Pharmaceutical Clean Room Construction to Canadian GMP Standards
Hexa Build constructs pharmaceutical clean rooms that satisfy Health Canada Good Manufacturing Practices, the Food and Drugs Act requirements and ISO classification standards.
Pharmaceutical clean room projects in Canada are governed by Health Canada and must comply with federal GMP requirements before a Site Licence is issued or amended. Hexa Build works directly with your quality team and consultants to ensure every construction decision supports your regulatory submission and validation pathway.
Controlled Environments Built to Perform
ISO 14644 classified environments from ISO 5 through ISO 8 designed and built to meet Health Canada GMP particle count and environmental control requirements.
HEPA and ULPA filtration, GMP-compliant air change rate calculations, pressure cascade design and validated temperature and humidity control.
Seamless, non-shedding, chemical-resistant finishes with coved corners, flush service panels and surfaces that support validated cleaning protocols per Health Canada GUI-0001.
Pressure-controlled entry systems maintaining classification integrity between zones per Health Canada GMP and ISO 14644 requirements.
Purified water, WFI systems, compressed gases, electrical and data infrastructure installed and documented to Health Canada GMP standards.
Installation Qualification and Operational Qualification packages prepared to support your Health Canada Site Licence application or amendment.
We Know What Health Canada Expects
Pharmaceutical clean room projects in Canada are governed by Health Canada. Canadian authorities lead on every project. American references are secondary only.
| Authority / Standard | What it covers | Priority |
|---|---|---|
| Health Canada GMP Guidelines (GUI-0001) | Federal Good Manufacturing Practices for pharmaceutical facilities including environmental controls, surface requirements and documentation | Primary |
| Food and Drugs Act and Regulations | Federal legislation governing pharmaceutical manufacturing environments and facility licensing in Canada | Primary |
| Health Canada Site Licence | Facility licence required before manufacturing pharmaceutical products, dependent on compliant built environment | Primary |
| Ontario Building Code (OBC) | Structural, mechanical, electrical and fire safety requirements for the facility | Primary |
| ISO 14644-1 and 14644-2 | International standard for clean room classification ISO 5 through ISO 8 and ongoing monitoring | Reference |
| ICH Q7 GMP Guide | International GMP guidance adopted by Health Canada for active pharmaceutical ingredient facilities | Reference |
| USP 797 and USP 800 | American Pharmacopeia standards referenced as supplementary guidance by some Canadian consultants only | Secondary ref |
From Classification Requirement to Validated Facility
We review your process requirements, product classification and Health Canada submission obligations before design begins.
All drawings produced with GMP and ISO compliance built into every design decision.
Complete permit packages submitted and managed by our team.
Coordinated construction with trade scheduling, quality checkpoints and progress reporting.
System commissioning and independent classification testing to confirm ISO compliance.
Full qualification documentation package ready for your Health Canada submission.
Building a Pharmaceutical Clean Room in Canada?
Tell us about your project and we will get back to you within 1 business day. No obligation, just an honest conversation.