速成课：热封机及封接机验证

First Step 第一步

A consistently reliable seal is the holy grail of a successful medical device launch and life cycle. Finding the right equipment, properly calibrated and validated, with optimal performance into the future is a major effort. It is also one of our personal favorite projects: helping clients set up and validate their in-house seal capabilities.*
一枚始终可靠的密封件是医疗设备成功上市并完成全生命周期的关键所在。找到合适的设备，确保其经过正确校准和验证，且在未来能保持最佳性能，是一项艰巨的工作。这也是我们个人最喜爱的项目之一：帮助客户建立并验证其内部密封能力。*

* If your organization has not yet implemented or planned for sealer validation in house, this will help you nail your plan. If your heat sealer station is up and running, this will help you gauge the health of your process.
* 如果贵机构尚未在内部实施或规划封口机验证工作，本内容将助力您制定完善的验证计划；如果您的热封机工位已投入运行，本内容将帮助您评估生产工艺的运行状况。

Prepare for In-house Heat Sealing 为内部热封做准备

Have a Plan. Selecting suitable equipment—and an experienced engineering partner—can go a long way to ensure a smooth validation. Knowing your existing process or understanding a future process is key.
制定计划。选择合适的设备以及经验丰富的工程合作伙伴，对于确保顺利完成验证大有裨益。了解现有流程或掌握未来流程是关键。

Be Ready. Packaging Compliance Labs performs and oversees many in-house installations and validations. A common oversight can lead to disappointment—and delays, when the equipment arrives. Ensure that proper hookups and surfaces are installed and correctly placed prior to equipment selection and delivery.
做好准备。Packaging Compliance Labs 负责并监督多项内部安装与验证工作。在设备选型和交付前，务必确保已安装合适的连接装置与安装面并摆放到位，否则设备到货时可能出现疏漏，导致不尽如人意的结果并造成延误。

Find the Right Heat Sealer 选择合适的热封机

Packaging Compliance Labs engineers often look to Pennsylvania firm, Packworld USA, for custom, compact heat sealers. “We love the technology, the quality, the reliability of the PackworldUSA products. We’ve found their products to be matched by their customer service and quick response times in delivering us the right solution for each client setting,” stated Sarah Rosenblum of PCL. “PackworldUSA and Packaging Compliance Labs share a commitment to unexpected speed without compromising quality.”
Packaging Compliance Labs 的工程师常常向宾夕法尼亚州的 Packworld USA 公司寻求定制化的紧凑型热封机。“我们十分认可 PackworldUSA 产品的技术、品质与可靠性。我们发现，他们的产品同样出色，而且客户服务和响应速度也很到位，能为我们每个客户的实际需求提供合适的解决方案，”PCL 的萨拉·罗森布鲁姆表示。“PackworldUSA 与 Packaging Compliance Labs 都秉持着在不牺牲品质的前提下实现超乎预期的高效服务这一理念。”

PackworldUSA assembles their mainstay, smaller sized sealers to a certain point of completion, where universal construction ends and customization begins. Conversations with packaging engineers and the client finalize the specifications. The partially assembled sealers are then finished based on the customized specifications for the client application and setting.
PackworldUSA 对其主营的小型封口机进行部分组装，完成到通用结构搭建完毕、个性化定制即将开始的阶段。与包装工程师及客户沟通后确定最终规格。随后，根据客户应用场景和设置的定制化规格，完成这些部分组装的封口机的最终制作。

If you are considering options for an in-house sealing station, an easy way to compare what you’re getting is to look at similarly sized equipment. A smaller PackworldUSA heat sealing machine, such as model PW3416, weighs about 100 lbs. Other heat sealers might look about the same, yet weigh half that. This can indicate less robust components. While weight alone doesn’t always signal quality, it is a factor in heat sealers. Quality can be indicated by weight and the size of the air cylinders, transformer and other operational components.
如果你正在考虑为内部密封工位挑选设备，比较产品配置的一个简便方法是参考同规格的设备。PackworldUSA 一款小型热封机（例如 PW3416 型号）重量约为100磅。其他热封机外观可能相差无几，重量却只有一半，这往往意味着其部件耐用性较差。虽然单看重量并不总能代表产品质量，但这是热封机的一个重要考量因素。设备的质量可通过重量以及气缸、变压器等运行部件的尺寸来判断。

A particularly unique—and appealing—feature of PackworldUSA sealers is their temperature control technology.
PackworldUSA 封口机有一个特别独特且极具吸引力的特点，那就是其温控技术。

Brandon Hoser of PackworldUSA explained, “Traditional thermocouple technology measures at a single point about the size of a thumbnail. If operators seal material on or off the singular point, you’ll get different results. We use technology that doesn’t rely on thermocouples. Our TOSS Technology with PIREG® temperature control has the ability to read and drive the temperature by interpreting the heat seal band itself. It acts as a large resistance temperature detector, knowing that X resistance = Y temperature, while measuring the whole length and width of the heat seal band. The benefit is a faster response, a precise result and more consistent heat seals."
PackworldUSA 公司的布兰登·霍泽解释道：“传统热电偶技术仅在一个约拇指大小的单点进行测量。如果操作人员在该单点上或偏离该单点对材料进行热封，得到的结果就会不同。我们采用的技术不依赖热电偶。我们搭载 PIREG® 温控系统的 TOSS 技术能够通过解读热封带本身来读取和调控温度。它相当于一个大型电阻温度探测器，可根据X电阻对应Y温度的原理，同时测量热封带的整个长度和宽度。其优势在于响应速度更快、测量结果更精准，且热封效果也更稳定。”

Packaging Compliance Labs finds value in the TOSS Technology. Rosenblum added, “Having confidence that equipment can quickly and sustainably establish and maintain the right conditions to produce consistent seals in sterile medical device packaging is a big deal.”
包装合规实验室发现了TOSS技术的价值。罗森布拉姆补充道：“能够确信设备能够快速且稳定地建立并维持合适的条件，从而在无菌医疗设备包装中实现稳定的密封，这是一件非常重要的事。”

Understand Calibration 了解校准

To really understand heat sealing temperatures of a machine, you need an independent NIST-calibrated device to verify what you think is happening. This is where thermocouples are needed. Hoser clarified, “While we do not need thermocouples to operate our machines, they are used as a calibration instrument.”
要真正了解一台机器的热封温度，你需要一台经过美国国家标准与技术研究院（NIST）校准的独立设备来验证实际情况。这就是热电偶的用武之地。霍泽解释道：“虽然我们操作机器并不需要热电偶，但它们被用作校准仪器。”

Thermocouple placement is important along with consistency in your process. The most accurate recording is obtained when the thermocouple junction is placed in the centerline of the heat seal band width. So if your heat seal band is 8mm wide, aim to place the junction 4mm in from the edge. The same can be said about what layer within the build up a thermocouple is placed. It could be put on the surface of PTFE tape which contacts the material or directly on the heat seal band. Whichever method, consistency is required to ensure the best results.
热电偶的布置与工艺的一致性同样重要。将热电偶接点布置在热封带宽度的中心线上时，可获得最精准的记录。因此，如果你的热封带宽度为8毫米，应将接点置于距离边缘4毫米的位置。热电偶在堆叠结构中的布置层级也遵循同样原则：可将其放置在与材料接触的聚四氟乙烯胶带表面，或直接置于热封带上。无论采用哪种方式，都需保持一致，以确保达到最佳效果。

PackworldUSA’s heat sealers get from ambient to sealing temperature within 400ms; however, thermocouples do not measure temperature this quickly. Even the quick response thermocouples take about 10 seconds to start stabilizing towards an accurate temperature reading, it is recommended running a 15-20 second dwell during temperature validation to ensure an accurate reading. A common mistake is trying to record temperature within a typical sealing time such as 2-4 seconds. Time and pressure are less tricky as there are ports on the machine which connect appropriate NIST calibrated devices.
PackworldUSA的热封机能在400毫秒内从环境温度升至密封温度，然而热电偶的测温速度无法达到这一水平。即便是响应速度最快的热电偶，也需要约10秒才能开始稳定并读出准确温度，因此建议在温度校准阶段保持15至20秒的停留时间，以确保读数准确。常见的操作误区是试图在典型的密封时间（如2至4秒）内记录温度。时间和压力的校准则相对简单，因为设备上设有接口，可连接经过美国国家标准与技术研究院（NIST）校准的相关设备。

Control the Process 控制生产流程

User-friendly PackworldUSA touch screen controls were developed through customer feedback. They are able to run in 21 CFR Part 11 compliance. The compliance capability involves user-defined security access and data logging features. Far from fluff, ease of use and convenience save time and engage technicians more productively in their work.
贴合用户需求的PackworldUSA触摸屏控制装置是根据客户反馈研发而成。该装置可满足21 CFR第11部分的合规要求，合规功能包含用户自定义的安全访问和数据记录特性。这些设计绝非华而不实，易用性和便捷性不仅能节省时间，还能让技术人员更高效地投入工作。

Aiming for foolproof operation has less to do with distrust than practical reality. All humans make mistakes. When those humans are busy, stressed or interrupted, the risk of blunders grows. Better a few alarms than a massive setback or injury.
追求万无一失的操作，与其说是出于不信任，不如说是基于现实考量。所有人都会犯错。当人们忙碌、压力大或被打断时，犯错的风险就会增加。宁可多设置一些警报，也不愿遭遇重大挫折或人员受伤。

PackworldUSA sealers, for example, use two stages of air pressure when the machine is cycled. A low pressure of 5-7 PSI actuates the bars to a nearly closed position. Then, a much higher pressure is initiated for the sealing cycle once a limit switch is met. This ensures only film thickness materials can be inserted or else an alarm is triggered. This mitigates issues when the curious technician says, “Maybe I can heat seal my pen.” For each run, set recipes that have been programmed into the machine ensure that only those authorized can make any change to the recipe. This protects all aspects of production and validation
例如，PackworldUSA 封口机在设备运行时会采用两级气压。5至7磅/平方英寸的低压先将压杆驱动至近乎闭合的位置。随后，当触达限位开关后，设备会启动更高的气压以完成封口工序。这一设计确保只有薄膜类厚度的材料才能被放入，否则设备会触发警报。这也能避免好奇的技术员说出“或许我可以用热封机封一下我的笔”这类情况引发的问题。每次运行时，设备中已预设的配方程序会确保只有授权人员才能对配方进行修改。这一机制保障了生产与验证的各个环节。

Train your Team 培训你的团队

Proper training is a must-have for anyone on your team who may interact with the seal process. Don’t skip or skimp on your investment or your production floor’s ability to produce compliant product.
对于团队中任何可能参与密封流程的人员来说，接受适当的培训是必不可少的。不要在相关投入上节省，也不要忽视生产线生产合规产品的能力。

Know your Application 了解你的应用场景

And select your heat sealer accordingly.
并据此选择热封机。

A common misconception is that getting a big sealer is a better idea. For example, logic might ask, “Why can’t I seal these 4-inch foil pouches with my 36-inch sealer? I’ll have more versatility for big or small packages!” More often than not, it takes more than that to produce consistent quality with such a size discrepancy. Talk with an engineer about a properly scaled process and whether it could be made to accommodate your scenario. If it’s possible, then the exact criteria can be set. If not, you can rule it out without wasting time or produce and identify a more suited machine for the task.
一个常见的误区是，购买大型封口机是更明智的选择。比如，从逻辑上讲可能会问：“为什么我不能用36英寸的封口机来密封这些4英寸的铝箔袋呢？这样我对大小包装都能有更多的通用性！”但实际上，要在这种尺寸差异下保证稳定的产品质量，往往远不止简单更换设备这么简单。你可以与工程师沟通，了解适配的工艺方案，以及该方案能否满足你的实际需求。如果可行，就可以确定具体的工艺标准；如果不可行，就可以直接排除该方案，避免浪费时间和产能，同时找到更适合该任务的设备。

Formalize the Process and Approach 规范流程与方法

Impulse heat-sealing technology is able to accommodate a broader selection of materials. But you’ve got to know the properties for each material and how those properties behave. Hoser explained, “If you seal a poly bag, you’ll likely experience constant heat fails. A cooling cycle is required in the process. The material must heat to its melting point. The sterile seal does not form until the molten portion solidifies. If the equipment opens prior to reaching the proper cooled temperature, the pouch or bag seal will shrivel. Not only is the seal unsuitable, it is visible. PackworldUSA impulse heat sealers incorporate a cooling cycle to mitigate operator risks such as handling the packaging before the seal is completely cooled.
脉冲热封技术能够适配更多种类的材料，但必须了解每种材料的特性及其表现。豪泽解释道：“如果对聚乙烯袋进行热封，很可能会出现恒温热封失败的情况，工艺中需要设置冷却循环。材料必须加热至熔点，熔融部分凝固后才能形成无菌密封。若设备在达到合适的冷却温度前开启， pouch 或袋子的密封处会收缩。这不仅会导致密封失效，还会留下明显痕迹。PackworldUSA 脉冲热封机配备了冷却循环功能，可降低操作人员的风险，例如在密封完全冷却前接触包装。”