Liquid Injectable small and large volumes are manufactured in Class A conditions starting from Washing of Component to Sealing Operation under Laminar Flow Hood as required by the cGMP.
Glass Containers of type A are washed with DI/WFI under HEPA filtered air & LFH, filtered distilled water and compressed air through 0.2µ filters {30 to 50psi} to maintain clean room conditions. Filling and Sealing of Ampoules LFH with 0.45m/s+20% (vertical) air velocity and air changes (60/min) in filling room are designed while Positive pressure in all aseptic areas for 24 hours. Filled ampoules are terminally sterilized with PLC Controlled Steam Sterilizer. Centralized PLC system from USA is effectively operating for continuous monitoring of all sterilizers & Temperature Controls.
Automatic Inspection Machine with data printer. This machine employs double check system for particles, Filling Height at High Speed using a light Transmission System. Packing Operations are performed under verification of QA. Quality Risk Management Principles are implemented effectively for Product Quality, Safety, Purity & Efficacy.
Separate Air handling units for each area to avoid cross contamination & contamination. HVAC based on Federal standard 209 E. Air-Handling Units are provided with Terminal HEPA filter at 99.97% efficiency and critical processes are further protected by LFH. The HVAC installed all areas including Raw Material Warehouse & other Controlled areas.
Various Automatic Air Compressors to provide Pharma Grade Oil and moisture free compressed air for process,Automatic PLC Controlled, Multi-effect WATER DISTILLATION PLANT with 5 Columns of cGMP standard ( AISI 316-L), Purified Steam generation to sterilize the vessel during cleaning process, 24 hours Water Loop system for circulation and storage at 80°c temperature are the few salient features for the cGMP compliant sterile liquid injectables section of the facility.