Horizontal HPHV Fully Automatic Double Hinged Door Rectangular Steam Sterilizer (610mm W x 910mm H x 1520mm D) (850 Liter)

Technical Specifications: The High-Pressure Vacuum Steam Sterilizer is used for sterilization of machine parts, change parts, fabric, tubing, bulk drugs, etc. in a pharmaceutical facility. The autoclave has been built in accordance to ASME guidelines and GMP norms.

CAPACITY / SIZE CHAMBER SIZE 1520mm (depth) x 610mm (width) x 910mm (height)

Chamber

Fabricated from AISI 316L with full argon/arc welding. Thickness – 6MM.
Chamber Surface will be polished to a finish of 0.4 Ra.
Chamber is provided with round corners for easy cleaning and a 2% slope for full draining of the condensate.
A baffle plate/sheet is provided for improved distribution of steam in the chamber. This also ensures that the incoming steam does not directly damage the load.
The chamber is also provided with a safety valve to ensure load, machine and user safety in case of over-pressure situations in an extreme case.
The compound gauges provided on the sterile and operating side allows the operator visual confirmation that the pressure is within the specified limits during the cycle operation.

Jacket

The chamber is re-enforced with Stainless Steel jacket 304L. Thickness – 8MM.
The jacket besides reinforcing the chamber also helps to maintain temperature uniformity in the sterilizing space.
The jacket too is provided with a mechanical-safety valve.
A pressure gauge on the operating side indicates the pressure to the operator at all times.

Doors

AISI 316L with Thickness 12MM with Double Hinged Door.

Door Safety

The following door safety features are provided for maximum operator safety: -

Door inter-lock to prevent simultaneous opening of both doors.
Process-lock to prevent opening of the door during the process.
Process-lock to prevent the opening of the non-sterile door after successful completion of the cycle.
Door obstruction safety.
Door Lock Cylinder provides for door safety. (Make: Festo)
Limit Switch also provides for door protection. (Make: Honeywell)

Steam Generator

Material: SS 304L
Capacity: 300 Liter
Thickness: 6mm

Insulation

The sterilization chamber is insulated with 100-mm thick Glass Wool, which is held in place by an outer cover of SS 304.

The average surface temperature of the machine will not be more than 350C.
Vacuum

Water Ring Vacuum Pump of 5 HP. (Make: Kirloskar)

A water ring vacuum pump is provided along with the system.

This Vacuum Pump is used for creating vacuum in the chamber for mechanical air-removal prior to sterilization and subsequently for post sterilization vacuum drying.

A Water ring vacuum pump is provided with all our Automatic autoclave for following reason

Pre vacuum: Before exposure of steam, the vacuum pump (available only in automatic system) creates vacuum through pulsing process (filling of vacuum with dry steam), thus removing the bio burden from the chamber and increasing the sterilization potency of the process.
Post vacuum: The vacuum pump removes the residual moisture after steam exposure from the chamber at the end of sterilization cycle to enhance the dryness of resultant load.

Piping Package

All process piping in contact with the chamber is fabricated from SS 304 with argon welding.
Piping in contact with the jacket is fabricated from SS 304 with argon welding.
All connections and fittings used are sanitary tri-clamp with silicone seals.
The piping is designed to ensure that the customer can provide utility connections at one single point.
All drain lines and exhausts are connected to a drain manifold. The pipelines also have a 2% slope for full draining to prevent contamination.
All pneumatic lines are of polyurethane with aluminum die-cast connectors.

Steam Accessories

The jacket and chamber are provided with an over pressure safety valve.
Thermodynamic steam trap (Make: Forbes Marshall) with special air vent arrangement required for condensate removal.
The pure steam supply to the machine can be provided with SS 304, sanitary construction, PRV. (PRV IS IN CUSTOMER SCOPE)
0.2 Micro Filter ensures Clean Air intake after sterilization to safeguard the sterile integrity of your load.
Railing

The chamber is provided with SS 304 railing with circular cross-section.
The rails can be easily removed for cleaning the chamber.

Automation

Hardware: PLC & HMI (Make: Honeywell & Fuji)

The control system consists of a PLC (Programmable Logic Controller) and a user friendly, 7” TouchScreen HMI (Human-Machine Interface) that allows the user to operate and monitor the machine with maximum ease.

The above Hardware devices and software used sequentially operate these devices to:

Receive input signals and readings from the various measuring/monitoring devices like the sensors, switches, and safety-devices.
Decipher and process the above inputs and values, and compare them to the cycle set-points.
In addition, based on the above information give output commands to the various controlling devices like valves, cylinders etc. as the cycle progresses.
The automation also continuously logs data in digital and print formats.

Instrumentation

Input and output devices as mentioned above:

Temperature Sensors are provided for Analog input for temperature at different points & Temperature Sensors (1 Nos.) is provided in the drain.
A pressure Transmitter that gives a 420mA signal is used to obtain an Analog input of process pressure/vacuum.
All Control valves in the process lines are pneumatically operated 2/2-way angle-seat valves. The contact parts are SS 304, with Teflon seals. These valves are in turn controlled by solenoid valves.
Process indication Lamps on the panel and the sterile and operating side indicate status of the Doors and the sterilization Cycle during various phases as the cycle progresses.
All process parameters, instrument status, Pressure/temperature values, Phase titles and values and elapsed and remaining time indications are at all times visible on the Touch-Screen
For operation in the Manual Mode in case of PLC failure, Rotary Switches, Temperature Controller, Timer etc. are provided for ease of operation.
Easy printing facility on dox matrix printer.

Working Pressure & Temperature:

Chamber – 15 PSI to 17 PSI (1.5 KG/ CM²)
Temperature: 121 DEG. C
Time Duration – 20 min
Chamber – 30 PSI (2.2 KG/ CM²)
Temperature: 134 DEG. C
Time Duration – 7.5 min

Sterilization Programmes:

The system includes the following pre-programmed cycles; additionally, unlimited number of user defined cycles can also be programmed into the memory of the system:

Leak Test Program
Bowie & Dick test program
Terminal Test Program
HPHV Test Program

Advantages:

3 level password protection for preventing unauthorized access
software ensures remote monitoring and control, and digital data storage
In-built Real Time Clock with date and time function required for On-line printing.
Power-failure logging.
Alarms are generated and logged for incoming utilities and errors.

Manual Back Up

The control system is provided with manual back up in case of PLC failure. Here all valves, pumps etc. can be operated via switches. A temperature indicator controller is also provided for automatic control of the steam in valve for temperature control.

Safety

In case of power failure, the sterilizer is put into a failsafe position, by means of locking all utilities to avoid any damage to the equipment and product.
One safety valve for the Chamber (set point 3 bars).
Door obstruction safety provided for all doors.
Emergency stop buttons on sterile and operating side. If pressed, then all the outputs to the valves and motors are Reset and all activates cease. After releasing the emergency stop button, the alarm has to be Acknowledged with a separate button on the operator panel. Only then, the cycle will restart exactly at that point of the program where the process was interrupted.
Password protection for modification of the software and editing of the sterilization program parameters.
Alarms

High temperature and pressure.
Sterilization timer stop in case of temperature drop.
Sterilization timer reset in case of temperature drop.
Too long time to create vacuum.
Too long time to heat up.
Vacuum pump trip.
Utility failure alarm
No supply voltage/power failure alarm
No Generator water alarm
Over Load relay alarm
No Mains water alarm
Maximum/Minimum chamber pressure alarm
Air in Chamber alarm
Door Open during cycle alarm
Doors not properly closed alarm