The US Pharmacopeial Convention (USP) developed the standard <800> Hazardous Drugs – Handling in Healthcare Settings to help protect personnel and patients from exposure to hazardous drugs in healthcare settings. The standard applies to physicians, nurses, veterinarians, pharmacists, and technicians, and all healthcare facilities where hazardous drugs (HDs) are handled, compounded, stored, transported, or administered.
A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH).
Click here for the list of hazardous drugs.
Which Section Applies to Triatek Products?
Section 5. Facilities and Engineering Controls and the secondary engineering controls for containment (C-SEC) requirement applies to Triatek products. It states that HDs must be received, stored, and compounded within a negative pressure room with either 12 or 30 air changes per hour (ACPH), depending on if the drugs must be stored or compounded within a non-sterile or sterile environment. There are primary engineering controls (C-PEC) like biosafety cabinets and then there are secondary engineering controls (C-SEC) like room pressure and ACPH.
Why Negative Pressure and So Many Air Changes?
USP requires hazardous drugs to be stored or compounded in negative pressure rooms (where the airflow cannot escape when the door is opened) to keep HD particulates from re-circulating in the air, prevent contamination, and prevent particulates from traveling into areas like break rooms or retail areas. The air changes per hour ensure the air does not become stagnant and keeps the airflow moving properly towards the exhaust system. This requirement from USP is also parallel to the ANSI/ASHRAE/ASHE Standard 170-2013 Ventilation of Health Care Facilities.
Whether your facility has only one negative pressure area, or if you need to control multiple spaces in a large hospital system through your BMS, Triatek’s FMS-1655 Room Pressure Controller can meet your needs. This easy-to-use product will help you feel secure that your critical spaces are in compliance and protecting you and your staff from the ancillary dangers of working with hazardous drugs. We can consult with you to figure out what your current air supply and exhaust set up is, and can help you create a cost-effective negative space (with positive anteroom) that is USP-800 compliant.
The FMS-1655 is available in plastic surface mount or stainless steel flush mount. It features Triatek’s signature Safety Halo™ which is a color-coded edge lighting that helps you monitor your spaces from across the room, and it alerts you if your airflow conditions become unsafe.
This controller has both audible and visual alarms and a user-friendly touchscreen with bold, modern graphics that simultaneously displays:
- Room pressure
- Room/alarm status
- Air changes
- Time and date
If you need a consultation on how to best outfit your critical spaces to ensure your secondary engineering airflow is compliant with USP-800, call us at 770-242-1922 or email firstname.lastname@example.org. For more complicated critical environments, Triatek’s Venturi Air Valves can also be installed within your ductwork to ensure your facility airflow is compliant with USP-800.