The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area.
This equipment is designed to provide a protective barrier for the operator. It is not iso-classified. It is not appropriate for any type of aseptic operation.
The StageThru800 is designed for incoming and outgoing material preparation. Any product exiting this equipment should be properly decontaminated and prepared for patient transport.
The StegeThru should be paired with the appropriate decontamination procedures, as well as appropriate bag out procedures for waste materials should be established.
Aseptic Enclosures manufactures a wide range of negative pressure equipment solutions for hazardous drug handling and USP 800 compliance.
The StageThru800 (CVE) removes the person from a level of exposure risk associated with contaminated inventory. The main purpose of the StageThru 800 is to make the staging and opening boxes that are coming in from shipping and receiving a safe process.
We at Aseptic Enclosures had discovered that the USP 800 is mistreating the events that can occur when opening boxes in neutral or negative pressure.
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. https://asepticenclosures.com/usp800vxltc800/
