Bio Reactor Sterilizer manufactured by Neelam industries are designed for c GMP to perform terminal sterilisation of large volume infusion / Parenteral solution in Non-deformable container (e.g. glass bottles) as well as in containers deformable by differential pressure under Heat exposure (e.g. plastic bottles, plastic bags) proven to withstand sterilization condition by hot water spray.
FEATURES :
Design for installation on the floor ( for loading with in-chamber & transfer trolley) or pit mounted (for loading at floor level with in/out trolleys or automatic loading/unloading units)
Single or double door with Sliding or Hinged door options to suit client specific requirements.
Cylindrical single-wall chamber in highly finish AISI 316L stainless steel.
Chamber pipings and fittings in AISI 316L stainless steel, Tri-clover clamp connection.
Water spray distribution headers fitted with nozzle suitably located to assure water uniform distribution on the product with consequent excellent temperature uniformity throughout the entire load.
High efficiency plate type heat exchanger, in AISI 316L S.S., for recirculation of heating / cooling water.
Pressure Monitoring inside the chamber by pressure transmitter.
Water level monitoring inside the chamber by sight level assembly and capacitive level sensors.
Automatic Printing facility for control in case of heat labile materials.
The touch-screen for visual process control and connections for measuring signals and printers.
Remote support connection
Online Printing and recording confirming to 21 CFR PART 11.
0.2 bacteria retentive, sterile air filter for vacuum break. [Optional SIP facility can be provided]
Contamination Seal to prevent cross-flow of air between the clean and un-clean area.
Saturated Steam Sterilizer manufactured by Neelam industries are the most versatile and flexible designed to meet the widest requirements of the Pharmaceutical Industry.
Neelam industries offer any specific sterile requirement and meet User's R & D and Production requirement with Standard or customized model of sterilizer.
Features :
Dimple steam Jacketed for better Uniformity of the heat Distribution. ( Technology for fast Sterilization cycle and low cost operating ).
Single or double door with Sliding or Hinged door options
Automatic Printing facility for control in case of heat labile materials.
The touch-screen for visual process control and connections for measuring signals and printers.
Remote support connection
Online Printing and recording confirming to 21 CFR PART 11.
0.2 bacteria retentive, sterile air filter for vacuum break. [Optional SIP facility can be provided]
Contamination Seal to prevent cross-flow of air between the clean and unclean area.
Validation ports for insertion of temperature sensors for thermometric testing.
Programs :
HPHV Cycle
Fast Exhaust Cycle
Slow Exhaust
Chamber Leack Test Cycle
Bowie Dick Test Cycle
AOP Cycle ( FOR Liquid Solution Sealed in Ampoule & Vial )
In Compliance With :
cGMP, GAMP, ISO 9001 : 2008
Main Applications :
Empty glassware (e.g. vials, ampoules, bottles)
Stoppers
Inox equipment and instruments
Inox machine parts
Empty containers
Filters and accessories
Rubber materials
Textiles
Liquid solutions and culture media in sealed or unsealed containers (e.g. vials, bottles, ampoules)
Plastic materials (able to withstand usual temperatures for saturated steam sterilization)
