About UsProductsClientsPartnersDownloadNewsCareersContact Us
Sterilizing Equipment
 

1. Fabtech bags the prestigious job for revival of DPT group of vaccine manufacturing facility at Kasauli,    2. Fabtech signs exclusive distribution with SANJO South Africa Forms Joint Venture SANJO FABTECH PTY LTD.   3. Fabtech files for ASTM certification of its partition system in February, 2010.   4. Fabtech applies for European Union  Certification of its partition system at the beginning of March, 2010.

Fabtech SterlingSanjo Fabtech
Products
Sampling Booth
Dispensing Booth
Laminar Air Flow Work Station
Pass Boxes
Biological Safety Cabinet
Safe Change Housing
Sterilizing / Depyrogenating Tunnel
Injectable Manufacturing Line
Return Air Risers
Fan Filter Unit
Air Filters
HEPA Filter Terminal Housing
Quick Change Terminal Box
Vision
Team Advantage
Photos

   Introduction

Sterilizing/Depyrogenation Tunnel
Fabtec® ISO CLASS 5 continuous sterilizer 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 used of parentral product packing.

Fabtec® continuous dry heat sterilizer ensures the glassware to exposed for depyrogenation temperature. The time required for the necessary reduction in endotoxins which at bare minimum is > LOG 3 at rated output.

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.

Generally Heat destroys micro organisms. The destruction process of microorganisms is a function of time and temperature. The rate of destruction is linear logarithmic, means in a given time interval and at a given temperature, the same percentage of the bacterial population will be destroyed. Hence forth Fabtec® introduce "Forced Conventional Dry Heat Sterilizer" (Sterilizing Tunnel).

The Forced Conventional Dry Sterilizer consists of Drying Zone to raise the temperature of the glassware and evaporate the wash water from the glassware. The Sterilizing Zone sterilize the glassware at 3500C (approx.) and the third section consist of cooling & sterilizing zone to restore the glassware temperature to ambient.


   Drying / Pre-Heat Zone II

Drying / Pre-Heat Zone Comprises of

Dry Heat Sterilizing Tunnel

SS 304 Module containing

  • EU -7 grade Pre filter.
  • Motor Blower assembly.
  • EU 13 grade Minipleat Filter utilizing state - of - art hot melt technology.
  • Mechanical differential pressure gauge to monitor pressure drop across Final filter with respect to ambient.
  • Proximity sensors, provided at infeed for dictation of vials/ampoules overload, and interlocked with START/STOP of conveyor operation.
  • Integrated PT 100 temperature sensor to monitor temperature in the specified zone.

   Sterilizing Zone II

Sterilizing Zone Comprises of

Sterilizing Tunnel  Zone
  • Double wall asbestos free ceramic wool insulated recirculatory module containing high temperature EU - 13 grade final HEPA filter with suck back mechanism suitable for 3500 C continuous repeated cycle.
  • This zone provides uniform hot air over the glassware for the Purpose of depyrogenation. In this zone the temperature raises as quickly as Possible by the help of heating element, without inducing cracking due to excessive thermal stress. The glassware remains in this zone at a required time period to meet The specified endotoxins reduction generally > 3 log scale.
  • This section consist of unidirectional hot air flow unit with turbine blower assembly, High temperature HEPA filter (upto 3500C) and heater bank assembly.
  • Integrated temperature sensors are provided for monitoring & controlling purpose of Temperature inside the sterilizing zone. For this purpose one sensor is placed above The HEPA filter and the sensor is placed at the entry side of sterilizing zone. For Extra precaution of temperature a Thermostat (0 5000C) is placed for protection of Heaters.
  • The entry and exit to the sterilizing zone consists of manually adjustable profile Plates resulting in maximum temperature uniformity and ensure consistent result for Glassware with varying sizes.
  • Mechanical differential pressure gauge to monitor pressure drop across final filter With respect to ambient.

   Cooliing / Stabilizing Zone II

SS 304 Module Containing

Stabilizing Zone II
  • EU - 7 grade Pre filter.
  • Motor Blower assembly.
  • EU - 13 grade Minipleat Filter utilizing state- of - art hot melt technology.
  • Integrated PT 100 temperature sensor provided to monitor temperature In the specified zone.
  • Mechanical differential pressure gauge to monitor pressure drop across Final filter with respect of ambient.
  • Extract blowers, provided underneath conveyor for cooling and stabilizing zone with Discharge duct which is integrated with vapour extract exhaust duct from Drying / Pre Heat Zone.

Vials/ampoules are subjected to significant thermal stress as they move from sterilizing zone to cooling zone which may cause cracking or impulsion. The air flow is profiled in such a way that the glass temperature as it exits sterilizing zone would be transitioned in a linear way.

   Displaying & Control Section II

Tunnel - Displaying & Control Section II
  • ALLEN- BRADELY PLC, with MMI for controls, storing and printing of data.
  • An online printer interface with PLC.
  • Integrated Temperature interface controller & transmitter.
  • Integration of control panel with Tunnel is standard execution.

Mode of Operation

  • Maintainance mode
  • Semi auto mode
  • Auto mode

   Standard Features

Automated Self Sterilization Tunnel
  • Automated Self Sterilization of the cool zone using Dry Heat
  • Documentation for qualification, validation (DQV)
  • ALLEN BRADELY PLC Modules and control alarms over 50 critical parameters to assure a repeatable and reliable depyrogenation process
  • Animation colour touch screen control panel with "panel view plus"
  • Advance interlocking software for controlling purpose with HELP screen Password Protection for the "Recipe Screen"
  • Graphical representation of temperature of respective zones
  • Auto shut down after batch completion
  • Automatic Start up by scheduled program
  • Automatic data logging onto the printer
  • Advance control panel designed for the safety operation purpose.
  • Dynamic pressure balance maintains a stability of pressure gradient between the filler and washer
  • The pressure difference in between the three specific zone, monitored by magnehelic differential pressure gauge.
  • High productivity due to reduced idle time and optimization of operating temperature.
  • Intelligent control systems for controlling temperature
  • The machining parts ensures high precision and quality
  • The upturned edges of the conveyor more with the glassware to keep them tightly Packed, with minimal friction between the glassware and rails, this reduces Breakage, scratching and the number of airborne particles.

Module FT-SDPT 450 FT-SDPT 650 FT-SDPT 750 FT-SDPT 950 FT-SDPT 1250
Power Supply 3ph/4wire 3ph/4wire 3ph/4wire 3ph/4wire 3ph/4wire
Voltage
Freq.
415/240VAC
50Hz
415/240VAC
50Hz
415/240VAC
50Hz
415/240VAC
50Hz
415/240VAC
50Hz
Control Voltage 24VAC/DC 24VAC/DC 24VAC/DC 24VAC/DC 24VAC/DC
Power Consumption 51K 60KW 77KW 80KW 88KW
Resistance Load 45KW 54zKW 69KW 72KW 80KW
Inductive Load 6KW 6KW 8KW 8KW 8KW
Dimension in mm
( L x W x H )
3200 x 1070
x 2450
3740 x 1230
x 2450
4020 x 1380
x 2450
4020 x 1530
x 2450
4260 x 1680
x 2450
Output 00 V
A
10ml  V
A
250VPM 260VPM 300VPM 350VPM 500VPM
360VPM 450VPM 630VPM 800VPM 1150VPM
100VPM 200VPM 230VPM 290VPM 390VPM
140VPM 310VPM 310VPM 550VPM 600VPM

Note - Due to continuous product improvement & customer interaction, designs & specifications may be modified or upgraded without notice.