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:

有三种基本类型的灭菌周期。根据待灭菌物质的类型进行选择。

 

Hard Goods (Vacuum)

坚硬装载（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

适用于那些易于灭菌的物质，因为空气清除和蒸汽穿透对这些物质是高度有效的。例如：敞开的玻璃器皿和大口径的管道

 

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

典型的坚硬物品灭菌循环在通入蒸汽达到设定灭菌温度前需要达到一个真空度。

 

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.

用于灭菌困难的物品，因为和坚硬品比起来空气清除和蒸汽穿透更难实现。

 

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

例如，有盖子的空瓶（玻璃或塑料），洁净服，长软管/管子，抽气过滤器，进/出口小的便携式容器。

 

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.

一个典型的包裹品灭菌循环在灭菌前至少进行 3 次抽真空。灭菌后通过真空将负载中的蒸汽抽走。

 

Liquids (Non-vacuum)

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.

一般含有液体的物品不能有大的真空度，否则液体会溢出。针对液体来说高压灭菌锅循环是在没有真空度的情况下加热和冷却。蒸汽进入腔室顶部置换空气，空气推入腔室的底部并排出。

 

The steps involved in choosing the right sterilisation cycle.

选择正确灭菌循环的步骤：

 

Consideration 2 Which load configurations to use?

注意事项 2：使用哪一种负载配置

 

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:

需要考虑的一个因素是选择固定装载还是可变的装载。在验证和操作灵活性之间需要一个权衡- 你是否验证大小装载以增加生产的灵活性？下面是需要考虑的一些典型装载模式：

 

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.

固定装载/固定位置模式 意味着, 任何待灭菌装载将以完全相同的方式放置在室内。在标准作业流程（SOP）中应有负载配置的图表，因此操作者可以在脑海中再现每一个运行过程的负载。这种情况要求少的验证运行（3），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/可变位置模式 指负载在高压灭菌器内的位置是可变的。在 SOP 中只需一个负载列表。在测试运行过程中，验证运行应通过轮换负荷物品逐个位置论证不同位置的等效性。如果经过 3 个run的验证证明了位置的等效性那就可以停止。固定负载/可变位置的模式给操作者操作高压灭菌器时带来灵活性。针对包含不同物品的大负载来说，这样可以节省时间。

 

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 指腔室内物品种类和/或数量不固定。验证运行时必须表明此循环周期可以满足大和小两个负载模式。小负载测试高压灭菌器腔室一个物品，必须证明其是难灭菌的一个物品。

 

Consideration 3 Choosing the right Control for liquid cycles

注意事项 3：选择合适的液体循环监控装置

 

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

液体灭菌时所选的监控决定了待灭菌的负载能否通过接收标准。

 

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:

需要不止一个液体监控装置以证明不同类型的瓶子和液体能满足灭菌要求。选择液体循环监控装置时需考虑以下因素：

 

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，液体监控装置所在应是难灭菌的（坏情况），放置在腔室内冷点（靠近前门或在排水口正上方）。

 

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.

不要试图使用与待灭菌装载完全不通过的液体监控装置，如果液体控制需要很长时间来达到灭菌温度，则负载其他位置中的蛋白质可能会变性（在监控装置到达灭菌温度的过程中，可能已经超出所要求的温度）。

 

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

不要对不同组分的负载尝试控制，如果液体控制需要很长时间还达不到灭菌温度，则负载介质中的蛋白质将会变性（这可能已经超出了控制的时候达到杀菌所需的温度）。

 

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.

可以根据相似粘度，瓶子大小和填充量大小进行分组，减少不同类型的液体和瓶子所需验证测试的次数。每个液体控制将有一个与之相关的大和小负载配置。

 

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.

使用程序化的控制，以确保每个液体控制所使用的液体、瓶子体积、填充量，及其在腔室内的位置，在验证期间和后续操作过程中保持一致。

 

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

注意事项 4：确定哪些装载物品是难灭菌的和哪些位置能代表灭菌的差情况

 

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).

由于负载包含很多不同类型物品，需要检测的位置似乎很多。在不影响物品灭菌能力或破坏物品（关注贵重物品）的情况下，将热电偶和指示剂（BI 与 CI）放入物品中也是非常困难的。

 

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.

我们必须逐个逐个评估每个物品，确定挑战方式。通常,物品必须以某种方式密封,以确保其蒸汽渗透状态不变。

 

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. 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.

 

本文由广州佳誉医疗器械有限公司/佛山浩扬医疗器械有限公司联合编辑