Your Lab Partner 12.7

CRNONO

Cleanroom Garment Standards System and Complete Selection Guide

一张表搞定所有配置

One Table Covers All Configurations

引言  | Introduction

制药行业洁净服的选购，本质上是一个"标准符合性"问题。从国际法规到国家标准，从行业规范到企业内控——每个层级的标准都对洁净服提出了明确的技术要求。然而，标准的复杂性往往让采购人员和生产管理者感到困惑：到底应该遵循哪个标准？不同标准之间如何衔接？如何将标准要求转化为具体的采购方案？

Cleanroom garment selection is fundamentally a standards compliance issue. From international regulations to national standards, each level sets clear technical requirements. 

本文将系统梳理制药行业洁净服相关的标准体系，并给出一份"从标准到配置"的全流程选购攻略，帮助您一步到位完成洁净服选型。

We will provide a complete standards-to-configuration guide.

一、国际标准体系  | International Standard System 

1.1 GMP法规  | GMP Regulations 

关键合规要点：

·A/B级：必须穿着灭菌连体服，全覆盖

·C级：连体或两件式洁净服，覆盖头发

·D级：合适洁净服，覆盖头发

·洁净服的灭菌、洗涤、使用次数必须有记录

Key Compliance Notes

• Grade A/B: Fully enclosed sterilized one-piece coveralls are mandatory
• Grade C: One-piece or two-piece cleanroom garments with full hair coverage
• Grade D: Appropriate cleanroom garments with full hair coverage
• Complete records shall be retained for garment sterilization, laundering and maximum service cycles

1.2 IEST标准  |  IEST Standards

IEST-RP-CC003.4是洁净服面料性能测试的国际权威标准，涵盖发尘量、粒子阻隔率、静电衰减时间等关键指标。

IEST-RP-CC003.4 is the globally recognized authoritative standard for cleanroom fabric performance testing, covering critical indicators such as particle generation rate, particulate barrier efficiency and static decay time.

1.3 USP标准  |  USP Standards

二、国内标准体系  | Domestic Standard System 

2.1 国家标准（GB）  |  National Standards (GB)

2.2 行业标准（FZ）  |  Industrial Standards (FZ)

2.3 团体标准（T）  |  Group Standards (T)

CRNONO作为5项标准的编制单位，对制药行业洁净服的技术要求、测试方法和管理规范有最深入的理解。这意味着选择CRNONO，就是选择最接近标准本质的产品。

As the lead drafting organization for five national, industrial and group standards, CRNONO possesses in-depth expertise in technical specifications, test methods and management protocols for pharmaceutical cleanroom apparel. Choosing CRNONO means selecting products engineered to align with the core intent of official standards.

三、材质合规要点  |  Material Compliance Requirements

3.1 低尘抗静电  |  Low Particle Generation & Antistatic Performance

·面料发尘量应符合IEST-RP-CC003.4和GB/T 24249要求

·表面电阻应控制在10^6~10^9Ω范围

·导电纤维应采用内部导电技术，洗涤不衰减

• Fabric particle generation shall comply with IEST-RP-CC003.4 and GB/T 24249
• Surface resistivity shall be maintained within the range of 10⁶–10⁹ Ω
• Conductive fibers adopt internal conductive technology with stable performance without attenuation after repeated laundering
  
  

3.2 透气滤尘平衡  |  Balanced Breathability & Particle Filtration

·透气率应在保障阻隔性的前提下尽量提升

·粒子阻隔率（≥0.5μm）应达到相应等级要求

·湿阻值应控制在合理范围，避免过度气闷

• Air permeability shall be optimized while retaining high barrier performance
• Blocking efficiency against particles ≥0.5 μm shall meet the requirements of corresponding cleanliness grades
• Appropriate moisture vapor resistance to prevent excessive stuffiness
  
  

3.3 耐腐蚀抗温  | Chemical & Thermal Resistance

·应能承受121°C高温蒸汽灭菌（A/B级）

·接触常用消毒剂（乙醇、过氧化氢等）不腐蚀

·多次灭菌后物理性能不显著衰减

• Withstand saturated steam sterilization at 121°C (for Grade A/B zones)
• Resist corrosion upon contact with common disinfectants such as ethanol and hydrogen peroxide
• Physical properties shall not degrade significantly after multiple sterilization cycles

四、分区配置方案：一张表搞定所有配置  

| Zonal Configuration Scheme: All-in-One Specification Table  

4.1 分区标准配置建议表 

 |  Recommended Standard Configuration by Cleanliness Grade

4.2 条纹规格对应表  

| Stripe Specification Reference Table  

五、尺码体系  |  Sizing System

5.1 服装尺码表  |  Garment Size Chart

*注：以上为参考尺码，实际选购时应以试穿为准。CRNONO提供XS-6XL全尺码覆盖。*

Note: Sizes are for reference only; on-site fitting is recommended for final selection. CRNONO provides full sizing coverage from XS to 6XL.

5.2 鞋码表  |  Shoe Size Chart

5.3 手套尺码表  |  Glove Size Chart

5.4 帽子/鞋套尺码  | Headwear & Shoe Cover Sizing 

帽子、披肩帽和鞋套均提供XS-6XL或均码选择，具体尺码参照服装尺码表对应。

Caps, shawl caps and shoe covers are available in XS–6XL or one-size-fits-all variants, matched to the garment sizing chart above.

六、选购决策流程  | Product Selection Decision Workflow 

6.1 五步决策法  |  Five-Step Selection Methodology

第一步：确定洁净等级
  │  对照GMP分区，明确A/B/C/D/CNC
  │
  ▼
第二步：选择材质
  │  确认面料规格：条纹间距、导电纤维配比
  │  确认面料特性：发尘量、防静电、透气性
  │
  ▼
第三步：选择款式
  │  连体/分体？四连/三连/二连？
  │  缝制袜/编织袜/平脚口？
  │
  ▼
第四步：选择配件
  │  帽子、口罩、手套、鞋/鞋套、眼罩
  │  配件等级与主服一致
  │
  ▼
第五步：确定尺码
  │  统计全员尺码分布
  │  服装XS-6XL、鞋35-50码、手套6-11号
  │  建议预留10%余量

Step 1: Confirm Cleanliness ClassificationRefer to GMP zoning to define applicable grade: A / B / C / D / CNC

Step 2: Select Fabric SpecificationsConfirm stripe pitch and conductive fiber ratioVerify fabric performance: particle generation, antistatic property, air permeability

Step 3: Select Garment StyleOne-piece or split design? 4-piece / 3-piece / 2-piece coverall?Sewn socks / knitted socks / plain cuffs?

Step 4: Match Supporting AccessoriesCaps, masks, gloves, shoes / shoe covers, gogglesAccessory cleanliness grade shall be consistent with main coveralls

Step 5: Finalize SizingCollect full staff size distribution dataGarments: XS–6XL; Shoes: EU 35–50; Gloves: Size 6–11A 10% stock buffer is recommended

6.2 选购决策速查表  | Quick Selection Reference Table 

七、总结  | Conclusion

洁净服选购不是"选一件衣服"，而是"构建一套合规的防护体系"。从国际法规到国家标准，从材质要求到配件配置，从尺码选择到管理方案——每一个环节都需要基于标准、结合实际、系统规划。

Selecting cleanroom garments is far more than purchasing a single piece of apparel — it requires building a fully compliant protective system. Every link, from international and domestic regulatory standards, material specifications and accessory matching to sizing selection and asset management, demands systematic planning grounded in official standards and on-site operational realities.

CRNONO作为5项国家/行业/团体标准的主编单位，不仅提供全等级、全品类的产品矩阵，更提供基于标准深度的专业选型指导。本文提供的分区配置表、尺码体系和决策流程，旨在帮助制药企业一步到位完成洁净服选型。

As the lead drafting unit for five national, industrial and group standards, CRNONO delivers a full-spectrum product portfolio covering all cleanliness grades, alongside professional technical guidance rooted in deep standard expertise. The zoning configuration tables, sizing guidelines and decision workflows outlined in this document enable pharmaceutical manufacturers to complete standardized cleanroom garment procurement efficiently.

记住：合规是底线，适配是关键，标准是依据，CRNONO是伙伴。

Core principles to bear in mind: Compliance is the baseline, adaptability is the priority, standards are the foundation, and CRNONO is your trusted partner.

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洁净服选购全攻略检查清单（Checklist）  

选购检查清单  |  Purchasing Checklist

[ ] 是否已确认对应区域的GMP洁净等级？

Have you confirmed the GMP cleanliness grade?

[ ] 洁净服是否符合EU GMP/FDA/NMPA对应要求？

Do garments comply with EU GMP/FDA/NMPA?

[ ] 面料性能是否满足IEST-RP-CC003.4标准？

Does fabric meet IEST-RP-CC003.4?

[ ] 是否符合GB/T 24249防静电洁净织物标准？

Does it comply with GB/T 24249?

[ ] 面料是否为100%聚酯纤维长丝？

Is fabric 100% polyester filament?

[ ] 导电纤维配比是否匹配等级（3%/2%）？

Does stripe specification match grade?

[ ] 条纹规格是否匹配洁净等级？

Does style meet full coverage?

[ ] 面料是否通过100次洗涤验证？

Do accessory grades match garment?

[ ] 款式是否满足区域全覆盖要求？

Do sizes cover XS-6XL?

[ ] 配件等级是否与主服匹配？

Do shoe sizes cover 35-50?

[ ] 头/面/手/脚各部位是否均有防护？

Does supplier have standard-setting qualifications?

[ ] 包装用品是否配置齐全？

Has TCO been evaluated?

[ ] 是否已统计全员尺码分布？

Has the size distribution of all staff been tallied?

[ ] 服装尺码是否覆盖XS-6XL？

Are garment sizes available ranging from XS to 6XL?

[ ] 鞋码是否覆盖35-50码？

Are shoe sizes covered from EU 35 to 50?

[ ] 手套尺码是否覆盖6-11号？

Are glove sizes available from Size 6 to Size 11?

[ ] 供应商是否具备标准编制资质？

Does the supplier hold qualification as a national standard drafting unit?

[ ] 供应商是否有制药行业头部客户案例？

Does the supplier have proven track records with leading pharmaceutical manufacturers?

[ ] 供应商是否提供智慧工服管理方案？

Can the supplier provide an intelligent uniform lifecycle management system?

[ ] 供应商是否提供完善的售后服务？

Does the supplier offer comprehensive after-sales service support?

[ ] 是否按TCO模型评估总成本？

Has the total cost of ownership (TCO) been evaluated?

[ ] 洗涤/灭菌/管理成本是否纳入预算？

Have laundry, sterilization and garment management costs been included in the budget?

[ ] 一次性配件消耗量是否预估？

Has the consumption volume of disposable accessories been estimated?

[ ] 是否有备货和应急方案？

Is there a stock reserve plan and emergency contingency plan in place?