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Humidity Control in NAPRA-Compliant Cleanrooms for Canadian Compounding Pharmacies

Why Humidity Control Matters in NAPRA Pharmacies

The NAPRA Model Standards for Pharmacy Compounding are the benchmark for pharmacy cleanroom design and operation in Canada. These standards emphasize air cleanliness, pressure relationships, and temperature control. However, one critical factor—humidity control—is not directly addressed.

In Canadian cleanrooms, humidity plays a major role in both compliance and safety:

  • Drug Integrity: Many compounded drugs are moisture-sensitive. If relative humidity rises above 60%, potency and stability may be compromised.
  • Microbial Risks: Humid environments encourage microbial growth, which conflicts with the sterile conditions required under NAPRA.
  • Comfort and Surfaces: Excess moisture leads to staff discomfort and condensation, adding contamination risks.

For this reason, humidity levels in Canadian compounding cleanrooms should always remain below 60% RH, with even tighter control when specific drug formulations require it.

Building Management Systems (BMS) for Canadian Cleanroom Control

Designing a Canadian cleanroom that meets NAPRA requirements goes beyond HVAC equipment, it requires integrated control. A Building Management System (BMS) provides:

  • 24/7 Monitoring: Tracks humidity and temperature in real time.
  • Automated Safeguards: Prevents conditions that could exceed 60% RH.
  • Energy Optimization: Coordinates HVAC systems to balance dehumidification and reheating efficiently.

For compounding pharmacies in Canada, a cleanroom with BMS integration is not only compliant but also more reliable and cost-effective.

DOAS with Heat Recovery Reheat: A Practical Solution

One example of effective humidity control in Canadian cleanroom design is using a Dedicated Outdoor Air System (DOAS) with Heat Recovery Reheat (HGRH).

  • Step 1: Overcooling Hot, Humid Air – The DOAS removes moisture by cooling outdoor air during Canada’s humid summer months.
  • Step 2: Reheating with Recovered Energy – Instead of consuming extra electricity, the unit reheats air using recovered heat from the system itself.

This approach ensures:

  • Consistent NAPRA compliance by keeping RH below 60%.
  • Energy efficiency compared to traditional electric reheating.
  • Improved system reliability with less strain on HVAC components.

For Canadian pharmacies, this cleanroom strategy combines compliance with sustainability.

Final Thoughts

Although humidity is not explicitly detailed in the NAPRA model standards, Canadian cleanroom design must account for it as a critical parameter. Keeping **relative humidity below 60% RH—or lower for certain drug types—**is essential to protect patients, staff, and product quality.

With the right BMS controls and advanced HVAC strategies like DOAS with HGRH, Canadian compounding pharmacies can achieve cleanrooms that are fully NAPRA-compliant, energy efficient, and built for long-term reliability.