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
• 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

Specifications

• 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

Applications

• Injectable Small Volume Parenterals
• Eye Drops
• Nasal Drops
• Sterile Oncology Products

• Download Literature: Injectable Plants (Small Volume)