Your Lab Partner 12.1

Cleanroom Garments in the Pharmaceutical Industry: Why Are They More Important Than You Think?

从GMP合规到药品安全，洁净服是制药企业最不可忽视的第一道防线

From GMP compliance to drug safety, cleanroom garments are the indispensable first line of defense

引言  |  

2023年，某国内知名药企在无菌制剂生产过程中，因洁净区人员防护不到位，导致一批次产品微生物限度超标，最终整批产品报废，直接经济损失超过200万元。事后调查发现，问题根源并非空调净化系统故障，也非操作流程失误，而是——洁净服的防护性能不达标。

In 2023, a well-known domestic pharmaceutical company experienced microbial limit exceedance in a batch of sterile preparations due to inadequate personnel protection in the clean area. The entire batch was scrapped, with direct losses exceeding 2 million RMB. The root cause was substandard cleanroom garment protective performance. 

这个案例并非孤例。在制药行业，洁净服往往被视为"消耗品"而非"关键工艺设备"，许多企业在采购时只关注价格，忽视了防护性能、耐用性和合规性。然而，在GMP监管日益严格的今天，洁净服的选择直接关系到药品质量、审计通过率和企业声誉。

This is not an isolated case. In the pharmaceutical industry, cleanroom garments are often treated as consumables rather than critical process equipment. With increasingly stringent GMP regulations, garment selection directly impacts drug quality, audit pass rates, and corporate reputation. 

从行业视角出发，本文系统梳理制药行业洁净服的重要性，并介绍在该领域深耕24年的CRNONO（司纳罗）品牌如何以专业实力重新定义洁净服标准。

This article systematically examines the importance of cleanroom garments and introduces how CRNONO, with 24 years of expertise, is redefining cleanroom garment standards.

一、洁净服：药品质量背后的"隐形守护者"  

|  Cleanroom Garments: The "Invisible Guardians" Behind Pharmaceutical Quality

1.1 洁净服的核心功能  |  Core Functions

制药行业洁净服绝非普通工作服的"升级版"，它承担着三重关键使命：

Cleanroom garments for pharmaceutical manufacturing are far more than an "upgraded version" of ordinary workwear. They fulfill three pivotal core missions:

保护产品免受人员污染。研究表明，一个静止状态下的人体每分钟会释放约10,000个微粒，而在正常活动时这一数字可飙升至1,000,000个。人体皮屑、毛发、呼吸飞沫、化妆品残留——这些对于无菌药品而言都是致命的污染源。洁净服的首要功能，就是将这些污染物有效阻隔在洁净区之外。

Protect products from personnel-induced contamination

Research shows a stationary human body releases approximately 10,000 particles per minute, and this figure can surge to 1,000,000 during regular physical activity. Human dander, hair, respiratory droplets, and cosmetic residues all constitute lethal contaminants for sterile pharmaceuticals. The primary function of cleanroom garments is to effectively block such contaminants outside cleanroom zones.

保护人员免受药品暴露风险。在高活性药物（HPAPI）、抗肿瘤药物、激素类药物的生产过程中，操作人员面临显著的职业暴露风险。合格的洁净服不仅要"防出"，还要"防入"，为操作者提供可靠的防护屏障。

Protect personnel from pharmaceutical exposure risks

During the production of High Potency Active Pharmaceutical Ingredients (HPAPIs), anti-tumor drugs and hormonal medications, operators face substantial occupational exposure hazards. Qualified cleanroom garments deliver dual protection: they prevent contaminants from exiting the wearer while also blocking hazardous substances from penetrating to the skin, forming a reliable protective barrier for operating staff.

维持洁净环境稳定性。洁净服本身的发尘量直接影响洁净室的洁净度等级。如果洁净服面料不合规、接缝处密封不良或配件脱落，洁净室的HVAC系统将承受额外的污染负荷，长期运行成本也会显著增加。

Stabilize the cleanliness of controlled environments

Particle shedding from cleanroom garments directly determines the cleanliness classification of cleanrooms. Non-compliant fabric, poorly sealed seams or detachable accessories on garments will impose extra contamination loads on the cleanroom HVAC system, driving up long-term operational costs significantly.

1.2 GMP对洁净服的明确要求  

|  Mandatory GMP Requirements for Cleanroom Garments

《药品生产质量管理规范》（GMP）对洁净服提出了明确要求：

·A/B级洁净区：应穿着无菌连体服，覆盖全身皮肤，包括头部、面部、手部和脚部，面料应为无脱落物材质，并经过灭菌处理

·C级洁净区：应穿着连体或两件式洁净服，覆盖头发和胡须

·D级洁净区：应穿着合适的洁净服，覆盖头发和胡须

此外，EU GMP Annex 1（2022版）进一步强化了对无菌区洁净服的要求，强调"污染控制策略（CCS）"中必须包含洁净服的生命周期管理。

The Good Manufacturing Practice (GMP) sets clear specifications for cleanroom apparel:

• Grade A/B clean zones: Sterile one-piece coveralls covering the entire body, including head, face, hands and feet, shall be worn. Fabrics must be non-shedding and subjected to sterilization treatment.
• Grade C clean zones: One-piece or two-piece cleanroom garments that fully cover hair and beards are required.
• Grade D clean zones: Appropriate cleanroom garments covering hair and beards shall be adopted.
• 
  

Furthermore, EU GMP Annex 1 (2022 Revision) tightens the criteria for garments used in sterile zones, mandating that Contamination Control Strategies (CCS) incorporate full lifecycle management of cleanroom garments.

二、CRNONO（司纳罗）：24年专注，重新定义洁净服专业标准  

| 24 Years of Specialization, Redefining Professional Standards for Cleanroom Garments 

2.1 品牌溯源  |  Brand Origin

CRNONO（司纳罗）是成都创世食安科技有限公司旗下品牌，由成都创始织造有限公司与上海创助纺织科技有限公司共同运营。自2002年创立至今，品牌已走过24年发展历程，始终专注于功能性职业工装的研发与制造。

CRNONO is a proprietary brand under Chengdu Chuangshi Food Safety Technology Co., Ltd., jointly operated by Chengdu Chuangzhi Weaving Co., Ltd. and Shanghai Chuangzhu Textile Technology Co., Ltd. Founded in 2002, the brand has accumulated 24 years of industry experience, focusing exclusively on the R&D and manufacturing of functional protective workwear.

这不是一个"什么赚钱做什么"的通用服装厂，而是一家将全部精力投入到洁净防护领域的专业企业。24年的专注，意味着对每一个缝线、每一种面料、每一个配件的深度理解。

CRNONO is not a general apparel factory chasing short-term profits across diverse sectors; it is a specialized enterprise dedicating all its resources to cleanroom protection. Twenty-four years of focused specialization enables in-depth mastery over every stitch, fabric type and accessory component.

2.2 实力数据  |  

2.3 标准制定者：从"执行标准"到"制定标准"  |  

CRNONO不仅通过了ISO质量管理体系认证，更获得国家高新技术企业和创新型中小企业认证。更值得关注的是，CRNONO是多项国家标准和行业标准的主编单位：

CRNONO holds ISO quality management system certification, alongside national High-Tech Enterprise and Innovative SME accreditations. Most notably, CRNONO serves as the lead drafting entity for multiple national and industrial standards:

其中，T/CNGA 85-2025 和 T/CPAPE 07-2025 两项团体标准专门针对制药行业洁净服制定，CRNONO作为主编单位，对制药行业洁净服的技术要求、测试方法和管理规范做出了系统性定义。

Among these standards, T/CNGA 85-2025 and T/CPAPE 07-2025 are tailored exclusively to pharmaceutical cleanroom garments. As the lead drafting organization, CRNONO systematically defines technical requirements, testing methods and management protocols for pharmaceutical-grade cleanroom apparel.

从"执行标准"到"制定标准"，这是企业技术实力的最高证明。

Evolving from a standard follower to a standard formulator stands as the highest testament to an enterprise’s technical prowess.

三、三大核心优势：合规、耐用、舒适  |  

CRNONO洁净服的竞争优势可以概括为三个关键词：

CRNONO cleanroom garments boast three defining strengths summarized by three keywords:

3.1 合规（Compliance）  |  

CRNONO洁净服全面符合GMP、IEST等国内外标准，覆盖A/B/C/D/CNC全场景需求。这意味着无论你的生产线处于哪个洁净等级，CRNONO都能提供对应的合规方案，无需在多个供应商之间"拼凑"。

CRNONO garments fully comply with domestic and international specifications including GMP and IEST, delivering customized solutions for all cleanliness grades (Grade A/B/C/D & CNC controlled zones). Manufacturers operating any cleanroom classification can source fully compliant apparel from CRNONO without assembling supplies from multiple disparate vendors.

3.2 耐用（Durability）  |  

CRNONO的耐用性体现在"辅件与主体同等耐用"的设计理念上。许多品牌的洁净服在主体面料尚可使用时，拉链、按扣、袖口等辅件已经老化失效。CRNONO通过强化结构设计，实现耐洗、耐高温、耐老化、耐储存，使用寿命提升20%以上。

CRNONO embodies a design philosophy that auxiliary components match the service life of garment main bodies. For many competing products, zippers, snap fasteners, cuffs and other fittings degrade and fail long before the main fabric reaches the end of its usable life. CRNONO reinforces structural design to achieve superior resistance to repeated washing, high-temperature sterilization, aging and storage, extending garment service life by over 20%.

3.3 舒适（Comfort）  |  

洁净服的舒适度直接影响操作人员的工作效率和失误率。CRNONO基于人体工学、运动力学、心理感知、湿热适应四维分析，在保障防护级别的同时，舒适性提升120%。这并非营销噱头，而是通过面料选型、版型设计和工艺优化实现的系统性改进。

The comfort level of cleanroom garments directly impacts operators’ work efficiency and error rates.CRNONO conducts four-dimensional analysis covering ergonomics, kinematics, sensory psychology and heat-moisture adaptability. While maintaining full protective performance, its garments deliver a 120% improvement in wear comfort. This advantage is not mere marketing rhetoric, but systematic optimization realized through targeted fabric selection, tailored pattern design and refined manufacturing craftsmanship.