Basic Info.

Trademark

Dr. Pharm

Origin

China

Trademark

Dr. Pharm

Origin

China

Product Desciption

FBG Series Fluid Bed Granulator




Purpose:
The machine is a process machine widely applied in such industries as drug, food, chemical industry, dairy products, etc. It has such functions as material mixing, drying, etc.

Working Principle:
After purified and heated, the air from the induced draft fan is sucked in at the bottom of the fluid-bed granulating dryer, and then passes through the air flow distribution board of the material silo, so as to make the powder materials or wet granules under the boiling and fluidizing status in the raw material vessel. After the granules are preheated by the purified and heated air and mixed, the adhesive solution is atomized and sprayed during granulating to make several particles agglomerate into granules containing the adhesive. Because the materials are continuously dried by hot air, the moisture in the granules is evaporated, and the adhesive is solidified. This process will be carried out continuously and repetitively to form ideal and even micro-porous ball granules.
The fluid-bed granulating method is a comprehensive application of atomizing technology and fluidizing technology. It completes the traditional mixing, granulating and drying process in a machine in one step to realize one-step granulating.


Structural Feature:
The main machine adopts the most advanced design concept of SAR LABORTECNIC Company. It improves material fluidity through powder granulating (mixing, granulating and drying).
*The operation is carried out in a closed negative system.
*The equipment is provided with the closed sampling function.
*The liquid supply spray gun system adopts the atomizing spray gun independently researched and developed by Hanlin Company.
*The air intake control valve adopts proportional adjustment.
*The air intake heating system can adopt two heating modes such as electric heating or steam heating.
*The machine is equipped with the advanced WIP cleaning system.
*The machine meets the requirements for production in FDA/cGMP.
*The machine can be provided with 10Bar explosion-proof design according to user requirements.





VALIDATION DOCUMENTATION

Terminology	Defined Meaning
Validation Plan (VP)	This document supports the VMP, but provides the detailed validation requirements for a specific piece of equipment.
User Requirement Specification (URS)	This document describes what the equipment is intended to do and all essential requirements such as production rates, operating ranges, etc.  The owner usually develops this document.  This document links to the PQ document which tests for each of the requirements.
Functional Requirement Specifications (FRS)	This document describes the detailed functionality of the equipment.  The supplier usually develops this document.  This document is linked to the OQ document which tests for each function.
Design Specifications (DS)	These documents describe the equipment in sufficient detail to enable it to be built. These documents are linked to the IQ document that tests for all design requirements.
Design Qualification (DQ) or Design Reviews	Planned and systematic review of specifications, design, and development throughout the life cycle.  Design reviews evaluate deliverables against standards and requirements, identity problems, and propose required corrective actions.
Installation Qualification (IQ)	Documented verification that all key aspects of the hardware and software installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.
Operational Qualification (OQ)	Documented verification that the equipment-related system or subsystem performs as specified throughout representative or anticipated operating ranges.
Factory acceptance test (FAT)	Documented verification that the equipment-related system or subsystem performs as specified throughout representative or anticipated operating ranges at manufacturer factory before shipment to end user's workshop.
Site acceptance test (SAT)	Documented verification that the equipment-related system or subsystem performs as specified throughout representative or anticipated operating ranges at site in end user's workshop.
Performance Qualification (PQ)	Documented verification that the process and / or the total process-related system performs as intended throughout all anticipated operating ranges while operating in its specified operating environment.
Commissioning	A well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the End User that results in a safe and functional environment that meets established design requirements and expectations.

V SHAPE MODEL VALIDATION





Equipment Lab