Informasi dasar.
Type
Pharmaceutical Milling Machinery
Finished Dosage Form
Tablet
Computerized
Computerized
Deskripsi Produk
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:
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 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. |
V SHAPE MODEL VALIDATION Equipment Lab
Alamat:
Yangfang Industrial Area, Changping District, Beijing, China
Jenis Usaha:
Produsen/Pabrik
Jangkauan Bisnis:
Kesehatan & Obat-obatan, Mesin Manufaktur & Pemrosesan
Sertifikasi Sistem Manajemen:
ISO 9000, GMP
Produk Utama:
Alat berat Pengisian Kapsul Otomatis, Alat berat pres tablet Kecepatan Tinggi Otomatis, Alat berat, Alat berat Otomatis, perlengkapan keseluruhan, Pengenalan Garis Pengisian tablet, Pengenalan Garis layar Kapsul, Lebar, mixer telinga Tinggi, pengering tempat Tidur, blender wadah
Pengenalan Perusahaan:
Pharm, yang didirikan tahun 1999, Beijing Hanlin Hanggyu Technology Development Inc., dikenal juga sebagai Dr. Pharm, adalah perusahaan teknologi tinggi, sekarang kami memiliki lebih dari 500 karyawan, dan bangga karena bisa menjadi perusahaan produsen mesin farmasi yang professional untuk dosis yang solid. Perusahaan kami telah membangun pabrik sebanyak lebih dari 50, 000 meter persegi, dan secara berurutan memperkenalkan hampir ratusan set peralatan CNC, yang memberikan jaminan siklus pengiriman dan kualitas produk serta meletakkan landasan suara untuk pengembangan di masa depan.
Untuk produk, perusahaan kami telah meningkatkan garis granulasi, peralatan transfer prosedur, peralatan pencampur, lapisan, dan peralatan pembersih. Kami membeli perusahaan Spanyol SAR Labortetnis dan memperkenalkan produk dan teknologinya. Perusahaan kami juga telah mendirikan laboratorium untuk memenuhi persyaratan GMP untuk menyediakan kemudahan bagi pengguna dalam uji proses. Dengan perkembangan cepat selama lebih dari satu dekade, kami mendapatkan reputasi dan ketenaran yang baik di pasar domestik, dan bermaksud membangun merek terkenal sebagai "Dr.. Mesin presisi Pharmacy" di dalam perusahaan lain di dalam dan luar negeri.
Memegang teguh konsep "ketulusan, efisiensi, inovasi dan menonjol", Dr. Dikembangkan untuk industri farmasi dan menyediakan pabrik obat dosis solid dengan solusi peralatan lengkap sambil memberikan kontribusi kami kepada kesehatan manusia.