Whether isolator or clean room based working areas, if were talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk.
The first known, is actually outside of the clean room 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. The issue we have with a dirty receiving area and in general negative pressure clean rooms for hazardous drug compounding is that, while it protects the rest of the facility.
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.
When the technician goes in, and opens the box, even with the proper protective gear on, it doesn’t really matter if it’s neutral or negative pressurized room, since the person is still getting exposed to any affluent that is coming of the hazardous material toad.
One of the major risks associated with opening a container in an open room or Laminar Air Flow Open Hood, can cause direct exposure to hazardous materials that are enclosed inside the lab toad. On one of our site visits while performing a cleanroom gowning & garbing training, we have encountered a pharmacy technician that has been placed under medical surveillance for the rest of his life, due to first air exposure to hazardous materials, that happened when opening a box that came in from shipping and receiving and contained broken vials filled with hazardous chemicals.
The facility that had witnessed this event had disclosed their commitment to remove all possibilities from similar incidents to reoccur in their pharmacy. With their help we have developed the StageThru800, a solution that houses the box that arrives in the room from shipping and receiving to be staged and opened in a negatively pressurized enclosure. With its comprehensive barrier and filtration technology, the StageThru800 provides the highest level of safety to the personnel handling incoming or outgoing hazardous materials.
The StageThru800 design allows product to go inside thru the entry accordion door, and once the box is opened and product is properly wiped it can safely enter the cleanroom. Our StageThru800 is fitted with accordion doors because of the fact that whenever the door is opened, the accordion system keeps the inner side in and the outer side out.
The standard StageThru800 model comes pre-equipped with the Photohelic Gauge Alarm System that is used to monitor the air pressure of the system and can help identify any issues with the building ventilation system, the fan or the HEPA filter. The StageThru800 is made of stainless steel for enhanced cleanability. Highly polished for superior lighting, smoothness and cleanability. Front and side panels as well as door panels and hinging system are made from clear polycarbonate.
We have also attached the StageThru800 to our negative pressure isolation system, the XLTC800 and have it directly connected with the Containment Engineering controls C-PEC & C-SEC. Besides building and developing our standard layout model, our team at Aseptic Enclosures can customize a StageThru800 enclosure to fit your specific needs and space requirements. We are experts in providing highly customable enclosure solutions.
Get in touch with us if you’d like to learn more about our StageThru800 CVE or our XLTC800 series isolation systems. A great side by side comparison of the performance of our XLTC800 and the minimum requirements of the USP 800.