ISO 5 级是什么意思？

ISO 14644-1 中 ISO 5 指每立方米空气中 ≥0.5 µm 颗粒不超过 3,520 颗，常用于无菌灌装等关键区；每升一级允许浓度约差 10 倍。

EU GMP Annex 1（2022 版）改了什么？

引入强制污染控制策略（CCS）、明确 A-D 四级在静止/动态下的限值，并要求 Grade A 关键操作做连续粒子监测。

洁净室为什么不能用普通拖把？

普通拖把会掉毛、扬尘，破坏粒子控制；应使用超细纤维拖把/无尘擦拭布与 HEPA 真空，避免纤维残留与交叉污染。

制药洁净室常用哪几级？

多为 ISO 5-8：ISO 5 用于关键无菌操作，ISO 6 为支持区，ISO 7-8 用于准备间与较低要求区。对应 EU GMP 的 A-D 级。

洁净室与制药 GMP 清洁设备指南（ISO 14644 与 EU Annex 1）

按 ISO 14644-1:2015 分级（ISO 5=3,520 颗/m³、ISO 8=352 万颗/m³）与 EU GMP Annex 1（2022 版）A-D 级要求，配置 HEPA 真空、超细纤维拖把、无尘擦拭布与除尘地垫，覆盖 ISO 5-8 日常清洁。

Following ISO 14644-1:2015 (ISO 5 = 3,520 particles/m³, ISO 8 = 3.52M) and EU GMP Annex 1 (2022) Grades A-D, configure HEPA vacuums, microfiber mops, lint-free wipes and entrance mats for daily ISO 5-8 cleaning.

洁净室分级：ISO 14644-1:2015

Cleanroom classification: ISO 14644-1:2015

该标准按每立方米空气中 ≥0.5 µm 颗粒数把洁净室分为 1-9 级，每升一级允许浓度约差 10 倍。常见值：ISO 5 = 3,520 颗/m³，ISO 7 = 352,000 颗/m³，ISO 8 = 3,520,000 颗/m³。制药行业最常使用 ISO 5-8 级。

This standard classifies cleanrooms from ISO 1 to 9 by the number of ≥0.5 µm particles per cubic metre of air, with each step up allowing roughly 10 times more. Typical values: ISO 5 = 3,520 particles/m³, ISO 7 = 352,000/m³, ISO 8 = 3,520,000/m³. Pharmaceutical sites most often use ISO 5-8.

制药无菌：EU GMP Annex 1（2022 版）

Sterile pharma: EU GMP Annex 1 (2022)

2022 年发布、2023 年 8 月 25 日生效的 Annex 1 定义 A/B/C/D 四级：A 级对应 ISO 5（关键无菌操作）、B 级为 ISO 5 静态/ISO 7 动态、C 级为 ISO 7/8、D 级为 ISO 8。它首次强制要求污染控制策略（CCS）并对 Grade A 区关键操作做连续粒子监测。

Published in 2022 and effective 25 August 2023, Annex 1 defines Grades A-D: A equals ISO 5 (critical aseptic operations), B is ISO 5 at rest / ISO 7 in operation, C is ISO 7/8, and D is ISO 8. It mandates a Contamination Control Strategy (CCS) for the first time and requires continuous particle monitoring in Grade A critical operations.

清洁工具的核心要求：无脱落、抗静电、HEPA 过滤

Core tool requirements: low-shedding, anti-static, HEPA filtration

洁净室不能用普通扫把和棉拖把——它们会掉纤维、扬尘，直接破坏粒子控制。正确组合是 HEPA 过滤真空、超细纤维（低绒）、抗静电工具与专用无尘擦拭布。

Ordinary brooms and cotton mops shed fibres and raise dust, destroying particle control. The right combination is HEPA-filtered vacuums, microfiber (low-lint), anti-static tools and dedicated lint-free wipes.

地面与台面：超细纤维拖把 + 无尘擦拭布

Floors and surfaces: microfiber mop + lint-free wipes

用超细纤维拖把配合经过验证的清洁剂擦拭地面，避免普通棉拖把掉毛；设备表面与台面用无尘擦拭布处理，杜绝纤维残留与交叉污染。

Use a microfiber mop with a validated cleaner for floors instead of cotton mops that shed lint; handle equipment and bench surfaces with lint-free wipes to avoid fibre residue and cross-contamination.

入口污染控制：铝合金除尘地垫

Entry contamination control: aluminium entrance mats

在更衣间、缓冲间入口铺设铝合金除尘地垫，截留鞋底带入的颗粒与泥沙，从源头降低洁净区的污染负荷，是分级控制的第一道物理屏障。

Lay aluminium dust-control mats at gowning and buffer-zone entrances to trap particles and grit brought in on shoes, cutting the contamination load on the clean zone at the first physical barrier.

监测与文件：粒子计数与清洁 SOP

Monitoring and documentation: particle counts and cleaning SOP

按 ISO 14644-2 做持续监测，建立书面清洁 SOP 与记录；A 级区关键操作需连续粒子监测，微生物限值与换气次数须纳入污染控制策略。

Monitor per ISO 14644-2, keep a written cleaning SOP and records; Grade A critical operations need continuous particle monitoring, with microbial limits and air-change rates built into the CCS.

ApexClean 洁净室清洁设备组合

ApexClean cleanroom cleaning set

抗静电 HEPA 真空 + 超细纤维拖把 + 工业无尘擦拭布 + 铝合金除尘地垫，覆盖 ISO 5-8 的日常清洁与消毒收尾，可对接客户的清洁验证与审计需求。

An anti-static HEPA vacuum + microfiber mop + industrial lint-free wipes + aluminium entrance mat covers daily ISO 5-8 cleaning and disinfection finishing, and can feed a client's cleaning validation and audit needs.