21 CFR part 11 software gives maximum security and to ensure the integrity of their documents, from unique usernames and login information to each individual, creating a clear audit trail, uses automatic timestamps that record exactly when something happened in your electronic records, protect data with strong passwords that are reset regularly, utilize electronic signatures when necessary, creating unlimited users and having unlimited storage for keeping record of saved recipe, audit trail and audit report.
Fluid bed equipment can be used for bottom spray/ Wurster spray for pallet coating, wurster columns with spray guns are provided, with adjustable height of wurster columns. Combo model is also available in which Drying, top spray and bottom spray can be done in single machine.
12 bar design gives maximum pressure resistance. This design also includes 20mm thick window glass, SS sheet used in 12 bar design are thicker than the SS used in other conventional FBD, it doesn’t have an explosion flap instead it has isolation valve one at inlet and other one at exhaust, at the time of explosion isolation valve stop the flow of air from inlet and outlet and it contains the explosion inside retarding chamber and because of 12 bar design it will help resisting high pressure at the time of explosion.
• Uniform distribution of all formulationingredients.
• Short drying and processingtime.
• Useful working capacity of up to 80% to 40% of bowlvolume.
• Uniform drying by continuously moving material.
• Wide range ofapplications.
• Easy scale up & Scale down between machinesizes.
• Bowl shape design to have no deadspaces.
• To achieve consistency in the product quality it is desirable to minimize / eliminate the human elements in monitoring the operational parameters of the machine including the desirable to record / store the critical data which may contribute to product quality. Machine has provision to generate audit trial & batch report, alarm history and same will be printable. Machine should not start automatically if power resume and it should be restarted only by manual input if power resume. Set recipe. Parameters should not change & data should not loss due to power failure & communication failure.
• The operational recipe data can be saved. To incorporate suitable provision in the system of data storage.
1. Broken filter bag detector/Solid Flow Monitor provided as standard. It stops the machine if there is any detection of solid particles in exhaust duct of the machine.
2. Antistatic finger bag.
3. The Proximity sensors for bowl detection into the FBE tower, machine will not start until bowl is properly fixed.
4. All corners rounded, to avoid accidental cuts.
5. The emergency stop button is provided to stop the machine in case of emergency.
6. The common pressure switch is provided for Incoming air pressure low.
7. Explosion flap ensures that there is no damage to the person operating the machine if there is an explosion inside caused by mixture of air and dust.
8. Temperature sensors for inlet air, product and outlet air provided.
9. Earthing probe provided as standard.
10. Warning signs provided over electrical panel to prevent accidents.
11. Blower stops if the air pressure in filter bag locking gasket drops below the set value.
12. Blower stops if the product container sealing gasket air pressure is below the set value.
CIP system consists of two nozzles spraying water and rotating at high speed inside the main chamber . These are connected by various solenoid systems such that three different wash mediums can be made to spray inside the bowl one after another. When running under PLC control, PLC will determine the opening and closing of various valves along with discharge opening. Client will have to provide for sufficient volume water of each type to our CIP wash central unit which is mounted over a trolley. Thus three connections for various water types should be provided in the same room and near location of dryer machine so that these connections can be made easily while going for CIP wash. A sample port is also provided on the discharge of dryer so that water sample can be taken out after each wash for lab testing if needed. There is an audio buzzer that will indicate that sample has to be taken out during drain. Drain water released through bottom valve in the plenum, which is connected to drain provided in the room. One central nozzle which rotates while spraying the water along with a nozzle mounted in the plenum assembly cleans the bowl and discharge assembly thoroughly.
This process is used to apply a coating to the granules or pallets resulting in favourable barrier properties. This type of barrier coating alters the product property with respect to Stability in storage, hygroscopic property, free flowing property, solubility, sustained release property, appearance, taste, odour etc. Here the spraying is done from bottom using cylindrical tubes through which spraying is done. It is also known as Wurster coater. Here in this process the spray is done inside a hollow cylinder and from the bottom of this cylinder the pallets are allowed in small quantity to enter the hollow cylindrical tube. Thus the particles are passing the bottom spray guns in orderly manner quickly moving upward the tubes to avoid agglomeration. Once they are outside the Wurster compartment, they move downward outside the compartment where they dry an another layer of coating can be supplied. Since the movement of the particle or pallets inside the Wurster chamber ( hollow tube) is totally controlled it ensures uniform coating.
◊ Spray gun Inlet pressure via. PLC Control with air pressure indication.
◊ Spray gun cleaning pressure via. PLC Control with air pressure indication.
◊ Product chamber and product bowl locating switch with inflatable gasket for top and bottom sealing of product container.
◊ Differential Pressure indication in PLC for Product bottom mesh clogging.
◊ Differential Pressure indication in PLC for HEPA filter.
◊ Differential Pressure indication in PLC for 5 microns pre filter.
◊ Differential Pressure indication in PLC for Outlet exhaust filter assembly.
This process is used in Fluid beds to form granules from a powder. The fluidized powder is wetted with binders using top spray guns. Binders are based on solvent or water and fluidized powder is wetted until liquid bridges are formed between particles. Segregation of powder doesn't take place as different powders are glued together on a micro scale. Since there is no impinging force in the fluid bed equipments the granules are weak and having good solubility. Effervescent products are made much better using this process. Once the granules are made they are dried in the equipment using hot air. Using this technology the granules that are formed are dust free granules with free flowing properties. Granules also have good dispersibility with excellent solubility due to porous structure. It also have low bulk density with wide grain size distribution.
