Description
Injectable Plants (Small Volume)
Features
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
- Skid Mounted System
- Designing the sterile mixing vessels as per the 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
Spesifications
- Sterile piping, valves and 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 + electropolished
- 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 matte finished to less than 0.8 Micron
- Sterile sampling devices, cleanable & sterilizable
- SS Matte finished control panel
- GMPvalidated Magnetic Agitator with required mixing profile ortop mounted compact agitator with sterile Mechanical Sealing systems
Applications
- Injectable Small Volume Parenterals
- Eye Drops
- Nasal Drops
- Sterile Oncology Products
Our Products
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