UPDATE: On September 23, 2019 USP announced that the official dates of the revised <795> and <797>, and the new general chapter <825> will be postponed until further notice. In the interim, the currently official chapters of <795> and <797> including the section Radiopharmaceuticals as CSPs will remain official.
USP General Chapter <800> is not subject to any pending appeals and will still become official on December 1, 2019. It is important to note that while 800 will become official, it will be informational only. It will not be apply until the appeals process is completed. Click here for the official notice from USP.
Are you currently undergoing or still planning to move forward with your pharmacy renovation? Our healthcare experts compiled a list of 20 best practices to apply to your spaces to ensure you a smooth construction project.
What are USP General Chapters 797 and 800?
To ensure the quality of compounded medicines and the safe handling of hazardous drugs by healthcare workers, the USP released new and revised standards.
USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations helps to ensure patients receive quality pharmaceutical preparations that are free from contaminants and are consistent in intended identity, strength, and potency.
USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings provides standards for safe handling of hazardous drugs to minimize the risk exposure to healthcare personnel, patients and the environment.
Best Practices to Apply
Renovating your pharmacy space to comply with the USP <797> & <800> standards is complex and time-consuming. These best practices will save you time and help you hit your deadline.
Make sure your construction schedule reflects the timeline for the certification.
The initial room certification takes approximately three to four weeks. It is important that you include this in your construction schedule.
Who is certifying the room?
Find out who is certifying the room and bring them on board early. This will allow you to ask any questions before the inspection and fully understand what is expected.
Revisit any rooms that were designed to the USP 797 minimum standards.
It is very probable that any room designed to the USP 797 minimum standards will fail the environmental testing that is done every six months. The three main reasons being (1) human error, (2) quantity of people in the rooms are constantly in flux, and (3) the equipment or stored materials in the room can introduce contaminates.
The cleanroom will be using quite a bit of energy.
The air handling unit cannot use nightly setbacks, as this will contaminate the rooms.
Rooms need 99.97% HEPA filtration through the supply air.
Supply and exhaust grill placement matters.
The supply grilles should be evenly distributed in the ceiling to prevent a higher concentration of contaminates in an area. The exhaust grilles should be near the areas of higher contamination (e.g. entrance to negative pressure room to draw out contaminates before they enter the room and near equipment such as fridges, hoods, storage carts, etc.)
The materials installed have to withstand constant cleaning.
Tighter tolerances need to be maintained when compared to other construction.
This includes pressure, temperature (68-degree rooms recommended), humidity (breeds bacteria!), air change per hour (60 ACPH recommended), and a constant state of microbial control. This is done by swabbing the walls, monitoring the contaminates present in the rooms and cleaning the rooms multiple times per day.
Set the room pressure delay alarm after 1 or 2 minutes.
Whoever is managing the building automation does not need an alarm every time the door is opened.
Access panels are not allowed in ideal clean rooms.
All mechanical shutoffs should be relocated outside of the cleanroom ceilings.
This includes above ceiling items that may feed other areas.
Auto operated doors should be held open around 3-6 seconds and be interlocked.
These can only open one at a time.
EVERYTHING needs to be caulked.
This includes door frames, sinks, outlet plate covers, inside outlet boxes, fire alarm strobes, auto operators, thermostats, lights, grilles, and diffusers.
Install electric balancing dampers in the exhaust/return system.
The area should have wall protection.
USP <800> states that rooms should be protected from damage from cleaning chemicals and tools.
Doors should have 1” undercut.
If the doors are aluminum, make sure they are sealed on top and bottom.
Coved flooring should be flush with drywall or wall protection.
Avoid creating any shelves or crevices for bacteria to collect.
There are long-lead items to take into account.
These items include air handling units (12 weeks out), FRP doors (10 weeks out), pass-throughs (10-12 weeks out), and HEPA filtered supply grilles.
It is highly recommended for the clean room to have its own air-handling unit vs. making modifications to an existing unit.
This is recommended so it is on its own isolated system.
Need Help Applying These Best Practices at No Cost?
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