Basic Info.
Type
Pharmaceutical Milling Machinery
Finished Dosage Form
Granules
Product Description
LHS Series High Shear Mixer:
The machine is widely used in such industries as drug, food, dairy products, chemical industry, etc. It is a process machine widely applied during production, for example, the production of tablets, capsules, granules, and other wet granules. It has many functions such as mixing, granulating, etc.
The materials are fed into the granulating pot through the vacuum feeder or lifting feeder. After the action of centrifugal force of mixing paddle, the pressure liquid supply system injects the adhesive through the spray gun. Meanwhile, the cutter rotates at a high speed. The materials are bonded into hollow granules in the pot and discharged to the next procedure (granule sizing or drying) after the granulating is finished.
*The main machine adopts the most advanced design concept of SAR LABORTECNIC Company. The pot is of a conical structure.
*As the pot diameter is large, the granules formed are more even. Material reproducibility is ensured reliably.
*The interval between the pot and mixing paddle is controlled to be within 1.5mm. There are no material residues at the bottom of the pot.
*The machine is provided with the terminal control system to provide reliable guarantee for granulating reproducibility.
*It combines gas seal and mechanical seal. It is also provided with gas seal pressure upper and lower limits inspection.
*The machine can be equipped with advanced WIP cleaning system.*It meets FDA/cGMP requirements for production.LHSG Series High Shear Mixer:
The machine is widely used in such industries as drug, food, dairy products, chemical industry, etc. It is a process machine widely applied during production, for example, the production of tablets, capsules, granules, and other wet granules. It has many functions such as mixing, granulating, etc.
Working principle
The materials are fed into the granulating pot through the vacuum feeder or lifting feeder. After the action of centrifugal force of mixing paddle, the pressure liquid supply system injects the adhesive through the spray gun. Meanwhile, the cutter rotates at a high speed. The materials are bonded into hollow granules in the pot and discharged to the next procedure (granule sizing or drying) after the granulating is finished.
Structure features:
*The main machine adopts the most advanced design concept of SAR LABORTECNIC Company. The pot is of a conical structure.
*As the pot diameter is large, the granules formed are more even. Material reproducibility is ensured reliably.
*The interval between the pot and mixing paddle is controlled to be within 1.5mm. There are no material residues at the bottom of the pot.
*The machine is provided with the terminal control system to provide reliable guarantee for granulating reproducibility.
*It combines gas seal and mechanical seal. It is also provided with gas seal pressure upper and lower limits inspection.
*The machine can be equipped with advanced WIP cleaning system.
*It meets FDA/cGMP requirements for production.
VALIDATION DOCUMENTATIONTerminology | 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
Address:
Yangfang Industrial Area, Changping District, Beijing, China
Business Type:
Manufacturer/Factory
Business Range:
Health & Medicine, Manufacturing & Processing Machinery
Management System Certification:
ISO 9000, GMP
Company Introduction:
Established in 1999, Beijing Hanlin Hangyu Technology Development Inc., also known as Dr. Pharm, is a high-tech enterprise, we now has more than 500 employees, and pride ourselves as a professional pharmaceutical machinery manufacturer for solid dose. Our company has built factory buildings of more than 50, 000 square meter, and successively introduced nearly hundred sets of CNC machine equipment, which provides guarantee for delivery cycle and product quality and lay a sound foundation for future development.
As for products, our company has improved the granulating line, procedure transfer equipment, mixing equipment, coating and cleaning equipment. We purchased Spain SAR Labortecnic company and introduced its products and technology. Our company has also established laboratories meeting GMP requirements to provide users with convenience for process tests. By over a decade of fast development, we earned a nice reputation and fame in domestic market, and aims to build up the famous brand as "Dr. Pharm Precision Machinery" in fellow companies home and abroad.
Adhering to the concept of "sincerity, efficiency, innovation and prominence", Dr. Pharm is developed to the pharmaceutical industry and provides solid dose drug manufacturing factories with complete-set equipment solutions while making our contributions to the human health cause.