ISPE 播客评论海普瑞坪山预充式注射器工厂：垂直设计与 AI 检验如何做成「灯塔项目」

图：ISPE 播客视频截屏：嘉宾 CaiXue Wei 出场，姓名条标注其职务，身后背景为坪山工厂画面（图源：MarketScale 页面视频）

制药 AI 现场观察 ｜ 主体材料：MarketScale（2026-10-22）

来源：MarketScale（ISPE 播客《Shaping the Future of Pharma》转录稿）

URL：https://www.marketscale.com/industries/sciences/hepalink-s-foya-winning-syringe-plant-inspects-24-000-units-an-hour-1269150

发布日期：2026-10-22（MarketScale Newsroom）

讲者：CaiXue Wei（海普瑞制造与运营副总裁、全球工业事务）；Bob Chew（ISPE 播客主持）

背景材料：Hepalink 新闻稿（2026-04-21、2026-10-07）；ISPE 项目综述（2026-09）

Hepalink's Pingshan prefilled syringe plant in Shenzhen won the Innovation (Novel Technology) category at ISPE's 2026 Facility of the Year Awards. In the transcript ISPE posted with its podcast, CaiXue Wei describes vertical design, AGV-assisted transfer, AI inspection and 5G-MEC as one integrated system built around a 330 million-syringe annual capacity; Hepalink's own release adds a 24-meter warehouse, sub-10 millisecond 5G and 24,000-unit-an-hour inspection.

海普瑞位于深圳的坪山预充式注射器工厂获得 ISPE 2026 年度设施奖（FOYA）「创新（新技术）」类别奖。在 ISPE 随播客发布的转录稿中，CaiXue Wei 把垂直设计、AGV 辅助转运、AI 检验与 5G-MEC 描述为围绕年产 3.3 亿支产能构建的一体化系统；海普瑞自己的新闻稿补充了 24 米仓库、低于 10 毫秒的 5G 时延与每小时 24,000 支的检验速度。

Hepalink needed to put 330 million prefilled syringes a year onto a plot of Shenzhen land that had no room to spread. In an April 21, 2026 press release, the company said the Pingshan site faced extreme land scarcity, so its engineers built the plant upward and sank a 24-meter-high automated warehouse into its core. The result won the Innovation (Novel Technology) category of the 2026 ISPE Facility of the Year Awards.

海普瑞需要在一块没有任何横向扩展余地的深圳土地上，实现每年 3.3 亿支预充式注射器的产能。公司在 2026 年 4 月 21 日的新闻稿中说，坪山基地面临极端的土地稀缺，工程师于是把工厂向上建，并将一座 24 米高的自动化立体仓库嵌入建筑核心。这一设计最终获得 2026 年 ISPE 年度设施奖（FOYA）「创新（新技术）」类别奖。

The International Society for Pharmaceutical Engineering (ISPE) announced the category winners on April 20, 2026, at its Europe Annual Conference in Copenhagen, BioProcess International reported the same day. In October 2026, CaiXue Wei, Vice President of Manufacturing and Operations, Global Industrial Affairs at Hepalink, joined host Bob Chew on ISPE's podcast, Shaping the Future of Pharma, to explain how the plant came together. That same month, in an October 7, 2026 press release from CPHI Milan, Hepalink said the project was the only Chinese winner on the 2026 roster.

据 BioProcess International 同日报道，国际制药工程学会（ISPE）于 2026 年 4 月 20 日在哥本哈根举行的欧洲年会上公布各类别获奖名单。2026 年 10 月，海普瑞制造与运营副总裁（全球工业事务）CaiXue Wei 做客 ISPE 播客《Shaping the Future of Pharma》，与主持 Bob Chew 讲述这座工厂如何建成。同月，海普瑞在 10 月 7 日发自 CPHI 米兰的新闻稿中说，该项目是 2026 年获奖名单上唯一的中国获奖者。

Your Pingshan facility won a FOYA Award for innovation. What makes this facility special?

你们的坪山设施获得了 FOYA 创新奖。这座设施的特别之处是什么？（ISPE 播客主持 Bob Chew 问）

In the written transcript ISPE posted alongside the episode, Wei answered that the plant treats capacity, sterility assurance, quality control and digital coordination as one integrated system. Within limited land, he said, automated warehousing, isolator filling, AI inspection, 5G and digital systems together improve space use, efficiency and supply stability. FOYA, in his words, recognized practical, system-level innovation built around real manufacturing needs rather than any single technology.

在 ISPE 随本期节目发布的文字转录稿中，Wei 的回答是：这座工厂把产能、无菌保障、质量控制与数字协同当作一个整体系统来处理。他说，在有限的土地内，自动化仓储、隔离器灌装、AI 检验、5G 与数字系统共同改善了空间利用、效率与供应稳定性。用他的话说，FOYA 认可的是围绕真实制造需求建立的、系统层面的实用创新，而不是任何单项技术。

一、深圳的土地短缺把仓库送上 24 米高空

Shenzhen's land shortage sent the warehouse 24 meters into the air

Hepalink's 24-meter automated warehouse raised space utilization 52 percent over a traditional layout, the company said in its April 2026 release. A stereoscopic warehouse, the term Hepalink uses, is automated high-bay racking: materials sit in tall steel shelving and machines, not forklift drivers, retrieve each pallet or tote. Embedding that tower in the middle of the building put storage beside production instead of at the far end of a site.

海普瑞在 2026 年 4 月的新闻稿中说，24 米高的自动化立体仓库使空间利用率较传统布局提高了 52%。海普瑞所称的立体仓库即自动化高位货架：物料存放在高层钢货架中，由机器而非叉车工取送每一个托盘或料箱。把这座塔库嵌入建筑中部，仓储就落在了生产旁边，而不是场地的远端。

The plant covers 297,715 square feet of floor area, was completed on February 4, 2025, and holds EU GMP certification, according to the same release. EU GMP is the European Union's good manufacturing practice standard, the inspection regime a plant must pass before its medicines can be supplied to the EU market. ISPE's own write-up of the project, posted on its site in September 2026, describes the location as one of China's most land-constrained urban environments and the vertical layout as a rethink of how a pharmaceutical plant is usually arranged.

同一新闻稿称，工厂建筑面积 297,715 平方英尺，2025 年 2 月 4 日竣工，持有 EU GMP 认证。EU GMP 是欧盟药品生产质量管理规范，是药品进入欧盟市场前必须通过的检查体系。ISPE 2026 年 9 月在其网站发布的项目综述，把选址描述为中国土地约束最强的城市环境之一，并把垂直布局称为对制药工厂通常排布方式的一次重新思考。

Instead of a traditional layout, the facility was built vertically. Why was this approach important, and what advantages has it delivered?

这座设施没有采用传统布局，而是垂直建造。为什么这一方式重要？它带来了哪些优势？（Bob Chew 问）

A vertical plant changes the logistics question before it changes anything else. When storage is stacked above the line instead of strung along a long horizontal flow, every move of material becomes a machine move, and a lift or a cart has to be timed against the filling line it feeds. That is the link between the building's shape and the automation that follows.

垂直工厂在改变其他一切之前，先改变了物流这个问题。当仓储叠在产线上方而不是沿一条长水平流展开，物料每一次移动都变成机器动作，提升机或转运车必须与它所服务的灌装线对上节拍。这就是建筑形态与后续自动化之间的联系。

图：ISPE 播客视频截屏：主持 Bob Chew（图源：MarketScale 页面视频）

二、依诺肝素的黏度先卡住泵，之后才会麻烦到患者

Enoxaparin's viscosity seizes pumps before it troubles a patient

The force needed to push a viscous liquid through a syringe needle rises in direct proportion to viscosity and climbs steeply as the needle bore narrows. Michael Adler, a Roche formulation scientist, laid out that relationship in a February 2012 American Pharmaceutical Review article using the Hagen-Poiseuille equation, which ties flow rate, viscosity, needle length and needle inner diameter to the travel force on the plunger. Of those variables, Adler wrote, the formulation scientist can change only viscosity; the syringe fixes everything else, and no generally accepted limit exists for injection force or injection time.

把黏稠液体推过注射器针头所需的力，与黏度成正比，并随针孔变窄而陡升。罗氏制剂科学家 Michael Adler 在 2012 年 2 月的 American Pharmaceutical Review 文章中，用 Hagen-Poiseuille 方程给出了这一关系：流速、黏度、针长与针内径共同决定推杆的行进力。Adler 写道，在这些变量里，制剂科学家能改的只有黏度；其余全由注射器本身固定，而注射力与注射时间也没有普遍接受的限值。

On a filling line the same property shows up differently. Hepalink's April 2026 release lists pump seizing on high-viscosity drugs and glass breakage during high-speed inspection as the industry problems the Pingshan project solved. Enoxaparin sodium, the anticoagulant the plant fills, is the high-viscosity product in question, and a dosing pump that stalls under a viscous load stops the line until it is cleared.

在灌装线上，同一性质以另一种方式显现。海普瑞 2026 年 4 月的新闻稿把高黏度药品的泵卡滞与高速检验中的玻璃破碎，列为坪山项目解决的两个行业问题。工厂灌装的抗凝药依诺肝素钠就是所说的高黏度产品，而计量泵在黏性负载下一旦停转，产线就得停下来处理。

What was the biggest challenge in making high viscosity prefilled syringes? And how did your team solve it?

制造高黏度预充式注射器最大的挑战是什么？你们的团队如何解决？（Bob Chew 问）

Wei's written answer widened the question. The main challenge, he said in the transcript ISPE posted, was building a plant that could meet large-scale capacity, international quality standards and sterility assurance requirements at the same time. The team combined vertical design, automated storage, isolator filling, AGV transfer, AI inspection and 5G coordination to attack space, capacity, quality and efficiency together.

Wei 的书面回答把问题拉宽了一层。他在 ISPE 发布的转录稿中说，主要挑战是建一座能同时满足大规模产能、国际质量标准与无菌保障要求的工厂。团队把垂直设计、自动化仓储、隔离器灌装、AGV 转运、AI 检验与 5G 协同组合起来，同时处理空间、产能、质量与效率。

三、下沉式 5G 边缘网络把时延压在 10 毫秒以内

A sunken 5G edge network holds latency under 10 milliseconds

Hepalink's release puts network latency on the plant's 5G multi-access edge computing architecture at less than 10 milliseconds. Multi-access edge computing, or MEC, means the servers that process plant data sit inside the facility beside the radio network, so a camera frame or an AGV position report never leaves the site to be processed. Hepalink calls the setup fully sunken, and its October 2026 release says this keeps data processing close to the production areas; ISPE's September 2026 write-up adds that the loop stays closed locally, which keeps the plant's data on the plant's own servers.

海普瑞的新闻稿称，工厂 5G 多接入边缘计算架构的网络时延低于 10 毫秒。多接入边缘计算（MEC）指处理工厂数据的服务器就放在厂内、紧挨无线网络，相机的每一帧画面或 AGV 的位置报告都不出厂区就能完成处理。海普瑞称这一部署为「全下沉」，其 2026 年 10 月的新闻稿说这使数据处理贴近生产区域；ISPE 2026 年 9 月的综述补充说，回路在本地闭合，工厂的数据留在工厂自己的服务器上。

In the transcript ISPE posted, Wei said the localized 5G-MEC layer carries AGV dispatching, AI image transmission, equipment monitoring and data collection for the MES and SCADA systems. A manufacturing execution system (MES) is the software that records each step of a batch, and SCADA (supervisory control and data acquisition) is the layer that reads and adjusts equipment. The image traffic is where latency bites: arithmetic on Hepalink's 24,000 units an hour puts nearly seven syringes a second in front of the inspection cameras, so each frame has to reach the edge servers and come back with a verdict inside that window.

在 ISPE 发布的转录稿中，Wei 说本地化的 5G-MEC 层承载着 AGV 调度、AI 图像传输、设备监控以及 MES 与 SCADA 系统的数据采集。制造执行系统（MES）是记录批次每一步的软件，SCADA（监控与数据采集）是读取并调整设备的那一层。图像流量是时延真正要紧的地方：按每小时 24,000 支计算，每秒有近 7 支注射器进入检验相机视野，每一帧都必须在这个时间窗口内到达边缘服务器并带回判定结果。

The same ISPE post describes a 5G electronic fence: AI vision systems watching work areas in real time for unsafe behavior, plus millisecond-level collision avoidance for the AGVs. It also reports an 18 percent reduction in unit energy consumption and estimated annual electricity savings of about RMB 4.09 million, roughly US$560,000, from thermal energy storage and energy management tied into the same network.

ISPE 同一篇综述还描述了 5G 电子围栏：AI 视觉系统实时监视作业区域的不安全行为，外加 AGV 的毫秒级避碰。文中还给出单位能耗下降 18%，以及接入同一网络的蓄热与能源管理带来的年节约电费约 409 万元人民币（约 56 万美元）。

图：ISPE 播客视频截屏：CaiXue Wei 谈 AGV 自动转运的收益，画面下方背景为坪山厂区航拍与车间照片（图源：MarketScale 页面视频）

四、AGV 把物料无人工接触送进 A 级隔离器

AGVs carry material into Grade A isolators without a human hand

Hepalink says the Pingshan line moves material from warehouse to Grade A isolators with no human handling, and it calls the design an industry first. An automated guided vehicle (AGV) is a driverless cart that follows a programmed route; a Grade A isolator is a sealed enclosure at the highest EU GMP cleanliness grade, where open product is filled and no operator reaches in. Between them, by the April 2026 release's description, sits a vaporized hydrogen peroxide (VHP) transfer chamber, a pass-through that fogs incoming surfaces with hydrogen peroxide vapor to decontaminate them before they enter the isolator. The chain works as a sequence of handoffs: the AGV docks at the chamber, the chamber runs its cycle, and the load passes into the isolator, with the 5G network carrying the dispatch and docking signals that time each step.

海普瑞说，坪山产线的物料从仓库到 A 级隔离器全程无人工搬运，并称这一设计属行业首创。自动导引车（AGV）是沿既定路线行驶的无小车；A 级隔离器是 EU GMP 最高洁净等级的密封腔体，敞口产品在这里灌装，操作员的手伸不进去。两者之间，按 2026 年 4 月新闻稿的描述，是汽化过氧化氢（VHP）传递舱：一种通过式腔体，用过氧化氢蒸气熏蒸来件的表面去污染，然后才放行进入隔离器。这条链按接力方式运转：AGV 在传递舱对接，舱内跑完去污染周期，负载转入隔离器；5G 网络承载调度与对接信号，为每一步计时。

The facility uses automated guided vehicle assisted automated transfer in key material flow steps with operators responsible for scheduling, process handover, and exception handling. What benefits has this brought to logistics efficiency, production, coordination, quality and safety?

设施在关键物料流步骤使用 AGV 辅助的自动转运，操作员负责排程、工序交接与异常处理。这给物流效率、生产、协同、质量与安全带来了什么好处？（Bob Chew 问）

Wei answered, in the transcript on ISPE's site, that the project put AGVs and conveyor lines for items and totes into material transfer, so operators are released from frequent manual handling and instead confirm schedules, hand off between process steps and deal with exceptions. That split, he said, improves logistics efficiency and production coordination while cutting unnecessary manual contact. ISPE's write-up puts the logistics network's delivery stability at 99.99 percent.

Wei 在 ISPE 网站的转录稿中回答，项目把 AGV 与输送线（用于物品和料箱）放进物料转运，操作员从频繁的手工搬运中解放出来，转为确认排程、做工序间交接、处理异常。他说，这样的分工提升了物流效率与生产协同，同时减少了不必要的人工接触。ISPE 的综述给出物流网络交付稳定性 99.99%。

图：ISPE 播客视频截屏：CaiXue Wei 谈 AI 检验之于质量、效率与供应（图源：MarketScale 页面视频）

五、深度学习检验机每小时读取 24,000 支注射器

Deep-learning inspection reads 24,000 syringes an hour

Hepalink says its deep-learning inspection machine checks 24,000 syringes an hour without glass touching glass. The April 2026 release describes an all-in-one nest removal and inspection machine; a nest is the plastic tray that holds filled syringes inside a sealed tub, and lifting syringes out of it for inspection is where glass used to break at speed. Combining removal and inspection in one machine takes out the transfer step where syringes knocked together. Hepalink reports 100 percent defect detection on the system.

海普瑞说，其深度学习检验机以每小时 24,000 支的速度检验，且玻璃不接触玻璃。2026 年 4 月的新闻稿描述了一台拔托与检验一体机；托盘（nest）是密封桶内盛放已灌装注射器的塑料托，把注射器从托里拔出来送检，正是高速下玻璃容易破碎的环节。把拔托与检验合并进一台机器，去掉了注射器互相磕碰的转运步骤。海普瑞报告该系统缺陷检出率 100%。

The AI here is machine vision, by Hepalink's description. Deep learning in this setting means software trained on large sets of images of good and defective units, which then classifies each syringe as it passes a camera; neither Hepalink release describes predictive control of the filling process itself. ISPE's September 2026 post says the inspection runs at efficiencies far beyond manual methods and that one operator can oversee multiple machines.

按海普瑞的描述，这里的 AI 是机器视觉。深度学习在此场景中指用大量合格品与缺陷品的图像训练软件，再由它对每支经过相机的注射器分类；两份海普瑞新闻稿都没有提到对灌装过程本身的预测性控制。ISPE 2026 年 9 月的综述说，该检验的效率远超人工方式，一名操作员可同时监管多台机器。

Hepalink has not published how it validated the deep-learning classifier for defect decisions on a GMP line, so a quality lead cannot yet read Pingshan as a template for AI validation under any regulator's guidance. What the company has put on the record is the throughput figure and the mechanical change that made it possible: no glass-to-glass contact during nest removal.

海普瑞没有公布其在 GMP 产线上如何针对缺陷判定对深度学习分类器做验证，因此质量负责人还不能把坪山当作任何监管机构指南下 AI 验证的模板。公司落到纸面上的，是产能数字与使它成为可能的机械改动：拔托过程中玻璃与玻璃零接触。

六、数字孪生让坪山与南山共享工艺配方

A digital twin lets Pingshan and Nanshan share recipes

Hepalink's April 2026 release describes a digital twin collaborative model linking the Pingshan and Nanshan sites, built for rapid transfer of technical resources and production recipes. A digital twin, in the company's October 2026 description, is a synchronously mapped digital copy of the physical plant that allows real-time perception, simulation and continuous optimization of the process. A recipe, in this context, is the full set of parameters and steps that define how a batch is made, so a shared twin means a recipe proven at one site can be run against the model of the other before it is run on the floor.

海普瑞 2026 年 4 月的新闻稿描述了一个连接坪山与南山两基地的数字孪生协同模型，用于技术资源与生产配方的快速转移。按公司 2026 年 10 月的描述，数字孪生是实体工厂的同步映射数字副本，可对工艺做实时感知、仿真与持续优化。这里的配方（recipe）指定义一个批次如何生产的全部参数与步骤，因此共享孪生意味着：在其中一个基地验证过的配方，可以先在另一个基地的模型上运行，再落到产线。

The reason that matters is the product's reach. Hepalink said in its April release that enoxaparin sodium injection was approved in 78 countries and regions and sold in more than 50; by October 2026 the company put approvals at 81 countries and regions. The company describes nearly three decades in heparin and a vertically integrated chain running from raw material through active pharmaceutical ingredient (API), the drug substance itself, to finished formulation and global commercialization.

这一设计的分量在于产品的覆盖面。海普瑞在 4 月新闻稿中说，依诺肝素钠注射液已在 78 个国家和地区获批、在超过 50 个国家销售；到 2026 年 10 月，公司把获批数更新为 81 个国家和地区。公司称其在肝素领域经营近三十年，拥有从原料到活性药物成分（API，即原料药本身）、再到制剂成品与全球商业化的垂直整合链条。

Techdow, Hepalink's wholly owned subsidiary, has carried the enoxaparin business since 2004, and its Inhixa became the first enoxaparin sodium biosimilar approved by the European Medicines Agency in 2016, Hepalink said in the October 2026 release. A biosimilar is a follow-on version of a biological medicine approved by showing it matches the original. For a supply chain planner, the Nanshan link is the resilience argument: Hepalink's own claim is that a shared digital model and the plant's added capacity strengthen stable supply across those markets.

海普瑞在 2026 年 10 月的新闻稿中说，全资子公司天道医药（Techdow）自 2004 年起运营依诺肝素业务，其 Inhixa 于 2016 年成为首个获欧洲药品管理局批准的依诺肝素钠生物类似药。生物类似药是通过证明与原研药一致而获批的生物药后续版本。对供应链规划者而言，与南山的联动就是供应韧性的论据：海普瑞自己的说法是，共享数字模型加上工厂新增产能，强化了这些市场的稳定供应。

七、FOYA 评审在「新技术」类别看重什么

What FOYA judges weigh in a Novel Technology entry

Scott Billman, a FOYA judge and Senior Vice President of Global Engineering, Technology, and Facilities at Solventum, told The Medicine Maker in an October 2025 interview that submissions open each August and that an ISPE committee first checks every entry against minimum criteria, including that the facility is actually producing the therapy it was built for and that construction met high safety standards. Only then does a panel of senior project leaders judge the field. Billman listed Novel Technology as one of five Innovation subcategories, beside Facility of the Future, Process Innovation, Process Intelligence and Equipment Innovation, and said the categories are revisited every year; ISPE's own site describes the Novel Technology award as recognizing innovative application of manufacturing technologies, facility design and engineering solutions.

FOYA 评委、Solventum 全球工程、技术与设施高级副总裁 Scott Billman 在 2025 年 10 月接受 The Medicine Maker 采访时说，申报每年 8 月开放，ISPE 委员会先对每个申报项目做最低标准核查，包括设施确实在生产它建成时所面向的疗法、建设满足高安全标准，之后才由资深项目负责人组成的小组评审。Billman 列出「新技术」是创新类五个子类别之一，与「未来设施」「工艺创新」「工艺智能」「设备创新」并列，并说类别每年复审；ISPE 官网把「新技术」奖描述为表彰制造技术、设施设计与工程解决方案的创新应用。

Pharmaceutical Technology, in an April 22, 2026 report, said the program dates from 2005 and that judges consider how facilities are designed, delivered and operated, with this year's panel weighing modular and digital manufacturing, sustainability-focused infrastructure, accelerated execution and integrated quality and supply strategies. It cited Parag Sane of Amgen, the judging chair, calling the winners new benchmarks for regulated manufacturing. ISPE does not publish a side-by-side scoring of past Novel Technology winners, so Pingshan's margin over earlier entries in the category cannot be measured.

Pharmaceutical Technology 2026 年 4 月 22 日的报道说，该奖项始于 2005 年，评委考察设施如何设计、交付与运营，今年的评审团关注模块化与数字化制造、面向可持续性的基础设施、加速执行以及整合的质量与供应策略。报道引用评审主席、安进的 Parag Sane 的话，称获奖者是受监管制造的新标杆。ISPE 不公布历届「新技术」获奖者的横向评分，因此无法衡量坪山在同类申报中的领先幅度。

资料来源：

MarketScale：Hepalink's FOYA-winning syringe plant inspects 24,000 units an hour，2026-10-22（本文附图截自该页视频）

Hepalink 官网新闻稿：Hepalink Pingshan Facility Wins 2026 ISPE FOYA for Innovation，2026-04-21

ISPE FOYA 获奖页：ispe.org/facility-year-awards/winners/2026/innovation-novel-technology

其他转引：BioProcess International（2026-04-20）、Pharmaceutical Technology（2026-04-22）、The Medicine Maker（2025-10）、Shenzhen Daily（2026-05-09）