Do not be afraid of USP 800
January 9, 2019
Most of our questions coming from compounders is regarding USP 800 non-sterile. This is the biggest market with most compounders going forward. And each compounder needs to start their plan, budget, and exact needs now to meet December deadline . Hazardous non-sterile compounding is not extremely difficult or extremely costly that we will detail in terms of economy of scale versus number of scripts and volume. Certain requirements is an enclosed room (and we mean completely sealed), with negative pressure air will be pulled from place of least resistance. We can overcome this obstacle. Sink within space. Simple as that. Well there is a few more details.
The budget for HVAC mechanicals is the biggest obstacle that gets overlooked. Will you be venting out of building or double hepa filtered with space. Will you use hood for negative pressure or a hepa fan system. Both are acceptable but both have drawbacks. Do you have a plenum to circulate air or direct access to provide required negative pressure. Remember earlier about pulling air from least resistance.
Second biggest issue that most lab designers do not build into your new plan is your exact workflow. Where are your work stations? How much space between your work station and counter or wall behind you? Where will you store chemicals and/or supplies? Less is more even for non-sterile compounding. Call us for a consultation.