The standards stack
HTM 03-01 provides the ventilation framework. HBN documents (HBN 26, HBN 04-01, HBN 04-02, etc.) provide room-specific design context. ISO 14644 covers cleanroom classification in pharmacy and ATMP. CIBSE TM43 and BESA TR19 (Air) cover hygiene. Local NHS trust policy may layer additional expectations.
Using the standards in practice
Most ongoing work — assessment, validation, hygiene, monitoring — is shaped by HTM 03-01 Part B and the relevant ISO 14644 class for cleanrooms. Design and major refurbishment work draws more heavily on Part A and the HBN suite.
Where the standards interact
Conflicts and ambiguities are common. A pharmacy aseptic unit will be informed by both HTM 03-01 and the relevant Quality System for pharmacy compounding. We work with estates, IPC, pharmacy and clinical leads to align the standards into a single workable verification programme.
Next step
Talk to a healthcare air quality specialist
Independent technical support for hospital ventilation, HTM 03-01 compliance, environmental monitoring and infection control air quality.
