Transferring items into and out-out rooms is something we all take for granted. It’s easy to pick up a folder and deliver it to an office down the hall, or load up a cart with paperclips and staples destined for the supply cabinet. Once you work in a cleanroom, however, this simple task turns into a “process.” Strict requirements govern the steps that personnel take for otherwise simple actions.
Think about moving a cryobox or tube rack into an ISO-rated cleanroom from an “unclassified” space that only requires you to wear a lab coat. You read the SOP, and know that you need to get to the gowning room and follow the time-consuming steps of removing jewelry, cleaning shoes, washing hands, garbing up, applying a face mask, covering your hair and walking through an air shower. How much time did that take, and what work would you have been doing otherwise?
Pharmacy compounders have a lot of factors to consider when making the decision to go into the business of mixing individual prescriptions, particularly those considered “hazardous.” It can be a lucrative operation, but one which is closely overseen. For good reason, though: mistakes in the recent past have taught us that sloppy procedures, partly resulting from a lack of regulations, can have deadly consequences.
Once you’ve make the commitment to move forward with your compounding pharmacy business model, you have to understand your responsibilities (and the associated costs) regarding equipment and furnishings. What used to be true for minimum “engineering controls” is no longer good enough, and regulators will make sure that pharmacies comply.