Stainless steel process vessels, pipework and control panels in a production facility.

Pharma and Biotech Facility Engineering

Avodahtec provides independent engineering for pharmaceutical and biotech facilities, supporting GMP upgrades, cleanrooms, containment laboratories, critical building systems, commissioning and qualification.

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Who we serve

We work with pharmaceutical and natural health product manufacturers, biotech and biomanufacturing companies, contract development and manufacturing organizations, universities, colleges and research institutes with containment laboratories, hospital and compounding pharmacies with sterile preparation rooms, diagnostic and public health laboratories, and medical device manufacturers. Food and beverage plants are covered on our Food and Beverage Processing page.

The challenges pharma and biotech facilities face

  • GMP expectations built into the building. Health Canada's Good manufacturing practices guide for drug products (GUI-0001) interprets the GMP requirements of Part C, Division 2 of the Food and Drug Regulations, including those for premises and equipment, and sterile manufacturing carries additional requirements. Layout, finishes, air handling and utilities all affect compliance.
  • Cleanrooms that must keep proving their performance. Classified rooms must hold their cleanliness class, pressure cascades and air change rates, and gradual drift in HVAC performance can put product and inspections at risk.
  • Containment laboratories under a national standard. The Canadian Biosafety Standard, third edition is the national standard for facilities where regulated human and terrestrial animal pathogens and toxins are handled or stored, with physical containment, operational practice and performance and verification testing requirements.
  • Aging laboratory and research buildings. Many institutional labs operate in older buildings whose ventilation, exhaust and utilities were not designed for today's loads, equipment or standards.
  • Growth without disrupting validated operations. New suites, capacity expansions and technology transfers must be designed, built and qualified without compromising areas that are already validated and in production.

Our pharma and biotech services

GMP facility design and upgrades

We plan and design new GMP suites, expansions and renovations with personnel and material flows, room classifications, finishes and segregation that support Health Canada GMP expectations. Building and Facility Design, Upgrades and Improvements

Cleanroom design and HVAC engineering

We design and review cleanroom HVAC, pressure cascades, air change rates, filtration and monitoring, and troubleshoot rooms that drift out of specification. Core Infrastructure Engineering and Design

Containment laboratories and biosafety

We assess and design containment laboratories against the Canadian Biosafety Standard, covering directional airflow, room integrity, biosafety cabinet placement, decontamination and performance and verification testing, and we build the biosafety programs that operate them. Health, Safety and Environment

Commissioning, qualification and validation support

We prepare user requirement specifications, commissioning plans and qualification protocols for facility systems and utilities, and support cleanroom validation through to handover. Project and Construction Management and Inspection

Independent design review

We provide independent multidisciplinary review of mechanical, electrical and fire protection designs for GMP and laboratory projects, catching problems before they are built. Core Infrastructure Engineering and Design

Process safety and hazard assessment

We assess hazards from flammable solvents, potent compounds, cryogens and compressed gases, and design controls that protect people, product and property. Industrial Process Safety and Optimization

Why pharma and biotech organizations choose Avodahtec

No product to sell

We are not tied to any cleanroom manufacturer, modular supplier or design-build contractor, so room classes, materials and systems are chosen for your process, not from a catalogue.

Biosafety expertise in-house

Our team includes a practising institutional Biosafety Officer, so containment requirements are understood from the operator's side, not just the designer's.

Truly independent design review

We can design or review, but never both on the same project, which keeps our quality reviews objective.

Regulatory fluency

We work directly from Health Canada GMP guidance and the Canadian Biosafety Standard, so designs are built around what inspectors will look for.

Full lifecycle in one team

Condition assessment, design, review, commissioning support and construction oversight sit under one roof.

Coverage for multi-site organizations

Licensure in Alberta, British Columbia, Saskatchewan, Ontario, Nova Scotia, Quebec and Yukon lets us support research networks and manufacturers with sites in several provinces.

Related insights

Frequently asked questions

What does a cleanroom consultant do?

A cleanroom consultant helps owners plan, design, upgrade and troubleshoot controlled environments. That includes defining the cleanliness class a process needs, designing the layout and HVAC to achieve it, reviewing designs, and supporting commissioning, qualification and ongoing performance.

What is a GMP facility?

A GMP facility is a building or suite designed, built and operated to meet good manufacturing practice requirements for the products made in it. In Canada, drug manufacturers follow Health Canada's GMP requirements, which cover premises, equipment, sanitation, personnel and quality systems.

Can you help our containment laboratory meet the Canadian Biosafety Standard?

Yes. We assess existing laboratories against the physical containment and performance and verification testing requirements of the Canadian Biosafety Standard, design upgrades to close gaps, and help develop the biosafety programs and documentation that support licensing and inspections.

Do you support commissioning and qualification?

Yes. We prepare user requirement specifications, commissioning plans and qualification protocols for facility systems and utilities, and support execution through to handover. Final product and process validation remains the responsibility of your quality team.

Plan your next GMP or laboratory project with confidence

Whether you are building a new suite, upgrading a cleanroom or bringing a containment lab up to standard, book a free consultation with our facility engineers.

Book a free consultation.