Injectable Plants (Small Volume)
Custom integrated injectable process equipment for highest classified sterile formulation right from design, commission and validation.
- Vessels, Valves & accessories in compliance up to Class 100 classified area
- SS Skid Mounted System.
- Designing the sterile mixing vessels as per highest cGMP standards with Design Qualification
- Clean environment manufacturing with Factory Acceptance Test facilities
- Providing custom required Automation as per MCA & 21 CFR Part 11
- Efficient Micro Filtration System of sterile application with pumping system
- Providing required sterile accessories
- Providing qualification documents like DQ, FAT & Protocols of IQ & OQ.
- “CE” marked Equipments are offered with Third Party Inspection & All Electrical Control with ERTL Approval & Test
- Sterile piping, valves an instrumentation
- Custom required Vessel agitation system, sterile Magnetic Agitator as required
- Mobile Auto CIP & SIP Units
- Skidded Systems with integrated piping, valves & Automation with Inbuilt CIP/SIP System.
- All contact parts SS 316L mirror polished to less than 0.5 Micron + electrpolished
- Zero Dead leg design for vessel and Flush bottom diaphragm valve
- Providing validated CIP & SIP devices without any shaded area in spray system
- Food grade Gasket conforming to FDA 21 CFR Part 177.2600
- Non-Contact parts SS 304 matt finished to less than 0.8 m Micron
- Sterile sampling devices, cleanable & sterilizable
- SS Matt finished control panel
- GMP validated Magnetic Agitator with required mixing profile or top mounted compact agitator with sterile Mechanical Sealing systems
- Injectable Small Volume Parenterals
- Eye Drops
- Nasal Drops
- Sterile Oncology Products
Download Literature: Injectable Plants (Small Volume)