Turnkey Cleanrooms
Process-driven cleanroom design, integrated execution and handover of a validated facility.
Industries
Medical Device Manufacturing
Clean Manufacturing Environments for Medical Devices
We provide cleanroom infrastructure for both equipment and disposable medical-device manufacturing.
Applications
Applications
Products and processes
- Catheters
- Tubing
- Disposable assemblies
- Surgical products
- Diagnostic consumables
- Wound-care products
- Sterile medical devices
- Device packaging
- Assembly and inspection
Solutions
Solutions
What we provide
- ISO-classified manufacturing rooms
- Assembly cleanrooms
- Inspection areas
- Packaging rooms
- Material transfer systems
- ESD flooring where required
- SS workstations
- Air filtration systems
Solutions
Solutions for medical devices
Cleanroom Panels
PUF/PIR wall and ceiling panels with hygienic coving, seamless flooring and flush glazing.
SS Furniture
SS 304 and SS 316/316L tables, cabinets, trolleys, racks and sinks fabricated for cleanrooms.
Validation
ISO 14644 performance testing, qualification activities and the complete documentation dossier.
Our engineering approach
From Concept to Validated Facility
Step 01
Requirement Analysis
Understanding your process, product, facility and regulatory requirements.
Step 02
Concept Design
Room zoning, workflow and preliminary cleanroom classification.
Step 03
Detailed Engineering
Architectural, HVAC, electrical, automation and equipment engineering.
Step 04
Manufacturing
In-house/custom manufacturing of panels, ducting, furniture and cleanroom equipment.
Step 05
Installation
Integrated site installation and coordination of architectural, HVAC, electrical and equipment systems.
Step 06
Commissioning
System balancing, controls verification and environmental stabilization.
Step 07
Validation
ISO 14644 testing and applicable qualification activities.
Step 08
Handover
As-built drawings, test reports, manuals and final project documentation.
Start a project
Build Your Next Controlled Environment With Us
Whether you are establishing a medical-device manufacturing unit, CAR-T cell therapy facility, MSC laboratory, BMT center, IVF laboratory, or injectable biopharma facility, our engineering team can develop a complete cleanroom solution around your process.
Send us
- Project location
- Approximate area
- Process description
- Required cleanroom classification
- Existing architectural drawing
- Equipment list
- Target completion date
We can provide
- Concept Layout
- Technical Proposal
- BOQ
- Engineering
- Manufacturing
- Installation
- Validation