I recently had an employee take a box into the IV room that was allowed due to the coating, however the lid had been torn off leaving the shredded non-coated area. I asked them to remove the box and informed them that it was only allowed if the box was not exposed in any way. The technician repeated again a few days later and stated that they do not agree enough to comply. To my knowledge once the box was torn open it would cause more particles than necessary. Am I correct or am I going overboard.
The "slick" cardboard used for vial cartons and "trays" that hold multiple vial cartons may be taken into the cleanroom (and opened). It is the corrugated cardboard used in "outside"/shipping cartons that should be banned from the cleanroom.
I agree with Robert but tearing the carton can create exposed paper board which is less than ideal. If you have a buffer area that meets the requirements of USP 797, then from a particle load perspective, I don't anticipate that you will have a problem. There are, however other issues that need to be addressed.
1. What does your policy and procedure say about these types of boxes? If you have a policy that prohibits them from entering the room, they you have an insubordinate employee that needs to be written up, counselled and if appropriate fired.
2. It is outside of the technician's purview and authority to decide whether they agree or disagree with an organizational policy. Again, this is insubordination and the technician is candidate for further disciplinary action including termination.
Revisit your PnP, make the changes if you are the supervisor, get them approved, and make sure everyone knows about the change. If it continues to be a problem, address it within the confines of your progressive disciplinary policies. The technicians attitude is not acceptable.
Here's hoping your technician staff is not unionized. I'd be more worried about what else the techs in your department have decided to unilaterally change or ignore. Some re-education on lines of authority and responsibility would be appropriate for your staff. Good luck.
I am a lead tech tech with some supervisory responsibility and I have to tell you that if I heard that one of my technicians blatantly disregarded a reasonable request from a pharmacist, we would need to sit down and have a long conversation about pharmacy roles and responsibilities. If this were a second or third offense, this is certainly something that would go to a manager.
