Your Lab Partner 12.2

CRNONO

Complete Guide to Grade A/B Sterile Area Cleanroom Garment Selection

从材质到款式的专业指南

A Professional Guide from Material to Style

引言  |  

A/B级无菌区是制药行业中洁净度要求最高的区域，主要用于无菌配制、灌装、冻干等关键工艺操作。在这里，一个微小的污染都可能导致整批产品报废，甚至引发药品安全事件。

Grade A/B sterile areas represent the highest cleanliness requirements in the pharmaceutical industry, used for sterile compounding, filling, and lyophilization. 

EU GMP Annex 1（2022版）和FDA 21 CFR 211.28对无菌区人员着装提出了极为严格的要求：必须穿着经过灭菌的连体洁净服，完全覆盖身体所有部位，且洁净服本身不得成为污染源。这意味着，A/B级洁净服不仅要"穿得住"，更要"穿得对"。

EU GMP Annex 1 (2022) and FDA 21 CFR 211.28 require sterilized coveralls fully covering all body parts.

本文将系统介绍CRNONO（司纳罗）针对A/B级无菌区的产品矩阵，并提供从材质到款式的专业选购指南。

CRNONO offers a complete product line from premium sterile coveralls to standard base layer undergarments.

一、A/B级无菌区：法规与标准要求  

|  Grade A/B Sterile Zones: Regulatory & Standard Requirements

1.1 洁净度定义  |  Cleanroom Classification Specifications

1.2 法规要求要点  |  Core Regulatory Mandates

EU GMP Annex 1（2022版）核心要求：

·无菌区洁净服应经过灭菌处理，确保无菌状态

·洁净服应覆盖全身，包括头部（含面部）、手部和脚部

·洁净服材质不得有纤维脱落，接缝处应密封

·洁净服的使用寿命和洗涤次数应有明确管理

·每位操作人员的洁净服应可追溯

EU GMP Annex 1 (2022 Revision) Key Requirements

• Sterile zone cleanroom garments shall be sterilized to maintain a sterile condition
• Garments must fully cover the entire body, including head (face inclusive), hands and feet
• Garment material shall be non-shedding, with fully sealed seams
• Clear management protocols shall be established to govern garment service life and washing cycles
• Each operator’s cleanroom garments shall be fully traceable
  
  

FDA 21 CFR 211.28要求：

·人员应穿着适合无菌操作的洁净服

·洁净服应保持清洁和无菌状态

·人员进入无菌区前应经过严格的更衣程序

FDA 21 CFR 211.28 Requirements

• Personnel shall wear cleanroom garments suitable for sterile operations
• Garments shall be maintained in a clean and sterile state
• Operators shall complete rigorous gowning procedures prior to entering sterile zones

二、CRNONO A/B级无菌区产品矩阵 

 |  CRNONO Product Portfolio for Grade A/B Sterile Zones

CRNONO针对A/B级无菌区提供完整的产品线，从高端无菌连体服到标准打底内衣，满足不同工艺需求。

CRNONO delivers a comprehensive product line tailored for Grade A/B sterile zones, ranging from premium sterile integrated coveralls to standard base undergarments to satisfy diverse process demands.

2.1 高端无菌系列  |  Premium Sterile Series

GW4L01 / W4L01：高端无菌帽衣裤缝制袜四连服

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

·条纹规格：4mm/5mm条纹/网格

·尺码范围：XS-6XL

·颜色选择：白/蓝/粉/黄

·适用场景：A级无菌灌装、B级无菌配制等最高洁净度场景

GW4L01 / W4L01: Premium 4-in-1 Sterile Coverall with Integrated Hood, Bodice, Trousers & Stitched Booties

• Stripe Specifications: 4mm / 5mm stripes / grid
• Size Range: XS–6XL
• Color Options: White / Blue / Pink / Yellow
• Application Scenarios: High-cleanliness environments including Grade A sterile filling and Grade B sterile formulation
  
  

GW4L02 / W4L02：高端无菌帽衣裤编织袜四连服

·英文名称：Sterile Coverall with Integrated Hood and Knitted Socks

·编织袜设计，脚部贴合性更佳

·适用于需要频繁移动但洁净度要求极高的场景

GW4L02 / W4L02: Premium 4-in-1 Sterile Coverall with Integrated Hood, Bodice, Trousers & Knitted Socks

• Knitted sock design delivers superior foot conformity
• Ideal for high-mobility operations with stringent cleanliness standards
  
  

GWS301 / WS301：高端无菌帽衣裤三连服

·英文名称：Sterile Hooded Cleanroom Coverall

·条纹规格：3mm条纹

·尺码范围：XS-6XL

·三连体设计（帽+衣+裤），脚部需另配洁净鞋/鞋套

GWS301 / WS301: Premium 3-in-1 Sterile Coverall with Integrated Hood

• Stripe Specification: 3mm stripes
• Size Range: XS–6XL
• 3-in-1 integrated design (hood + top + trousers); separate cleanroom shoes or shoe covers required for feet
  
  

GWS302 / WS302：高端平脚口无菌帽衣裤三连服

·英文名称：Sterile Cleanroom Coverall

·平脚口设计，可搭配各类洁净鞋使用

GWS302 / WS302: Premium Sterile Hooded Coverall with Plain Cuffs at Ankles

• Plain ankle cuffs for flexible matching with all types of cleanroom footwear
  
  

GW2L01 / W2L01：高端无菌衣裤二连服

·英文名称：Sterile Cleanroom Coverall

·条纹规格：2mm条纹

·尺码范围：XS-6XL

·二连体设计（衣+裤），需另配无菌帽

GW2L01 / W2L01: Premium 2-in-1 Sterile Top & Trousers

• Stripe Specification: 2mm stripes
• Size Range: XS–6XL
• 2-piece integrated design (top + trousers); separate sterile hood required
  
  

GW2L02 / W2L02：高端平脚口无菌衣裤二连服

·平脚口设计，搭配灵活

GW2L02 / W2L02: Premium 2-in-1 Sterile Coverall with Plain Ankle Cuffs

• Plain ankle cuffs for highly flexible matching options

2.2 标准内衣系列  |  Standard Base Undergarment Series

BWFN02 / WFN02：标准连帽连袜分体内衣

·英文名称：Cleanroom Two-Piece Undergarment

·分体设计，穿着方便

·作为四连服/三连服内层穿着，增强防护

BWFN02 / WFN02: Standard Two-Piece Undergarment with Integrated Hood and Socks

• Split two-piece construction for easy donning and doffing
• Worn as inner layer beneath 3-in-1 or 4-in-1 coveralls to boost protective performance

BWFN01 / WFN01：标准圆领分体内衣

·英文名称：Base Layer Garment

·材质：97%聚酯纤维 + 3%导电纤维

·尺码范围：XS-6XL

·圆领设计，作为洁净服内层基础打底

BWFN01 / WFN01: Standard Crew-Neck Two-Piece Base Undergarment

• Material: 97% Polyester + 3% Conductive Fiber
• Size Range: XS–6XL
• Crew neck design, serving as fundamental inner base layer under cleanroom garments

三、面料科技：为什么材质决定一切 

 | Fabric Technology: Why Material Determines Overall Performance 

A/B级洁净服的面料是防护性能的基础。CRNONO无菌系列面料具备四大核心特性：

Fabric forms the foundation of protective performance for Grade A/B cleanroom garments. CRNONO sterile series fabrics feature four core proprietary properties:

3.1 高阻隔性能  |  High Barrier Performance

采用新型聚酯纤维，通过科学的纤维排列和织物结构设计，同步突破阻尘性、透气性和耐用性的技术瓶颈。面料能有效阻隔人体微粒向洁净环境扩散，同时保证操作人员的透气舒适度。

Novel polyester fibers paired with engineered fiber alignment and woven structure break technical tradeoffs between dust resistance, air permeability and durability. The fabric effectively blocks human-sourced particles from dispersing into clean environments while sustaining breathable comfort for operators.

3.2 防静电性能  | Permanent Anti-Static Performance

面料采用纤维内部导电技术，灰色导电纤维以长方形排列嵌入织物中。相比传统表面涂层防静电处理，内部导电技术不会因洗涤而衰减，防静电性能持久稳定。表面电阻控制在10^6~10^9Ω范围内，满足IEST-RP-CC003.4要求。

Internal fiber conduction technology embeds rectangular grey conductive filaments throughout the weave. Unlike conventional surface-coated anti-static treatments, embedded conductive fibers retain consistent anti-static properties after repeated laundering. Surface resistivity is controlled within 10⁶–10⁹ Ω, fully complying with IEST-RP-CC003.4 standards.

3.3 舒适体感  |  Optimized Wearing Comfort

CRNONO专研洁净面料，在保障防护级别的同时，通过织物密度和后整理工艺优化，减少传统洁净服常见的"气闷感"，并提升面料弹性，使操作人员在长时间穿着时仍能保持良好状态。

CRNONO develops specialized cleanroom textiles that balance robust protection with enhanced wearability. Optimized fabric density and finishing treatments eliminate the stifling sensation common in generic cleanroom apparel and improve fabric elasticity, keeping operators comfortable during extended shifts.

3.4 长效抑菌  |  Long-Lasting Bacteriostasis

经实验室验证，面料在洗涤100次后，抑菌性能仍满足相关标准要求。这一特性对于需要反复洗涤灭菌使用的A/B级洁净服尤为重要。

Laboratory testing verifies antibacterial performance remains compliant with relevant standards after 100 washing cycles — a critical advantage for Grade A/B garments subject to repeated laundering and sterilization.

3.5 耐腐蚀抗温  |  High Corrosion & Temperature Resistance

A/B级洁净服通常需要经过121°C高温蒸汽灭菌。CRNONO面料在接触121°C高温灭菌时不易腐蚀、软化、变形，确保多次灭菌后面料性能不衰减。

Grade A/B garments routinely undergo 121°C high-temperature steam sterilization. CRNONO fabrics resist corrosion, softening and deformation under 121°C autoclave cycles, preserving full material performance across multiple sterilization runs.

四、功能细节：每一处设计都有道理  

|  Functional Design Details: Every Feature Engineered for Purpose

CRNONO洁净服的功能设计体现了"极简但无遗漏"的原则：

CRNONO cleanroom garments follow a "minimalist yet fully comprehensive" design philosophy for functional components:

五、选购要点：A/B级洁净服配置建议 

 | Procurement Guidelines: Grade A/B Cleanroom Garment Configuration Recommendations 

5.1 款式选择决策树  |  Style Selection Decision Tree

是否需要最高级别防护（A级灌装/冻干）？
├─ 是 → 四连服（GW4L01/W4L01），全身一体式覆盖
│       内搭：BWFN02/WFN02 连帽连袜分体内衣
└─ 否（B级配制/辅助操作）
    ├─ 需要独立帽子？ → 三连服（GWS301/WS301）
    └─ 需要灵活搭配？ → 二连服（GW2L01/W2L01）+ 独立无菌帽

Do you require maximum-level protection (Grade A filling / lyophilization)?

├─ Yes → 4-in-1 Coverall (GW4L01/W4L01), full integrated body coverage

│ Inner layer pairing: BWFN02/WFN02 hooded socked two-piece undergarment

└─ No (Grade B formulation / auxiliary operations)

      ├─ Require standalone hood integration? → 3-in-1 Coverall (GWS301/WS301)

     └─ Require flexible matching? → 2-in-1 Coverall (GW2L01/W2L01) + separate sterile hood

5.2 条纹规格选择  |  Stripe Specification Selection Guide

CRNONO洁净服面料的导电纤维以条纹形式排列，不同条纹间距对应不同的防护等级：

·5mm网格/条纹：最高防护级别，适用于A级核心区

·4mm条纹：高防护级别，适用于A级外围和B级核心区

·3mm条纹：标准防护级别，适用于B级区域

·2mm条纹：基础防护级别，适用于B级辅助区

Conductive fibers in CRNONO cleanroom fabrics are arranged in parallel stripes; different stripe spacings correspond to tiered protection grades:

• 5mm grid / stripes: Maximum protection grade, for core Grade A zones
• 4mm stripes: High protection grade, for peripheral Grade A areas and core Grade B zones
• 3mm stripes: Standard protection grade, for general Grade B zones
• 2mm stripes: Basic protection grade, for Grade B auxiliary zones
  
  

5.3 配件推荐  |  Supporting Accessory Recommendations

A/B级无菌区需要配套使用以下配件：

六、总结  |  Conclusion

A/B级无菌区洁净服的选择，不是"选一件衣服"，而是"构建一道无菌屏障"。从面料的纤维排列到拉链的每一个齿，从袖口的罗纹密度到灭菌后的性能保持——每一个环节都不可疏忽。

Selecting cleanroom garments for Grade A/B sterile zones is far more than purchasing apparel — it means constructing an intact sterile barrier. No step can be overlooked, from fiber alignment in base fabrics and zipper teeth structure, to rib density on cuffs and post-sterilization performance retention.

CRNONO以国家标准制定者的技术深度、24年的行业积累和头部药企的实战验证，为A/B级无菌区提供从四连服到分体内衣的完整产品矩阵。合规是底线，耐用是保障，舒适是加分——三者缺一不可。

As a national standard drafting institution with 24 years of industry expertise and validated performance at leading pharmaceutical manufacturers, CRNONO delivers a complete product ecosystem for Grade A/B sterile zones spanning full 4-in-1 coveralls to split undergarments. Regulatory compliance forms the baseline, durability delivers reliable performance, and comfort adds operational value — all three elements are indispensable.

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

A/B级无菌区选购检查清单（Checklist）  |  

 选购检查清单  |  Purchasing Checklist

[ ] 是否已确认A/B级区域的具体洁净度要求？

Have you confirmed specific cleanliness requirements for Grade A/B areas?

[ ] 洁净服是否经过灭菌处理（121°C高温蒸汽/辐照）？

Are garments sterilized (121C steam / radiation)?

[ ] 面料条纹规格是否匹配对应洁净等级？

Does the fabric stripe specification match the cleanliness grade?

[ ] 款式选择是否覆盖全身（头/面/手/脚）？

Does the style provide full body coverage?

[ ] 是否配置了内层打底内衣？

Are base layer undergarments configured?

[ ] 配件（眼罩/口罩/手套/鞋套）是否为无菌级？

Are accessories sterile grade?

[ ] 拉链/按扣是否为耐腐蚀洁净级？

Are zippers/snaps corrosion-resistant cleanroom grade?

[ ] 是否有双重门襟设计？

Is there a double placket design?

[ ] 尺码是否覆盖全体操作人员？

Do sizes cover all operators?

[ ] 是否建立了洁净服洗涤灭菌次数追溯记录？

Is there a wash/sterilization cycle traceability record?