XLTC800 exceeds the minimum standards established by USP800

Please share your thoughts!

We have met some resistance concerning the perceived “compliance” with USP 800 of the equipment​​ (XLTC800) discussed below. For those that don’t know, USP800 is a pharmacopeia establishing guidelines for hazardous drug (HD) handling in hospital and independent pharmacy settings. ​​ The resistance met is not because anyone feels the approach inferior, to​​ the contrary, all USP800 expert panel members, BOP executives and pharmacy directors we have presented to, pretty much unanimously feel this equipment, as a “stand alone” installation, yields a safer and more aseptic environment. ​​ However, bureaucratic interpretation of semantics can sometimes present a challenge. ​​ Perhaps your comments can help provide clarity and enhance patient and staff safety!

So, to illustrate our position, we start with a diagram to highlight the equipment’s basic aseptic-containment operating principles. ​​ Then we picture some common scenarios. ​​ First, using our preferred (XLTC800) approach. ​​ Then we have a couple depictions of the standard configuration and what some consider a more “compliant” approach. ​​ To us, It seems quite obvious where more risk lies. ​​ What do you think?

XLTC800 operational brief:

The blue arrows represent system air flow path. ​​ The labeled boxes show chamber names and relative pressurizations. ​​ Unpacking, staging, storage, bag out/decon prep is done in the unclassified rightmost chamber called the Containment Vented Enclosure (CVE) It is the most negative of the three. ​​ It draws air in from both the ambient and the middle chamber know as Containment Secondary Engineering Control. This C-SEC is ISO5 used for wipe​​ down type disinfection of all surfaces that are to be transferred into the Containment-Primary Engineering Control. ​​ The C-PEC is ISO5 and positive pressure to the C-SEC. It is the leftmost chamber used for HD sterile transfer.


Clearly, this is not a cGMP grade parenteral process. Please keep in mind, we are comparing the XLTC800 to the typical pharmacy configuration of an open BSC in a negative pressure cleanroom. A cleanroom that has no sterile processing equipment. It usually runs negative pressure to the anteroom. It often houses a “non-cleanroom grade”, HD storage refrigerator and all the HD inventory storage, because it is the only containment room. ​​ Surface contaminated product is constantly being walked directly into these areas. ​​ At best, wipe down disinfection with Sterile IPA is all that is happening prior to placement in the BSC. ​​ HD receiving/staging is normally done in a non-adjacent area that “may” be negative pressure and then product is transported into the cleanroom. Breaks, drops and spills can yield exposure risk.




Which areas do you feel have more exposure risk?