Product Details

Steam sterilizer

Steam Sterilizer continues to be one of the ancient but widely used sterilization techniques in the Life-Science & HealthCare Industry. The process systems now have to meet the most exacting demands for temperature and pressure / Vacuum control and process documentation. A sterilization system represents Therefore, Machinfabrik takes measures to ensure that our Sterilizers provide and life cycle economy. Every Sterilizer is produced to your specifications and needs. Flexible options allow the selection of the right equipment for each specific sterilization load and packaging.

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Tech Specification

Injectable / Sterile Unit Autoclaves

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 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 reinforced with a SS 304, 5mm thick jacket.

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 Cabinet Enclosure houses the pressure vessel, piping system, electrical systems and SS 304 facia panels of the unit. Service doors are provided on the sides for maintenance and cleaning.

A cross-contamination seal is provided at the clean side for double door units to separate the clean and unclean sides. The system is designed to minimize the flow of the air from the clean area.

A water ring vacuum pump along with a mechanical seal is provided for creating a vacuum in the chamber.

A shell and tube type condenser fabricated from SS304 is fitted in the exhaust /vacuum line to condense the steam before entering inside the vacuum pump.

A 0.2μ bacteria retentive, vacuum break filter (hydrophobic type) is provided on the unloading side for pressure equalization after vacuum creation.

All process piping in contact with the chamber is fabricated from SS 316L with argon welding. All connections and fittings used are sanitary tri-clamp with silicone seals.

The process valves in contact with the chamber have SS 316L contact parts with Teflon seat and tri-clamp connections. All other valves have threaded connections.

For periodic validation and testing of the system, Validation Ports with tri-clamp connections are provided.

The chamber can be provided with SS316L perforated Shelves in case of smaller systems for easy loading & unloading.

The chamber can be provided with SS 316L carriage with removable Shelves (perforated/wire-mesh type) for loading. Each carriage is provided with four concave-shaped wheels with sealed bearings impregnable to the steam.

The floor trolley is fabricated from SS 304 sturdy tubular members welded together with castor wheels.

The chamber is provided with SS 316L railing with a circular cross-section. The rails can be easily removed for cleaning the chamber.

The functioning of the Steam 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 an 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.

TEST PROGRAMS

Vacuum Leak Test
Pressure Leak Test (optional)
Bowie and Dick Test.

OPERATIONS PROGRAMS

Warm up cycle.

Gravity Displacement Sterilization Program.
Pre-Vacuum with Vacuum Sterilization Program.
SIP of Vent Filter (optional).

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 online 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, Electric Steam Generator, Automatic Hinge Door, Vacuum Pump with Recirculation and Cooling System, Vent Filter with SIP Facility, Sanitary PRV for Chamber Steam, Black Steam PRV for Jacket Steam, fittings and tubing to carry out steam quality testing, manual diaphragm valves for sampling of inlet Pure Steam to the Chamber and the steam condensate from the chamber, Air Detector Device in the drain line to generate an alarm in case of presence of air pockets, UPS supply, PID control valves, Pure steam by pass arrangement, drain condenser, sanitary accessories, level switch in drain line, hot air drying arrangement, jacket cooling & monitoring, utility isolation valves & gauges.