USP 800 — Proposed new guidelines for compounding non-sterile hazardous drugs

Our compounding pharmacy customers are reviewing proposed new guidelines, USP <800> Hazardous Drugs—Handling in Healthcare Settings, for compounding hazardous drugs (HD).

Hazardous drugs are a category of pharmaceutical products that can harm the people who prepare them even though they are designed to have a therapeutic effect on the patients who use them.

Included are drugs that are carcinogenic, genotoxic, teratogenic, have reproductive toxicity, or are toxic to organs.

HDs may require either sterile or non-sterile compounding.

Our customers use our Ductless Containment Hoods for non-sterile compounding.

“No acceptable level of personnel exposure to HDs” – USP <800>

USP <800> proposes a separate room for non-sterile HD compounding. No matter which type of hood is used, it must have HEPA filtration and be exhausted to the exterior of the building.

The block diagram below uses the terminology of the proposed USP <800> document.

Block diagram of USP <800> proposed room for non-sterile hazardous drug compounding.

Our Ductless Containment Hoods are Class I Biological Safety Cabinets with HEPA filters, easy to connect to existing building ductwork with our plenums.

The drawing below shows how pharmacists who use our Ductless Containment Hood can connect our ductless hoods to existing building ventilation ductwork and contribute to the proposed air-pressure requirements for the room.

The noted line numbers refer to specific lines in the proposed USP <800> standard.

3D drawing of room for non-sterile hazardous drug compounding with air flows and Sentry Air air purification equipment.

 

Sentry Air's Model ss-300-msp plenum.What’s a plenum?

The photo to the right shows a plenum attached to a Model 300 chassis.

Plenums are used to create enclosed chambers within ventilation systems that can affect air pressure within a building or room.

A 6-inch collar on the plenum allows HEPA-filtered air to be exhausted into central exhaust ductwork.

Our plenum is not a special build or a custom product.

We’ve had plenums in our catalog for years because we have customers who need them.

Modular design at its most effective

Modular design can seem like an ephemeral concept – until it solves a problem for you.

Some compounding pharmacists have called to bemoan their earlier purchases of hoods that cannot be modified.

We feel their pain, but we can’t help but acknowledge the diverse customer worlds made available to us due to modular design.

The modular design of Sentry Air air purification devices  produces straight-forward manufacture across product lines.

Our air cleaners are effective on lab hoods, on and under tables, rolled around the workplace, as well as hung on walls and stands because their modular design makes for straight-forward manufacture across product lines and operational reliability.

Proposed 12-air-exchanges-per-hour requirement

We think pharmacists should investigate the value of air exchanges as a method for controlling exposure to airborne hazards.

Experts in industrial hygiene don’t favor air exchanges to control exposure.

Give us a call

If you’re wrestling with the <800> proposal and want to talk about it, call Sentry Air Systems at 800.799.4609. You can also email us at sales@sentryair.com, visit our website or fill out the feedback form below.