药学热点话题：用药安全——无菌配药常见问题解答

欢迎收听ASHP官方播客，本节目将为您解读药物使用、公共卫生及药学专业相关议题。

Welcome to the ASHP official podcast, your guide to issues related to medication use, public health, and the profession of pharmacy.

感谢收听本期《药学热点话题》，我们将与专家们共同探讨当前药学领域最受关注的问题。

Thanks for joining us in this episode of pharmacy hot topics where we sit down with our experts and discuss what is currently top of mind in the world of pharmacy.

我是主持人莎拉·韦瑟，本期嘉宾包括：Pure Microbiology微生物学家艾比·罗斯、Simplify Plus临床项目经理安妮·兰伯特，以及我的搭档——Sutter Health系统无菌配药协调员梅兰妮·霍恩。

My name is Sarah Weiser, and joining me for today's episode is Abby Roth, microbiologist at Pure Microbiology, Annie Lambert, clinical program manager at Simplify Plus, and my cohost, Melanie Horn, system sterile compounding coordinator at Sutter Health.

我们将讨论自2023年11月1日USP 800标准及USP 797修订版正式实施以来，业内无菌配药专家最常被问及的核心问题。

We'll discuss the top sterile compounding questions our sterile compounding experts working within industry have received since USP 800 and revisions to USP seven ninety seven became official on 11/01/2023.

欢迎各位，感谢今天参与我们的节目。

Welcome, and thanks for joining us today.

非常感谢邀请我们，莎拉。

Thanks so much for having us, Sarah.

是的。

Yes.

谢谢。

Thank you.

能参与节目我们非常激动。

We're thrilled to be here.

谢谢你，莎拉。

Thank you, Sarah.

太棒了。

Awesome.

我已经迫不及待要开始了。

I'm excited to get this started.

那么我们就从第一个问题开始。

So we'll start off with our first question.

这与即时配制有关。

It's related to immediate use compounding.

这适用于哪些场景？

Where does that apply?

它是否指代像手术室这样的操作区域？

And does it refer to procedural areas like the OR?

是的。

Yeah.

关于即时配制这个话题确实频繁出现，因为大家都在试图更深入地理解更新后的要求。

This this topic of immediate use is definitely, coming up a lot, as folks are trying to figure out a little bit more, about the updated requirements.

我认为讨论即时配制的良好起点是——什么是药物配制？

And I think a good place to start, for immediate use compounding is, you know, what is compounding?

因此需要先理解配制的定义，然后在您的机构中观察哪些地方存在这类操作。

And so thinking about the definition of compounding and then kind of looking in your facility to see where that is happening.

所以在手术室中，这绝对适用，其他操作区域也是。

So, in the OR, it definitely could apply or other procedural areas.

比如将药物抽入注射器以备手术或操作需要，或是在静脉输液袋或注射器内混合不同成分。

Thinking about medication being drawn up into a syringe, in anticipation of need for a case or a procedure coming up, or combining, different components, either in an IV bag or within the syringe itself.

具体说到手术室，这可能让一些人感到压力，因为他们未曾接触过手术室，或是那里的医护人员对工作用具有诸多特定偏好。

So, specifically thinking about the OR, I think that that might be intimidating for some folks because, they haven't been in the OR before or those, providers can be, have a lot of different preferences of things that they wanna work with.

这里有几个建议：首先要明确实际发生配制的时机。

So a couple of tips there are think about, you know, when is it actually happening.

如果它是在给药前即刻进行的，那可能就不符合配制药物的定义。

If it's happening sort of immediately before administration, then that may not fit the definition of compounding.

实际上更多考虑的是，如果他们是在为预期的手术做准备时使用它。

Really thinking more about, well, if it's being used if they're preparing things in anticipation of that procedure.

如果药物需要放置一段时间，那你肯定要考虑那些配制定义和标准。

If gonna it's be sitting around a little bit, then you definitely wanna consider some of those, compounding definitions and standards.

还有其他方法可以规避这个问题，比如考虑是否有503b外包产品能帮助减少配制需求，或是在那些手术区域内直接操作。

There are other ways that you can also kinda get around that by thinking about are there five zero three b outsourced, products that could help, minimize the need for compounding or that manipulation right within those procedural areas.

这些选择当然也各有优缺点。

There's certainly pros and cons to to those options as well.

更宏观来看，在新的USP797章节中，对即时使用配制药物的程序要求更加严格，无论发生在哪里。

Bigger picture here is that in the new USP seven nine seven chapter, there's there are a lot more requirements around having more of a a program around immediate use compounding, wherever that may be occurring.

因此，这需要制定相应政策，对执行即时使用配制的所有员工进行培训和能力评估。

So that, does require having policies in place, training, and competency for any staff who are performing immediate use compounding.

我认为这才是真正棘手的地方——这涉及到很多人，比如急诊科或手术区的药剂师、护理人员、医疗人员等等。

And I think that's where it really kinda feels like it's opening up a big can of worms and who could that include, whether that's, you know, pharmacists in the emergency department or procedural areas, nursing staff, provider staff, lots of other folks.

还需要将视野扩展到住院区域之外的流动医疗区域。

And then also looking beyond those inpatient areas to even those ambulatory areas too.

最后我想补充的是，不要过分纠结'这到底算不算配制'的问题。

Last thing that I want to add here is don't get too hung up on the kind of is it compounding question.

请记住，任何药物准备过程都应遵循无菌技术、良好手部卫生和用药安全规范。

Remember that anywhere medications are prepared really should be done with aseptic technique, good hand hygiene, and medication safety practices.

所以，过分纠结具体操作细节，反而可能妨碍整体用药安全规范的执行。

So, kind of splitting hairs about what you're doing, may get in the way of just overall good medication safety practices.

请记住这一点。

So keep that in mind.

太棒了。

Awesome.

感谢分享这些实用技巧，特别是针对我们围手术期专家和其他您提到的那些工作流程可能略有不同的特殊领域。

Thank you for sharing those helpful tips and tricks, especially for our perioperative experts and other more unique special areas that you talked about where the workflows might be a little bit different.

接下来是另一个常见问题。

On to the next common question.

那么初级工程控制区内的消毒剂是否需要无菌，以及你们将它们存放在哪里？

So do disinfecting agents for inside the primary engineering control have to be sterile, and where do you store them?

是的。

Yeah.

这是另一个重大变化。

This is another big change.

我们都习惯了清洁我们的通风柜和PEC，但现在的要求是任何进入PEC内部的物品——无论是清洁剂还是清洁产品——都必须是无菌的。

We're all used to cleaning our our hoods and our PECs, but now the requirement is that those products anything that goes inside of the PEC really needs to be sterile, whether that's a cleaning agent, a cleaning product.

当然，我们还有可重复使用的清洁工具，这些也需要进行清洁。

Certainly, we have reusable cleaning tools that also need to be cleaned.

因此要求是任何清洁剂、消毒剂或那些forest idle制剂也都需要是无菌的。

So the requirement is that any cleaning, disinfecting, or those forest idle agents also, need to be sterile.

即使你不使用即用型配方，如果你要稀释这些制剂，也需要使用无菌水来稀释。

And even if you're not using ready to use formulations, if you're diluting those out, then you also need to use sterile water to, dilute those agents.

再回到为什么，为什么这很重要？

Kind of getting back to why, again, why is this important?

PEC（初级密闭空间）实际上就是，你知道的，直接配药区域，那是离我们配制CSPs（无菌复合制剂）的主环境最近的位置。

Well, the PEC, that's really the, you know, the direct compounding area is that closest the closest spot, the part of the main environment where we are preparing those CSPs.

我们希望能尽可能保持该区域的清洁。

And we wanna keep that as clean as possible.

因此我们使用无菌手套，定期消毒，现在使用无菌清洁剂，这进一步降低了额外不必要生物负荷进入该区域的风险。

And so we use sterile gloves, we disinfect regularly, and now using sterile cleaning agents, it's further reducing the risk of additional, unnecessary bioburden coming into that area.

其他一些工作流程问题可能大家会遇到，比如如何保持这个产品无菌、这个清洁剂无菌，以及你知道的，该存放在哪里？

So some other workflow things that are probably coming up for folks are, you know, how how do I keep this this product sterile, this cleaning agent sterile, and how you know, where do I store it?

有些层流工作台确实非常小。

There's there's some of these hoods are really small.

里面没有太多可用空间。

There's not a lot of real estate in there.

所以想澄清几个相关问题。

And so just wanna clarify a couple of those questions.

所有无菌剂必须在PEC内的ISO5级空间开封，当然要确保放入前已消毒——虽然这似乎无需强调——但确实需要在无菌ISO5区域开封清洁剂，然后根据制造商规范标注有效期或使用期限。

Once you you so all the, sterile agent needs to be opened within the ISO five space inside the PEC and make sure, of course, you're disinfecting it before you put it in there, which seems like you shouldn't need to say it, but disinfecting a cleaning agent before you put it in, opening it in the sterile ISO five area, and then putting on an expiration date or beyond use date per your manufacturer specifications.

厂商应为此提供相关参考说明。

They should be providing some references for that.

开封后，你可以选择将其保留在PEC内部。

And then once it's opened, you can either keep it there inside the PEC.

但我说过如果空间不足，可以密封后移回ISO7级空间。

But I said if you're you're running out of room, then you can seal it up and then bring it back out into the ISO seven space.

但要确保在ISO7和ISO5区域间转移时，每次都进行表面消毒。

But make sure, again, that you when you're moving it back and forth between, your ISO seven and your ISO five, that you're always beacon disinfecting it.

艾比，你在这方面还有什么想法或问题吗？

Abby, do you have any other thoughts or, you know, questions that are coming up for you, in this area?

是的，安妮。

Yeah, Annie.

这是我最近进行的最有趣的对话之一。

This has been one of the really interesting conversations that I've been having lately.

而且参观了几处地点后，看到主工程控制区存放着多瓶清洁剂，这有点令人担忧。

And having visited a few locations and seeing multiple bottles of cleaning agents being stored in a primary engineering control is a little bit concerning.

我知道这里的核心思想是保持或希望保持这些试剂的灭菌状态，但我们也要记住，把所有瓶子都放在里面会影响主工程控制区的气流，最终可能影响直接配制区域的气流。

So I know the whole idea here is to maintain or hoping to maintain the sterility of those agents, but we have to remember too that by keeping all of those bottles in there, that's gonna affect the airflow of the primary engineering control and could ultimately end up affecting the airflow within the direct compounding area.

因此，如果你打算将试剂存放在里面（其实没必要，它们可以存放在ISO五级区外），关键是要确保进行动态气流烟雾测试，以证明这些瓶子不会干扰PEC内部的气流。

So it is critical that if you are going to store the agents in there, which you don't have to, they can can be stored outside of the ISO five, that you make sure that you're doing a dynamic airflow smoke pattern test with your certifier to show that those bottles are not gonna interfere with the airflow within that PEC.

这确实是我目前看到的最大问题之一，不仅是试剂瓶，还有悬挂的无菌擦拭巾袋。

So that's really one of the the biggest concerns that I've kind of seen so far of just bottles of agents and then also hanging of bags of sterile wipers.

不是那种预设的可重复密封的，就是其他干燥的无菌擦拭巾袋也挂在那里。

Like, not the, like, preset resealable ones, but the other just dry sterile wipers, bags hanging in there too.

我们想尽量保持这些东西的无菌状态，但也不能让主工程控制区超载，导致没有工作空间。

So all of those things we wanna try to to maintain the sterility, but we also can't overload our primary engineering controls and not have a space to work.

说得好，艾比。

Great points, Abby.

感谢分享这个观点。

Thanks for for sharing that perspective.

我现在脑海里浮现出这些工作台——随着我们不断增加静脉输液工作系统、无菌清洁剂等设备，直接配制区域变得越来越小。

I'm just picturing these hoods that are getting the the direct compounding area is getting smaller and smaller and smaller as we're adding IV workflow systems and, sterile cleaning agents and all these things.

所以我们也要把复合区域考虑进去。

So we gotta keep keep that compounding area in mind too.

好的。

Alright.

嗯，那真是一场很棒的讨论。

Well, that was a great discussion.

我非常感谢大家直接分享关于PEC的见解。

I really appreciated all of that insight directly about the PEC.

接下来进入下一个议题，我们来讨论能力和培训要求。

And so moving on into our next topic, let's think about competency and training requirements.

如果某家机构的药剂师通过静脉工作流技术远程检查他们配制的无菌制剂呢？

What if an institution has pharmacists who check their compounded sterile preparation remotely via an IV workflow technology?

这些药剂师需要什么样的培训和能力？

What training and competency is required for those pharmacists?

是的。

Yeah.

谢谢，梅兰妮。

Thanks, Melanie.

我知道，现在还有很多很多人正在努力实施这些静脉工作流技术，或者研究如何用这些技术优化工作流程。

And I know, many many folks are working to still implement these, IV workflow technologies or figuring out how how they're gonna optimize their workflow with that.

我认为这个问题的简单答案是——按照你们的SOP来执行。

And I think the simple answer for this this question is it's it's per your SOPs.

章节里就是这么规定的。

That's what the chapter says.

我是说，这非常明确地说明了你是积极参与配制工作还是负责监督配制工作。

I mean, it's very clear about if you're actively compounding or you're overseeing, compounding.

但那些主要通过静脉输液工作流程技术系统进行最终验证检查的人员，无论是视频验证还是照片验证等方式，这些团队成员可能拥有所谓的直接监督权，也可能实际上并不参与配制工作。

But folks that are doing more of that sort of final verification check through an IV workflow technology system, whether that's video verification or, you know, photos, things like that, these team members may or may not have that kind of quote, unquote direct oversight of or, you know, actually be performing compounding.

因此我认为这个问题不断被提出，是因为人们正在思考谁需要达到本章节所描述的培训和能力水平，包括手套指尖测试等要求。

And so this question, I think, keeps coming up because people are trying to think about who needs the the level of of training and competency as it is described in the chapter and including, you know, gloved fingertip tests and things like that.

所以更详细的回答是，需要持续梳理每个人的职责分工，并切实审视这些岗位职责。

So the the longer answer, I think, is kind of, again, keep working through who's doing what and really look at those those job duties.

本章节另一个要求是，你们的培训与能力计划必须确保员工具备完成工作所需的知识和技能。

And that's the other thing that the chapter requires is that that that your training and competency program must equip staff with the knowledge and skills they need to do their job.

如果药剂师要执行这些流程中的检查工作，比如最终验证环节，他们如何知晓具体要求？

And if pharmacists are performing those in process checks with, you know, with final verification, how do they know what's expected of them?

你们如何确保他们始终如一地完成任务？

How do you know that they're completing their tasks consistently?

在实施该系统时，是否进行过培训确认或该流程的能力文件记录？

When you implemented the system, did you have a a kind of a training sign off or competency documentation of that process?

因此我认为这是思考他们如何真正了解自己在做什么，以及是否正确执行的方法。

And so I think that's, you know, a way to think about, you know, how do they really know what what they're doing and that they're they're doing it correctly.

我们还需要考虑人员配置模式的问题，因为在理想状态下，药剂师可能通过分散的工作地点甚至居家远程技术来检查最终产品。

I think we also have to think about staffing model considerations here, just because, you know, in a perfect world that their pharmacists are, you know, maybe checking final products from, you know, decentralized locations or maybe even from home, in the remote technology that we have now.

我们都知道理想状态难以持久，总会遇到周末、节假日、天气问题等突发状况——这些药剂师是否会被要求进入静脉输液室，或对配药人员实施更直接的监督？

We all know that that the perfect world doesn't last very long and that there, are, you know, weekends, holidays, weather related issues, will those pharmacists ever be required to enter the IV room, or have more direct oversight of compounders?

如果确实需要，那么你们必须考虑最坏情况，确保他们已通过完整的培训和能力认证，能够规范穿戴防护装备并执行任务。

And, you know, if they do, then you really need to think about that worst case scenario and making sure that they have their competencies and training in order, to be able to gown up, glove up, you know, go in and

以及进行一些复合制剂的操作。

and do, some compounding.

或者，与我们最初关于即时使用复合制剂的问题相关，他们是否也会在不同环境下执行部分这类操作？

Or, kind of relating to our first question about that immediate use compounding, will they be performing some of those things in a different setting as well?

所以这里并没有一个简单明了的答案。

So the there's not a a cut and dry short and sweet answer here.

我认为关键在于培训和能力。

I think it's this the the training and competency.

这就是为什么我们必须认真考虑你们机构的具体情况以及组织内部的实际运作。

That's why we really have to think about your facility and what things what happens at your organization.

我知道，梅兰妮，你对这个问题也有些其他想法。

I know, Melanie, you've had some other thoughts on this too.

你还有什么问题吗？

Questions coming up for you.

你遇到过哪些情况？

What what have you come across?

是的。

Yeah.

完全正确。

Absolutely.

我知道在我们机构里，我们尝试研究如何解决这个问题，最终确定由专人进行CSP的目视检查。

I know in our organization, we have tried to look at how we can tackle this to really have an end final check-in who can visually inspect the CSP.

采用那些静脉工作流技术是否足够，让我们的技术人员参与最终CSP检查，核对其所有特性——这些通常由药剂师在最终验证时完成的工作。

Is using those IV workflow technologies going to be sufficient enough in adopting, having our technicians play roles in looking at the final CSP, inspecting it for, you know, all of those characteristics that, you know, pharmacists are usually doing in a final verification.

是否有可能让整个团队都参与最终检查？

Is there ever a possibility to have the whole team be part of that final check?

要让我们的技术人员能够结合我们实施的技术来执行这些任务，需要什么条件？

What does that take to have our technician able to perform those tasks in conjunction with the technology that we implement.

正如你所说，它对具体要求的规定并不严格，但关键在于我们如何安全地实施，并采用优质技术，确保向患者提供的CSPs始终保持最高标准。

So like you said, it's not very prescriptive in what the requirements are, but it's really a matter of how do we do this safely and implement good technologies to keep everyone with the highest level of CSPs being released to our patients.

我认为你提到的这些观点非常到位。

So I think really good points you touched on there.

确实如此。

Definitely.

我知道我们州甚至在考虑技术人员和药剂师之间的执业范围问题。

I know our I know our state is considering that in even in terms of scope of practice between technicians and pharmacists.

因此随着技术进步，我们希望我们的实践和规则也能同步发展。

And so as as the technology advances, we hope that our our practices and our rules will advance as well.

所以我们也需要逐州关注这方面的动态。

So we'll have to keep an eye on that state by state also.

确实。

Definitely.

确实。

Definitely.

是的。

Yes.

接下来我们要讨论的热点话题是：机构如何决定是否应该使用真菌琼脂作为采样的一部分，而不是普通的TSA型琼脂平板。

And so in our next topic, one of the things that we wanna know about that's been a hot topic is how does an organization determine if they should use fungal agar as a part of sampling rather than a general TSA type agar plate.

无菌配药人员在选择培养基时应关注哪些特性？

What are some of the characteristics that sterile compounders should look for in their media?

是的。

Yep.

我是说，梅兰妮，这个话题似乎永远讨论不完。

I mean, Melanie, this has been kind of a never ending topic of discussion.

通常当我去不同机构工作时，发现那些使用真菌培养基的人其实并不清楚使用原因，只是被告知要这么做，或是实验室建议的。

And, usually, when I go in and work with different locations, those that have or are using the fungal media don't really know why they're using it other than, well, this is what we were kind of told to do, or this is what our lab recommended.

因此每个机构是否使用真菌培养基都应基于风险评估来决定，这非常重要。

So it's really important for each organization to base whether or not they're gonna use that fungal media on risk.

我们需要先看看你们配制的药品类别。

So we wanna take a look at what categories are you compounding.

是只做一、二类药品并严格遵守章节规定的使用期限，还是进行三类药品配制从而承担更高风险？

Are you gonna be just doing category one and two, and you're sticking by the chapter with the beyond use states where we're not, like, pushing for anything longer, or you're doing category three compounding and you have a little bit of a higher risk?

设施设计在这里可能很关键。

Facility design could be important here.

我们是否存在微生物污染侵入的问题？

Do we struggle with, ingress and microbial contamination problems?

我们是否真正实现了良好的整体微生物控制状态？

And just do we have really a good overall microbial state of control?

因为如果回顾历史数据发现确实存在真菌检出率偏高或微生物侵入问题，那么添加真菌培养基可能就是合理的。

Because if we take a look at past trends and realize that we do struggle with fungal recovery or overall just other microbial ingress challenges, maybe it makes sense to add it.

所以我强烈建议：如果你们正在使用真菌培养基却不清楚原因，请回头仔细分析你们的数据。

So I would strongly recommend that if you're currently using fungal media but don't really know why, go back and look at your data.

你是否经历过大量真菌恢复的情况？

And have you had a lot of fungal recovery?

你能否识别出一年中特定时期的这种恢复现象？

Are you able to identify that recovery during certain times of the year?

也许如果这种情况确实只发生在春秋季，你可能不需要全年使用，但在这些具有挑战性的季节里添加使用。

And maybe if it just really happens in the spring and the fall, maybe you don't really use it all year long, but you add it in those times of year that are a challenge.

或者我们是否进行了新建工程，正试图了解设施内空间中正常的微生物群落构成。

Or have we had new construction, and we're trying to learn what our facility has as its normal microorganisms in the space.

因此在新建设施刚完工并启动时，同时使用TSA培养基和真菌培养基一段时间可能更有益，以便从微生物角度更好地理解你所恢复的内容。

So right after new construction and kind of starting up a new facility, it might be beneficial to both use the TSA and the fungal media for a period of time to better understand sort of what you're recovering from a a microbial standpoint.

这就是我们关于何时使用真菌培养基的基本思路。

So that's kinda where we we go from, like, when to use fungal media.

但我仍然经常被问到：在选择培养基时应该关注什么？

But I get a lot of questions still too about just, like, what do I look for in media that we're going to use?

最关键的一点是选择经过终端灭菌的产品。

And one of the biggest things is to look for something that's terminally sterilized.

这听起来可能有点傻——你会觉得所有培养基不都应该是灭菌或无菌的吗？

And it might seem, don't know, kind of silly where you're like, well, I thought all media was sterilized or sterile.

它确实应该是无菌的。

And it should be sterile.

有些培养基是通过无菌灌装的，但有些则是经过终端灭菌处理的。

Some of it's aseptically filled but some of it will also be terminally sterilized.

因此从终端灭菌产品开始使用，能确保我们初始使用的培养基就是无菌的。

So for starting with a terminally sterilized product, it just makes us sure that we are starting with sterile media.

此外，那些终端灭菌的培养基通常采用双层或三层包装，这使得将其转移至洁净室变得容易得多，因为没人愿意为了把东西送进去而反复擦拭。

Also, along with that terminally sterilized media, it's usually double or triple wrapped, which makes it way easier to transfer into the clean room because nobody likes having to wipe something down multiple times to get it into the space.

这很不错。

This is nice.

你只需脱去一层包装就能转移它。

You can just shed a layer and transfer it.

我们有时也会采用室温储存，这样能稍微延长保质期，而且你也不用寻找冰箱空间。

We sometimes then too will have room temperature storage, which will extend the expiration date a little bit, plus then you're not looking for refrigerator space.

最后一种组件是查看制造商提供的分析证书，你可以从制造商官网获取。

And then the last kind of component is just taking a look at the certificate of analysis from the manufacturer, and you can get that from the manufacturer's website.

关于培养基我要提醒一句——虽然是开玩笑但也不全是——只要我愿意，明天就能在车库里开个培养基生产作坊。

One word of caution that I always give when we talk about media, and I say this jokingly, but not always, is that I could start a media manufacturing business in my garage tomorrow if I would like to.

因此我强烈建议大家都仔细看看是谁在生产你们的培养基，以及他们供货给谁。

So I really strongly urge everybody to take a a good look at who's producing your media and who do they supply.

如果他们通常为无菌生产供货，那很可能这是个值得选用的优质培养基制造商。

If they normally supply aseptic manufacturing, it's probably a good bet that that's a a good manufacturer of media to use.

听起来根据不同区域和正在进行的复合类型存在很多差异，正如我们所知，这需要我们的领导者在这些现场进行审查和分析。

Sounds like there's lots of variation depending on the areas and types of compounding that's occurring, which, as we know, requires some review and analysis that are at these sites by our leaders.

那么进入下一个常见问题。

So onto the next frequently asked question.

表面取样在何时以及如何进行？

When and how are surface samples collected?

好的。

Alright.

关于表面样本，USP797确实要求首先进行采集，之后对一类和二类CSPs每月采样，三类CSPs则每周采样。

So with surface samples, USP seven ninety seven, does require that they are gonna be collected initially, and then, we're doing monthly surface sampling for category one and two CSPs, and then weekly surface sampling for category three CSPs.

我们可以在USP797第六章找到所有需要的信息。

So we find all of the information that we need for this in section six of USP seven ninety seven.

另外需要牢记的是，表面采样应在配制活动或班次结束时进行，但需在该区域清洁消毒之前完成。

And the other thing that we have to keep in mind is that surface sampling really should be performed at the end of a compounding activity or a shift, but before that area is cleaned and disinfected.

现在我们还必须将表面采样作为培养基灌装测试的一部分。

We also have to now collect surface samples as part of the media fill test.

因此关键是要将这项内容纳入你的能力评估体系。

So it's critical that you have that included in part of your competency, assessment as well.

关于表面采样最后要强调的是，我在实地发现有些地方先擦拭表面再采样，而正确流程应是采样后再擦拭以去除残留物。

The last thing to mention just with the surface samples is that in the field, I'm running across locations that are wiping the surface first and then collecting the sample, when we're supposed to be wiping the surface afterward to remove any sort of residue.

如果想评估清洁效果，可以制定特殊采样方案：清洁后采集一批表面样本，以此测试清洁效果。

So if you're going to want to sort of assess your ability to clean, you can create kind of a different sampling plan where after cleaning, you can go in and collect a bunch of surface samples, and then test sort of cleaning efficacy.

但我们必须确保采样前不擦拭表面，否则就完全违背了采样的初衷。

But we wanna make sure that we're not wiping that surface first before we collect the sample because that totally defeats the purpose of the sample collection.

艾比，这样梳理时间线确实很有帮助，特别是考虑到我们部门需要与任务驱动型团队协作以确保符合所有要求。

Breaking down the timeline there, Abby, is definitely very helpful, especially when thinking about the task driven teams that our departments, you know, have to work with to ensure compliance with all of these requirements.

是的。

Yeah.

莎拉，对很多机构来说，光是实施月度采样就已经是个巨大挑战，这导致——虽然有点跑题——很多地方购置培养箱，现在准备自己进行样本培养分析，都是因为这个新要求。

And, Sarah, it's been a huge challenge, I think, for a lot of places to implement even the monthly sampling, and that has then, I think, resulted to and not really part of the topic, but a lot of places are getting incubators and now looking to do their own incubation and analysis of these samples because of of this new requirement.

你们机构是否也面临这样的挑战呢？

So, I mean, are you seeing that as a challenge in your organization?

是的。

Yes.

我们确实不得不在工作流程和程序上做出一些调整，以确保合规性，同时培养新技能并培训员工，使他们掌握正确的培训内容，理解这些要求以及如何利用自有设备，当然在条件允许时也会选择外包。

We have definitely had, had to flex a little bit in our workflows and processes to make sure that we are compliant and acquiring new skills and training people to make sure that they have the correct, training to make sure that they are understanding what these requirements are and how we can utilize our own equipment, but then also outsource when able for sure.

好的。

Alright.

我们接下来的问题是：无菌区域负责人应当关注哪些构成优质实验室报告的要素？

The next question we have here is what components should our sterile area leaders be looking for that makes up a good lab report?

没错。

Yes.

因为这也是个有趣的问题，它确实与我们刚才讨论的表面采样有些关联——某些地点选择内部完成这类分析，而你们可能每六个月就将活性空气采集样本外包给认证机构检测。

Because this is also an interesting question, and it does kinda tie into what we just talked about with the surface sampling and, some locations keeping that in house to do that analysis versus you're likely going to outsource maybe your viable air collection every six months or every six months sampling to your certifier.

那么在这些文件中应该看到哪些内容？

So what should you see in those documents?

但也要将我即将分享的部分信息应用到内部操作时应当记录的内容中。

But also kind of applying some of the information that I'm gonna share just to what you should be capturing even if you're doing all of this internally.

我们确实有一份文件。

So we do have a document.

它来自CEDA（受控环境测试协会）。

It's from CEDA, which is the Controlled Environment Testing Association.

也就是cagoo九号文件。

So that's c a g, o o nine.

CDA代表应用指南，其全称为《无菌配药设施活性环境监测指南》。

It stands for CDA application guide, and that's titled viable environmental monitoring for sterile compounding facilities.

这份文件列出了所有应包含在样本采集过程和报告中的内容。

And this document has kind of a list of everything that should be part of the sample collection story and reporting.

所以当你查看报告时，你需要关注诸如：是否标注了使用的培养基、批次号、有效期，以及采样原因等信息。

So when you are taking a look at your report, I mean, you wanna look for things like, you know, do you have an indication on there of the media that was used, the lot numbers, the expiration dates, Why the sampling was done?

在报告中包含这些内容是个好主意，因为如果有检查员或调查员审阅报告，这些信息对他们很有帮助。

It is a good idea to include that on the report because if you have an inspector or surveyor reviewing the report, it's helpful for them to know.

这是常规监测的一部分吗？

Was this part of routine monitoring?

这是调查的一部分吗？

Was this part of an investigation?

我是说，我们应该看到行动标准。

Mean, we should see action levels.

从日期角度你会注意到几个要点，这些都是需要你去仔细查看的。

Couple of things that you'll notice from a date perspective, and these are things that you wanna go and, like, take a look at.

样本是什么时候采集的？

When were the samples collected?

它们是什么时候送到实验室开始检测的？

When did they get put on test at the lab?

又是什么时候完成分析的？

And when did they finish up analysis?

这很有意思，因为你可以通过这些日期了解整个流程应该需要多长时间，进而提出疑问：比如这些样本在9号采集，但直到13号才在实验室开始培养。

And it's kinda cool because you can take a look at those dates knowing what that turnaround time should kind of be and kind of be able to question, like, well, these were sampled, you know, on the ninth, but they didn't start incubation at the lab until the thirteenth.

发生了什么情况？

What happened?

所以我们确实应该在报告上看到那些日期。

So we really should be seeing those, dates on the report.

然后，显然你要确保所有结果都清晰列出，并且标注了正确的单位。

And then, obviously, you wanna make sure that you have all of the, results very clearly, listed out and have the right, units applied to them.

对于空气样本，我们应该看到每立方米空气中的菌落形成单位（CFU）。

So for your air samples, we should see colony forming units or CFU per cubic meter of air.

至于表面样本，可能会以每台设备或每个平板的单位列出。

And for surface, it's probably gonna be listed as, like, per device or per plate.

我还要提到的另一个重点是微生物的鉴定，要确保你们实际获得了属水平的鉴定结果。

The one other big one that I will kind of mention too is just the identifications of the microorganisms and being sure that you're actually getting a genus level identification.

最近我遇到过不少实验室报告，遗憾的是无菌配药人员只做了革兰氏染色，而没有进行完整的鉴定。

I've run across a number of lab reports recently where, unfortunately, the sterile compounders are only getting Gram stains and not actually getting a a full identification.

所以这些实验室报告其实可以包含更多内容。

So there's a lot that could be included on those lab reports.

这些都是你们需要重点关注的事项要点。

Those are some of the highlights of things that, you know, you definitely wanna be looking for.

是的。

Yeah.

我觉得这真的很有帮助，相当于给我们列了个检查清单。

I mean, I think that's really helpful, to kinda give us some checklist things to go through.

就像我们很多人花了不少时间才理解认证报告内容一样，我觉得实验室报告也是需要更深入理解的层面，我们获得了更多信息，因此需要知道该关注什么。

And, you know, as as many of us took took a while to kinda understand what was in our certification reports, I think the the lab report's really kinda that next level too of, there's we're getting just a lot more information, and so we need to know what to look for.

感谢你提供了这么全面的背景说明。

So thanks for providing providing all that context.

是的。

Yeah.

绝对如此。

Absolutely.

因为你提到了认证报告。

Because the you mentioned the certification reports.

这些报告本身就够难读的了，因为它们各不相同。

Those are challenging enough to read as it is because they're all different.

取决于你查看的是哪家公司的报告，它们看起来完全不同。

Depending on, you know, the report that you're looking at from one company, it looks totally different from another.

实验室报告也是同样的状况。

The lab reports are the exact same way.

有些报告包含你需要的信息。

And some have the information that you need.

有些报告则缺少信息。

Some have missing information.

有些报告包含大量你并不真正需要的额外信息，而且有时这些信息并不总是正确的。

Some have a lot of extra information that you really don't necessarily need, and sometimes it's not always correct.

所以我仍然建议你花时间仔细阅读这些报告。

So still would recommend that you take your time, take a look through those.

如果你有任何疑问，可以联系合同实验室，请他们澄清你在报告中看到的内容。

And if you have any questions, reach out and ask the the contract lab to clarify, what you're seeing on that report.

好的。

Yeah.

说得好。

Excellent point.

确实，考虑到所有变化因素和我们一直以来的疑问，大家认为无菌配药领域未来一年究竟会面临怎样的局面？

And really, in all of the things that have changed and kind of looking through everything that we have kind of had questions around, what do you all think is the what does the next year of sterile compounding really hold for us?

我们的发展方向在哪里？

Where are we going?

让我摇摇我的魔法八号球，看看能不能预测出什么。

Well, let me shake my magic eight ball and see if I can come up with something here.

我想这正是我们所有人都在思考的问题，也是我们需要持续探讨的原因。

I think that's what we're all wondering, and I think why we need to keep talking about it too.

如果要我预测的话，我认为接下来会是不断验证调整的一年——制定计划、执行、验证、调整。

So, you know, I guess my prediction, if you will, is that, I I really see a year of kind of check and adjust or plan, do you check and adjust?

我们都已经制定了计划来符合USP新规。

We've we've all made plans, to to comply with the USP updates.

多数机构已完成实施，但各州在执法力度和截止日期上仍存在差异。

Most sites have implemented, but we know that there's still some variation across the states and in terms of enforcement and deadlines and timelines there.

可以肯定的是，联合委员会、ACHC和PCAP等认证机构一定会严格审查。

We definitely know that the accreditation bodies like Joint Commission and ACHC and PCAP, they will definitely be looking.

然后我们需要观察之前制定的计划能否真正通过监管检查和认证评估。

But then we need to really see how we've we've you know, those plans that we've made really shape up against those regulatory inspections and those accreditation surveys.

我希望随着检查工作的展开，我们能共享经验教训，推动整个行业持续进步。

And so I I hope that as we start to get into this inspection mode, that we can also share those lessons learned so that we can, you know, as an industry, continue to improve.

在我看来，符合USP标准是一个持续完善的过程。

And, I really see compliance with the USP standards as a journey.

这其实并不是一个终点，我们虽然会到达那里，看似成功了，但我们仍需持续改进、检查和调整。

It's it's not really a a destination that we're we're gonna get there and, like, we finally made it, but we're always gonna be continuing to improve, to check and adjust.

当然，我们需要制定年度审查的要求以及类似事项的频率。

Certainly, have requirements for annual reviews and and frequencies of things like that.

但我想我们只能先观望，看看情况如何发展，然后再进行讨论。

But I I think we're just gonna have to wait and see, see what happens, and then talk about it too.

所以我认为这就是我们的方向。

So that's where I think we're heading.

艾比，你怎么看？

Abby, how about you?

我同意这个观点。

I mean, I I agree.

监管环境将在很大程度上影响我们未来一年看到的变化。

The regulatory landscape is gonna drive a lot of what we see in in the next year.

而且，我认为你提到的'调整安妮'可能是每个人都需要应对的最重要一点——一旦各州最终明确告诉我们具体执行标准，我们就会看到执法上的灵活性，这将是一个持续的调整过程。

And, I think your mention of adjust Annie is probably one of the the most important points that everybody's gonna have to sort of manage is that once we do finally get some of the states to let us know exactly how things are gonna be enforced, then we see some enforcement discretion, and it's gonna just continuously be that that adjustment.

具体来说，我认为重点会集中在微观层面——特别是活体样本采集、表面采样和平板计数这些环节。

Specifically, as far as where I think there's gonna be a lot of focus, and not to kind of be biased, but I think it's gonna be the micro stuff, specifically with the the viable sample collection, the surface sampling, and the reading of the plates.

那么把这些工作内部化处理，你们有培养箱吗？

So taking that in house and do you have incubators?

你们是否具备可以称为实验室空间的场所？

Do you have really what would kind of be a lab space?

你们是否接受过菌落计数方面的培训和能力评估？

Do you have training and competency on how to count colonies?

我认为会有很多值得关注的地方，因为我们正从药剂师和技术人员更多承担复合制剂角色，逐渐扩展到微生物领域。

I think there's gonna be a lot of look at that because we're really going from pharmacists and technicians doing more of that compounding role to branching over more and more into to micro.

我知道长期以来你一直在阅读金手指和培养基灌装测试，但我要告诉你，读取一个带有50个CFU的接触平板，与读取一个只有2个CFU的发光手指测试是完全不同的。

And I know for a long time you've been reading gold fingertip and media fill tests, but I'll tell you what, reading a contact plate with 50 CFU on it is not the same as reading a glow fingertip test with two CFU.

因此我认为我们都需要做好准备，接受对这些方面更频繁的监管审查，包括无菌和内毒素检测等项目。

So I think we all need to be prepared for a lot more regular regulatory scrutiny on those aspects of things and also along even with things like sterility and endotoxin testing.

抱歉。

Excuse me.

因为即使在微生物领域，我们也面临许多与这些技术相关的变化，而这些方法的验证确实将成为重点关注对象。

Because we have a lot of changes just in the micro world related to those technologies, and validation of those types of methods are are are really gonna be something that are gonna be looked at.

是的。

Yeah.

都是非常精辟的观点，确实展现了一个改进、学习和调整的前景。

All excellent points and really kind of a a horizon of, you know, improvement and learning and making adjustments.

我非常感谢大家进行的这场精彩讨论。

I really appreciate what a great discussion we've all had.

我要感谢艾比·罗斯、安妮·兰伯特以及我的共同主持人莎拉·韦瑟今天加入我们，讨论关于零配方的十大最常见问题。

I want to thank Abby Ross, Annie Lambert, and my cohost, Sarah Weiser, for joining us today to discuss the top most frequently asked zero compounding questions.

如果你还没看过，我建议你查看ASHP的在线资源，包括ASHP复合资源中心。

If you haven't before, I encourage you to check out ASHP's online resources, including the ASHP Compounding Resource Center.

你可以找到会员专享资源，如指南、最佳实践、实施检查清单以及关于热门复合主题的网络研讨会，包括USP795和797的修订内容。

You can find member exclusive offerings such as guidelines, best practices, implementation checklists, and webinars on hot compounding topics, including revisions to USP seven ninety five and seven ninety seven.

想就某些主题与ASHP会员建立联系吗？

Looking to connect with ASHP members on certain topics?

欢迎访问ASHP的Connect社区配药专区，您可以向ASHP会员提问并学习他们的个人经验。

Check out ASHP's Connect community on compounding, where you can ask fellow ASHP members questions and learn from their personal experiences.

感谢您的参与。

Thank you for joining us.

如果您喜欢本期节目，请务必订阅ASHP官方播客。

And if you enjoyed this episode, be sure to subscribe to the ASHP official podcast at ASHP official podcast.

感谢收听ASHP官方频道——推动医疗进步的药剂师之声。

Thank you for listening to ASHP official, the voice of pharmacists advancing health care.

请访问ashp.org/podcast发现更多精彩内容，查看节目笔记并下载文字稿。

Be sure to visit ashp.org/podcast to discover more great episodes, access show notes, and download the episode transcript.

若您喜欢本期节目并想收听更多，请务必订阅、评分或留下评论。

If you loved the episode and wanna hear more, be sure to subscribe, rate, or leave a review.

下期ASHP官方节目再见。

Join us next time on ASHP official.