Cleanroom Systems for Hospitals | ISO 5 & ISO 7 Operating Theatre Solutions | OPES ORION
Home / Services / Infrastructure / Cleanroom Systems
Healthcare Infrastructure

CLEANROOM SYSTEMS
FOR HOSPITALS

Planning a new operating theatre or upgrading infection control systems?
OPES ORION designs and delivers ISO 5 & ISO 7 cleanroom environments engineered for surgical precision, regulatory compliance, and long-term operational performance.

Healthcare-grade cleanroom engineering ISO 14644 compliant airflow systems Integrated OT & HVAC solutions

In modern hospital projects, cleanroom systems are not optional — they are critical to surgical safety, infection control, and regulatory compliance.

Understanding Cleanrooms

What Is a Hospital Cleanroom?

A hospital cleanroom is a specially engineered space where the air quality, temperature, humidity, and pressure are tightly controlled to prevent airborne contamination from reaching patients or sterile equipment.

In a standard room, air contains thousands of microscopic particles — dust, bacteria, skin cells. During surgery, even one of these particles landing on an open wound can cause a life-threatening Surgical Site Infection (SSI).

A cleanroom eliminates that risk by continuously filtering the air through HEPA filters, pushing clean air down over the patient in an unbroken curtain — a process called laminar airflow — and exhausting any contaminated air away from the surgical field.

99.995%
H14 HEPA Filtration Efficiency
0.3μm
Smallest Particle Captured
20×
Air Changes Per Hour vs. Standard Room
+15 Pa
Positive Pressure vs. Corridor

HEPA Filtration

High-Efficiency Particulate Air (HEPA) filters capture 99.995% of airborne particles down to 0.3 microns — including bacteria, viruses, and fungal spores.

Laminar Airflow

Clean air flows downward in a smooth, uniform sheet from ceiling to floor — forming an invisible sterile curtain over the patient and pushing contaminants away continuously.

Positive Pressure Zones

The operating theatre is kept at slightly higher air pressure than surrounding corridors. This ensures that air always flows outward — not in — blocking external contaminants from entering.

Temperature & Humidity Control

OT environments are maintained at 18–22°C and 50–60% relative humidity — conditions that inhibit bacterial growth while keeping surgical teams and patients comfortable.

For new builds and OT upgrades, cleanroom design must be integrated early into architectural and MEP planning to ensure full compliance and performance.

══════════════════════════════════════ -->
ISO Classification

ISO 5 vs ISO 7
Cleanroom Standards

Cleanrooms are classified under ISO 14644, which defines allowable airborne particle concentration per cubic metre. Every hospital operating theatre requires at least two zones — each with a different ISO classification.

Selecting the correct cleanroom classification depends on surgical function, risk level, and regulatory requirements — a critical decision during hospital design and upgrading phases.

ISO 5

Ultra-Clean Surgical Zone

Max 3,520 particles (≥0.5μm) per m³

ISO 5 is the highest level of air cleanliness required in clinical settings. This ultra-clean zone is maintained directly above the operating table — protecting the patient and sterile instruments at the most critical moment. Think of it as an invisible sterile shield over the patient.

  • Laminar airflow canopy above operating table
  • Sterile surgical instrument zones
  • Pharmaceutical sterile compounding areas
  • Implant and prosthetics preparation zones
ISO 7

Operating Theatre Room

Max 352,000 particles (≥0.5μm) per m³

ISO 7 cleanliness is maintained throughout the entire operating theatre room. While less stringent than the surgical field directly above, this controlled environment is essential for preventing contamination from reaching the sterile core — and for protecting the wider surgical team.

  • Full operating theatre environment
  • Clean medical preparation and scrub rooms
  • Pharmaceutical processing areas
  • Medical diagnostic laboratories
Engineering Reference
Precision Airflow: Integrating ISO 5 & ISO 7 Standards in the Operating Theatre
Precision Airflow — How ISO 5 & ISO 7 work together inside a hospital operating theatre, from 3-stage filtration through to the pressure cascade hierarchy.
Technical Reference
OPES ORION Cleanroom Systems — Full Engineering Overview
Covers ISO standards, airflow physics, filtration stages, pressure cascades & integration requirements.
Read Full PDF
How ISO 5 & ISO 7 Work Together — Dual-Zone Cleanroom Approach
ISO 5 ZONE
Sterile Surgical Field — Operating Table
air pushes contaminants away
ISO 7 ZONE
Full Operating Theatre Room
The laminar airflow system creates an ISO 5 sterile zone directly above the patient, while the surrounding ISO 7 zone maintains overall theatre cleanliness — together delivering the highest standard of surgical infection control in line with international cleanroom standards.
ISO 14644 HTM 03-01 ASHRAE 170 MOH Compliant
Project Enquiry

Planning a Cleanroom
For Your Facility?

Designing a new operating theatre
Upgrading infection control systems
Expanding surgical capacity
Aligning with ISO / MOH compliance

OPES ORION provides end-to-end cleanroom engineering and implementation tailored to your project requirements.

Request Technical Consultation
The Process

How We Build Your Cleanroom

From design brief to commissioning and lifecycle support, OPES ORION delivers fully integrated cleanroom systems aligned with MOH, ISO 14644, and HTM standards — ensuring compliance, performance, and operational continuity.

STEP 01

Design & Engineering

Our architects and MEP engineers develop a cleanroom layout tailored to your clinical workflows — covering airflow modelling, pressure zoning, HVAC sizing, and full MOH regulatory compliance review.

KKM · JKR · C-CAP Submissions
STEP 02

Installation & Build

We install all cleanroom systems in your live or new hospital environment — modular OT walls, laminar airflow units, HEPA filtration, medical gas, and all M&E works — with minimal disruption to ongoing operations.

Modular · M&E · Medical Gas
STEP 03

Testing, Commissioning & Support

Every system is tested and commissioned to ISO 14644, HTM 03-01, and MOH standards before handover — with ongoing preventive maintenance, 24/7 technical support, and lifecycle management thereafter.

ISO Verified · Lifecycle Support

This structured approach ensures seamless coordination between infrastructure, clinical systems, and medical technologies across every phase of your project.

══════════════════════════════════════ -->
Technical Performance

Aseptic Airflow Dynamics

Our laminar flow systems utilise a pressurised ceiling plenum and H14 HEPA filtration to deliver a uniform column of sterile air — effectively displacing pathogens away from the surgical field continuously throughout every procedure.

Filtration H14 HEPA — 99.995% particle removal at 0.3μm
Laminar Velocity 0.36 – 0.54 m/s (ISO 14644 standard range)
Pressure +15 Pa maintained vs. adjacent zones
Air Changes 20–25 ACH minimum in OT environments
Temperature 18 – 22°C ± 1°C controlled
Humidity 50 – 60% RH ± 5% maintained
HEPA Filtration Ceiling — Laminar Airflow
Surgical Field
OPES ORION Solutions

Designed for Healthcare Precision

We specialise in designing and implementing advanced healthcare cleanroom systems for hospitals, surgical centres, and clinical environments — delivering fully integrated solutions from concept to lifecycle support.

01
Airflow Engineering

Laminar Airflow Systems

Laminar airflow systems deliver a steady, unidirectional stream of HEPA-filtered air across the surgical field. This controlled airflow pushes contaminants away from the patient and instruments — maintaining sterile conditions throughout every procedure.

  • Unidirectional downflow ceiling units
  • HEPA H13 / H14 filtration
  • Variable airflow volume control
  • ISO 5 zone compliance testing
02
HVAC Engineering

Hospital HVAC & Pressure Control

Healthcare HVAC goes far beyond standard air conditioning. We design and install full hospital-grade ventilation systems — maintaining precise positive and negative pressure differentials to prevent cross-contamination between zones.

  • Positive / negative pressure zoning
  • Multi-zone HVAC with BMS integration
  • Chilled water systems and AHUs
  • Energy-efficient variable air volume control
03
Modular Systems

Modular Operating Theatre Walls

Our modular OT wall systems use medical-grade HPL panels with hermetically sealed joints — designed for rapid decontamination, clinical durability, and fast on-site installation even within live hospital environments.

  • Anti-bacterial HPL wall panels
  • Hermetically sealed silicone joints
  • Flush-mounted cleanroom LED lighting
  • Integrated service panels and outlets
04
Infection Control

Bio-Safety & Isolation Rooms

We design negative pressure isolation rooms and positive pressure immunocompromised suites for high-dependency and infectious disease environments — preventing pathogen transmission while maintaining full patient care access.

  • Negative / positive pressure isolation
  • Airlock ante-room design
  • HEPA exhaust filtration
  • Real-time pressure differential monitoring
Where We Work

Clinical Applications

Cleanroom environments are required across multiple high-risk clinical spaces — not just operating theatres.

Operating Theatre

Operating Theatres

Standard and hybrid OTs requiring ISO 5 surgical zones and ISO 7 room classification.

ICU

Intensive Care Units

Controlled environments supporting immunocompromised and critically ill patients.

Isolation Room

Isolation Rooms

Negative or positive pressure rooms for infectious disease management and transplant patients.

CSSD

CSSD Departments

Central sterile services requiring strict contamination control and clean-dirty corridor separation.

Hybrid OR

Hybrid Operating Rooms

Complex hybrid ORs combining surgical and imaging requirements with high air-quality demands.

Pharmacy

Sterile Pharmacy

ISO 5 sterile preparation rooms and compounding pharmacies for chemotherapy and IV admixtures.

Lab

Medical Laboratories

Research and diagnostic labs requiring controlled particulate environments for accuracy and safety.

Oncology

Oncology Units

Specialised controlled environments for immunocompromised oncology and bone marrow transplant patients.

Why Choose Us

Trusted Healthcare Engineering Partner

OPES ORION combines decades of combined healthcare engineering expertise with full compliance under Malaysian MOH and international ISO standards — delivering cleanroom solutions that perform reliably from day one.

We are not just a supplier — we are your end-to-end delivery partner from design brief through to long-term lifecycle maintenance.

GDPMD Certified MDA Registered ISO 14644 Compliant MOH Approved

Specialist Healthcare Team

Our engineers carry 16–50 years of combined experience in hospital infrastructure, MEP systems, and clinical compliance — not generic contractors.

Full Regulatory Compliance

Every system is designed, tested, and commissioned against ISO 14644, HTM 03-01, ASHRAE 170, and Malaysian MOH requirements — from design to handover.

End-to-End Project Delivery

From system design and equipment supply through to installation, commissioning, testing, training, and long-term maintenance support — all under one roof.

Lifecycle Maintenance Support

24/7 technical operations, predictive maintenance programs, and spare parts logistics to keep your facility performing at peak standard.

Build a Safer
Surgical Environment

Whether you're planning a new hospital, modular operating theatre, or healthcare cleanroom facility — our engineering team is ready to assist from day one.