About Us
Engineering Clean Spaces for Critical Processes
We provide end-to-end cleanroom engineering and stainless-steel fabrication solutions for facilities where environmental control is directly linked to product quality, patient safety and process integrity.
Our approach
Our approach begins with understanding the process
…and continues through
- URS
- Concept Design
- Layout & Zoning
- Engineering
- Manufacturing
- Installation
- Commissioning
- Validation
- Handover
Design basis
Cleanroom design is developed around
ISO 14644-4 specifically addresses the process of creating cleanrooms from requirements through design, construction and start-up.
- 01Personnel flow
- 02Material flow
- 03Process flow
- 04Equipment positioning
- 05Pressure zoning
- 06HVAC requirements
- 07Contamination-control strategy
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.
Why choose us
One coordinated project partner
One-Stop Turnkey Solution
Design, manufacturing, installation and validation under one coordinated project.
Life-Science Specialization
Focused on cell therapy, medical devices, BMT, IVF and biopharma environments.
Custom Engineering
Solutions are developed around your process rather than forcing your process into a standard room.
Integrated HVAC & Automation
Cleanroom architecture, HVAC, electrical and monitoring systems designed as one system.
SS Fabrication
Custom stainless-steel furniture and equipment manufactured for controlled environments.
Validation Support
Testing and documentation aligned with the applicable ISO 14644 framework.
Standards positioning
Validation support aligned with ISO 14644
Designed, commissioned and tested in accordance with applicable ISO 14644 requirements.
ISO 14644-1
Classification of air cleanliness
The principal standard for classification by airborne particle concentration.
ISO 14644-3
Cleanroom test methods
The test-method framework for cleanrooms and clean zones.
ISO 14644-4
Design, construction and start-up
Addresses the process of creating cleanrooms from requirements through design, construction and start-up.
Validation states (ISO 14644-3)
- As-Built
- At-Rest
- Operational
Company details
Totigen Bioinfra
Clean Spaces for a Healthier Tomorrow
- Registered office
- Flat No D13, Srinivas Heights, Adarsh Nagar, Uppal, Hyderabad – 500039, India
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