「英中对照」你的生物制药生产清洁流程是否在损耗时间、资金并造成环境影响？

When biopharmaceutical manufacturers need more production capacity, the focus often turns to new facilities, additional equipment or expanded production lines. However, significant untapped capacity may already exist within existing operations.当生物制药制造商需要更多产能时，关注点往往转向新建工厂、增购设备或扩建生产线。然而，现有运营中可能已经存在大量未被利用的产能。

The constraint is often not production itself, but the time between batches.制约因素往往不是生产本身，而是批次之间的时间。

Cleaning and disinfection directly influence equipment availability, changeover times and overall throughput, but they are still widely treated as compliance requirements rather than operational processes that can be optimised. As manufacturers look to maximise existing assets before making major capital investments, this perspective is beginning to change.清洁和消毒直接影响设备可用率、切换时间和总吞吐量，但它们仍被普遍视为合规要求，而非可以优化的运营流程。随着制造商在进行重大资本投资之前寻求最大限度利用现有资产，这种观念正开始转变。

Increasingly, cleaning is being recognised as an opportunity to improve manufacturing performance by challenging long-standing assumptions.清洁正日益被认可为通过挑战长期固有假设来提升生产绩效的机会。

Looking beyond compliance放眼合规之外

Cleaning programmes are typically established early in a facility’s lifecycle and, once validated, are rarely revisited. As products, equipment and manufacturing priorities evolve, this can leave organisations relying on processes that are no longer fit for purpose.清洁程序通常在工厂生命周期早期建立，一旦经过验证，便很少被重新审视。随着产品、设备和生产优先级发生变化，这可能使组织依赖不再适用的流程。

Without regular reassessment, conservative cycle times, precautionary steps and operating parameters can become embedded in routine operations. At the same time, valuable operational data is often overlooked because validation is treated as the end of process development rather than the start of continuous improvement.若不定期重新评估，保守的循环时间、预防性步骤和操作参数便可能固化到日常运营中。同时，宝贵的运营数据往往被忽视，因为验证被视为工艺开发的终点，而非持续改进的起点。

These legacy practices reduce equipment availability and quietly constrain manufacturing capacity.这些遗留做法会降低设备可用率，并悄然限制生产产能。

Common examples include:常见示例包括：

• Cleaning cycles that are longer than necessary, such as extended rinse times, redundant wash steps or conservative hold times that have never been re-evaluated. 
不必要地延长的清洁周期，例如从未重新评估过的延长冲洗时间、冗余洗涤步骤或保守的保持时间。
• Operating conditions that are more conservative than required, such as higher temperatures or chemical concentrations that consume additional resources without improving cleaning performance.
比要求更保守的操作条件，例如更高的温度或化学品浓度，消耗额外资源却未提升清洁效果。
• Overly cautious validation strategies, including conservative acceptance criteria and extensive sampling plans that increase effort while adding little value.
过于谨慎的验证策略，包括保守的可接受标准和繁复的取样计划，增加工作量却几乎不带来价值。
• Greater use of water, energy and cleaning agents, increasing both operating costs and environmental impact.水、能源和清洁剂的用量增加，从而同时提高运营成本和环境影响。

Current regulatory guidance, including ICH Q7, ICH Q9(R1) and EU GMP Annex 15, supports science and risk-based approaches to cleaning validation rather than prescriptive methods.当前法规指南（包括 ICH Q7、ICH Q9(R1) 和 EU GMP 附录15）支持对清洁验证采用基于科学和风险的方法，而非规定性方法。

Organisations that develop a strong understanding of their processes and use operational data to justify decisions can often streamline cleaning and validation activities while maintaining compliance, improving equipment utilisation and increasing manufacturing throughput.若组织能够充分理解自身工艺，并使用运营数据证明决策的合理性，通常可以在保持合规的同时精简清洁和验证活动，提高设备利用率并增加生产吞吐量。

Finding the hidden capacity发掘隐性产能

Inefficient cleaning, over-cleaning and overly conservative validation often share the same root cause: decisions based on habit rather than evidence. A useful starting point is to ask a question: Which elements of our cleaning process are genuinely required to manage risk, and which have never been challenged?低效清洁、过度清洁和过于保守的验证往往具有相同的根本原因：决策基于习惯而非证据。一个有用的切入点是提出一个问题：我们清洁流程中的哪些要素是管理风险真正必需的，哪些又从未受到过质疑？

Answering that question requires collaboration and a data-driven approach. The goal is not to impact cleaning standards, but to eliminate activities that add time without improving product quality or compliance.回答该问题需要协作和数据驱动的方法。其目标不是影响清洁标准，而是消除那些增加时间却未提升产品质量或合规性的活动。

The impact can be significant. In one manufacturing facility, two identical pieces of equipment producing the same product followed different cleaning procedures. By reviewing the processes, removing unnecessary steps and standardising the approach, the site increased annual manufacturing capacity by approximately 15% (equivalent to several additional production batches) without investing in new equipment or expanding the facility.其影响可能十分显著。在一家生产设施中，两台完全相同、生产同一产品的设备采用了不同的清洁程序。通过审视流程、取消不必要的步骤并使方法标准化，该工厂在未投资新设备或扩建设施的情况下，将年生产能力提高了约15%（相当于增加数个生产批次）。

This example demonstrates that hidden capacity often already exists and simply needs to be uncovered through systematic evaluation of cleaning processes.这一示例表明，隐性产能往往已经存在，只需通过对清洁流程的系统评估将其挖掘出来。

Building optimisation into the facility lifecycle将优化融入设施生命周期

Cleaning optimisation delivers the greatest benefits when it is considered throughout the facility lifecycle rather than as a one-off improvement project. Manufacturers can create more efficient, adaptable operations by focusing on four key areas:如果在整个设施生命周期中都考虑清洁优化，而不是将其作为一次性改进项目，清洁优化就能带来最大收益。制造商可通过聚焦四个关键领域，打造更高效、更具适应性的运营：

Design for cleanability
可清洁性设计

Consider cleaning requirements during equipment selection and facility design to minimise dead legs, improve drainage and reduce manual intervention throughout the equipment lifecycle.
在设备选型和设施设计阶段考虑清洁要求，以在设备整个生命周期内最大限度减少死角、改善排液并减少人工干预。

Use operational data
运用运营数据

Monitor cleaning performance to identify which process parameters genuinely influence cleaning efficacy and where unnecessary variability or inefficiency exists.

Adopt risk-based decision-making

Replace historical assumptions with evidence-based approaches that align cleaning and validation activities with actual process risk while maintaining regulatory compliance.
监控清洁绩效，以识别哪些工艺参数确实影响清洁效果，以及何处存在不必要的变异或低效。
采取基于风险的决策 以循证方法取代历史假设，使清洁和验证活动与实际工艺风险相一致，同时保持法规合规。

Embed continuous improvement
嵌入持续改进

Treat cleaning as an evolving manufacturing process, using cross-functional collaboration and digital technologies to identify further optimisation opportunities over time.将清洁视为一项不断演进的生产流程，利用跨职能协作和数字技术，随着时间的推移识别更多优化机会。

These practices transform cleaning from a fixed operational requirement into a measurable contributor to manufacturing performance, helping facilities improve throughput without additional capital investment.这些实践将清洁从一项固定的运营要求转变为可衡量的制造绩效贡献因素，帮助工厂在无需额外资本投资的情况下提高生产吞吐量。

A competitive advantage hidden in plain sight隐藏在显眼处的竞争优势

As biologics manufacturing becomes more flexible and production schedules more dynamic, rapid equipment turnaround will increasingly influence operational performance. Facilities that continue to treat cleaning solely as a compliance activity risk overlooking one of the most accessible opportunities to improve throughput. Those that approach cleaning as a process to be designed, measured and continuously refined will be better positioned to maximize existing assets before considering major capital investment.随着生物制品生产变得更加灵活、生产排程更具动态性，设备快速周转将对运营绩效产生越来越大的影响。若工厂仍将清洁仅仅视为一项合规活动，就可能错失提高吞吐量的最易把握机会之一。而将清洁作为一个需要设计、衡量和持续完善的流程来对待的工厂，将更有条件在考虑重大资本投资之前最大化利用现有资产。

Cleaning and disinfection will always be fundamental to protecting product quality and patient safety. Increasingly, however, they are also becoming strategic tools for improving operational performance. For many biopharma manufacturers, the next opportunity to increase capacity may already exist within their facilities, waiting to be unlocked with a fresh look at the cleaning process.清洁与消毒始终是保护产品质量和患者安全的基础。然而，它们也正日益成为提升运营绩效的战略工具。对许多生物制药制造商而言，下一个产能提升机会可能早已存在于其设施之中，只需重新审视清洁流程即可将其释放。

Author: Georgios Koukoulas, Global Technical Consulting Manager, Ecolab作者：Georgios Koukoulas，Ecolab全球技术咨询经理

• Companies:公司：
• Ecolab Life Sciences

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