Cleanroom Knowledge Hub
Plain-English guides to cleanroom standards, validation, testing and project planning. Whether you are specifying your first cleanroom or reviewing an existing facility, these resources will help you make informed decisions.
Standards & Compliance
ISO 14644 vs GMP: What's the Difference?
ISO 14644 and EU GMP are both used to classify and regulate cleanroom environments, but they serve different purposes. This guide explains the relationship between the two and how they apply to pharmaceutical, healthcare and manufacturing environments.
GMP Annex 1: What It Means for Your Cleanroom
EU GMP Annex 1 sets out requirements for the manufacture of sterile medicinal products. The 2022 revision introduced significant changes. This guide explains the key requirements and their implications for cleanroom design and operation.
ISO Cleanroom Classification: A Plain-English Guide
ISO 14644-1 classifies cleanrooms by the concentration of airborne particles. This guide explains each ISO class from ISO 1 to ISO 9, the equivalent GMP grades, and which classification your industry typically requires.
Validation & Testing
Filter Integrity Testing in Cleanrooms
Filter integrity testing is a critical step in verifying that HEPA and ULPA filters are free from defects and performing to specification. This guide explains how testing is carried out, what pass/fail criteria apply, and when retesting is required.
Cleanroom Particle Count Testing: What to Expect
Particle count testing is the primary method of classifying a cleanroom to ISO 14644-1. This guide explains how testing is conducted, what at-rest and in-operation testing means, and how to interpret your classification results.
HEPA Filter Integrity Testing (DOP/PAO): A Guide
HEPA filter integrity testing — also known as DOP or PAO testing — verifies that filters are installed correctly and free from defects. This guide explains the test method, when it is required and what pass/fail criteria apply.
Project Planning
How Long Does a Cleanroom Installation Take?
Project timelines vary significantly depending on cleanroom type, size, classification requirements and regulatory framework. This guide provides realistic timeline expectations for modular cleanroom installation, with and without validation.
What Does a Cleanroom Installation Cost?
Cleanroom installation costs depend on a range of factors including room size, ISO classification, construction method, sector-specific requirements and validation scope. This guide explains the key cost drivers and provides indicative cost ranges by ISO class.
Choosing the Right Cleanroom Type: Hardwall vs Modular vs Softwall
There are three main types of cleanroom construction: hardwall (stick-built), modular panel and softwall. Each has different cost, lead time and performance characteristics. This guide helps you understand which is right for your project.
ISO Cleanroom Classification — Full Reference
ISO 14644-1:2015 classifies cleanrooms from ISO Class 1 (most stringent) to ISO Class 9 (least stringent), based on the maximum concentration of airborne particles ≥0.1µm.
| ISO Class | GMP Grade | Max Particles ≥0.5µm / m³ | Typical Applications |
|---|---|---|---|
| ISO 1 | — | 10 | Semiconductor, nanotechnology (ultra-critical zones) |
| ISO 2 | — | 100 | Semiconductor research |
| ISO 3 | — | 1,000 | Hard disk manufacture |
| ISO 4 | — | 10,000 | Microelectronics |
| ISO 5 | Grade A / B | 100,000 | Aseptic filling, critical pharmaceutical zones |
| ISO 6 | Grade B | 1,000,000 | Background to ISO 5 aseptic suites |
| ISO 7 | Grade C | 352,000 | Less critical pharmaceutical manufacturing steps |
| ISO 8 | Grade D | 3,520,000 | Preparation areas, gowning rooms, medical devices |
| ISO 9 | — | 35,200,000 | Controlled environments — room air |
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