What is ventilation, and how do I determine whether external ventilation is needed for non-sterile compounding?
Ventilation (the “V” in HVAC) is an engineering control intended to remove or control contaminants released in indoor work environments by bringing in fresh air. The Canadian Centre for Occupational Health and Safety (CCOHS) Fact Sheet on Industrial Ventilation may be helpful for background information on this subject, such as the purpose of a ventilation system.
For non-sterile compounding, the Designated Manager, pharmacy department head or non-sterile compounding supervisor (if one has been appointed) must determine what ventilation is required for their pharmacy practice; they can do so through their risk assessment, taking into account cumulative risk.
Ventilation must be controlled in such a way as to avoid decomposition and contamination of chemicals while maintaining the quality and efficacy of stored products and ensuring the safety and comfort of compounding personnel. For example:
- Air vents should not be located directly over work areas, to avoid contamination of the products.
- Fans are unsuitable for ventilation as they merely blow the contaminant around the work area without effectively removing or controlling them.
- Opening a window or door might introduce outdoor air, but it is uncontrollable and risks bringing in additional contaminants and disrupting the compounding environment.
The external ventilation requirements differ between Levels A, B and C and are summarized below. Refer to the guidance document additional details. Note that “external” means the air must go outside the building (not outside the room).
| Level | External Ventilation | Guidance Document Section |
|---|---|---|
| All levels | The OCP’s Standards of Operation for Pharmacies require pharmacies to be designed, constructed and maintained to ensure the integrity and the safe and appropriate storage of all drugs and medications. This includes proper conditions of sanitation, temperature, light, humidity, ventilation, segregation and security. | n/a |
| A | External ventilation is not required for the designated compounding area Refer to the requirements for all levels of compounding | 5.4.1.3 |
| B | External ventilation is not required for the compounding room. However, this dedicated room must be entirely closed off (i.e., separate from the rest of the pharmacy) and well-ventilated If a ventilated containment device (C-PEC*) is installed in the room, the C-PEC should either be externally vented (the preferred option) or have redundant HEPA filters in series. | 8.2 9.1 9.2.1 |
| C | The room in which the C-PEC is placed (the C-SEC†) must be separate, under negative pressure, and have appropriate air exchange, with external ventilation through HEPA filtration. The C-PEC installed in the C-SEC should be externally vented (the preferred option) or have redundant HEPA filters in series. | 8.3 9.1.1 9.1.2 9.1.5 9.2.1 |
Compounding personnel should also understand how the secondary ventilation system operates (i.e., the HVAC of the C-PEC) and be able to recognize and address any problems with it.
*C-PEC – containment primary engineering control, designed to minimize the exposure of workers and the environment to hazardous products when such products are being handled directly.
†C-SEC – containment secondary engineering control (i.e., room in which the C-PEC is placed).
Refer to the Sections of the NAPRA Guidance Document for Pharmacy Compounding of Non-Sterile Preparations referenced in the table below. Note that where the guidance document uses the language of “should,” it may be acceptable to meet the required standard using other technologies, techniques, materials and procedures than those suggested only if they have been proven to be equivalent or superior to those described in the guidance document.