Pharmaceutical Cleanroom Solutions and Project Consulting
Turnkey Cleanroom Solutions: Engineering, Fabrication, Installation – FDA, GMP, ISO 14644 Compliant
Manufacturing Capacity & Delivery Track Record
| Product | Annual Capacity |
|---|---|
| Laminar Air Flow Units & Biosafety Cabinets | 600 Units/Year |
| HEPA & ULPA Filters | 25,000 Units/Year |
| Oil Filtration & Purification Systems (KEOC Series) | 250 Units/Year |
| Modular Cleanroom Sandwich Panels | 150,000 m²/Year |
Turnkey Cleanroom Engineering & Fabrication
Project Overview
The company specializes in design, engineering, manufacturing, installation, commissioning, testing and validation of cleanroom systems, modular operation theatres (OTs), air filtration products and pharmaceutical HVAC solutions for healthcare, pharmaceutical, biotechnology and medical device industries. The organization successfully completed 10 Greenfield cleanroom projects and 20 modular operation theatre projects with comprehensive engineering activities and in-house manufacturing capabilities including laser cutting, CNC sheet-metal processing, phosphating, powder coating, polyurethane panel production, filter pleating, electrical assembly, aerosol integrity testing and final product validation.
Engineering & Regulatory Expertise
- US FDA Compliance
- MHRA (UK) Standards
- EU GMP Requirements
- WHO GMP Compliance
- ISO 14644 Cleanroom Classification
- ISO 13485 Medical Devices
- CE Mark Documentation
Design & Engineering Process
Project Approach
Every greenfield project commenced with comprehensive engineering activities using Computer-aided Design (CAD) software for preparation of detailed technical documentation and layouts.
Engineering Activities
- User Requirement Specification (URS)
- Facility master planning
- HVAC load calculations
- Airflow modelling
- Cleanroom classification design
- Pressure cascade design
- Material and personnel movement studies
- Equipment layout preparation
- Utility planning
- Regulatory compliance review
- Risk assessment
CAD Documentation Deliverables
- General Arrangement Drawings
- HVAC Layouts
- Cleanroom Layouts
- Duct Routing Plans
- Electrical Layouts
- Utility Drawings
- Installation Sequences
Modular Operation Theatres (OTs)
Product Overview
Modular operation theatres are complete, integrated surgical suites including wall panels, ceiling systems, hermetically sealed doors, LED lighting, medical gas outlets, HVAC systems and integrated control panels designed for optimal surgical environment control and patient safety.
Major Components
- Pre-fabricated wall panels
- Integrated ceiling systems
- Hermetically sealed entry doors
- Surgeon control panel
- LED surgical lights
- Ceiling-mounted pendants
- HVAC terminal units
- Laminar airflow ceiling
- Medical gas outlets
- Pressure monitoring systems
Manufacturing & Validation
Factory Acceptance Testing (FAT): All major components completed and tested before shipment to ensure compliance with specifications and performance requirements.
Applications
- Cardiac surgery
- Neurosurgery
- Orthopaedic surgery
- Organ transplant surgery
- General surgery
- Emergency trauma care
- Robotic surgery suites
HEPA & ULPA Filter Manufacturing
Product Overview
HEPA and ULPA filters are manufactured with high-performance glass fibre media meeting stringent filtration standards for cleanroom applications, pharmaceutical manufacturing, hospitals and biotechnology facilities.
Manufacturing Process
Glass Fibre Media Pleating
High-grade glass fibre media precision pleated to maximize surface area and filtration efficiency.
Separator Installation
Aluminum or plastic separators installed between pleats to ensure proper airflow distribution.
Frame Fabrication
Aluminum frames fabricated to precise specifications for filter sealing and installation.
Adhesive Sealing
Pleated media sealed to frame using validated adhesive application for airtight assembly.
Potting Process
Filter corners potted with polyurethane or other approved sealants for complete integrity.
Curing
Cured in controlled environment to achieve final sealing integrity and performance.
Leak Testing
Each filter subjected to comprehensive leak testing to verify seal integrity.
Aerosol Integrity Testing
Aerosol photometer testing validates efficiency and confirms filtration performance.
Filter Testing Capabilities
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Applications
- Cleanroom air terminal units
- Hospital HVAC systems
- Semiconductor manufacturing
- Biotechnology facilities
- Pharmaceutical production
- Aerospace applications
Laminar Air Flow Units & Biosafety Cabinets
Product Overview
Laminar airflow units and biological safety cabinets are manufactured with integrated HEPA filtration, blower systems and control panels providing contamination-free work environments for aseptic processing, research and diagnostic applications.
Manufacturing Process
Cabinet Fabrication
Stainless steel or powder-coated mild steel cabinets fabricated with precision for cleanable surfaces.
Blower Installation
High-efficiency centrifugal blowers installed and tested for required air volume and pressure.
HEPA Filter Installation
HEPA filters installed in ceiling or sidewall configuration with proper sealing.
Electrical Wiring & Controls
Complete electrical wiring and control panel installation with safety interlocks.
Control Panel Installation
PLC-based control system with user interface for speed control and monitoring.
Velocity Balancing
Airflow distribution balanced to achieve uniform downward velocity across work surface.
Airflow Testing
Validated airflow testing to confirm laminar pattern and velocity compliance.
Final Qualification
Complete equipment qualification including performance and safety testing.
Applications
- Aseptic dispensing
- Sterile compounding
- Microbiology laboratories
- Tissue culture laboratories
- Hospital pharmacies
- Microbiology research
- Cell culture work
- Vaccine development
- Clinical laboratories
Oil Filtration & Purification Systems (KEOC Series)
Product Overview
KEOC Series oil filtration and purification systems are engineered for transformer oil purification, turbine lubrication systems, hydraulic oil conditioning and industrial machinery maintenance applications requiring high-quality fluid conditioning.
Applications
- Transformer oil purification
- Turbine lubrication systems
- Hydraulic oil conditioning
- Industrial machinery maintenance
- Power generation plants
Modular Cleanroom Sandwich Panels
Product Overview
Pre-fabricated sandwich panels are manufactured for cleanroom wall and ceiling construction providing high thermal insulation, smooth cleanable surfaces, low particulate generation and excellent structural strength.
Manufacturing Process
Sheet Preparation
GI, Stainless Steel 304/316 or Aluminum sheets prepared and cut to specifications.
PUF Injection
Polyurethane foam (PUF) injected between sheet layers for thermal insulation.
Honeycomb Core Placement
Aluminum or paper honeycomb cores placed for structural integrity and weight reduction.
Hydraulic Pressing
Pressed under controlled temperature and pressure for optimal adhesion and density.
Lamination
Outer lamination applied for finish and aesthetic appearance.
Edge Finishing
Panel edges finished and sealed for structural completeness.
Dimensional Inspection
Every panel dimensional verified for flatness and specification compliance.
Panel Properties
- High thermal insulation value
- Smooth, cleanable surfaces
- Low particulate generation
- Excellent structural strength
- Fire-rated options available
- Customizable dimensions and finishes
Applications
- Pharmaceutical cleanrooms
- Medical device manufacturing
- Biotechnology facilities
- Hospital operating theatres
- Research laboratories
In-House Fabrication & Equipment
Sheet Metal Fabrication Equipment
- CNC Laser Cutting Machine
- CNC Turret Punch
- CNC Press Brake
- TIG Welding Machines
- MIG Welding Machines
- Hydraulic Presses
- Grinding Machines
Surface Treatment Line
- Seven Tank Pretreatment Line
- Automated Degreasing
- Zinc Phosphating System
- Powder Coating Booth
- Powder Curing Oven
- Passivation System
Panel Manufacturing Equipment
- PUF Injection Machine
- Hydraulic Laminating Press
- Honeycomb Panel Line
- Edge Trimming Machines
Filter Manufacturing Equipment
- Filter Pleating Machine
- Adhesive Dispensing System
- Potting Equipment
- Curing Ovens
- Aerosol Leak Testing System
Electrical Assembly & Testing
- Wiring Stations
- Electrical Testing Equipment
- PLC Programming Systems
- Control Panel Assembly
Validation & Testing Equipment
- Particle Counters
- Aerosol Photometers
- Air Velocity Meters
- Differential Pressure Gauges
- Temperature & Humidity Data Loggers
- Noise Meter
- Lux Meter
- Smoke Visualization Equipment
- HEPA Integrity Testing Equipment
Project Execution & Validation
Installation Activities
- Cleanroom erection
- HVAC installation and balancing
- Utility connections
- Electrical commissioning
- System start-up and testing
Validation & Commissioning Testing
Performance Qualification
- Air balancing
- Particle count verification
- Air velocity measurement
- Recovery testing
- Smoke visualization studies
- Airflow pattern analysis
Environmental Verification
- Temperature mapping
- Relative humidity verification
- Pressure differential testing
- HEPA filter integrity testing
- Documentation handover
Modular OT Validation
- Microbial Air Count
- Surface Microbial Count
- Illumination Testing
- Noise Level Measurement
- Medical Gas Leakage Testing
- Positive Pressure Verification
- Electrical Safety Testing
Manufacturing & Project Utilities
Manufacturing Facility Utilities
- Industrial power supply
- Diesel generator backup
- Compressed air system
- Process water
- HVAC systems
- Chilled water
- Nitrogen supply
- Dust extraction systems
- Fire protection system
- Building management system (BMS)
- Environmental monitoring systems
- Material handling equipment
- EOT cranes and forklifts
Project Site Utilities (Installation)
- Chillers
- Air handling units (AHUs)
- Fan coil units (FCUs)
- Ducting systems
- Terminal HEPA units
- Electrical panels and distribution
- Clean steam generation (where required)
- Medical gas pipelines
- Vacuum and compressed air systems
Product Protection & Transportation
Protective Packaging Methods
- Protective film wrapping
- Bubble wrapping
- Foam cushioning
- Wooden crates and plywood boxes
- Export-quality packaging materials
- Moisture barrier packing
- Shock indicators
- Edge protectors
- Stretch wrapping
- Palletization
- Identification labels
- Installation sequence markings
Special Handling
Sensitive items such as HEPA filters, laminar airflow units and biosafety cabinets are transported in specially designed crates to prevent mechanical damage and maintain cleanliness during shipment.
Regulatory Standards & Validation
International Compliance Standards
- US FDA Regulations
- MHRA (UK) Standards
- EU GMP Annex 1
- WHO GMP Guidelines
- ISO 14644 Cleanroom Classification
- ISO 13485 Medical Devices
- CE Mark Documentation
Documentation Standards
All validation activities documented in accordance with ISO 14644, GMP Annex 1 and relevant healthcare standards with complete traceability and regulatory compliance records.
Integrated Cleanroom Solutions
The successful completion of 10 Greenfield cleanroom projects and 20 modular operation theatre installations, supported by in-house manufacturing of panels, filters, laminar airflow units and biosafety cabinets with annual capacities of 600 LAF units, 25,000 HEPA filters, 250 oil purification systems, and 150,000 m² of sandwich panels, demonstrates comprehensive capability to deliver complete turnkey engineered solutions. These solutions comply with stringent international standards including FDA, GMP, ISO 14644 and CE requirements for pharmaceutical manufacturing, medical devices and healthcare infrastructure globally.
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