NAPRA Compliant Pharmacy Cleanrooms

In June 2016 the National Association of Pharmacy Regulatory Authorities adopted the new Model Standards for compounding in Pharmacies in Canada. Within the new standards there is a new requirement to perform certain compounding processes within a certified cleanroom space. This new standard has lead to a requirement for many pharmacies and hospitals to build new pharmacy compounding facilities.

A key requirement of the new standard is that the compounding must be performed in controlled rooms meeting an ISO Class 7 cleanroom standard. Similarly, anterooms must be provided meeting the ISO standards. Complicating matters further for hospitals is are the requirements to further upgrade facilities to the latest building code standards which introduce other, sometimes competing, requirements. In this presentation we will focus on key challenges and solutions when completing pharmacy compounding facility upgrades.