Injectable Section

 

 

Vertical/Horizontal Sliding Door Rectangular Autoclave

Inner Chamber
SS 316
Steam Jacket
SS 316
Working pressure
1.2kg/cm2 & 2.1kg/cm2
Working Temperature
121°C / 134°C
Mode of Control

The control system is provided with PLC and user friendly HMI .The system is provided with manual back up in case of PLC failure by manual Operating Switches. Here all valves, pumps etc. can be operated via switches.

Door
  • The Sterilizer is provided with Single or Double automatic vertical or horizontal sliding doors fabricated from SS316.
  • The door is with mineral wool insulation held in place by a stainless steel outer cover. The door sealing is affected with the help of a silicone door gasket. The gasket is pressurized by compressed air and retracted by vacuum. The door is moved vertically or Horizontally via a pneumatic cylinder. Compound gauges, for gasket pressure, with door status indications are provided on both loading and unloading sides.
  • The following door safety features are provided for maximum operator safety:
    1. Door inter-lock to prevent simultaneous opening of both doors.
    2. Process-lock to prevent opening of the door during the process.
    3. Process-lock to prevent the opening of the non-sterile door after successful completion of the cycle.
    4. Door obstruction safety.

Insulation

The sterilization chamber is insulated with 50-mm thick mineral wool, which is held in place by an outer cover of SS 304.

Cabinet Enclosure

The Sterilizer is mounted on a stainless steel skid and is provided with paneling on all sides. The cabinet is provided with one service door on the side for maintenance and cleaning.

Vacuum Pump

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 or post sterilization vacuum drying

Steam Condenser

The shell and tube type condenser fabricated from SS 304 is fitted in the exhaust/vacuum line to condense the steam before entering inside the vacuum pump. -

Vacuum Break Filter

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

Piping

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

Validation Ports

The chamber is provided with validation ports with tri-clamp connections

Valves

The process valves in contact with the chamber have SS 316 contact parts, are pneumatically actuated angle valves with Teflon seat and tri-clamp connections. The valves are actuated by instrument air controlled via solenoid valves.

INSTRUMENTATION
  • Safety Valve
  • Vacuum Breaker
  • Non-Return Valve
  • Steam Trap
  • Water inlet and Water outlet valves.
Sequence of Automatic operation includes the following;
  • Automatic water filling for the steam generator
  • Vacuum Leak test.
  • Bowie- dik test
  • Gravity Displacement Program
  • Spore-test results from approved lab submitted
  • Pulsing ( vacuuming, purging and pre-heating)
  • Sterilization with temp and balance time displayed and data logged
  • Exhaustion appropriate to liquid, instruments and fabric cycles.
  • Drying cycle with vacuum pump.
  • Sterilization completes with F.O values Displayed and data’s logged.
CGmp Documentation (DQ, IQ, OQ and PQ) will be supplied
Optional :
  • Fully Automatic Micro processor or PLC based programmable with solenoid valve operation. Suitable for Liquid, Instruments and Fabric cycle.
  • Suitable SS Trolley and SS Carriage
  • Data Logging System
  • Single/Double Door System
  • Vertical/Horizontal Sliding door
  • Pulsing Controller
  • A six point strip chart recorder

Model Chamber mm
Dia x Deepmm
Volume
Ltr
Voltage Power
Kw
Dimension
W x L x HT mm
Door
Lock
HR1836 450x450x900 182 440 12 675x1500x1800 Radial
HR224 600x600x1200 432 440 18 835x1800x1900 Radial / Sliding
HR234 600x900x1200 648 440 24 835x1800x1900 Radial / Sliding
HR235 600x900x1500 810 440 36 835x2100x2000 Radial / Sliding
HR334 900x900x1200 972 440 36 1125x1850x2000 Radial / Sliding
HR335 900x900x1500 1215 440 36 1125x2100x2000 Radial / Sliding

 

Bung processer cum steam sterilizer

Specification
Bung processer cum steam sterilizer

Bungs are generally used as a stopper in vials and these are to be sterilized as they are in direct contact with the product. Though using Pre sterilized bungs in the market is not recommended due to various handling and transportation issues leading to questions on sterility.

Bung processer are designed for fully treatment of sealing devices for pharmaceutical products, like rubber and plastic stoppers, droppers, metal rings and similar components.

The BUNG PROCESSOR is fitted with a Clean in Place (CIP) system for washing the chamber and the rotating carriage to prevent the dirt released during one phase from being carried over into the subsequent phases.

Specifications
Inner Chamber
SS 316
Steam Jacket
SS 316
Working pressure
1.2kg/cm2 & 2.1kg/cm2
Working Temperature :
121°C / 134°C
Door
Sliding door (Vertical/Horizontal)
Mode of control
PLC/ SCADA
Pressure switch
An automatic pressure switch adjustable type is provided to set the required pressure.
Pre-vacuum and Post vacuum
To eliminate air packs and ensure effective sterilization.
Vacuum drying
An effective vacuum drying is caused with powerful ejector and vacuum breaker which draws air from the atmosphere. It is filtered, pre-heated(sterilized) and finally enters the working chamber for effective drying.

 

 

 

Features
  • Jacket cooling recirculation system with plate heat exchanger and level controller
  • Heat Exchanger is provided for condensate cooling to bring the condensate below 600 C
  • Sterile Air purging to ensure proper fluidization of the bungs
  • Siliconizing through recycling pump
  • Rotating drum bung processing facility with automatic discharge
  • Suitable Trays , Carriage and Trolleys are provided

 

 

Super Heated Water Spray Sterilizer

Our super heated steam sterilizer was developed specifically for terminal treatment of solutions in closed flexible containers. It was developed primarily to overcome the temperature-pressure restrictions of the conventional steam sterilizer, so as to counteract the effects of the overpressure, which unavoidably forms inside containers when these are sterilized using conventional saturated-steam autoclaves.

Specifications
Inner Chamber
SS 316
Door
Hinged Door /Sliding door (Vertical/Horizontal)
Mode of control
PLC/ SCADA
Pressure switch
An automatic pressure switch adjustable type is provided to set the required pressure.

 

 

 

Applications :
  • Large volume parenterals in glass containers, rigid or semi-rigid plastic, flexible plastic.
  • Injectable products in plastic ampoules, syringe ampoules.
  • Solution in plastic metering containers, in cans with flip-off or threaded closures.

 

Features
  • High powered centrifugal pump used for re-circulation of water in the system
  • Single or double door with Sliding or Hinged door options to suit client specific requirements.
  • Plate type heat exchanger for efficient heating and cooling of water.
  • Special distribution plate arrangement for optimal water shower
  • 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.
  • Installation is floor or pit mounted
  • Optional automatic loading - unloading system
  • Single or double door, semi-automatic hinged type or automatic sliding type
  • Temperature & pressure monitoring inside the chamber
  • PLC & HMI based control system with provision for SCADA connectivity.
  • Range of alarms & safety devices for product, process & operator safety
  • Strip chart or paperless recorders available

 

Class 100 dry heat sterilizer

Dry heat sterilizer or Depyrogenation sterilizer are used in pharmaceutical and Biotech Industry for complete destruction & removal of all micro-organisms by means of dry heat using air as a medium of Sterilization for depyrogenation of glassware, containers, vessels, machine and components.The air is heated electrically by heating elements and is circulated in the chamber by a re-circulation blower. The system also comprises of pressure Module for fresh air intake and an exhaust module for exhausting the air.

Specifications
Inner Chamber
SS 316
Maximum Temperature
300°C
Working Temperature
250°C
Door
Door
Mode of control
PLC/ SCADA
Door Seal
Silicone Gasket
Insulation
Resin Bonded Glass Wool

Features :
  • HEPA filters are installed in the fresh air, recirculation and exhaust module. In addition, 0.5 micron "Micro B" filter is installed as a pre-filter to the Fresh Air HEPA
  • Three modules for air handling
    1. Fresh Air Module
    2. Recirculation Module
    3. Exhaust Module
  • Temperature Uniformity of +/- 2 degree Celsius within the chamber for the entire cycle.
  • Adjustable Damper is provided in the Exhaust Module.
  • Extended shaft motor for chamber recirculation.
Safeties and Alarms-
  • High temperature cut-off independent of the main process controller
  • Over-load and single phase protection for all electric motors.
  • Interlock to prevent switching on of the heaters in case the circulation blower stops.
  • Sterilization timer stop in case of temperature drop
  • Sterilization timer reset in case of temperature drop
  • Blower trip
  • Utility failure alarm.
  • Door Interlocking to prevent simultaneous opening of both doors.
  • Door Process lock to prevent opening of doors when process is on.
OPTIONAL:
  • Manual Back up
  • Thyristor controlled operation
  • Strip chart recorder
  • Printer

Suitable Shelves for Handling

 

Multi column distillation water plant.(Capacity 50 ltrs/hr. To 5000 ltrs/hr)

Specification

Multi Column Distillation plant produces Pyrogen free sterile water for injection (W. F. I.). The Water for Injection (WFI) produced by these plants is quite economical due to low maintenance and low operational cost. Multi Column Distillation plant consists of specially designed columns which make optimum use of the principles of inter-stage heat exchange to produce pure Pyrogen free sterile distilled water for Injectables as per IP/BP specification.

 

Specification :
  • The complete unit is made up of SS 316 / 316 L with active surface being electro polished
  • Distillate temperature 95 0C which meets IP/BP/USP specifications.
  • Double tube sheet for first heat exchanger where boiler steam is used.
  • Insulation is done by Resin bonded glass wool
  • All contact parts are S. S 316/316L and all joints are sealed with Teflon Gasket.
  • PLC based fully automatic panel board provided with printer.
  • Orbital welding for tube-to-tube sheet joints
  • Pyrogens are removed by centrifugal force developed and specially designed spiral baffle.

 

Features :
  • Total energy saving is 75% as less heating energy and less cooling water is required.
  • Maintenance cost is low as there are no moving parts except pump.
  • Sanitary triclover fittings for quick and easy preventive maintenance.
  • Provided with compact control panel board made up of SS304
  • Conductivity meter for feed water and final distillate.
  • Feed water pump is a positive displacement piston type-reciprocating pump.
  • User-friendly operator interface to allow the easy visual inspection of the cycle monitoring and control.

Models : Capacity 50 ltrs/hr. - 5000 ltrs/hr

Pure Steam Generator. (Capacity 100 Kg/hr to 1000 Kg/hr)

Pure steam generator is designed to produce Pyrogen Free Sterile for Steam Sterilization for Pharmaceutical and Biotech industries. This is more reliable than Boiler Clean Steam. The Pure Steam Generator steam meets the IP/BP and standard.

Applications

It is used for Sterilization and Sanitization of Pharma Equipments, Autoclaves, Piping & Tanks.

Specification :
  • The complete unit is made up of SS 316 / 316 L with active surface being electro polished
  • Double tube sheet for first heat exchanger where boiler steam is used.
  • Insulation is done by Resin bonded glass wool
  • All contact parts are S. S 316/316L and all joints are sealed with Teflon Gasket.
  • PLC based fully automatic panel board provided with printer.
  • Orbital welding for tube-to-tube sheet joints.

Features :
  • Sanitary triclover fittings for quick and easy preventive maintenance.
  • Provided with compact control panel board made up of SS304
  • Conductivity meter for feed water and final distillate.
  • Pure Steam generated surpasses the steam quality tests like non condensable gases, degree of super heat and saturation test as per requirement.
  • User-friendly operator interface to allow the easy visual inspection of the cycle monitoring and control.
  • Audiovisual alarm to indicate any fault condition such as high conductivity of the generated pure steam.
  • Pressure reducing valve can be provided for incoming plant steam for effective control of incoming steam pressure.

 

Models : Capacity (100 Kg/hr - 1000 Kg/hr)

 

Sterilizing tunnels (models 300v, 450v, 600v, 900v, 1200v)

Specification

Sterilizing Tunnel is a fully automated system which utilizes dry heat by means of forced convection of filtered air, through high efficiency particulate air filter to achieve sterilization and depyrogenation of washed empty pharmaceutical glassware such as Ampoules and Vials etc. Continuous dry heat sterilizer ensures the glassware to exposed for depyrogenation temperature. The Sterilization Depyrogenation cycle is based on selection of cycle times and exposure of temperature that will sterilize or depyrogenate the glassware to an acceptable low probability level of contamination, without adversely affecting the critical parameters of the product.

 

  • Class 100 laminar air flow throughout drying sterilizing, cooling & stabilizing zones.
  • Circulating airflow is constantly kept free of particles by means of a High-Efficiency
  • Particulate Air (HEPA) filter.
  • The conveyor transportation to integrate automatic washing and filling lines
  • PLC based automation with provision for data logging and printing of F H values
  • Thyristor controlled Temperature Controller.

 

 

Features
  • Multiple layer insulation of the tunnel prevents heat loss, keeping energy consumption low.
  • The belt speed and temperature can be programmed precisely and can therefore be optimized to suit to any kind of Ampoule/Vial.
  • Advance interlocking software for controlling purpose
  • Dynamic pressure balance maintains a stability of pressure gradient between the filler and washer
  • Sterilizing conditions are documented and are reproducible. Temperature is monitored and controlled electronically through PLC.
  • Advance control panel designed for the safety operation purpose.

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Contact Us

Address : No 217, SIDCO Industrial Estate, North Phase, Ambattur, Chennai – 600 098. India
Phone:– 044 - 26244383, 26244393
Mobile:+91-9962567028, 9962567020
Email Id: reico@relianceinstruments.com

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