Parameters

SPECIFICATIONS

Chamber

Material

SS316L with full Argon welding

Thickness

4mm

Internal

Mirror Finished

Design Temperature

134°C

Vacuum

Full

Operating Pressure

2.2 KG/ CM 2

HYDROTEST PRESSURE

5 KG/ CM 2

All Piping and

Connection to Chamber

All process piping in contact with the chamber-SS316L

All connections and fittings used are sanitary tri-clamp with silicone seals.

All non-contact piping is fabricated from SS 304

All connections used are threaded.

The pipelines also have a 2% slope for full draining to prevent contamination.

Pressure Guage (SS)

1 no. SS304 gauge provided

Vacuum  Gauge (SS)

1 no. SS304 gauge provided

One Dial temperature

Gauge

SS 304 temp gauge provided with Chamber.

S.S. Ball Valves

½” ball valves provided as per design.

Jacket

Material

SS 304L

Thickness

3mm

Operating Pressure

1.5 Kg/Cm² or 3.5 Kg/Cm²

Test Pressure

5 Kg/Cm²

Design Temperature

134°C

Safety valve

2 nos SS304 safety valve provided

Pressure Gauge

2 nos SS304 gauge provided

Door

Material

SS304L

Thickness

16mm

No of Door

One redial central locking door with SS shooting roads.  The door plate is fabricated from  SS  304L.

Pressure/vacuum-tight sealing of the door is affected with help of an internal central locking arrangement and silicone gasket fixed on the door. The door components are fabricated from SS material.

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

·    Process-lock to prevent the opening of the door during the process.

Gasket

Pure silicon  squre12mmx12mm

Boiler

SS 304 with size 300mmX350mm

Insulation

45-mm thick Mineral/Fiber Glass wool. The average surface temperature of the machine will not be more than 450 or 55° C. (Room temperature 23 + 20 C)

Stand

The stand is made from M.S. tabular heavy-duty Pipe with a CI level adjustment flange.

CONTROL BOX

The M.S control box is provided with complete wiring, Switch indicator

Outer Insulation

M.S powder coated.

 Contamination Seal

A Stainless Steel flush mounting is fitted around the cabinet enclosure

and the sterile area wall to avoid any cross-flow of air between the sterile and non-sterile sides. (optional and will cost extra).

Automation:

The control system is provided with a PLC and user-friendly HMI as a front-end user interface. The key salient features are as follows: -

·    3 level password protection for process security.

·    RS 232 port for data communication.

·    In-built Real-Time Clock with date and time function.

·     Battery backup for automatic restart in case of power failure.

·      F0 calculator for automatic computation of process lethality.

VACUUM PUMP

A 1hp water ring noiseless vacuum pump is provided along with the system. This Vacuum Pump is used for creating a vacuum in the chamber for mechanical air removal prior to sterilization and subsequently for post sterilization vacuum drying.

VACUUM       BREAK FILTER

A 0.2-micron vacuum break filter is provided on the sterile side for pressure equalization after vacuum creation.

VALVE PACKAGE

The process valves in contact with the chamber have SS 304L contact parts

with Teflon seat and tri-clamp connections. All non-contact valves have SS 304 contact parts with Teflon seat.

All automatic valves are solenoid direct-acting.

STEAM ACCESSORIES

The jacket and chamber are provided with an overpressure safety valve. The chamber is provided with a steam trap.

STEAM

GENERATOR

The steam generator is fabricated from SS 304 sheets with industrial immersion heaters.  The steam generator will be provided with automatic pressure control and other safety features like low water cut-off to safeguard heaters, safety valve gauge glass, etc.  All other necessary inlet, outlet, and drain connections with valves are provided.

SURFACE FINISH

The chamber and doors are finished to a surface finish better than 0.8 Ra value.

All other non-contact parts are polished to a surface finish better than 180 grit.

VALIDATION PORTS

The chamber is provided with validation ports with tri-clamp connections. The validation ports are provided with special leak-tight ferrules for the insertion of 16 flexible temperature sensors for validation of the system.

HANDLING

ACCESSORIES

SHELVES – as per standard supply.

Material - SS 304L.

VACUUM          LEAK

TEST

This is a test program to check the integrity of the chamber under vacuum. The

program is automatic and checks the system leakage against the predefined leak rate of 1.3mbar/min.

BOWIE & DICK TEST

This is a test program to check the efficacy of the system to remove air and

ensure efficient steam penetration. The test is usually carried out in conjunction with standard test packs.

GRAVITY DISPLACEMENT PROGRAM

This is a production program used for sterilization of material, which cannot withstand the action of vacuum (liquid in glass flasks)

TEMPERATURE

AND          PRESSURE SENSORS

1 RTD Pt100 sensor is provided; 1 in the drain.

A pressure transmitter is connected to the chamber. This generates a 4-20mA

output in a range of –1.0 to 3 Bar.

ELECTRICAL

SWITCHGEAR

The control cabinet is provided with a main isolator for the three-phase supply

and a separate switch for the control supply. All cabling is flexible, PVC cabling routed via PVC channels mounted in the panel.  All cabling for temperature and pressure signals is shielded for minimum Electro-magnetic interface. Necessary relays, contactors, MCBs, etc. are also mounted in the control panel.

MANUAL BACK UP

The control system is provided with manual backup 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 the valve for temperature control.

SAFETIES           AND

ALARMS

The process management system is provided with a series of safety and alarm features.

·    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 the vacuum.

·    Too long time to heat up.

·    Vacuum pump trip.

PROCESS

RECORDING

80 Column dot matrix data printer for recording – date, time, process parameters, process status, alarms, etc.

FACTORY ACCEPTANCE TEST

Inspection and testing as per in-house FAT protocol.

QUALIFICATION

DOCUMENTATION

The equipment is supplied with the following: -

·    Maintenance and service manual.

·    Design Qualification Document.

·    Installation Qualification Document.

·    Operational Qualification Document.

·    Testing and Calibration Reports.