Super Heated Water Spray Sterilizer manufactured by Neelam industries are designed for cGMP 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.
The working principle of Neelam Industries’ Autoclaves is based on the automatic counter pressure by injection of compressed air into the chamber during the entire cycle to minimize the differential pressure across the containers generated by the exposure to heat.
Using sanitary-type centrifugal pump, water from the bottom of the chamber will be circulated through a heat exchanger.
After that water will be circulated into the upper part of the chamber and it will be distributed on the load by a system of spray nozzles.
Water is maintained in liquid form at superheated temperature due to positive pressure in the chamber and thereby efficiently sterilizes the load.
Positive pressure is maintained in the chamber that counterbalances pressure build up in flexible containers thus preventing container bursting or deformation.
- 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.
- Validation ports for insertion of temperature sensors for thermometric testing.
Sizes available from 1000 lts. to 15,000 lts.
In compliance with :
cGMP, GAMP, ISO 9001 : 2008
Main applications :
- Large volume infusion/parenteral solutions in sealed glass, PP, PE, etc. bottles – quick cycle
- Large volume infusion/parenteral solutions in sealed PVC, PP, PE, etc. bags – quick cycle