In healthcare, pharmaceuticals, diagnostics, and advanced manufacturing, even the smallest airborne particle can compromise safety, quality, or patient outcomes. A cleanroom is more than a dust-free space; it is a precisely engineered environment designed to control contamination, air quality, temperature, humidity, and pressure.

Modern cleanroom solutions are vital for hospitals, modular operation theatres, pharmaceutical facilities, diagnostic laboratories, and high-tech industries like electronics and food processing. They ensure compliance with stringent standards, protect patients and products, and provide staff with a safe, functional workspace.

This page explains cleanroom principles in clear, easy-to-understand language while showcasing the technical depth required for healthcare and high-performance industries.

What is a Cleanroom? (Simple Explanation)

A cleanroom is a controlled space where airborne particles, microbial contamination, temperature, and humidity are maintained within strict limits. Unlike ordinary rooms, cleanrooms use specialised construction materials, air handling systems, and finishes to prevent contamination.

They are categorised by classes (ISO 5 to ISO 9) based on particle concentration, with healthcare facilities typically aligning with NABH and WHO guidelines, while industries like pharmaceuticals adhere to GMP and ISO standards.

Key Elements of a Modern Cleanroom

1. Architecture & Layout

• Wall Panels: Modular PUF panels or powder-coated steel partitions for seamless construction.
• Doors & Windows: Hermetically sealed cleanroom doors and view panels to maintain pressure balance.
• Flooring: Epoxy or vinyl flooring for a seamless, chemical-resistant finish.
• Ceilings: Modular ceiling grids integrated with HEPA filters and lighting.
• Learn more about specialised PUF Insulated Doors and Operation Theatre Doors designed to meet cleanroom hygiene standards.

2. HVAC & Filtration

• Air Handling Units (AHUs): Provide filtered, conditioned air.
• HEPA Filters: Remove 99.97% of airborne particles ≥0.3 microns.
• Air Changes per Hour (ACH): Higher rates ensure dilution of contaminants.
• Pressure Control: Positive or negative pressure zoning depending on application (e.g., sterile compounding vs isolation rooms).

Our Turnkey Projects service ensures cleanroom HVAC systems are designed, validated, and documented to meet global benchmarks.

3. Finishes & Surfaces

• Epoxy flooring for seamless cleaning in pharma and healthcare.
• Vinyl flooring for flexibility in electronics and diagnostics labs.
• Antimicrobial coatings to reduce bioburden.

4. Services Integration

• Lighting: LED fixtures designed for cleanroom ceilings.
• Medical gases & utilities: For healthcare cleanrooms and ICUs.
• Fire safety & emergency exits: Integrated with fire exit doors for compliance.

Types of Cleanrooms by Industry

Healthcare & Hospitals

In hospitals and surgical centres, cleanrooms take the form of modular operation theatres and ICUs, where sterility saves lives. These require specialised designs to comply with NABH standards.

Pharmaceuticals

Pharma cleanrooms must align with GMP standards, ensuring sterility during production and packaging. Our dedicated pharmaceutical cleanroom solutions address this need.

Diagnostics & Laboratories

Diagnostics labs demand controlled environments for accurate test results. Learn more about solutions for diagnostics laboratories.

Electronics & Semiconductors

Even a speck of dust can destroy a semiconductor wafer. Our electronics & semiconductors cleanrooms achieve ISO Class 5–7 conditions.

Food & Beverages

In food and beverage facilities, cleanrooms maintain hygiene, preventing microbial contamination and ensuring product safety.

For sector-specific case studies, explore industries we serve.

Advantages of Modular Cleanroom Solutions

• Faster Installation — Prefabricated panels and doors reduce project timelines.
• Flexibility — Easy expansion or reconfiguration as processes evolve.
• Cost-Effective — Reduced civil work and downtime.
• Better Quality Control — Factory-manufactured components ensure consistent quality.
• Compliance Ready — Built to meet NABH, WHO, GMP, and ISO standards.

Turnkey Approach for Cleanroom Solutions

We provide end-to-end solutions through our Turnkey Projects model:

• Requirement Assessment — Understanding your process, compliance needs, and space.
• Design & Engineering — Layouts optimised for airflow, zoning, and workflow.
• Manufacturing — In-house production of cleanroom doors, panels, and flooring systems.
• Installation — Rapid modular assembly with minimal disruption.
• Validation — Particle counts, airflow testing, and HEPA integrity checks.
• Documentation & Training — Complete handover for accreditation and audits.

Compliance & Standards — Why It Matters

Cleanrooms must be compliance-ready to avoid regulatory issues. Key references include:

• NABH guidelines for hospitals and OTs.
• WHO recommendations on infection control and sterile environments.
• GMP and ISO standards for pharma and manufacturing cleanrooms.

Validation tests include:

• Airflow velocity and uniformity tests.
• HEPA leak and integrity tests.
• Pressure differential verification.
• Microbiological monitoring.

Common Questions (FAQs)

Q. What class of cleanroom is needed for hospitals?
A. Modular OTs typically require ISO Class 7 or 8 conditions with laminar airflow and HEPA filtration.

Q. Are modular cleanrooms durable?
A. Yes. With proper maintenance, modular cleanrooms last 15–20 years or longer.

Q. Can cleanrooms be customised for small labs?
A. Absolutely. Modular systems scale from compact diagnostic labs to large pharma plants.

Q. What is the difference between cleanrooms for pharma vs electronics?
A. Pharma cleanrooms focus on microbial control; electronics cleanrooms prioritise particle control at sub-micron levels.

Q. How often should HEPA filters be replaced?
A. Typically every 1–3 years, depending on usage and test results.

Maintenance & Lifecycle Management

• Preventive Maintenance: Regular checks of HVAC, filters, and seals.
• HEPA Testing: Integrity tests ensure continued performance.
• Flooring Care: Epoxy and vinyl floors require periodic polishing and repairs.
• Documentation: Keep logs for audits and NABH/ISO compliance.

Looking to build a cleanroom that balances compliance, performanchttps://operationtheaterdoors.com/resources/e, and cost? Explore our Cleanroom Solutions service page for detailed offerings, or reach out directly via Contact Us. You can also read more insights on our Blog and download technical guides from our Resources section.

Why AUM Industries is the Right Partner

Delivering a cleanroom is not just about walls and filters; it is about precision engineering, compliance expertise, and lifecycle support.

AUM Industries combines deep knowledge in healthcare, pharmaceuticals, diagnostics, and high-tech industries with in-house manufacturing of cleanroom components. From design to commissioning, we provide turnkey cleanroom solutions trusted by hospitals and industries across India.