GMP指南:验证高压灭菌器时的十大注意事项

发布时间:2023年12月20日 浏览次数: 169 次

Top10 considerations when validating an autoclave

验证高压灭菌器时的十大注意事项

杭州美卓生物科技有限公司 | GMP指南:验证高压灭菌器时的十大注意事项

Consideration 1 Choosing the right sterilisation cycle to implement

注意事项 1:选择正确的灭菌周期

There are three basic types of sterilisation cycles. Choose the right one according to the type of goods to be sterilised:

灭菌周期有三种基本类型。根据需要灭菌的物品类型选择合适的灭菌周期:

Hard Goods (Vacuum)

1、硬质物品(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

适用于易于灭菌的物品,因为空气排除和蒸汽渗透对这些物品非常有效,例如开放式玻璃器皿和大直径管道。

A typical hard goods cycle may draw one vacuum prior to introducing steam to reach the desired sterilisation temperature.

典型的硬质物品循环在引入蒸汽之前可能会抽一次真空,以达到所需的灭菌温度。

Wrapped Goods (Vacuum)

2、包装货物(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.

用于难以消毒的物品,因为与硬质物品相比,这些物品更难排出空气和渗透蒸汽。

e.g., empty bottles (glass or plastic) with lids, gowns, long hoses/tubes, vent filters, portable vessels with small inlet/outlet ports

例如:带盖的空瓶(玻璃瓶或塑料瓶)、防护服、长软管/管子、通风过滤器、带小入口/出口的便携式器皿

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.

在灭菌之前,一个典型的包装物品循环可能要抽三次或更多次真空。灭菌后的真空将蒸汽从装载物品中抽出。

Liquids (Non-vacuum)

3、液体(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.

含有液体的物品一般不能抽成很深的真空,否则液体会被抽出。液体高压灭菌器的加热和冷却循环一般不抽真空。蒸汽被引入腔室顶部,取代空气。空气被推到腔室底部并被排出。

The steps involved in choosing the right sterilisation cycle.

选择正确灭菌周期的步骤:

杭州美卓生物科技有限公司 | GMP指南:验证高压灭菌器时的十大注意事项

Consideration 2 Which load configurations to use?

注意事项 2:使用哪种负载配置?

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:

需要考虑的一个变量是使用固定负载还是可变负载配置。这需要在验证工作和操作灵活性之间权衡--您是否希望验证多种负载配置,以提高生产部门在高压釜负载方面的灵活性?以下是一些需要考虑的典型负载配置:

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.

固定负载/固定位置配置是指在每次处理过程中,要灭菌的负载都将以完全相同的方式放置在灭菌室内。标准操作程序 (SOP) 中应包含负载配置图,以便操作员在每次处理运行时都能复制负载。这种情况需要的验证运行次数最少(3 次),但负载配置没有灵活性。

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.

固定负载/可变位置配置意味着负载物品在高压灭菌器中的位置可以变化。SOP 只要求列出负载中的物品清单。验证运行必须通过在测试运行期间将物品从一个位置旋转到另一个位置来证明位置等同。如果三次验证运行后证明位置等效,则可以停止。固定装载/可变位置配置为操作员装载高压灭菌器提供了灵活性。当装载大量不同类型的物品时,可以节省时间。

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 .

可变负载配置是指可将不同的物品组合和/或任何物品的数量放入腔体内。验证运行必须证明,循环足以满足最大和最小负载配置的要求。最小负载测试是在高压灭菌器中只放入一个物品的情况下进行的,该物品是经证明最难灭菌的负载物品。

Consideration 3 Choosing the right Control for liquid cycles

注意事项 3:为液体循环选择合适的控制装置

The choice of the Control used when sterilising liquids determines whether the load you are sterilising will pass all the acceptance criteria.

液体灭菌时使用的控制装置的选择决定了灭菌负载是否能通过所有验收标准。

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:

可能需要一个以上的液体控制装置来验证需要灭菌的所有不同类型的瓶子和液体。为液体循环选择控制装置时应考虑以下因素:

  • 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-瓶子越大其体积越大,就越难灭菌。
  • The thickness of the glass –thicker glass is more difficult to sterilise than thinner glass.玻璃的厚度,厚玻璃比薄玻璃难灭菌
  • The viscosity of the liquid – the greater the viscosity, the slower the heat-up time, and the harder it is to sterilise.液体的粘度 – 粘度越大传热越慢,就越难灭菌。

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).

理想情况下,液体控制装置是最难消毒的装置(最坏情况),并位于箱体内最冷的位置(靠近前门的低层或下水道的正上方)。

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.

不要轻易使用与负载成分大相径庭的对照品。如果液体控制剂达到灭菌温度的时间过长,那么负载中其他培养基的蛋白质成分(在控制剂达到灭菌温度时可能已超过所需温度)可能会变性。

If in doubt, perform preliminary studies using different liquid Controls to obtain information on the load's heat-up times and F0-values.

如有疑问,请使用不同的液体控制装置进行初步研究,以获得有关负载加热时间和 F0 值的信息。

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.

通过将粘度、瓶子大小和灌装量相似的液体分组,可以减少不同类型液体和瓶子所需的验证运行次数。每种液体控制都有其独特的最大和最小负载配置。

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.

使用程序控制,确保在验证运行和后续处理运行期间,保持每个 "控制 "所用的液体选择、瓶子大小和填充量,以及在腔体内的位置。

Consideration 4 Determining which load items are the most difficult to sterilise and which location(s) within the items represents the worst-case conditions

注意事项 4:确定哪些装载物品最难灭菌,以及物品中哪个(些)位置代表最恶劣的条件

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).

由于装载的物品种类繁多,物品内可能的测试位置似乎无穷无尽。此外,要将热电偶和指示器(BI 和 CI)放入物品中而不影响物品的消毒能力和/或毁坏物品(这是昂贵物品的一个问题)也很困难。

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.

我们必须根据具体情况对每件物品进行评估,并确定如何以最佳方式对物品提出质疑。通常情况下,必须以某种方式对物品进行密封,使其恢复到与蒸汽渗透等效的状态。

Some examples:

举例:

Q. What is the most difficult point to sterilise in a hose of uniform diameter?

问:一个直径均一的软管内哪一点最难灭菌?

A. In the centre of the length of hose.

答:在软管长度的中心。

Q. How do you get a 3 m length of thermocouple into the middle of a 20 m hose?

问:如何将一个 3 米长的热电偶插入 20 米的软管中间?

A. 在软管中间开一个槽,然后将热电偶从槽中插入,确保用硅胶密封槽口。如果不密封,就无法正常挑战软管。或者,找两根 10 米长的软管(如果有的话),将热电偶插入接头后,用连接器将它们连接起来。使用这种方法不会损坏 20 米长的软管。

答:在软管中间刻一插槽,热电偶沿着插槽插入软管,确保用硅胶将插槽密封,如果你没有密封,则不能挑战软管。或者,将两个 10 米的软管(如有)插入热电偶后用连接器将其连接,用这种方法则不用破坏 20 米长的管子。

Q. What is the worst-case location within a bottle, flask or cylinder?

问:瓶子、锥形瓶和柱形瓶那个位置最难灭菌?

A. In the centre near the bottom (but not touching the floor).

答:在靠近底部的中间(但不接触底面)。

Q. How do you hold a thermocouple in position inside a sealed bottle?

问:如何保持热电偶在一个密封瓶子里的位置?

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:选择一个内径与热电偶探头相近的硅橡胶管件套住它以确保不会滑落。在瓶盖上钻一个和管子外径一样大的孔。通过孔将管子插入瓶中。将探头推入管子中,推动探头直至到达瓶子中所需位置。确保它不会触碰瓶壁。对于橡胶瓶塞的瓶子,在筛子中间钻一个小孔,足以使热电偶通过。

Consideration 5 Wired temperature thermocouples are cumbersome and don’t always give accurate data

注意事项 5:有线热电偶较复杂,且并非总是提供准确的数据

The list below highlights some considerations when using wired thermocouples:

下面重点介绍一些使用热电偶传感器时的注意事项:

  • 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.当导线的外层塑料保护膜被切割并且有空气或蒸汽通过,就会发生一些蒸汽损耗(泄漏),可能会导致泄漏测试失败。
  • 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.在腔室内的热电偶会吸冷凝水,需要在腔室外部将热电偶保护层切开以将冷凝水释放。如冷凝水通过热电偶流到验证仪电子元件,热电偶将损坏。
  • 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).热电偶可能难以在不影响物品灭菌和/或破坏物品 (贵重物品)的情况下,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.当进料或出料时热电偶可能被高压灭菌器的轮子卡住(并损坏)
  • 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.将热电偶装在密封瓶里并且不碰到内壁是很难做到的,并且降低瓶子的无菌程度。
  • You may be limited by the number of wires you can place through the autoclave's inlet.你可能会受限于高温灭菌器进口的导线数量。

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/后校准确认符合标准,某些位置热电偶电阻也会发生变化,从而导致数据不准确和/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.

此示例包含装载腔室内的9个热电偶。他们均匀分布在顶部,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.

该研究使用有线热电偶用于测试 121.1℃ 40 分钟的负载腔体 。内室最大压力 2.16bar(在任何时间)相当于 122.7℃。一个探头(顶部前左)温度持续维持在123.3 °C - 123.5 °C之间。所有其他探头则在规定温度范围120.1℃ +2 ° C/-1 ° C内,在122.4 ° C 至 122.7 ° C 之间

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.

温差始于加热阶段,并在灭菌和真空冷却后阶段保持不变。设备工程师和制造商一致认为,该位置的温度读数不准确、不可靠。热电偶读数与蒸汽压力指示和其他热电偶读数不一致。因此,在该位置没有收集到有用的数据。

Consideration 6 Determining the acceptance criteria

注意事项 6:确定验收标准

An example:

一个例子:

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?

您进行了验证研究,却发现自己无法满足其中一项验收标准。但是,一开始真的需要这样做吗?

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?

了解高压灭菌器循环的目的及其参数非常重要。例如,是用于灭菌还是去污?装载的是热敏性货物,还是可以进行过度杀菌循环?是多孔负载(硬质/包裹货物),还是液体?

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.

大多数验证部门都有一个标准操作程序 (SOP),详细说明灭菌过程的验证要求。其中包括所有验收标准的完整清单。

Each phase of the autoclave cycle is likely to have different acceptance criteria:

灭菌柜不同阶段的循环周期存在不同的遵循标准:

Phase I – Heat distribution (empty chamber)

第一阶段 - 热分布(空载)

Phase II – Heat distribution (loaded)

第二阶段 - 热分布(装载)

Phase III – Heat distribution (loaded) cold spot determination within

第三阶段 - 热分布(装载)内部冷点测定

Phase IV – Heat penetration

第四阶段 - 热穿透

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).

如果是对液体(非真空)和多孔物品(真空)进行灭菌,则第三和第四阶段的要求也可能不同,例如,灭菌结束时 F0 > 15(仅限液体)。

Typical acceptance criteria are as follows:

典型的验收标准如下:

  • 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).所有多孔循环在灭菌结束时都需要最小 SAL 10-6。所有多孔物品都至少要进行一次真空后循环,以去除灭菌室中的蒸汽(第三和第四阶段)。
  • 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).所有液体循环都要求在循环结束时达到最小 SAL 10-6,最小 F0 > 15,因为它们不使用真空,并受到自然冷却(第三和第四阶段)。
  • 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.在整个灭菌阶段,所有温度都在 3 °C 范围内(第二、第三和第四阶段),例如,121.1 °C -1 °C/+2 °C。
  • Throughout the sterilisation phase all temperatures in the chamber are within 1.0 °C of the chamber's mean temperature (Phase II).在整个灭菌阶段,灭菌室内的所有温度都保持在灭菌室平均温度的 1.0 °C 以内(第二阶段)。
  • The steam's temperature corresponds to its vapour pressure (Phases II, III & IV).4蒸汽的温度与其蒸气压力相适应(阶段 II,III 及 IV)。
  • Timed measurements are to be controlled to an accuracy of ±1%.时间计时控制在±1%的精度范围内(阶段 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.验证前和验证后温度测量系统的准确度在± 0.5℃的范围内。
  • The load is visually dry at the end of the cycle (porous cycles only).灭菌结束时装载目测干燥(只针对多孔装载)。
  • All autoclaved Biological Indicators (BIs) are negative and the control is positive following incubation (Phase IV).所有生物指示剂培养结果阴性,阳性对照阳性(阶段IV)。

Consideration 7 Adequately documenting the validation test runs

注意事项 7:充分记录验证测试运行情况

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:

记录验证测试运行期间所做的工作,关键在于了解需要记录什么以及如何进行记录。这种记录必须清晰,在不同的试运行之间保持一致和透明,并且必须符合所有 GMP 要求。文件必须完整,必须包括以下项目:

  • a diagram showing the location of all load items within the autoclave chamber显示高压灭菌腔室内所有装载物品位置的图表
  • the precise location/number of each thermocouple, BI and CI within each item各热电偶、BI、CI的数目和精确位置
  • the printout from the data recorder数据记录器(热电偶)打印输出
  • the printout or chart from the autoclave从灭菌器打印或输出图表
  • the time the sterilisation period began and finished (per the data recorder time)灭菌周期起始和结束(根据数据记录器的时间)
  • the time difference between the autoclave controller and the validation temperature monitoring device高压灭菌柜控制器和温度验证仪的时间差
  • the results of each BI and CI各生物指示剂和化学指示剂的结果
  • Label each document with the equipment ID, load description, date, test run number and cycle start/end time.
  • 每个记录分别标明设备 ID、负载说明、日期、测试编号和循环开始/结束时间。

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.

如果在进行验证测试运行时未能生成良好的文档,那么在编写报告时就无法对数据进行分析。支持验证过程的数据不充分或质量差,将无法通过审计师的审查。

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.

对于验证热电偶准确性所采用的验收标准要谨慎。如果标准过于严格(例如,所有热电偶都必须符合验收标准),那么在运行后,如果有一两个热电偶停止工作或超出温度公差范围,您可能会损失大量运行次数。

Consideration 8 The frequency of thermocouple accuracy verification

注意事项 8:热电偶精度验证频率

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.

如果要进行大量的测试运行(例如,在几个星期内),则需要考虑验证热电偶准确性的时间点。这可以在每次运行后和/或整个测试期结束时进行。如果等到测试期结束后再进行验证,就有可能出现所有运行都因不符合验证验收标准而失去价值的情况。然而,在每次运行后进行验证会大大增加完成测试所需的时间。每三次运行或每隔几天进行一次验证是一个合理的折中方案。

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.

如考虑因素 6 所述,您用于验证热电偶准确性的验收标准应允许至少有一个或两个热电偶失效。

Consideration 9 Having adequate time and access to the autoclave to complete the validation

注意事项 9:有足够的时间和途径使用高压灭菌器来完成验证

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.

我们很容易低估验证高压灭菌器所需的时间,以及在验证过程中您需要接触高压灭菌器的程度。

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,设置运行可能需要四个小时,即准备负载、将探针、BI 和 CI 放入负载等。如果生产部门需要使用高压灭菌器,而您又需要移除探针、BI 和 CI,那么您就需要重新开始,这实际上会浪费一天的时间。在规划验证项目时,请与生产部门合作,以确保您有足够的时间使用高压灭菌器。

Another approach is to combine Phase II and III (Heat Distribution) with Phase IV (Heat Penetration) studies to save time.

另一种方法是将第二和第三阶段(热分布)与第四阶段(热渗透)研究结合起来,以节省时间。

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:

将这三个阶段结合起来,可以减少完成验证项目所需的时间;但是,这样做时需要考虑以下几点:

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、您需要将探针同时放入腔室和负载物品中。高压灭菌器的入口是否能装入所有探针?如果不能,则需要分别对每个阶段进行验证,或者减少探头的数量。

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、将这三个阶段结合起来,可以大大增加准备时间。如果您的工作时间很紧(例如,在建筑工地上,您需要在某个时间撤离),您可能没有时间完成研究。如果出现这种情况,那么完成工作所需的时间可能会比分别完成每个阶段所需的时间更长。

3 If you are under time pressure, there is a greater chance that you will miss something or make a mistake.

3、如果时间紧迫,您就更有可能遗漏或犯错。

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、需要考虑的数据更多。如果在进行下一项研究之前只检查几项关键要求,可能会遗漏一些不符合验收标准的数据。这可能意味着所有后续研究都有风险,因为数据无法验证。例如,探头的读数可能过高。

5 Allow enough time for the report to be completed.

5、准备充足的时间来完成报告。

If you are validating a new autoclave, then you need to allow enough time for:

如果你是对新的高压灭菌器进行验证,那么你需要足够的时间进行:

(一)writing a validation plan

(一)编写验证计划

(二)writing the commissioning and IQ protocols

(二)编写试机和 IQ方案

(三)preparing the OQ/PQ protocols

(三)准备 OQ / PQ方案

(四)performing OQ/PQ studies

(四)开展 OQ / PQ 的研究

(五)writing the OQ/PQ reports, preparing folders, etc.

(五)编写 OQ / PQ 的报告,准备文件等

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.

如果要进行大量的测试运行(例如,在几周内),则需要确保分配足够的时间来准备 文件夹和撰写报告。留出一天时间进行测试,另一天时间分析数据,即每项研究留出两天时间。此外,还要留出时间来撰写方案和报告,并由其他人(如适用)进行审核和批准。如果您正在制定验证周期,那么这也需要时间。

Consideration 10 Have the right procedural controls in place to ensure ongoing consistency and correct operation

注意事项 10:制定正确的程序控制,确保持续的一致性和正确的操作

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?

恭喜您,您刚刚完成了对一台新高压灭菌器的多个不同周期和负载配置的验证。现在,需要采取哪些控制措施来确保一致地使用经过验证的负载?

  • 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.应编制新高压灭菌器的标准操作程序 (SOP)。它必须包括每个验证周期的明确指南,包括负载配置图。请一名典型的操作员使用假负载按照说明操作,以测试程序的清晰度。
  • Each operator who uses the autoclave should be trained and tested on the SOP.对每个使用高压灭菌器操作者进行培训和 SOP 考试。
  • Logbooks should be in place for each cycle.每个程序都应有记录。
  • 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.采用基于风险评估的方法制定检修指南,包含在 SOP 里。制造商的文件和网站可能有常见故障的详述。
  • An ongoing requalification program for the autoclave and the loads is required. The frequency can be 6, 12 or 24 months.对于高压灭菌器和装载来说,持续再确认程序是必需的,频率可为 6,12 或 24 个月。

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