Basic Info.
Type
Pharmaceutical Milling Machinery
Finished Dosage Form
Tablet
Product Description
BG Series High Efficiency Coating MachinePurpose:The BG series high efficiency intelligent coating machine is mainly used in such industries as medicine, biological products, food, etc. As an efficient, energy saving, safe, clean mechanically and electrically integrated coating machine conforming to GMP requirements, it is used for organic film coating, water soluble film coating, sustained-release and controlled-release coating, sugar coating, and gum and chocolate coating for tablets, pills, sugars, etc.Working Principle:Through the streamlined diversion device, the plain film continuously makes movement of complex tracks in the clean, closed rotary coating drum. During the movement, reasonable process parameters are set according to the process flow. The coating media are automatically coated on the surfaces of plain film under the double actions of the peristaltic pump and gas spray gun. Meanwhile, hot air is supplied under the negative status through the negative automatic control unit. The hot air is discharged from the exhaust unit at the bottom of the coating pot after passing through the film cores, so that the coating media sprayed on the film surfaces are dried rapidly and evenly and solid, dense and smooth film is formed.Structural Feature:*The machine adopts the most advanced design concept of SAR LABORTECNIC Company, featured by reasonable structure, stable performance and simple operation.*It adopts the anti-blocking spray gun independently researched and developed by Hanlin.*The mixing tank adopts the stepless speed change pneumatic motor and unique eddy current mixing paddle.*The in-place cleaning function is realized.*The machine is provided with the functions of online memory of production process parameters, printing output, etc.*It fully meets FDA/cGMP requirements.Technical Parameters:
HBG Series Hopper Replacement Coating MachinePurpose:The hopper replacement coating machine realizes production of different batches of products through one machine, so that floor space is saved and investment is reduced. It is mainly used in such industries as medicine, biological products, food, etc. As an efficient, energy saving, safe, clean mechanically and electrically integrated coating machine conforming to GMP requirements, it is used for organic film coating, water soluble film coating, sustained-release and controlled-release coating, sugar coating, and gum and chocolate coating for tablets, pills, sugars, etc.Working Principle:Through the streamlined diversion device, the plain film continuously makes movement of complex tracks in the clean, closed rotary coating drum. During the movement, reasonable process parameters are set according to the process flow. The coating media are automatically coated on the surfaces of plain film under the double actions of the peristaltic pump and gas spray gun. Meanwhile, hot air is supplied under the negative status through the negative automatic control unit. The hot air is discharged from the exhaust unit at the bottom of the coating pot after passing through the film cores, so that the coating media sprayed on the film surfaces are dried rapidly and evenly and solid, dense and smooth film is formed.Structural Feature:*The machine adopts the most advanced design concept of SAR LABORTECNIC Company, featured by reasonable structure, stable performance and simple operation.*It adopts the anti-blocking spray gun independently researched and developed by Hanlin.*The mixing tank adopts the stepless speed change pneumatic motor and unique eddy current mixing paddle.*The in-place cleaning function is realized.*The machine is provided with the functions of online memory of production process parameters, printing output, etc.*It fully meets FDA/cGMP requirements.Technical Parameters:
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.
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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.
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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 itsspecified 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.
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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.
