Hot Water Spray Sterilizer

The principle that terminal sterilization provides a higher degree of sterility assurance than aseptic processing is well understood and leads regulatory agencies around the world to require that if the product can be terminally sterilized it must be. The technology of hot water sterilization with counter-pressure has been developed specifically for the terminal treatment of solutions in sealed containers.
The working principle is based on 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 exposure to heat. The water shower over the product ensures that uniform temperature distribution is maintained throughout the chamber during the sterilization phase. The high rate of water circulation and the two-stage water distribution system ensures accurate and homogenous temperature distribution in the product to be sterilized. Since the water comes into physical contact with the container the heat transfer is more efficient and the process efficiency is not affected by air pockets. The pressure in the chamber is continuously adapted to the internal pressure of the containers and the entire process can be controlled easily and accurately.

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  • All MACHINFABRIK Sterilizers are designed to comply with ASME Pressure Vessel codes, current GMP norms, EN 285, USFDA, EU, PIC etc. The system will be provided with DQ, IQ, OQ documents.
  • The technology of hot water sterilization with counter pressure has been developed specifically for the terminal treatment of solutions in sealed containers.
  • The working principle is based on 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 exposure to heat. The water shower over the product ensures that a uniform temperature distribution is maintained throughout the chamber during the sterilization phase.
The high-volume water circulation rate and the two- stage water distribution system ensure accurate and homogenous temperature distribution in the product to be sterilized. Since the water comes into physical contact with the container, the heat transfer is more efficient and the process efficiency is not affected by air pockets. The pressure in the chamber is continuously adapted to the internal pressure of the containers and the entire process can be controlled easily and accurately.
  • The 6mm thick chamber is fabricated with SS316L with high quality inert gas argon welding and is provided with round corners for easy cleaning and a 2% slope for full draining of the condensate.
  • The chamber is also provided with a safety valve and compound gauge (on both sides), RTD sensors, pressure switch and pressure transmitter.
  • The sterilizer is provided with one/two automatic sliding SS316L door reinforced with SS 304/mild steel. Mineral wool insulation is provided which is held in place by a stainless steel outer cover.
  • CNC machined groove for superior performance and excellent sealing of the door gasket can be provided.
  • The door is automatically moved vertically / horizontally via a pneumatic cylinder to ensure the safety of the operator and the equipment during the entire operation.
  • Compound gauges for gasket pressure, with door status indications are provided on both Loading & Unloading sides.
  • The sterilizer chamber is insulated with 50-mm thick mineral wool, which is held in place by an outer cover of SS304.
  • The chamber and doors are finished to a surface finish better than 8 micron Ra value. All other non-contact parts are polished to a surface finish better that 180 grit.
  • The re-circulation system is used for heating, cooling and showering the process water on the load to be sterilized. This comprises of the Heat Exchanger, Circulating Pump and Water Shower Manifold.
    • Heat Exchanger:- SS 316L shell and tube type for heating and cooling the process water with silicone/PTFE sealing gaskets.
    • Circulating Pump:- For the circulation of the process water a high flow centrifugal pump is provided. The pump is driven by a 3 phase, TEFC electric motor.
    • Water sprinkling Manifold:- At the top of the chamber and along the depth a SS 316 spray manifold is provided. The system ensures a dense and uniform shower over the entire load.
  • All process piping in contact with the chamber is fabricated from SS 316L with argon welding All connections and fittings used are threaded [<50mm] and flanged for bigger connections. .
  • The process valves in contact with the chamber have SS 316L contact parts with Teflon seat and threades / flanged connections.
  • For periodic validation and testing of the system, Validation Ports with tri-clamp connections are provided.
  • The chamber can be provided with SS 316 L carriages with removable racks & trays for loading. Each carriage is provided with four wheels with sealed bearings impregnable to the steam.
  • Floor trolley is fabricated from SS 304 sturdy tubular members welded together with castor wheels.
  • The chamber is provided with SS 316L railing. The rails can be easily removed for cleaning the chamber.
  • Automatic loading and unloading system of carriages can be provided. It consists of a SS chain conveyor driven via a geared motor. Conveyor indexing is via push buttons.

 

  • The functioning of the Sterilizer is automatic and is controlled by a PLC. The PLC is operated with the help of a color, touch screen HMI with user-friendly features.
  • The PLC, instrumentation and electrical switchgear are housed in a SS304 panel installed on the skid.
  • The control cabinet is provided with a main isolator for the three-phase supply and a separate switch for the control supply.
  • To ensure flexibility, accuracy, highly reliable performance and compliance to regulatory requirements the Hot Water Spray Sterilizer is provided with up to 6 Sterilization Programs.
  • A Six-Channel Strip Chart Recorder for recording temperature at 5 points and pressure at 1 point is provided as a watchdog-recording device.
  • For on-line process recording a data printer is provided in the control panel.
  • For ease of operation and safety of the operator all critical and non-critical alarms are displayed on the HMI as a text message and audio signal is provided via an audio buzzer.
  • Optionally, the following features can be provided in the system based on URS:- CE Marking, vacuum pump with mechanical seal and vent filter, Compressed Air Filter with SIP Facility, UPS supply, utility isolation valves & gauges.
  • The system can be optionally provided with Industrial PC (IPC) or PC with 21CFR Part 11 Compliant System.
  • Optionally we can provide a 21CFR Part 11 compliant Chartless Recorder with a 4” LCD display.
  • After manufacturing and in-house testing customer inspection and testing can be performed as per in-house FAT protocol at our manufacturing facility.

MACHINFABRIK INDUSTRIES PVT. LTD.

MACHINFABRIK INDUSTRIES PVT. LTD.
Manufacturer
India

Primary focus area

Injectable / Sterile Unit

Analytical Products & Services

Project Management / Consultants

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