Your Lab Partner 12.3

CRNONO

Grade C/D Clean Area Cleanroom Garment Selection Guide

标准配置与性价比分析

Standard Configuration and Cost-Effectiveness Analysis

引言  |  

在制药企业的洁净区规划中，A/B级无菌区往往最受关注，而C/D级洁净区虽然洁净度要求相对较低，但同样承担着关键的生产职能。片剂生产、口服液灌装、原料药精制、包装材料准备等工艺通常在C/D级洁净区进行，这些区域的洁净服选择同样关乎产品质量和合规性。

Grade C/D areas serve critical production functions including tablet production, oral liquid filling, and API purification. Over-specifying A/B garments wastes money; under-specifying creates risks. The key is finding the optimal balance between compliance and cost.

如果C/D级区域"过度配置"A/B级洁净服，会造成不必要的成本浪费；如果"配置不足"，则可能带来污染风险和审计缺陷。如何在合规与成本之间找到最佳平衡点？本文将结合CRNONO（司纳罗）C/D级产品矩阵，为您提供专业选购指南。

Over-specification of Grade A/B cleanroom garments for Grade C/D zones leads to unnecessary cost waste, while under-specification poses contamination risks and audit deficiencies. How to strike the optimal balance between regulatory compliance and cost control? This article presents a professional purchasing guide supported by CRNONO’s complete product portfolio for Grade C/D clean zones.

一、C/D级洁净区：定义与要求  |  

1.1 洁净度标准  |  

1.2 法规要求  |  Regulatory Mandates

·C级：应穿着连体或两件式洁净服，覆盖头发和胡须，面料应低发尘、防静电

·D级：应穿着合适的洁净服，覆盖头发和胡须，面料应不易产生纤维脱落

• Grade C: Operators shall wear one-piece or two-piece cleanroom garments covering all hair and facial hair; fabrics must be low-shedding and anti-static.
• Grade D: Appropriate cleanroom garments covering hair and beards are required, constructed from non-fiber-shedding materials.
  
  

与A/B级的关键区别在于：C/D级洁净服不强制要求无菌状态，但仍需严格控制发尘量和防静电性能。这意味着C/D级洁净服在面料选择上可以采用更经济的方案，但在核心防护性能上不可妥协。

The core distinction from Grade A/B zones lies in sterilization obligations: Grade C/D garments are not mandated to be sterile, yet particulate shedding and anti-static performance remain strictly controlled. This allows more economical fabric solutions for C/D apparel without compromising core protective properties.

二、CRNONO C/D级洁净区产品矩阵 

 |  CRNONO Product Portfolio for Grade C/D Clean Zones

2.1 标准打底服  |  Standard Base Layer Garments

BTDD01 / TDD01：标准打底服

·英文名称：Base Layer Garment

·材质：防静电碳黑涤纶丝针织布

·尺码范围：XS-6XL

·颜色选择：白/蓝

·适用场景：C/D级洁净服内层打底，增强穿着舒适度和防护效果

BTDD01 / TDD01 Standard Base Layer Garment

• Material: Anti-static black carbon polyester filament knit fabric
• Size Range: XS–6XL
• Color Options: White / Blue
• Application: Worn underneath Grade C/D cleanroom garments to enhance wear comfort and secondary protection.
  
  

2.2 标准洁净连体服系列  |  Standard Integrated Cleanroom Coverall Series

BJ4L01 / J4L01：标准洁净衣帽裤缝制袜四连服

·英文名称：Cleanroom Coverall with Integrated Hood and Booties

·全身一体式覆盖，缝制袜设计

·适用于C级核心区域，需要较高洁净度的操作场景

BJ4L01 / J4L01 Standard 4-in-1 Coverall with Integrated Hood, Bodice, Trousers & Stitched Booties

• Full-body integrated coverage with stitched booties
• Suitable for core Grade C zones requiring high cleanliness during critical operations
  
  

BJ4L02 / J4L02：标准洁净衣帽裤编织袜四连服

·编织袜设计，脚部贴合性更佳

·适用于C级区域中需要频繁移动的场景

BJ4L02 / J4L02 Standard 4-in-1 Coverall with Integrated Hood, Bodice, Trousers & Knitted Socks

• Knitted sock construction delivers superior foot conformity
• Designed for high-mobility operations within Grade C zones

BJS301 / JS301：标准洁净帽衣裤三连服

·英文名称：Cleanroom Hooded Cleanroom Coverall

·条纹规格：3mm条纹

·尺码范围：XS-6XL

·颜色选择：蓝/白/粉/黄/本白

·三连体设计，灵活性更高

BJS301 / JS301 Standard 3-in-1 Hooded Cleanroom Coverall

• Stripe Specification: 3mm conductive stripes
• Size Range: XS–6XL
• Color Options: Blue / White / Pink / Yellow / Natural White
• Integrated hood-top-trouser design with excellent operational flexibility

BJS302 / JS302：标准平脚口洁净帽衣裤三连服

·平脚口设计，可搭配各类洁净鞋使用

·适用于C/D级区域

BJS302 / JS302 Standard 3-in-1 Hooded Coverall with Plain Ankle Cuffs

• Plain ankle cuffs compatible with all styles of cleanroom footwear
• Applicable to both Grade C and Grade D zones

BJ2L01 / J2L01：标准洁净衣裤二连服

·英文名称：Cleanroom Coverall

·条纹规格：2mm条纹

·尺码范围：XS-6XL

·颜色选择：蓝/白/粉/黄

·二连体设计，需另配洁净帽

BJ2L01 / J2L01 Standard 2-in-1 Cleanroom Coverall

• Stripe Specification: 2mm conductive stripes
• Size Range: XS–6XL
• Color Options: Blue / White / Pink / Yellow
• Two-piece integrated top-trouser design; separate cleanroom hood required
  
  

BJ2L02 / J2L02：标准平脚口洁净衣裤二连服

·平脚口设计，搭配灵活

BJ2L02 / J2L02 Standard 2-in-1 Coverall with Plain Ankle Cuffs

• Plain ankle cuffs enabling flexible footwear matching
  
  

2.3 高端洁净分体服  |  Premium Two-Piece Cleanroom Garments

GJFT02 / JFT02：高端连帽洁净分体服

·英文名称：Cleanroom Two-Piece Garment

·材质：97%聚酯纤维 + 3%导电纤维

·尺码范围：XS-6XL

·颜色选择：蓝/白/粉/黄/本白

·分体设计，上下装独立穿着，方便更换

·适用于D级区域或C级非核心区域

GJFT02 / JFT02 Premium Hooded Two-Piece Cleanroom Suit

• Material: 97% Polyester + 3% Conductive Fiber
• Size Range: XS–6XL
• Color Options: Blue / White / Pink / Yellow / Natural White
• Separable top and trousers for convenient donning, doffing and replacement
• Ideal for Grade D zones or non-core Grade C areas

三、C/D级 vs A/B级：关键差异对比  

|Grade C/D vs Grade A/B: Core Performance Comparison  

理解C/D级与A/B级洁净服的差异，是做出正确选型的基础：

四、性价比分析：如何优化采购成本 

 |  Cost-Performance Analysis: Strategies to Optimize Procurement Expenses

4.1 按区域精准配置  

|  Targeted Garment Allocation by Clean Zone Classification

制药企业不同区域的洁净等级不同，洁净服配置应"对号入座"：

C级核心区（配液/过滤等）
   → BJ4L01/J4L01 四连服 + BTDD01/TDD01 打底服
   → 条纹规格：3mm

C级非核心区（物料缓冲/清洗等）
   → BJS301/JS301 三连服
   → 条纹规格：3mm

D级核心区（制粒/压片/包衣等）
   → BJ2L01/J2L01 二连服 + 洁净帽
   → 条纹规格：2mm

D级非核心区（包装/暂存等）
   → GJFT02/JFT02 分体服
   → 灵活搭配，成本最优

Pharmaceutical facilities feature zones with varying cleanliness grades; garments must be assigned to match each zone’s specification precisely:

• Core Grade C Zones (media preparation, filtration):BJ4L01/J4L01 4-in-1 coverall + BTDD01/TDD01 base layer, 3mm conductive stripes
• Non-Core Grade C Zones (material airlocks, washing stations):BJS301/JS301 3-in-1 coverall, 3mm conductive stripes
• Core Grade D Zones (granulation, tableting, coating):BJ2L01/J2L01 2-in-1 coverall + separate clean hood, 2mm conductive stripes
• Non-Core Grade D Zones (packaging, intermediate storage):GJFT02/JFT02 two-piece suit for maximum cost efficiency
  
  

4.2 总拥有成本（TCO）考量  |  Total Cost of Ownership (TCO) Assessment

洁净服的成本远不止采购单价，应从全生命周期评估：

4.3 颜色管理策略  |  Color-Coded Zone Management Strategy

CRNONO C/D级洁净服提供蓝/白/粉/黄/本白多种颜色选择。建议企业采用颜色管理策略，通过不同颜色区分区域和岗位：

·蓝色：C级生产区

·白色：D级核心生产区

·黄色：D级辅助区/维修人员

·粉色：参观人员/临时人员

·本白：特殊岗位

颜色管理不仅直观清晰，还便于管理人员快速识别是否有人员"串区"，降低交叉污染风险。

CRNONO Grade C/D garments are available in blue, white, pink, yellow and natural white. Facilities are recommended to implement color zoning to distinguish production areas and job roles:

• Blue: Grade C production zones
• White: Core Grade D production zones
• Yellow: Grade D auxiliary areas / maintenance staff
• Pink: Visitors / temporary contractors
• Natural White: Specialized job stations

Color coding delivers intuitive visual identification, enabling supervisors to quickly detect unauthorized cross-zone movement and mitigate cross-contamination risks.

五、选购要点：C/D级洁净服配置建议  

| Purchasing Guidelines: Grade C/D Garment Configuration Recommendations 

5.1 材质选择  |  

C/D级洁净服面料以100%聚酯纤维长丝为主体，嵌入导电纤维实现防静电功能。关键指标：

·发尘量：应符合GB/T 24249要求

·防静电性能：表面电阻10^6~10^9Ω

·透气性：在保障阻隔性的前提下，尽量提升透气性

·耐洗涤性：应能经受至少50次以上洗涤而不显著衰减

Grade C/D cleanroom fabrics are primarily constructed from continuous polyester filament embedded with conductive fibers for static dissipation. Key performance indicators:

• Particle shedding: Compliant with GB/T 24249
• Anti-static performance: Surface resistivity between 10⁶ Ω and 10⁹ Ω
• Air permeability: Maximized while retaining effective particulate barrier performance
• Wash durability: Sustained performance with no significant degradation after a minimum of 50 wash cycles

5.2 款式选择建议  |  

5.3 配件搭配  |  

C/D级区域配件无需无菌级别，但应选用洁净级：

六、总结  |  Conclusion

C/D级洁净区的洁净服选择，核心在于"精准匹配"——既不能为追求安全而过度配置造成浪费，也不能为节约成本而降低防护标准。关键在于深刻理解不同区域的洁净度要求，并选择对应等级的产品。

The core principle for selecting Grade C/D cleanroom garments lies in precise matching. Over-specifying for extra safety generates unnecessary expenditure, while cost-cutting via under-specification compromises protective standards. Facilities must fully understand zone-specific cleanliness requirements and select corresponding tiered garments.

CRNONO为C/D级洁净区提供从标准打底服到高端分体服的完整产品矩阵，配合多颜色管理和智慧工服系统，帮助制药企业在合规前提下实现成本最优化。记住：最好的洁净服不是最贵的那件，而是最适合你的生产工艺的那件。

CRNONO provides a complete Grade C/D product lineup ranging from standard base layers to premium two-piece suits, complemented by multi-color zoning solutions and intelligent uniform management systems. This portfolio enables pharmaceutical manufacturers to achieve cost optimization without violating regulatory compliance. Remember: the optimal cleanroom garment is not the most expensive option, but the one perfectly tailored to your production processes.

----------------------------------------

C/D级洁净区选购检查清单（Checklist）  |  

选购检查清单  |  Purchasing Checklist

[ ] 是否已明确C/D级各子区域的洁净度要求？

Have you identified cleanliness requirements for C/D sub-areas?

[ ] 洁净服面料是否符合GB/T 24249防静电洁净织物标准？

Does fabric comply with GB/T 24249?

[ ] 条纹规格是否匹配区域洁净等级（C级3mm，D级2mm）？

Does stripe specification match area grade (C:3mm, D:2mm)?

[ ] 款式是否满足区域操作需求（连体/分体）？

Does style meet operational needs?

[ ] 是否配置了标准打底服作为内层？

Is a standard base layer configured?

[ ] 配件是否选用洁净级（非无菌级即可）？

Are accessories cleanroom grade (not sterile)?

[ ] 颜色管理方案是否已制定并落实？

Is a color management plan established?

[ ] 尺码是否覆盖全体员工（XS-6XL）？

Do sizes cover all employees?

[ ] 洗涤方案是否已确定（自洗/外包）？

Is a washing plan determined?

[ ] 总拥有成本（TCO）是否已评估？

Has TCO been evaluated?