Cleanrooms play a key role in managing contamination. They protect delicate processes and products from particles and microbes that could harm them. However, cleanrooms aren’t all the same. Various sectors like pharma, biotech, space tech, chip making, and more stick to their own rules and groups based on what they need. In this post, we will explain how cleanroom rules change from one industry to another, what guides they use, and why these differences are important.
What is a Cleanroom Standard?
At its heart, a cleanroom has an environment that keeps airborne particles, microbes, and contaminants to a minimum. The ISO 14644-1 standard classifies cleanrooms by counting the number and size of particles in each cubic meter of air.
Here are some examples:
- ISO Class 1: <10 particles (0.1µm or larger)
- ISO Class 5: You’ll often find this in drug manufacturing (like making sterile medications)
- ISO Class 8: This comes into play for less sensitive tasks (such as packaging).
But don’t forget, while ISO standards set the groundwork, every industry adds its own rules and expectations on top.
1. Pharmaceutical Industry Should follow Cleanroom Standards
Key Standards:
- ISO 14644
- FDA cGMP (21 CFR Part 210 & 211)
- EU GMP Annex 1
Unique Requirements:
Pharmaceutical cleanrooms this advanced cleanroom prioritise sterility. This industry focuses on both particulate and microbiological control, especially in aseptic processing. Environmental monitoring, HEPA filtration, gowning protocols, and frequent validation are essential.
Classification Example:
- Grade A (ISO 5): Critical zones where sterile products are exposed.
- Grade B (ISO 5 at rest / ISO 7 in operation): Background environment for aseptic areas
2.Biotechnology Industry
Key Standards:
- ISO 14644
- FDA cGMP (Part 600 for biologics)
Unique Requirements:
While biotech cleanrooms share some similarities with pharmaceutical ones, they often deal with living cells, proteins, or gene therapy products. This brings an increased focus on preventing cross-contamination and ensuring that environments remain sterile yet biologically active.
Emphasis:
- Containment of genetically modified organisms (GMOs)
- Airflow direction and pressure differentials
- Segregation of upstream and downstream processes.
3. Aerospace & Defense
Key Standards:
- ISO 14644
- NASA-STD-8739.1
- MIL-STD-1246
Unique Requirements:
In aerospace the use of cleanroom standards, contamination can compromise spacecraft systems, optics, and satellite integrity. While sterility isn’t required, particle control is extremely strict.
Focus Areas:
- Molecular contamination control
- Surface cleanliness levels (often measured in Angstroms)
- Electrostatic discharge (ESD) protection
4. Semiconductor & Electronics Cleanroom Standards
Key Standards:
- ISO 14644
- IEST-RP-CC001
- SEMI Standards
Unique Requirements:
Semiconductor manufacturing is done in ultra-clean environments (often ISO Class 1–3). One speck of dust can ruin a microchip.
FOCUS AREA
- Sub-micron particle control
- Static control and outgassing
- Continuous monitoring of airborne molecular contamination (AMC)
5. Medical Device Manufacturing For Cleanroom Standards
Key Standards:
- ISO 13485
- ISO 14644
- FDA QSR (21 CFR Part 820)
Unique Requirements:
Medical devices require cleanrooms to meet the cleanliness level of the product’s risk classification. Sterility isn’t always required but bio burden control and traceability are.
Common Cleanroom standard Classes:
- ISO 7–8 for most assembly processes
- ISO 5–6 for final sterilization steps
Why the Differences Matter
Each industry balances risk, cost, and product sensitivity differently. While a pharmaceutical company can’t afford microbial contamination, a semiconductor fab is more concerned with nanometer scale particulates. Understanding these differences helps companies.
- Stay compliant with regulatory bodies
- Design appropriate cleanroom environment
- Protect product quality and patient/user safety
Looking to build or upgrade a cleanroom tailored to your industry?
👉 Contact our cleanroom specialists today for expert guidance on standards, design, equipment, and compliance.
Whether you are in biotech, aerospace, or pharma we’ll help you create an environment where quality and precision come first.
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