CRNONO

CNC Controlled Area Workwear Selection Guide

实用性与经济性的平衡

Balancing Practicality and Economy

引言  |  Introduction

在制药企业的整体环境控制体系中，CNC（Controlled Non-Classified，受控非分级）区域是一个容易被忽视但又不可或缺的环节。CNC区域不是洁净室，但也不是普通办公环境——它有着明确的环境控制要求，需要在实用性与经济性之间找到平衡点。

Within the overall environmental control system of pharmaceutical manufacturers, CNC (Controlled Non-Classified) zones are an easily overlooked yet indispensable component. A CNC zone is neither a cleanroom nor a regular office space; it has defined environmental control criteria and requires a balanced approach that reconciles practicality and cost-effectiveness.

许多药企在CNC区域的工服选择上容易走两个极端：要么"高配"洁净服造成成本浪费，要么"低配"普通工装导致环境控制失效。本文将结合CRNONO（司纳罗）CNC区域产品线，为您提供专业选购指南。

Many pharmaceutical companies fall into two extreme practices when selecting uniforms for CNC zones: over-specifying with full cleanroom garments, which creates unnecessary expenditure, or under-specifying with ordinary workwear, leading to failed environmental control. Drawing on CRNONO’s full product line tailored for CNC zones, this article delivers professional procurement guidance.

一、CNC受控区：定义与特点 

 |  CNC Controlled Zones: Definition and Characteristics

1.1 什么是CNC区域  |  1.1 Definition of CNC Zones

CNC（Controlled Non Classified）受控区，是指对环境参数（如温度、湿度、压差）有一定控制要求，但不达到GMP洁净级别（A/B/C/D）的区域。在制药企业中，CNC区域通常包括： 

·物料接收与暂存区：原料、辅料、包装材料的接收和暂存

·一般生产区：非无菌制剂的非关键工序

·走廊与缓冲区：连接不同洁净等级区域的通道

·辅助功能区：设备清洗间（非洁净级）、维修间等

·质量检验区（非微生物）：理化检验等非无菌操作区域

CNC (Controlled Non-Classified) controlled zones refer to areas with regulated environmental parameters (temperature, humidity, differential pressure, etc.) that do not meet GMP cleanroom grades (Grade A/B/C/D). Typical CNC areas in pharmaceutical facilities include:

• Material receiving and staging zones: Receipt and temporary storage of raw materials, excipients and packaging materials
• General production areas: Non-critical procedures for non-sterile formulations
• Corridors and airlocks: Passageways connecting zones of varying cleanliness classifications
• Auxiliary functional areas: Non-clean equipment washing rooms, maintenance workshops, etc.
• Non-microbiological quality control labs: Physical and chemical testing and other non-sterile operations
  
  

1.2 CNC区域工服的核心需求  

| Core Performance Requirements for CNC Zone Uniforms 

CNC区域虽然不要求洁净室级别的防护，但工服仍需满足以下要求：

·防静电：保护电子设备、防止粉尘吸附

·低发尘：控制区域内的粒子水平

·耐洗涤：频繁洗涤不影响性能

·穿着舒适：适应长时间日常作业

·识别度：便于区分不同岗位和区域

与洁净区工服的关键区别在于：CNC区域工服不需要极低发尘量，不需要灭菌处理，防静电要求可适度放宽，因此可以采用更具成本优势的方案。 

While CNC zones do not demand cleanroom-grade protection, uniforms must satisfy the following criteria:

• Anti-static performance: Safeguard electronic equipment and prevent dust adhesion
• Low particle shedding: Maintain acceptable particulate levels within the zone
• Launder resistance: Retain stable performance after repeated washing cycles
• Wear comfort: Suitable for long-duration daily operations
• Visual differentiation: Easy identification by job role and work zone
  
  

The key distinction from cleanroom apparel: CNC uniforms do not require ultra-low particle shedding or sterilization, and anti-static thresholds can be moderately relaxed, enabling more cost-efficient material solutions.

二、CRNONO CNC区域产品矩阵 

 | CRNONO Product Portfolio for CNC Zones

2.1 高端系列  |  Premium Series

GJFT01 / JFT01：高端洁净分体服

·英文名称：Cleanroom Two-Piece Garment

·分体设计，上下装独立穿着

·适用于CNC区域中有较高防静电和低发尘要求的岗位

GJFT01 / JFT01 Premium Two-Piece Cleanroom Suit

• Split two-piece construction for separate top and trouser donning
• Designed for CNC zone positions requiring enhanced anti-static and low-shedding performance
  
  

GJDG01 / JDG01：高端洁净大褂

·英文名称：Cleanroom Lab Coat

·材质：97%聚酯纤维 + 3%导电纤维

·尺码范围：XS-6XL

·颜色选择：蓝/白

·适用于QC实验室、巡检、参观接待等场景

GJDG01 / JDG01 Premium Cleanroom Lab Coat

• Material: 97% Polyester + 3% Conductive Fiber
• Size Range: XS–6XL
• Color Options: Blue / White
• Ideal for QC laboratories, routine patrol inspections and visitor reception
  
  

2.2 标准系列  |  Standard Series

BKFT01 / KFT01：标准工作分体服

·英文名称：Two-Piece Work Clothes

·材质：98%聚酯纤维 + 2%导电纤维

·尺码范围：XS-6XL

·颜色选择：蓝/白/粉/黄

·适用于CNC区域日常生产作业

BKFT01 / KFT01 Standard Two-Piece Work Suit

• Material: 98% Polyester + 2% Conductive Fiber
• Size Range: XS–6XL
• Color Options: Blue / White / Pink / Yellow
• Suitable for routine production operations in CNC zones
  
  

BKFT02 / KFT02：标准连帽工作分体服

·连帽设计，覆盖头发

·适用于CNC区域中有粉尘产生的工序

BKFT02 / KFT02 Standard Hooded Two-Piece Work Suit

• Integrated hood design for full hair coverage
• Recommended for CNC zone processes generating airborne dust
  
  

BKDG01 / KDG01：标准工作大褂

·英文名称：Lab Coat

·材质：98%聚酯纤维 + 2%导电纤维

·尺码范围：XS-6XL

·颜色选择：白/蓝

·适用于一般辅助岗位、仓库管理、设备巡检等

BKDG01 / KDG01 Standard Work Lab Coat

• Material: 98% Polyester + 2% Conductive Fiber
• Size Range: XS–6XL
• Color Options: White / Blue
• Applied to general auxiliary roles, warehouse management and equipment patrol inspections
  
  

三、CNC区域 vs 洁净区：选型差异分析  

|CNC Zones vs Cleanrooms: Specification & Selection Differences  

3.1 材质差异对比  | Material Performance Comparison

3.2 款式差异对比  | Garment Style Comparison 

四、成本效益分析  | Cost-Benefit Analysis 

4.1 采购成本对比  | Procurement Cost Comparison 

以100人配置为例，不同方案的年度成本对比：

Cost projection for a facility with 100 staff across three specification strategies:

过度配置不仅增加采购成本，还增加洗涤和管理成本；低配则可能导致环境监测不达标，带来更大的合规风险成本。

Over-specification inflates procurement, laundry and administrative overheads. Under-specification may trigger out-of-spec environmental monitoring results, leading to far costlier regulatory non-compliance liabilities.

4.2 "2%导电纤维"的经济价值  

|Economic Advantages of the 2% Conductive Fiber Formulation  

CRNONO标准系列工服采用98%聚酯纤维 + 2%导电纤维的配方，相比洁净区的3%导电纤维配方：

·成本降低约15-20%：导电纤维用量减少

·防静电性能足够：2%配比已能满足CNC区域防静电需求

·透气性更优：导电纤维比例降低，面料透气性提升

·舒适度提升：更柔软的触感，适合日常长时间穿着

CRNONO’s standard uniform range adopts a 98% polyester + 2% conductive fiber blend, delivering clear economic benefits compared to the 3% conductive fiber mix used for cleanroom apparel:

• Approximately 15–20% cost reduction via lower conductive fiber dosage
• Sufficient static dissipation performance to meet all CNC zone anti-static requirements
• Improved air permeability thanks to reduced conductive fiber content
• Softer fabric hand feel for enhanced comfort during all-day shifts
  
  

五、选购要点：CNC区域工服配置建议  

| Procurement Guidelines: CNC Zone Uniform Matching Recommendations 

5.1 岗位匹配方案  |  

5.2 颜色管理方案  | Color-Coded Zone Management System

CNC区域工服提供蓝/白/粉/黄四种颜色，建议：

·蓝色：常驻生产人员

·白色：QC/质量管理人员

·黄色：设备维修/工程人员

·粉色：参观人员/临时访客

颜色管理不仅提升管理效率，还能在审计时直观展示企业的人员管控体系。

CRNONO CNC uniforms are available in blue, white, pink and yellow; the following color zoning scheme is advised:

• Blue: Permanent production operators
• White: QC and quality management personnel
• Yellow: Engineering and equipment maintenance teams
• Pink: Visitors and temporary contractors

Color coding streamlines on-site management and provides auditors with a clear visual demonstration of the facility’s personnel segregation controls.

5.3 配件搭配建议  | Supporting Accessory Matching Guidelines  

CNC区域配件选用标准工作级即可：

六、总结  | Conclusion 

CNC受控区的工服选择，体现了制药企业成本管理的精细化水平。不是所有区域都需要最顶级配置，也不是所有地方都能"省着用"——关键在于精准匹配需求与产品。

The selection of uniforms for CNC controlled zones reflects the precision of a pharmaceutical manufacturer’s cost management protocols. Not every area requires top-tier protective apparel, nor can every zone cut corners on protection standards — the core principle lies in precise alignment between operational demands and garment performance grades.

CRNONO为CNC区域提供从高端洁净大褂到标准工作分体服的完整产品线，配合2%导电纤维的经济配方和多颜色管理方案，帮助企业在满足环境控制要求的前提下，实现成本最优化。记住：工服管理的最高境界，是让每一分钱都花在刀刃上。

CRNONO offers a complete CNC zone product portfolio spanning premium cleanroom lab coats to standard two-piece work suits. Combined with the cost-efficient 2% conductive fiber fabric formula and multi-color zone identification system, our lineup enables manufacturers to minimize total expenditure while fully satisfying environmental control specifications.

The highest standard of uniform management is ensuring every investment delivers maximum targeted value.

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CNC受控区选购检查清单（Checklist）  |  

选购检查清单  |  Purchasing Checklist

[ ] 是否已明确CNC区域的环境控制要求（温湿度/压差）？

Have you identified CNC area environmental control requirements?

[ ] 工服防静电性能是否满足区域设备防护需求？

Does workwear anti-static performance meet equipment protection needs?

[ ] 材质选择是否匹配岗位需求（98%聚酯+2%导电纤维）？

Does material match position needs (98%+2%)?

[ ] 款式是否适应操作特点（分体服/大褂）？

Does style suit operational characteristics?

[ ] 颜色管理方案是否已制定并落实？

Is a color management plan established?

[ ] 配件是否选用标准工作级（非洁净级/无菌级）？

Are accessories standard work grade?

[ ] 尺码是否覆盖全体人员（XS-6XL）？

Do sizes cover all personnel?

[ ] 洗涤方案是否已确定？

Is a washing plan determined?

[ ] 是否避免了过度配置（误用洁净级工服）？

Have you avoided over-specification?

[ ] 年度工服预算是否按TCO模型评估？

Is the annual budget evaluated using TCO?