Use the applicable pharmacy framework
NAPRA publishes separate model standards for non-hazardous sterile, hazardous sterile and non-sterile compounding. Implementation is governed by the relevant provincial, territorial or Canadian Armed Forces pharmacy regulatory authority. Confirm the applicable framework with the pharmacy team before defining room requirements.
Prepare the facility brief around the intended preparation and workflow. Identify staff entry, materials, primary equipment, cleaning and waste routes. Hazardous and non-hazardous activities must not be treated as interchangeable room uses.
Coordinate the enclosure and environmental systems with the qualified pharmacy and facility team. Agree the documents and checks needed for the installation, and keep operating procedures and personnel responsibilities separate from equipment supply.
Configuration decisions
| Decision | What to define |
|---|---|
| Preparation type | Identify sterile, non-sterile and hazardous characteristics. |
| Jurisdiction | Confirm the responsible pharmacy regulator and applicable requirements. |
| Workflow | Map staff, materials, primary equipment and waste. |
| Facility evidence | Agree design records and acceptance activities with the project team. |
Does a cleanroom class alone establish NAPRA suitability?
No. The preparation, workflow, equipment and applicable regulatory implementation all matter. Particle classification is only one part of the facility and operating context.
Technical references
Requirements depend on the intended use and project conditions. Consult the relevant current documents when defining the final specification.