Temel bilgiler.
Tip
İlaç frezeleme Makineleri
Bitmiş dozaj Formu
Tablet
Hassasiyet
Yüksek Hassasiyet
Ürün Açıklaması
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 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
Adres:
Yangfang Industrial Area, Changping District, Beijing, China
İşletme Türü:
Üretici/Fabrika
İşletme Aralığı:
Sağlık ve Tıp, Üretim ve İşleme Makineleri
Yönetim Sistemi Sertifikasyonu:
ISO 9000, GMP
Şirket Tanıtımı:
1999 yılında kurulan ve Dr. Pharm olarak da bilinen Beijing Hanlin Hangyu Technology Development Inc., yüksek teknoloji ürünü bir kuruluştur. 500′den fazla çalışana sahip ve katı dozda profesyonel ilaç makinesi üreticisi olarak kendimizle gurur duyuyoruz. Şirketimiz 50, 000 metrekareden fazla fabrika binaları inşa etmiş ve teslim döngüsü ve ürün kalitesi için garanti sağlayan ve gelecekteki gelişimlere sağlam bir temel oluşturan yaklaşık yüz adet CNC makine ekipmanı seti piyasaya sürmüştür.
Ürünlerimiz için şirketimiz; granül hattı, prosedür aktarım ekipmanı, karıştırma ekipmanı, kaplama ve temizleme ekipmanlarını iyileştirmiştir. İspanya SAR Labortecniknik şirketini satın aldık ve ürün ve teknolojisini tanıttık. Şirketimiz ayrıca kullanıcılara proses testlerinde kolaylık sağlamak için GMP gereksinimlerini karşılayan laboratuvarlar da kurmuştur. On yıldan uzun bir süre hızlı bir şekilde gelişerek, iç pazarda güzel bir üne ve ününe sahip olduk ve ünlü markayı "Dr Pharm Precision Machinery" adlı bir eğitim kitabı veriyor.
"Samimiyet, verimlilik, yenilik ve önem" kavramına bağlı kalan Dr. Pharm, ilaç sektörü için geliştirilmiştir ve katı dozlu ilaç üretim fabrikalarına eksiksiz ekipman çözümleri sunarken, insan sağlığı nedenine katkılarımızı da sağlar.