Cleanrooms Case Studies

USP797 Pharmacy Compounding

USP 797 Pharmacy with Grade B Compounding and Formulation

Services Provided

  • Cleanroom Design
  • AHU System Design
  • CFR21 Part 11 Monitoring System
  • HEPA Filtered Pass Throughs & Cart Pass Through
  • nora Cold Welded Seamless Rubber Flooring
  • 2oC to 8oC Walk In Cooler

Pharmaceutical Manufacturing Upgrade

Cleanroom Upgrade – Existing Drywall Walls – ALUMA1 Cleanroom Wall System installed to provide new multiple room layouts, including Airlocks for cascading air pressures

Installation of the ALUMA-T Cleanroom Ceiling below the original Drywall Ceiling to provide a new lower ceiling increasing air change rates

Services Provided

  • Cleanroom ALUMA1 Wall & Ceiling Systems

Pharmaceutical Pilot Manufacturing Suites

2011 Therapure Pilot Suites

Three Independent Suites:

  1. Grade A / ISO 5 for Filling, including modifications to existing OXATHERM & Nicomac Cleanrooms
  2. Independent Pilot Grade C / ISO 7 Cleanrooms, with separate Personnel Change Rooms and Air Locks, as well as Material Air Locks, with Access and Magnetic Locks.

Services Provided

  • Complete Turn Key Design Build Including Architectural / Mechanical / Electrical & Structural

Pharmaceutical Packaging

Construction of the ISO 7 Pharmaceutical Packaging Rooms with the flexibility of the ALUMA1 Cleanroom Wall System allows for changes in configuration as required.

Services Provided

  • Cleanroom Design
  • Project Management and Protocol Training

Sunnybrook Health Sciences – DDL & cGMP Cleanrooms

Initial User Group Interviews to determine requirements for design within space allocated and budget for funding.

Services Provided

  • ISO 5 Cleanrooms
  • LED Tear Drop Light Fixtures
  • ECM HEPA Fan Filter Modules save energy and reduced noise levels

McMaster University – Nuclear Research Building Cleanroom

ISO 7 & 8 Cleanroom

Services Provided

  • ALUMA1 Cleanroom Walls & Ceiling
  • Polypropylene Casework
  • ECM HEPA Fan Filter Modules save energy, and allow one point electrical connection
  • Custom HVAC System

Veterinary Vaccine Manufacturing

Assistance with original design and regulatory approval with CFIA.

BSL2 Enhanced with HEPA Filtration Supply and Return for Containment

Services Provided

  • ALUMA1 Cleanroom Wall & Ceiling System
  • Custom HVAC Systems
  • 2 to 8oC Walk In Coolers
  • 35oC Incubator

Nano Technology Cleanroom

Nanotechnology ISO 6 & 7 Cleanrooms Design Build Proposal

Custom HVAC System Designed in sections to allow delivery up elevator

Services Provided

  • Hybrid Design Air Handling Units and Fan Filter Modules
  • Custom Air Showers
  • Grey Corridor for Gases and Equipment
  • TEK-AIR Fume Hood Control

Downflow Booth

Therapure Biopharma required a downflow booth is a corner in three weeks.

Using the ALUMA1 Cleanroom Wall System, we were able to frame it up, and have the unit operational for testing in two weeks

The system uses the existing back wall, as well as the ceiling to be the plenum, and the new walls and ceiling installed to maintain the containment.

See our DOWNFLOW BOOTH DATA SHEET for more information

Services Provided

  • ALUMA1 Walls & Windows
  • ALUMA-T Ceiling allows access and sprinkler heads
  • ECM HEPA Fan Filter Modules save energy, and allow one point connection

Optical Component Manufacturing

Services Provided

  • ISO 5 Cleanrooms
  • Cleanroom Design
  • ECM HEPA Fan Filter Modules save energy and reduced noise levels
  • Structural Catwalk for Fan Filter Module Access

Pharmaceutical Manufacturing & Packaging

Bracco – Hattiesburg Mississippi.

ISO 7 Cleanroom

Services Provided

  • Initial Cleanroom Design Assistance
  • Design Review with local trades and engineers
  • Cleanroom in a Box components and Air Handling Unit
  • On Site Cleanroom Protocol Training and On Site Management

Pharmaceutical Packaging

Design Assistance and Drawings

ISO 8 Cleanrooms

Services Provided

  • HVAC System Design
  • ALUMA1 Cleanroom and Self Supporting Ceiling
  • Structural Support Inside Wall for Sliding Doors
  • Return Air Design through Adjacent Rooms

Prollenium Technologies Inc.

ISO 5 Cleanroom – Wash Up and Packaging Roo

Services Provided

  • Cleanroom Design and Programming
  • Budgeting & Design to meet budget
  • ECM HEPA Fan Filter Modules save energy and reduced noise levels
  • Epoxy Floor
  • Tear Drop Light Fixtures
  • Return Air Upper Plenum

Fermentation Cleanroom BSL

BioVectra Inc. – Charlottetown – PEI

Cytotoxic Formulation Production

Services Provided

  • Design and Approval Drawings
  • Cleanroom in a Box including ALUMA1 Cleanroom Walls & Ceilings
  • Custom AHU designed for Biological Containment
  • ECM HEPA Fan Filter Modules for Production Suite & Airlocks
  • On Site Cleanroom Protocol Training and On Site Management

Vaccine Manufacturing Cleanroom & Biological Safety Containment 2 Enhanced

Microbix Biosystems Inc. – Mississauga

Services Provided

  • Air Handling Units Designed for internal platform saving major structural upgrades
  • ALUMA1 Cleanroom Wall & Ceiling System
  • 2 to 8oC Walk In Coolers
  • 32oC Incubators
  • MMA Flooring
  • Complete Design Build and Fit Out of entire facility from offices to warehouse

Veterinary Pharmaceutical

Bimeda MTC ISO 7 Cleanroom

Services Provided

  • Design and Approval Drawings
  • ALUMA1 Cleanroom Wall & Ceiling System
  • ALUMAfrp Wall Panels – 24′ Wall Height
  • 2oC to 8oC Walk In Cooler

Compounding Pharmacy with Chemo BSC

Project 8 weeks from Design to Turn Over

Services Provided

  • ALUMA1 Cleanroom Walls & Ceiling
  • Stainless Steel Pass Throughs and Cart Through
  • ECM HEPA Fan Filter Modules save energy, and allow one point connection
  • Design Filtration Laminar Air Flow Workstations
  • Combination Make Up Air – Cooling Unit

Pharmaceutical Packaging Delineation

The walls were required to delineate various packaging lines

Services Provided

  • ALUMA1 Cleanroom Wall System
  • Components Pre-Cut for ease of on site installation
  • Lexan Windows
  • 4′ X 8′ Double Doors

Pharmaceutical Membrane Manufacturing Cleanroom

Natrix Separations Inc. – Burlington

Services Provided

  • Redesign of original configuration
  • ALUMA1 Cleanroom Wall System with ALUMAfrp Panels
  • 2 to 8oC Walk In Coolers
  • Construction Project Management
  • HVAC Design utilizing re-locatable components
  • Polycrete NOVLAC Floor Coating

Dry Room

Spectral Diagnostics – Toronto

Design & Construction of a room to maintain less than 20% Relative Humidity

Services Provided

  • System Conceptual Design
  • ALUMA1 Cleanroom Wall System
  • Custom Manufactured AHU with Bry-Air Desiccant Drier
  • Carel Control System

University of Toronto – CADIFT Electronics ISO 5 Cleanroom

Mechanical Engineering Cleanroom

Services Provided

  • Redesign of original configuration
  • ECM HEPA Fan Filter Modules save energy and lower noise
  • 80% Filter Coverage
  • Existing Air Conditioning System used in design

Compounding Pharmacy

Chiron Compounding Pharmacy – Guelph

The Cleanrooms consist of a cluster of 5 ISO 7 Suites.

The project consisted of the design, installation of the Cleanrooms, and the HVAC System

Services Provided

  • ALUMA1 Cleanroom Wall System
  • 1 1/2 Inch Gasketed T Bar
  • Tableting Room with Return Air HEPA Fan Filter Module and Strip Curtains
  • Integrated HVAC System
  • ECM HEPA Fan Filter Modules save energy and lower noise

Pharmaceutical Grade A Space

Pharmaceutical Grade A Space

ALUMA1 Snap Lock Pharma System

Services Provided

  • Design Assistance to meet requirements for Entry & Exit Airlocks
  • Reuse of Existing Supply Air Terminal HEPA Filters
  • Installation of Return Air HEPA Filters
  • Custom HEPA Filter for Exhaust from Exit Anterooms

Regenerative Medicine Cleanroom

Lake Superior Centre for Regenerative Medicine – Thunder Bay

ISO 4 Cleanroom.

Designed to fit in a very tight location, with no headroom

Custom AHU built to be above ceiling in adjacent room

Services Provided

  • Complete Deign Build Cleanroom from Concept to Certification

UVic SEOS Trace Metals Cleanroom

Trace Metals Cleanrooms require that the room construction does not add contamination from metal elements.

The ALUMA1 wall system was used in these ISO Class 5 & 6 Cleanrooms. Utilizing ALUMAfrp wall panels and the Co-Extruded PVC Battens provided a metal free surface in the Cleanrooms and the Airstream

All other structural components were powder coated, as well as all components that were in contact with the airstream.View Site >

Services Provided

  • Cleanroom Design Build
  • Custom Make Up Air with 3 Temperature / Pressure Zones & Atmospheric Mercury Filtration

Aseptic Fill Suite

Hemosol – (Thearpure Biopharma)

The project included a progressive wall and ceiling system by Oxatherm, of France

6 Months from Initial Contact to Validated System by Health Canada

Services Provided

  • Cleanroom Layout & Design
  • HVAC System Design & Construction – Return Air Chase Saves $100,000