Pharmalab

INJECTABLE PLANTS (SMALL VOLUME)

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 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 Equipment’s are offered with Third Party Inspection & All Electrical Control with ERTL Approval & Test.

SPECIFICATIONS

• 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 + 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 matte finished to less than 0.8 Micron.
• Sterile sampling devices, cleanable & sterilizable.
• SS Matte 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