As pharmaceutical microbiology continues to evolve under tighter regulatory expectations and advancing technologies, manual microbiological testing methods remain a critical area of focus, including many aspects of the environmental monitoring (EM) workflow. From surface sampling to plate counting, many tasks remain manual, not due to a lack of innovation but because methods like applying a contact plate to a surface remain the most practical way to detect microbes in open manufacturing environments. Furthermore, EM responsibilities are often assigned to early-career or newly hired personnel, which can limit the practical insight needed to master the nuanced techniques and decision-making that come with experience. While environmental monitoring workflows remain essential for understanding contamination control of classified environments, they continue to carry a persistent challenge for microbiologists: inconsistency. Variability introduced by human technique and error can result in under-detected contamination, misleading trend data, and potential regulatory concerns.
随着制药微生物学在更严格的监管期望和不断进步的技术下不断发展，手动微生物检测方法仍然是一个关键的重点领域，包括环境监测 （EM） 工作流程的许多方面。从表面采样到平板计数，许多任务仍然是手动的，不是因为缺乏创新，而是因为在表面应用接触板等方法仍然是在开放式制造环境中检测微生物的最实用方法。此外，EM 职责通常分配给处于职业生涯早期或新雇用的人员，这可能会限制掌握经验带来的细微技术和决策所需的实际洞察力。虽然环境监测工作流程对于了解分类环境的污染控制仍然至关重要，但它们仍然给微生物学家带来了一个持续的挑战：不一致。人为技术和错误引入的可变性可能导致污染检测不足、趋势数据误导和潜在的监管问题。

To improve consistency and detection in environmental monitoring, the industry has explored alternative technologies, such as Biofluorescent Particle Counters (BFPCs)(1) and integrated digital workflows, that aim to reduce reliance on manual methods. While these innovations offer promising advancements (2) for air sampling methods, traditional surface sampling remains widely used and continues to present its own challenges. Unlike equipment-based methods such as viable air samplers and particle counters, which incorporate built-in calibration and performance qualification steps, surface sampling lacks the same level of standardization. This is especially significant given that these manual techniques are often used to assess critical product-contact surfaces under Grade A conditions at the end of aseptic filling processes. Ensuring reliable results will continue to depend on well-trained, qualified personnel who understand both the method and the implications of the data it generates.
为了提高环境监测的一致性和检测能力，该行业已经探索了替代技术，例如生物荧光粒子计数器 （BFPC）和集成数字工作流程，旨在减少对手动方法的依赖。虽然这些创新为空气采样方法提供了有希望的进步 ， 但传统的表面采样仍然被广泛使用，并继续带来其自身的挑战。与基于设备的方法（如可行的空气采样器和粒子计数器）不同，表面采样缺乏相同级别的标准化。鉴于这些手动技术通常用于在无菌灌装过程结束时评估 A 级条件下的关键产品接触表面，这一点尤为重要。确保可靠的结果将继续取决于训练有素的合格人员，他们了解该方法及其所生成数据的含义。

So, how do we reduce variability and improve confidence in these foundational, manual, technique-dependent practices? This article explores that question by further examining the role of surface sampling in environmental monitoring and its place within the broader contamination control strategy. Then, we will take a closer look at how recovery efficiency (3) is measured, the factors that influence it, and how it applies to both contact and swab surface sampling methodologies. The discussion will include the regulatory and contamination control aspects of recovery efficiency, particularly in light of updated expectations outlined in EU GMP Annex 1 (4). We will then review data from several recent studies that shed light on current challenges and areas for improvement in surface sampling. Finally, the article will consider how the pharmaceutical and compounding industries can move forward through standardization, structured training, and qualification of personnel to ensure consistent, reliable performance of microbial surface sampling.
那么，我们如何减少可变性并提高对这些基础的、手动的、依赖于技术的实践的信心呢？本文通过进一步研究表面采样在环境监测中的作用及其在更广泛的污染控制策略中的地位来探讨这个问题。然后，我们将仔细研究如何测量回收效率 ， 影响回收效率的因素，以及它如何应用于接触式和拭子表面采样方法。讨论将包括回收效率的监管和污染控制方面，特别是考虑到欧盟 GMP 附录 1  中概述的最新期望。然后，我们将回顾最近几项研究的数据，这些数据阐明了表面采样的当前挑战和需要改进的领域。最后，本文将考虑制药和复合行业如何通过标准化、结构化培训和人员资格认证来向前发展，以确保微生物表面采样的一致、可靠性能。

The Role of Surface Sampling in Environmental Monitoring
表面采样在环境监测中的作用

Surface sampling is a foundational element of environmental monitoring programs in pharmaceutical manufacturing, playing a key role in ensuring the detection and control of classified environments. Two of the most common methods used for surface sampling are contact plating and swabbing, each with specific applications and limitations. Contact plates are typically used for smooth, flat, non-porous surfaces such as glass and stainless steel and building materials such as ceilings, floors, and doors. When applied correctly, either rolled or pressed with consistent pressure, they offer relatively high recovery efficiency and are straightforward to use. Swabs, on the other hand, are more commonly used when sampling irregular, textured, or hard-to-reach surfaces where contact plates cannot make adequate contact. These locations also tend to be product contacting, in the case of needles or stopper hopper bowls for traditional aseptic filling or tubing port connections for manual ATMP filling. However, swabbing introduces additional downstream variability due to its more complex workflow, which includes moistening the swab, applying a consistent technique, ensuring adequate surface area, and performing secondary processing steps to extract microbes before incubation.
表面采样是制药生产环境监测程序的基本组成部分，在确保受控环境的检测与控制方面发挥关键作用。表面采样最常用的两种方法是接触平板法和拭子法，每种方法都有特定的应用场景和局限性。接触平板法通常用于光滑、平整的无孔表面，如玻璃、不锈钢等材质，以及天花板、地板和门等建筑材料表面。若操作得当——无论是以均匀压力滚动还是按压平板——该方法可实现较高的微生物回收率，且使用简便。拭子法则更适用于采样不规则、有纹理或难以触及的表面，这些位置通常是接触产品的部位（例如传统无菌灌装中的针头或胶塞料斗碗，或手动ATMP灌装中的管道接口），接触平板法难以在这些表面充分贴合。然而，由于拭子法工作流程更复杂，会引入更多下游变异性，具体包括：湿润拭子、采用一致的擦拭技术、确保足够的采样面积，以及在培养前执行提取微生物的二次处理步骤等。

Each surface sampling method presents its own set of challenges. Recovery rates can vary significantly based on the type of surface sampled, the material of the swab or plate, and, critically, the technique of the individual performing the sampling. Manual variability in pressure, duration, and contact area can all influence the reliability of results. Despite these known limitations, the data obtained from surface sampling is often used to support the release of batch-related materials across a wide range of pharmaceutical operations, from aseptic manufacturing to advanced modalities such as cell and gene therapy and sterile compounding. As facilities build more robust Environmental Monitoring Risk Assessments (EMRAs)  to identify critical sampling locations that narrow in on real process impact, ensuring those samples are collected with accuracy and consistency becomes even more important. Manual surface sampling is also likely to remain in use due to its historical significance and alignment with established regulatory standards. The question then becomes not whether to continue performing surface sampling but how confidently we can stand behind the results generated by these manual methods.
每种表面采样方法都面临着独特的挑战。回收率可能因采样表面类型、拭子或平板的材质，以及（关键在于）采样人员的操作技术而显著不同。压力、持续时间和接触面积的手动操作变异性，均会影响结果的可靠性。尽管存在这些已知局限性，但从表面采样获得的数据仍广泛用于支持各类制药操作中批次相关物料的放行，涵盖从无菌生产到细胞与基因治疗、无菌配制等先进模式。随着各设施建立更完善的环境监测风险评估（EMRA）以识别对实际工艺影响较大的关键采样位置，确保这些样本采集的准确性和一致性变得更加重要。此外，由于手动表面采样的历史重要性及其与既定监管标准的契合性，该方法可能会继续沿用。    因此，问题的核心不再是是否继续进行表面采样，而是我们对这些手动方法所产生结果的置信度究竟如何。

Understanding and Measuring Surface Recovery Efficiency
表面回收率的理解与测定

Recovery efficiency is a key concept in evaluating the performance of environmental monitoring (EM) methods, and still, it has not been adequately applied to viable surface monitoring. It refers to the percentage of viable microorganisms that a sampling method can effectively collect from a surface, the air, or personnel and adequately culture for enumeration. In practical terms, it reflects how well a method transfers microbes from the sampled area to the growth medium, allowing the resulting colony counts to be compared to relevant acceptance criteria given the many variables involved. Accurate recovery is critical to ensure that monitoring data genuinely reflects the microbial state of the environment rather than the limitations of the method used to assess it.
回收率是评估环境监测（EM）方法性能的关键概念，但目前仍未充分应用于有活力的表面监测。它是指采样方法能够从表面、空气或人员中有效收集并通过培养进行计数的存活微生物百分比。    在实际应用中，回收率反映了一种方法将微生物从采样区域转移到培养基的能力，考虑到诸多相关变量，这使得所得菌落计数可与相应的合格标准进行比较。准确的回收率至关重要，它确保监测数据真实反映环境的微生物状态，而非用于评估的方法本身存在局限性。

Regulatory expectations have placed increasing emphasis on recovery efficiency, particularly in the revised EU GMP Annex 1, where the expectations are clear in stating that sampling methods and equipment must be fully understood and that supporting data on recovery efficiency must be available. This notion also aligns with USP General Chapters <1115> Bioburden Control of Nonsterile Drug Substances and Products and <1116> Microbiological Control and Monitoring of Aseptic Processing Environments , which emphasize the need for scientifically sound EM programs and a deep understanding of both contamination risks and the performance characteristics of monitoring tools. For sterile compounding, USP <797> Pharmaceutical Compounding—Sterile Preparations reinforces that individuals involved in cleanroom operations, including those performing sampling activities, must demonstrate initial and ongoing viable surface sampling competency. Together, these guidances push the industry toward not only justifying method selection but also validating the effectiveness of those methods in real-world use to ensure that their sampling methods can consistently detect contamination and that these methods are applied in a controlled and qualified manner. Data integrity can become compromised when recovery efficiency is very low, inconsistent, or poorly understood. This can result in either false negatives, where microbial contamination goes undetected, or false positives due to poor sampling techniques or handling, which may trigger unnecessary investigations or render certain classified areas no longer fit for processing.
监管层面对回收率的重视程度与日俱增，尤其是在经修订的《欧盟GMP附件1》中明确要求：必须充分了解采样方法和设备，且必须提供回收率相关的支持数据。这一理念也与《美国药典》（USP）通则<1115>《非无菌原料药和产品的生物负荷控制》及<1116>《无菌工艺环境的微生物控制与监测》一致，这些通则强调环境监测（EM）程序需具备科学合理性，同时需深入理解污染风险和监测工具的性能特征。对于无菌配制操作，USP<797>《药品配制—无菌制剂》进一步强调：参与洁净室操作的人员（包括执行采样任务的人员）必须证明其在有活力表面采样方面的初始能力和持续能力。总体而言，这些指南推动行业不仅要证明方法选择的合理性，还要验证这些方法在实际应用中的有效性，以确保采样方法能够持续检测到污染，并且这些方法以受控且合格的方式应用。当回收率极低、不稳定或未被充分理解时，数据完整性可能受到损害。这可能导致两种后果：一是假阴性（微生物污染未被检测到），二是因采样技术或操作不当导致的假阳性（可能引发不必要的调查，或使某些洁净区域不再适合生产操作）。

Different sampling methods also provide different levels of recovery efficiency. For surface sampling, contact plates typically offer higher recovery from flat, non-porous surfaces, while swabs are necessary for irregular or hard-to-reach areas but often yield lower and more variable recovery. Proper aseptic technique, especially by the analyst performing the sampling, is vital to ensure consistency and reduce contamination or false results. Air sampling methods such as impactors depend on factors like airflow rate and sampler design to capture viable particles efficiently, whereas settling plates, being passive, tend to have much lower and less predictable recovery, if any (9). Personnel monitoring, often conducted via glove or garment sampling with contact plates, also has its limitations, especially on certain fabrics where microbes may actually be trapped or embedded and thus hinder recovery.
不同的采样方法也会带来不同水平的回收率。对于表面采样，接触平板通常能从平整无孔的表面获得更高的回收率，而拭子则适用于不规则或难以触及的区域，但往往回收率更低且变异性更大。恰当的无菌操作技术（尤其是采样人员的操作）对于确保结果一致性、减少污染或假阳性结果至关重要。   

 空气采样方法（如撞击式采样器）依赖气流速率和采样器设计等因素来有效捕获有活力的颗粒，而沉降平板作为被动采样工具，其回收率通常极低且难以预测（甚至可能无法有效回收）。人员监测（通常通过接触平板对手套或工作服采样）也存在局限性，尤其是在某些织物表面，微生物可能实际被截留或嵌入纤维中，从而影响回收率。

Recovery efficiency can be influenced by a range of factors. The physical properties of the surface being sampled, whether smooth, like stainless steel, or porous, like certain plastics, can impact how easily microorganisms are liberated during sampling. Microbial characteristics also play a role; for example, certain organisms may adhere more tightly to surfaces while others may evade capture altogether. The sampling technique itself is another major variable, including how well the contact plate method is applied to the surface, as well as characteristics of swabs such as tip material and moisture content. Post-sampling steps, including incubation conditions and the analyst’s ability to visually detect and enumerate colonies, also affect the final result as well. Most of the variables for surface sampling rely on manual technique, and experience-based methods throughout the entire workflow.
回收率可能受到一系列因素的影响。采样表面的物理特性（如不锈钢般光滑，或如某些塑料般多孔）会影响采样过程中微生物脱离表面的难易程度。微生物特性同样发挥作用：例如，某些微生物可能更紧密地附着于表面，而另一些可能完全逃避捕获。   

 采样技术本身是另一个主要变量，包括接触平板法在表面的应用效果，以及拭子的特性（如拭头材质和含水量）。采样后的步骤（包括培养条件和分析人员目测检测及计数菌落的能力）也会影响最终结果。   

 表面采样的大多数变量依赖于手动操作技术和整个工作流程中基于经验的方法。

Recovery efficiency is not just a technical parameter, as it has direct implications for a facility’s contamination control strategy, too. Low-efficiency methods may lead to an underestimation of microbial risks, affecting the ability to identify probable root causes during investigations or recognize trends that may require action. Overconfidence in a method’s performance or the dataset it provides, without a full appreciation of its limitations or proper controls in place, can erode the foundation of a site’s environmental monitoring program. This is especially important when certain EM results could inform critical product safety or batch release decisions.
回收率不仅是一个技术参数，它对生产设施的污染控制策略也有直接影响。低效的采样方法可能导致微生物风险被低估，影响调查期间识别潜在根本原因的能力，或无法察觉需要采取措施的趋势。   

 在未充分了解方法局限性或未实施适当控制的情况下，对方法性能或其提供的数据集过度自信，会削弱生产场地环境监测程序的基础。当某些环境监测结果可能为关键产品安全或批次放行决策提供依据时，这一点尤为重要。

Understanding recovery efficiency is not limited to optimizing one methodology over another; rather, it’s about ensuring that the data collected is meaningful and supports robust contamination control. This requires both method validation and vigilance regarding how surface sampling is executed, interpreted, and incorporated into the overall process and product quality.
理解回收率不仅限于在不同方法间优化选择，更在于确保所收集的数据具有实际意义，并为强有力的污染控制提供支持。这需要同时做到方法验证，以及对表面采样的执行、解读和其融入整体工艺及产品质量的方式保持高度审慎。

Recent Studies on Microbial Surface Sampling Efficiency
微生物表面采样效率的近期研究

Recent research from pharmaceutical microbiology labs and various companies has provided valuable insights into the factors influencing microbial recovery efficiency in surface sampling, emphasizing the critical roles of sampling techniques, personnel training, and material selection. Four recent studies are discussed below, each determining recovery efficiency using slightly different approaches tailored to their specific study objectives. Currently, no universally adopted method for calculating recovery efficiency across the industry exists, and the results may not be directly comparable. However, collectively, they illustrate that recovery efficiency is influenced by multiple variables.
制药微生物实验室和多家公司的最新研究为影响表面采样中微生物回收效率的因素提供了有价值的见解，强调了采样技术、人员培训和材料选择的关键作用。以下讨论四项近期研究，每项研究均采用根据其特定研究目标量身定制的略有不同的方法来确定回收效率。目前，行业内尚未存在普遍采用的计算回收效率的方法，且结果可能无法直接比较。然而，总体而言，这些研究表明回收效率受多个变量影响。

First, AstraZeneca’s investigation into 55 mm contact plate sampling methodologies demonstrated the influence of application technique on microbial recovery. In the study “Evaluation of Three Different Contact Plate Methods for Microbial Surface Sampling of Naturally Occurring Human Borne Microbial Contamination”, researchers evaluated three manual methods using tryptic soy agar (TSA) contact plates by rolling the plate over the surface for one second, rolling the plate for five seconds, and a firm, direct press application. The findings indicated that both rolling techniques outperformed the single press, yielding average recovery efficiencies of 53% and 48% for the 1-second and 5-second rolls, respectively. While the single firm press produced a significantly lower efficiency of just 16%, it was thought to be a result of reduced overall contacted surface area. The study calculated recovery efficiency by performing two consecutive samples on the same surface. Efficiency was determined by comparing the microbial count from the second (B) sample to the first (A), using the formula: Recovery (%) = [1 – (B / A)] × 100, where a lower second count indicates higher recovery. This study reinforces the importance of technique standardization and suggests that the physical method of sample collection directly affects its ability to capture microbes.
首先，阿斯利康（AstraZeneca）针对55毫米接触平板采样方法的研究揭示了操作技术对微生物回收效率的影响。在《三种不同接触平板法对自然存在的人体源性微生物污染表面采样的评估》这一研究中，研究人员使用胰酪大豆琼脂（TSA）接触平板评估了三种手动操作方法：将平板在表面滚动1秒、滚动5秒以及用力直接按压。结果表明，两种滚动技术的效果均优于单次按压-1秒滚动和5秒滚动的平均回收效率分别为53%和48%，而单次用力按压的效率显著较低，仅为16%，这被认为是总体接触表面积减少所致。   

 该研究通过在同一表面进行两次连续采样来计算回收效率，具体方法是将第二次采样（B）与第一次采样（A）的微生物计数进行比较，使用公式：回收率（%）=[1–(B/A)]×100，其中第二次计数越低表明回收率越高。这项研究强调了操作技术标准化的重要性，并表明样本采集的物理方式直接影响其捕获微生物的能力。

A second study  performed by the same group, titled “To Determine the Microbial Recovery from Different Surfaces Using a Standard Contact Plate Sampling Method” investigated microbial recovery from various cleanroom surfaces using the 1-second rolling contact plate technique. The surfaces examined included stainless steel, polyester garments, latex, and EPDM, which are all materials found and routinely sampled in pharmaceutical cleanroom environments. The study showed that surface characteristics such as texture and finish may play a role in microbial recovery rates, with smooth, non-porous surfaces like stainless steel and copolyester goggles yielded a higher recovery rate of ~80% when compared to less smooth materials such as garments and gloves that yielded a recovery rate of ~70%. Recovery efficiency in this study was calculated using the same method described in the previous AstraZeneca study. This data reinforces the industry’s need to understand not only sampling methods but also how those methods take into consideration the specific surface types to ensure accurate environmental monitoring.
同一研究团队进行的第二项研究，题为《使用标准接触平板采样法测定不同表面的微生物回收率》，采用1秒滚动接触平板技术，对制药洁净室环境中常见的不锈钢、聚酯工作服、乳胶和三元乙丙橡胶（EPDM）等表面的微生物回收率展开了调查。研究表明，表面纹理和光洁度等特性可能对微生物回收率产生影响：不锈钢和共聚酯护目镜等光滑无孔表面的回收率较高，约为80%；而工作服和手套等光滑度较低的材料，回收率约为70%。该研究采用与阿斯利康前一项研究相同的方法计算回收效率。这些数据进一步表明，行业不仅需要了解采样方法，还需考虑这些方法如何针对特定表面类型进行调整，以确保环境监测结果的准确性。

Figure 1 Contact Plate % Recovery by Participant Sampling Event
图 1 按采样人员划分的接触平板回收率百分比（采样事件）

Next, a study assessing the influence of proper training and techniques for contact plate sampling was explored in a multi-year study  conducted by Stratix Labs (a USP company). This study assessed approximately 1,155 individual participant sampling events across the industry using 55 mm contact plates on standardized test surfaces that were precoated with a specific quantity of viable microbes. In this study, each individual data point represented an average of three replicate microbial-coated samples, and a 20% recovery efficiency threshold was used as a benchmark value. In this study, the recovery efficiency was calculated as the number of microbes recovered on the contact plate divided by the total number on the surface. This study demonstrated significant variability in recovery efficiency across participants. While some consistently achieved high recoveries above 60–80%, other participants fell below 20%, and some even approached 0% recovery (Figure 1). The observed variation is most likely attributable to human factors, such as inconsistent pressure, variation in contact time, lack of rolling motion, and overall, poor aseptic technique. In addition, and importantly, the sampling device used and the human factors of the individual combine to create the ‘sampling system’ that directly influences the recovery efficiency for viable surface sampling. These findings point to the critical importance of analyst training and qualification, technique consistency, and ongoing competency assessment to ensure the integrity of environmental monitoring data.
接下来，在 Stratix Labs（一家 USP 公司）进行的一项多年研究 中探讨了评估适当培训和技术对接触板采样的影响的研究。这项研究评估了整个行业大约 1,155 个个体参与者的采样事件，使用 55 毫米接触板在标准测试表面上预涂有特定数量的活微生物。在这项研究中，每个单独的数据点代表平均三个重复的微生物包被样品，并使用 20% 的回收效率阈值作为基准值。在本研究中，回收效率的计算方法是在接触板上回收的微生物数量除以表面的总数。这项研究表明，参与者之间的恢复效率存在显著差异。虽然一些参与者始终实现 60-80% 以上的高回收率，但其他参与者的回收率低于 20%，有些参与者甚至接近 0% 的回收率 （图 1）。观察到的变化很可能是由于人为因素造成的，例如压力不一致、接触时间的变化、缺乏滚动运动以及总体上无菌技术不佳。此外，重要的是，所使用的采样装置和个人的人为因素相结合，形成了直接影响有效表面采样的回收效率的“采样系统”。这些发现指出了分析师培训和资格认证、技术一致性和持续的能力评估对于确保环境监测数据的完整性至关重要。

Beyond contact plates, swabbing is another important surface sampling method to consider, as recovery efficiencies can vary significantly depending on the swab material, sampling technique, and the characteristics of the surface being sampled. A 2024 study published by Kumarajith, et al. (13) evaluated the uptake and release efficiency of four different swab types: cotton, foam, and two flocked designs, including a variety of buffers. Cotton swabs demonstrated the highest uptake efficiency (~96%) but released microbes poorly, often under 50%, and are not permitted in cleanroom environments. Flocked swabs, by contrast, showed strong performance in both uptake (over 80%) and release (over 70%), with overall recovery efficiencies from stainless steel surfaces ranging between 55–80%, depending on the buffer used. Foam swabs were found to have the lowest uptake (~58%) but moderate release capabilities. In this study, overall swab efficiency was calculated by first determining uptake efficiency, based on the difference between the number of cells applied to a surface and the number remaining after swabbing, and release efficiency, measured as the percentage of those cells successfully released from the swab into a buffer. These two components were combined to assess total recovery from stainless steel surfaces using a capillary electrophoresis detection method. These results indicated that the material of the swab significantly impacts recovery efficiency and that method selection must be aligned with surface type and sampling methodology. In addition, industry expert microbiologist Tim Sandle (14) has also commented on the variability of swab performance, emphasizing that even the best-performing flocked swabs typically achieve 50–60% recovery in the field and that technique also remains a major determinant of successful recovery rates.
除接触平板外，拭子法是另一种需要关注的重要表面采样方法，其回收效率可能因拭子材质、采样技术和采样表面特性的不同而存在显著差异。Kumarajith等人2024年发表的一项研究（13）评估了四种不同类型拭子（棉签、泡沫拭子和两种植绒拭子）在多种缓冲液条件下的捕获效率和释放效率。结果显示： 

 a. 棉签的捕获效率最高（约96%），但微生物释放能力较差（通常低于50%），且不允许在洁净室环境中使用；

 b. 植绒拭子在捕获（超过80%）和释放（超过70%）两方面均表现优异，在不锈钢表面的总体回收效率为55%–80%（具体取决于所用缓冲液）； 

 c. 泡沫拭子的捕获效率最低（约58%），但释放能力中等。    

该研究中，拭子的总体效率通过以下方式计算：首先基于涂布到表面的菌量与拭子采样后残留菌量的差值确定捕获效率，再通过拭子成功释放到缓冲液中的菌量占比确定释放效率，最后结合这两个指标、使用毛细管电泳检测法评估不锈钢表面的总回收率。结果表明，拭子材质对回收效率有显著影响，方法选择必须与表面类型和采样方式相匹配。此外，行业微生物专家Tim Sandle（14）也指出拭子性能的变异性，强调即使性能最佳的植绒拭子在实际应用中通常也只能达到50%–60%的回收率，而操作技术仍是影响回收率的关键因素。

Collectively, these four studies reveal that a combination of surface characteristics, sampling methodologies, and operator proficiency influences microbial recovery efficiency. Addressing these factors through standardized procedures, rigorous training and qualification, and appropriate material selection (in the case of swabs) is essential for obtaining reliable data in environmental monitoring of pharmaceutical cleanroom surfaces.
总体而言，这四项研究表明，表面特性、采样方法和操作人员熟练程度共同影响着微生物回收效率。在制药洁净室表面的环境监测中，通过标准化程序、严格的培训与资质认证以及适当的材料选择（如拭子材质）来解决这些因素，是获取可靠数据的关键。

Moving Toward a Standardized and Qualified Approach
迈向标准化和合格化的方法

Inconsistent sampling techniques by unqualified or inadequately trained personnel can introduce variability into environmental monitoring data, potentially affecting the accuracy of contamination control trends. Human sampling errors or failures to follow procedure can include inconsistent pressure, poor timing, or lack of aseptic technique, thus resulting in data that does not reliably reflect environmental conditions. This highlights the criticality of comprehensive training programs that go beyond procedural awareness and focus on building true competency in surface sampling execution and ownership over microbial recovery. The competency must ensure that the analyst understands what they are sampling, the parameters of the test, and how their specific technique can directly influence the outcome of the recovery efficiency. It is in the best interest of all companies to detect actual contamination, should it be present on the surface. Even though this article has narrowed in on surface sampling, the proper handling of culture plates, in general, is also foundational to both viable air sampling and personnel monitoring.
不合格或培训不足的人员采用不一致的采样技术，可能会给环境监测数据带来变异性，进而可能影响污染控制趋势的准确性。人为采样误差或未遵循程序的情况可能包括压力不一致、时间控制不当或缺乏无菌操作技术，从而导致数据无法可靠反映环境条件。    

这凸显了全面培训计划的重要性——此类计划需超越对程序的表面认知，重点培养表面采样执行的真正能力以及对微生物回收效果的责任感。相关能力必须确保分析人员理解采样对象、检测参数，以及其特定操作技术如何直接影响回收效率结果。对于所有公司而言，若表面确实存在污染，检测到实际污染才是最符合利益的。尽管本文聚焦于表面采样，但总体而言，培养皿的正确处理也是有活力空气采样和人员监测的基础。

Expectations around method understanding and performance are increasingly being discussed in regulatory and compendial guidance. For example, the current language in the FDA Aseptic Processing Guidance, EU GMP Annex 1, and USP chapters <797>, <1115> and <1116> all support the fundamental requirements that surface sampling methods should be well understood and appropriately controlled. While surface sampling is recognized as a semi-quantitative method with well-characterized limitations, industry efforts can still be made to improve its consistency and reliability. Standardizing the variables discussed in this article, where possible, can enhance the reproducibility of results and thus ensure recovery efficiency is optimized. Personnel qualification plays a critical role in minimizing method-related variability, and consistent training is key to achieving reliable outcomes.
监管和药典指南中对方法理解与性能的要求正成为越来越多的讨论焦点。例如，美国FDA无菌工艺指南、欧盟GMP附件1以及USP通则<797>、<1115>和<1116>均支持以下基本要求：表面采样方法应被充分理解并得到适当控制。尽管表面采样被公认为是一种具有明确局限性的半定量方法，但行业仍可致力于提高其一致性和可靠性。在可能的范围内对本文讨论的变量进行标准化，可增强结果的可重复性，从而确保回收效率达到最优。人员资质认证在最大限度减少方法相关变异性方面发挥关键作用，而持续一致的培训则是实现可靠结果的核心。

A path forward includes the development of structured, competency-based qualification programs for personnel who perform viable surface sampling. These programs should include hands-on instruction with established methods, initial and periodic assessment of the sampler’s skills, and clear procedural guidance that defines essential method parameters such as contact time, applied pressure, and aseptic handling. Ultimately, strengthening personnel training and qualification presents an opportunity to reinforce confidence in the manual microbiological methods widely used in pharmaceutical manufacturing. It is unlikely that current surface sampling methods will be fully replaced by more modern alternatives soon, making a focus on consistency and competency all the more important. Continued investment in education, targeted training, and personnel qualification, particularly when linked to recovery efficiency performance, can help reduce variability and enhance the reliability of microbial surface sampling data in controlled environments.
未来的发展路径包括为执行有活力表面采样的人员制定结构化、基于能力的资质认证计划。这些计划应包含以下内容：

- 采用既定方法的实操指导；   

- 对采样人员技能的初始和定期评估；   

- 明确界定关键方法参数（如接触时间、施加压力、无菌操作）的程序性指南。 

 归根结底，加强人员培训与资质认证有助于增强对制药生产中广泛使用的手动微生物采样方法的信心。当前的表面采样方法短期内不太可能被更现代化的替代方案完全取代，因此，关注操作一致性和人员能力尤为重要。持续投资于教育、针对性培训和人员资质认证（尤其是将其与回收效率表现挂钩时），有助于减少变异性，提升受控环境中微生物表面采样数据的可靠性。

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