ISOLATOR FOR COMPOUNDING / MANUFACTURING

· Negative Pressure Isolator

· Rigid wall construction in SS316L

· Internal surface finish is 0.4 µm & external surface finish is 0.8 µm

· Weighing balance for weighing API / Excipient

· La – Calhene (Getinge) RTP provided for material transfer & waste disposal

· La – Calhene rotate alpha – beta port for vessel integration with Isolator

· Dynamic double door pass box to transfer the material inside the chamber

· Automatic Leak Testing

· AHU for supply & exhaust air with recirculation system

· SS304 supply & return ducting between AHU & the Isolator

· Air inlet through panel type HEPA filters

· Air exhaust through safe change Push–Push HEPA filters

· Monitoring & controlling of pressure, temperature & RH

· Provision for connection to SCADA as per 21 CFR part 11

· Data Logging

· Oxygen analyzer with nitrogen purging system

· ATEX approved components inside the Isolators

· Provision for VHP sterilization

· Vertical opening glass doors with door locks & interlocks

· Oval shape glove ports with Hypalon gloves

· WIP guns & spray balls for CIP

· Catch pot to collect drain water from Isolator

· ERGO model acceptance test