Catalog    

1.     FLUID BED UNIT:

-        MATERIAL OF CONSTRUCTION:

-        Product contact parts should be constructed of SS 316L grade stainless steel as complying with the requirements of WHO-GMP.

-        All none product contact surfaces should be constructed of SS 304 grade stainless steel.

-        All internal surfaces are fully polished to obtain a surface roughness of ISO Ra0.5 so that the product particles are freely moving and smoothly mixed without the powder sticking trouble

-        Gaskets, air seals  coming in direct / indirect contact of product surface should be constructed of FDA approved polymeric materials only.

1.1 Filter chamber:

Filter Bag

-        There should be a pharmaceutical grade antistatic filter bag arrangement for prevent particle escaping from dryer.

-        Shaking of Filter bag should be controlled by automatic pneumatic control system with less retention time while operation. 

-        There should be an arrangement for easy and quick removal & fixing of finger bag assembles.

1.2 Expand chamber  for top spraying:

-        Spray nozzle ports: 3 EA

-       Observation Port :There must be a main window & lighting system   in the chamber for visualizing the fluidization of the product. Material of window is acrylic sheet

1.3 Product Container

-        There should be 01 (one) SS 316 L container to contain the product with SS 304 Trolley.

-        Product contact surface shall have a surface better than Ra 0.5 .

-        There should be quick dismantling of Dutch sieve & perforated sheet at the product container.

-        Product observation port :

There must be a window  in the chamber for visualizing the fluidization of the product. Material of window is acrylic sheet

1.4 Air distributor

1.5 Seal

Compliant with FDA  Regulation Silicon joint. There should be air seal at bowl mouth. There should be air pressure regulator for sealing of inflatable gasket.

2.     INLET AIR HANDLING UNIT

Pre-filter: - Class: EU3/EU4

Intermediate Filter: - Class: EU8 or EU9

Option:  Dehumidifier  with  control  valve  with temperature controller by chilled water

Chilled water temperature: Inlet 5 C, Return 10 C

 -        Electric heater: should be made of S.S. 304

-        Final filter : HEPA filter with 2 DOP port before and after the filter         - Class: EU13         - Efficiency: 99,99%

-        Max drying temperature: 90 C.

 3.      EXHAUST AIR FILTER UNIT

-        Exhaust air should be passed through 2-stage filtration EU–8/EU-9  & EU–13 including indication of differential  pressure  Arrangement  to  prevent environment pollution.

4.      EXHAUST FAN

-        Impeller of exhaust fan motor should be made of long lasting materials with statically & dynamic balanced.   xhaust blower should be of centrifugal type with high performance fan.

-        Motor Siemens-Germany: 2900 rpm, 415V±10%, 3phase, 50Hz.

-        Inverter ABB or Siemens- Germany

-        Vibration absorbers should be mounted with the base frame of the fan.

-        There is a silencer to achieve a noise level not more than 75 dBA.

5    OPERATION,  MEASURING  &  CONTROLLING SYSTEM

The operational requirements for this FBD include the following:

5.1   Alarms

-        Error messages on HMI shall be in plain text with fault code.

-        A light on the machine shall indicate all alarms.

5.2    Electrical box:

-        All electrical equipment located in process areas should be rated to IP55 (dust proof and    protected against water jets) unless specified otherwise and terminations within the machine   made in sealed junction boxes.

-        Electrical equipment located in non-process technical (plant) areas should be rated to IP41 minimum.

6.      INLET AND OUTLET DAMPER:

-        There should be fast valve both in the Inlet & Outlet damper. They are controlled by automatic pneumatic control system

7.      DUCT: -        Inlet Duct and out let duct should be made of S.S. 304.

8.      CLEANING:

-        Automated WIP, at first the equipment will be washed by portable water then final rinse will be done by purified water.

-        There should be spray ball nozzle in the spray nozzle port for cleaning the inner side of the machine tower.

9.      EXPLOSION RELIEF PORT

-        There should be expansion flap incase of excessive pressure 2 bar generation in the chamber.

10.    OPTIONAL:

10.1 Loading System:      Port for gravity charging

10.2 Unloading System:  Vacuum transfer should transfer dry granules to IBC bin through dry milling cum shifter