SNOWBELL - Compounding Isolator
ฝัง
- เผยแพร่เมื่อ 9 ก.ย. 2024
- Features :
• 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