We have done a lot of work in pharmacy planning and design.
We do strongly recommend implementation of isolator-based solutions for facilities that do not implement any type of isolator, but certainly will design to our clients interests.
Whether isolator or cleanroom based if we’re talking about both sterile and hazardous sterile we will approach the job with six general zones.
The first known general zone, is actually outside of the cleanroom and is the pre-cleaning station. In the hazardous drug area we like to see packages from shipping and receiving brought into a negative pressure zone for staging and preparation.
Because we always try to set all the negative pressure zones together, we can also manipulate pressure differentials in a significantly more aseptic method. This is because we can make the unconditioned dirty receiving area more negative to the subsequent clean areas.
We also implement custom designed pass-throughs that enable appropriate airflow to keep interior contents cleaner and to minimize traffic into the cleaner sides.
Separation in the facility is at the highest level – two sets of rooms grouped according to the type of drugs handled and compounded, Hazardous and Non Hazardous. They are completely segmented by the pharmacy work area in between.
The amount of protection for the people entering the hazardous drug zone can even sometimes be worse due to the concentration and inventory of materials. Opening boxes from shipping and receiving, while it isn’t mandated by USP 800 to be in a negative pressure zone, we strongly recommend that be the case.
This is a good example of just how detailed our designs are: you can see the entry area to the positive pressure clean room, the layout of the sink, the data sheet for the sink, location of low wall returns automatic sliding door, and some detail of the laminar flow hood.
When we do a pharmacy planning and design job we are designing down to the nuts and bolts so that when the package is approved and turned over there is no question about what this facility will look like.