HVAC for pharmacies and sterile compounding
Sterile and hazardous compounding rooms live or die by their air: clean HEPA supply, enough air changes, and pressure that always moves in the right direction. We design these suites for retail, hospital and specialty pharmacies, and test them so your certifier and regulator see the numbers.
What makes it hard
- Pharmacy regulators in most provinces now expect compounding rooms to follow the NAPRA model standards, which draw heavily on USP 797 and USP 800.
- Hazardous drug rooms must be negative to their anteroom while non-hazardous buffer rooms stay positive, often side by side in a small footprint.
- Retail pharmacies are usually tenants with a shared rooftop unit, so the compounding suite needs its own dedicated, controllable air supply.
- Room pressure, temperature and humidity have to be monitored and recorded, and a door left open or a loaded filter can push a room out of range.
Our solutions
Design, build, test and tune: the services we bring to pharmacies and compounding.
Codes and standards we work to
- NAPRA Model Standards for Pharmacy Compounding (sterile and hazardous preparations)
- USP General Chapters 797 and 800
- ISO 14644-1 cleanroom classification
- CETA certification guidance for compounding facilities
- Your provincial college of pharmacists' requirements
Questions
Do you certify the hoods and the room?
We design, balance and commission the room HVAC. Hood and room certification is done by an independent certifier; we set the system up so it passes, and we can coordinate with your certifier.
Can a compounding room run off the store's rooftop unit?
Rarely well. A buffer room needs steady HEPA airflow and pressure around the clock, so most suites get a dedicated unit or fan filter units with their own controls.
We already have a compounding room. Can you assess it?
Yes. We measure airflow, air changes and pressures against the current standards and give you a list of what needs to change, ranked by risk.
Further reading
- Hospital pharmacy compounding rooms (USP 797 and 800)
Learn how USP 797 and 800 and the NAPRA model standards shape HVAC design for hospital and community pharmacy compounding rooms, and what certification involves.
- Cleanroom pressurization cascades
Learn how pressure differentials keep contamination flowing in the right direction, how to choose airlock types, and how to calculate and control the airflow offsets that create the cascade.
- ISO 14644 cleanroom classification explained
Learn how ISO 14644-1 cleanroom classes are defined, how to read the class limit table, and what a classification test involves under the 2015 edition.
- HEPA and ULPA filter systems
Learn how HEPA and ULPA filters are classified, how housings and seals affect performance, and how installed filters are leak tested and maintained.
- Room pressurization control: offset vs direct pressure
Learn how flow offset and direct pressure control maintain room pressure, the strengths and weaknesses of each, and when a cascaded approach makes sense.
- Cleanroom certification and testing
Learn which tests are performed to certify a cleanroom, in what order and how often, and how to read the results and respond to failures.
Talk to us about your pharmacy
Tell us about the building and what you need. We’ll be in touch within one hour.