Industries

Injectable Biopharma Facilities

Aseptic & Sterile Manufacturing Infrastructure

Our turnkey solutions support controlled environments for injectable and sterile pharmaceutical manufacturing.

  • Injectables
  • Aseptic processing
  • Sterile manufacturing
  • QC laboratories
Controlled production room with process machinery, flush ceiling lights and a stainless-steel double door

Facility areas

Facility Areas

Process and support areas

  • Component preparation
  • Washing
  • Sterilization interfaces
  • Solution preparation
  • Aseptic processing
  • Filling
  • Inspection
  • Packaging
  • Material airlocks
  • Personnel airlocks
  • Sampling
  • QC laboratories

Integrated systems

Integrated Systems

Systems integrated into the facility

  • AHU/HVAC
  • HEPA filtration
  • Pressure cascade
  • Cleanroom panels
  • Dynamic pass boxes
  • Dispensing booths
  • LAF systems
  • Isolators
  • SS furniture
  • Monitoring and automation
  • Validation

Solutions

Solutions for biopharma

Our engineering approach

From Concept to Validated Facility

  1. Step 01

    Requirement Analysis

    Understanding your process, product, facility and regulatory requirements.

  2. Step 02

    Concept Design

    Room zoning, workflow and preliminary cleanroom classification.

  3. Step 03

    Detailed Engineering

    Architectural, HVAC, electrical, automation and equipment engineering.

  4. Step 04

    Manufacturing

    In-house/custom manufacturing of panels, ducting, furniture and cleanroom equipment.

  5. Step 05

    Installation

    Integrated site installation and coordination of architectural, HVAC, electrical and equipment systems.

  6. Step 06

    Commissioning

    System balancing, controls verification and environmental stabilization.

  7. Step 07

    Validation

    ISO 14644 testing and applicable qualification activities.

  8. 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

  1. Concept Layout
  2. Technical Proposal
  3. BOQ
  4. Engineering
  5. Manufacturing
  6. Installation
  7. Validation
CallRequest a Consultation