putting together the report. Inadequate or poor quality data to support the validation process will not survive the scrutiny of an auditor.
當(dāng)進(jìn)行驗(yàn)證測(cè)試過程中，如果你沒有良好記錄，在報(bào)告時(shí)，你將無(wú)法進(jìn)行數(shù)據(jù)分析。用不充分或不良的數(shù)據(jù)來(lái)支持驗(yàn)證過程將無(wú)法通過審計(jì)。
Tip:
提示
Be cautious about the acceptance criteria you employ to verify the accuracy of thermocouples. If the criterion is too tight (e.g., all thermocouples must meet the acceptance criteria), you may lose a lot of runs if one or two thermocouples cease functioning or are outside the temperature tolerance after the runs.
注意謹(jǐn)慎使用熱電偶的精確度接受標(biāo)準(zhǔn)，如果標(biāo)準(zhǔn)過高（如所有的熱電偶必須達(dá)到接受標(biāo)準(zhǔn)），如有一或兩個(gè)熱電偶停止工作或在測(cè)試后超出溫度容許偏差，則可能會(huì)丟失大量運(yùn)行。
Consideration 8 The frequency of thermocouple accuracy verification
注意事項(xiàng) 8：熱電偶準(zhǔn)確度確認(rèn)的頻率
If you are performing a large number of test runs (e.g., over the course of several weeks), you need to think about the points at which you will verify the thermocouples' accuracy. This could be done after every run and/or at the end of the entire testing period. If you wait until the end of the testing period, you run the risk that all of the runs are of no value due to their failure to meet the verification acceptance criteria. Verifying after every run, however, adds considerably to the length of time required to complete the testing. Performing the verification every three runs or every few days is a reasonable compromise.
如果你正在進(jìn)行（如，在幾個(gè)星期內(nèi)）大量的驗(yàn)證測(cè)試，你需要考慮熱電偶的準(zhǔn)確度。可以在每次運(yùn)行和/或在整個(gè)測(cè)試周期結(jié)束后進(jìn)行。如果等到測(cè)試周期結(jié)束,則存在由于熱電偶未滿足接受驗(yàn)收標(biāo)準(zhǔn)而導(dǎo)致所有測(cè)試失效的風(fēng)險(xiǎn)。但是，在每次測(cè)試后做檢查，則會(huì)大大增加完成測(cè)試所需的時(shí)間。每三次運(yùn)行或每隔幾天執(zhí)行一次準(zhǔn)確性檢查是一種合理的折衷方案。
As noted in Consideration 6, the acceptance criterion you employ to verify the thermocouples' accuracy should allow at least one or two thermocouples to fail.
正如注意事項(xiàng) 6 指出，驗(yàn)證熱電偶的準(zhǔn)確度，應(yīng)允許至少一個(gè)或兩個(gè)熱電偶失效。
Consideration 9 Having adequate time and access to the autoclave to complete the validation
注意事項(xiàng) 9：確保足夠的時(shí)間和支配來(lái)完成驗(yàn)證
It’s easy to under estimate the length of time it takes to validate an autoclave, and how much access you need to it during the process.
人們很容易低估驗(yàn)證高溫滅菌器所需的時(shí)間，以及在整個(gè)驗(yàn)證過程中你需要做些什么。
For example, it can take up to four hours to set up your run, i.e., prepare the load, place probes, BIs and CIs into the load, etc. If Production needs to use the autoclave and you need to remove your probes, BIs and CIs, then you need to start all over again, effectively losing a day. Work with the Production department when planning the Validation project to ensure that you have adequate access to the autoclave.
例如，可能需要長(zhǎng)達(dá)四個(gè)小時(shí)進(jìn)行準(zhǔn)備，例如，準(zhǔn)備裝載，放置探頭，將BI和 CI 放入負(fù)載中等。如果生產(chǎn)需要使用高壓滅菌器，你需要將探頭，BI 和 CI挪出來(lái)，然后從頭再來(lái)，白白浪費(fèi)一天。在規(guī)劃驗(yàn)證項(xiàng)目時(shí)與生產(chǎn)部門合作，以確保你能有足夠的支配。
Another approach is to combine Phase II and III (Heat Distribution) with Phase IV (Heat Penetration) studies to save time.
另一種方法是將階段II、階段III（熱分布）與階段IV（熱滲透）結(jié)合在一起，以節(jié)省時(shí)間。
Combining these three phases could reduce the time it takes to complete the validation project; however, you need to consider the following when doing this:
這三個(gè)階段結(jié)合一起做可以減少完成驗(yàn)證的時(shí)間，不過，這樣做需要考慮以下幾點(diǎn)：
1 You will need to place probes into the chamber and into load items at the same time. Can you fit all the probes through the autoclave's inlet? If not, then you need to either validate each phase separately, or reduce the number of probes.
1、需要同時(shí)將探頭放入墻體內(nèi)和負(fù)載物上。通過高壓滅菌器驗(yàn)證口你能安裝所有的探頭嗎？如果不能，那么你需要單獨(dú)驗(yàn)證每個(gè)階段，或降低探頭的數(shù)量。
2 Combining these three phases greatly increases your preparation time. If you are working on a tight schedule (e.g., on a construction site where you need to evacuate at a certain time), you may not have time to complete the study. If this happens, then it may take more time to perform the work than if you had done each phase separately.
2、這三個(gè)階段結(jié)合在一起做會(huì)大大增加你的準(zhǔn)備時(shí)間。如果你的時(shí)間較緊(例如，在需要在特定時(shí)間撤離的建筑工地上),，你可能沒有時(shí)間完成這項(xiàng)分析。如果發(fā)生這種情況，那么它需要完成的時(shí)間比單獨(dú)做每個(gè)階段的時(shí)間要長(zhǎng)。
3 If you are under time pressure, there is a greater chance that you will miss something or make a mistake.
3、如果你的時(shí)間很緊，將很容易遺忘一些東西或者犯錯(cuò)誤。
4 There are more data to consider. If you check only a few critical requirements before proceeding to the next study, you may miss something that did not meet an acceptance criterion. This may mean that all subsequent studies are at risk, because the data cannot be verified. For example, a probe may be falsely reading too high.
4、還有更多的數(shù)據(jù)需要考慮。進(jìn)行下一個(gè)研究前，如果你只檢查了幾個(gè)關(guān)鍵點(diǎn)，您可能會(huì)疏忽一些不符合驗(yàn)證標(biāo)準(zhǔn)的內(nèi)容，這可能意味著所有后續(xù)的研究處于風(fēng)險(xiǎn)之中，因?yàn)閿?shù)據(jù)無(wú)法得到證實(shí)。例如，一個(gè)探頭讀數(shù)可能過高。
5 Allow enough time for the report to be completed.
5、準(zhǔn)備充足的時(shí)間來(lái)完成報(bào)告。
If you are validating a new autoclave, then you need to allow enough time for:
如果你是對(duì)新的高壓滅菌器進(jìn)行驗(yàn)證，那么你需要足夠的時(shí)間進(jìn)行：
（一）writing a validation plan
（一）編寫驗(yàn)證計(jì)劃
（二）writing the commissioning and IQ protocols
（二）編寫試機(jī)和 IQ方案
（三）preparing the OQ/PQ protocols
（三）準(zhǔn)備 OQ / PQ方案
（四）performing OQ/PQ studies
（四）開展 OQ / PQ 的研究
（五）writing the OQ/PQ reports, preparing folders, etc.
（五）編寫 OQ / PQ 的報(bào)告，準(zhǔn)備文件等
If you are performing a large number of test runs (e.g., over the course of several weeks), then you need to ensure that enough time has been allocated to prepare the folders and write the reports. Allow one day to do a run and another day to analyse the data, i.e., two days per study. Also allow time to write protocols and reports, and to have them reviewed and approved by other people (if appropriate). If you are developing the validation cycles, then this will also take time.
如果你正在進(jìn)行（例如，在幾個(gè)星期內(nèi)）大量運(yùn)行測(cè)試，那么你需要確保有足夠的時(shí)間準(zhǔn)備文件和編寫報(bào)告。確保測(cè)試一天，再用一天來(lái)分析數(shù)據(jù)，也就是說，每項(xiàng)測(cè)試2天。同樣預(yù)留充足的時(shí)間編寫方案和報(bào)告，并進(jìn)行審核簽批（如適用）。如果你正在開發(fā)驗(yàn)證程序，那么這也將需要時(shí)間。
Consideration 10 Have the right procedural controls in place to ensure ongoing consistency and correct operation
注意事項(xiàng) 10：制定正確的程序進(jìn)行控制，以確保持續(xù)一致和正確操作
Congratulations, you have just finished validating a new autoclave for a number of different cycles and load configurations. Now, what controls need to be in place to ensure that the validated loads are used consistently?
恭喜你，你剛剛完成了一個(gè)包含不同周期和負(fù)載的新滅菌柜的驗(yàn)證?，F(xiàn)在，需要那些控制，確保一致地使用經(jīng)驗(yàn)證的裝載？
A Standard Operating Procedure (SOP) for the new autoclave should be prepared. It must include clear guidelines for each of the validated cycles, including diagrams of the load configurations. Test the procedure's clarity by asking a typical operator to follow the instructions with a dummy load.
準(zhǔn)備新高溫滅菌器的標(biāo)準(zhǔn)操作程序（SOP）。對(duì)每個(gè)驗(yàn)證程序必須有明確的指引，包括負(fù)載圖。應(yīng)準(zhǔn)備新高壓滅菌器的標(biāo)準(zhǔn)操作程序 (SOP)。它必須包括每個(gè)經(jīng)過驗(yàn)證的周期的明確準(zhǔn)則,包括負(fù)載配置圖。要求一個(gè)典型操作員按照SOP進(jìn)行操作來(lái)檢查SOP的清晰度。
Each operator who uses the autoclave should be trained and tested on the SOP.
對(duì)每個(gè)使用高壓滅菌器操作者進(jìn)行培訓(xùn)和 SOP 考試。
Logbooks should be in place for each cycle.
每個(gè)程序都應(yīng)有記錄。
Use a risk-based approach to determine the troubleshooting guidelines to include in the SOP. The manufacturer’s documentation and website may detail things that commonly go wrong.
采用基于風(fēng)險(xiǎn)評(píng)估的方法制定檢修指南，包含在 SOP 里。制造商的文件和網(wǎng)站可能有常見故障的詳述。
An ongoing requalification program for the autoclave and the loads is required. The frequency can be 6, 12 or 24 months.
對(duì)于高壓滅菌器和裝載來(lái)說，持續(xù)再確認(rèn)程序是必需的，頻率可為 6，12 或 24 個(gè)月。
來(lái)源：GMP辦公室
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