HPAPI Sterile Dispensing Isolator

Single chamber barrier isolator configured in order to grantthe dispensing procedure for API product achieving the followingtasks:• Assure a sterile environment inside the isolator. Assure operator protection, when the processedproducts are highly active.The barrier isolator operates under a positive pressure regime,as required for sterile manufacturing processes. Connection on the bottom part of the working chamber ininterface with the reactor loading device with PTFE gasket inorder to allow the operation with high temperature. Double RTP transfer system on the right side of the isolator. Oval glove ports with safety bar to prevent the operator accessin the working chamber if the temperature at the dischargingconnection does not correspond to the prefixedacceptable safety range.Cleaning of the isolator is performed by means of spray balland washing gun. Integrated weighting scale with 0,02g accuracy. Integrated video camera for visual control of theloading operation.Integrated H2O2 generator for the bio-decontamination ofclean, hard, dry surfaces within sealed enclosures for volumesup to 2m3.

Containment systems for sterile applications may be proposed in the form of closed isolators or Restricted Access Barrier Systems (RABS).
A sterile isolator allows to avoid the use of sterile cleanrooms, reducing the sterile volume around the process being executed.
Turbulent or unidirectional flow may be adopted for airflow.
Typical applications are:

• sterility testing
•  aseptic filling lines
•  vessel charging
•  Dispensing
•  sterile jet milling
•  dryers discharge of sterile products.