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Tofflon Max-Fill Medium/High-Speed 100%IPC Check Weighing Vial Filling Machine
Novel vaccines (genetically engineered vaccines, combined vaccines, live attenuated vaccines, therapeutic vaccines for major infectious diseases, etc.), biotherapeutic and genetically engineered drugs (cell therapy, biological monoclonal antibodies, etc.), large molecule drugs, blood products, slow/controlled release complex injections (emulsions, liposomes, microspheres, etc.), and antineoplastic products are innovative drugs with very high added value and requirements for the relevant performance indicators of aseptic filling equipment.
In
recent years, filling technology has been an essential part of production lines
for aseptic injection filling processes. Many high value-added injection drugs
are required to meet high standards and requirements during the filling
production process. How to achieve the stability and reliability of high
value-added pharmaceutical filling accuracy, implement automatic calibration of
the filling volume in the filling system with minimal or even zero loss of
medicinal liquid in the production preparation stage, ensure no filling volume
drift during the filling process and achieve the process quality control of
100% filling volume, and empty the tailings to minimize the residue and
material loss at the end of the filling production or reduce material loss to
the volume of even one vial with the emptying mode are severe risks and
challenges of traditional filling technology in the guarantee of many key
processes.
Max-Fill 100% IPC medium/high-speed check weighing vial filling machine is pharmaceutical filling equipment in direct contact with medicines. It affects the quality of medicine in the production directly and is the crucial equipment in aseptic preparation filling production lines. The innovative filling system design defines a new quality standard for the Max-Fill 100%IPC medium/high-speed check weighing vial filling machine. The device allows full-automatic detection (100% control) without loss of yield or productivity. It can thoroughly perform 100% medium/high-speed online quality control under different production modes before, during, and after production, striving to achieve the filling without product loss at start-up or near clearing of product loss. Hence, the filling yield of medicine is improved to guarantee the high added value entirely and effectively.
300 vials/min medium/high-speed 100% IPC check weighing vial filling line
Medium/high-speed 100% IPC check weighing vial filling machine
Max-Fill Technical Performance Indicators
Max-Fill Host Features and Advantages
Comply with
cGMP, EU-GMP and FDA regulations
Outstanding
industrial aesthetic design, excellent human-machine interface
GMP concept
aseptic design, easy to clean, operate and maintain
Diversified
layout: single-sided operation, double-sided operation, L-shaped layout,
I-shaped layout
Advanced multi-link linear servo transmission system that ensures gentle and stable conveyance of vials
No filling or
stoppering without vial
Three
independent output channels: qualified products, sampling and kick-off channels
Toolless
plug-in type quick-change mold specifications
Restricted
barrier system that can be integrated with the following: oRABS, cRABS and
Isolator
Control system
compliant with GAMP 5 and 21 CFR Part 11
Batch records
and reports that meet the computerized system requirements
Max-Fill Important Configuration Options
Filling system that can be integrated with CIP-SIP system
Nitrogen filling system (nitrogen charging before
filling-during filling-after filling-stoppering)
Various filling or compound filling methods such as
piston pump-peristaltic pump-time pressure method
Can be integrated with 100% IPC medium and high-speed
check weighing system
Each filling system is independently driven and
controlled by a servo motor to adjust the filling volume automatically
“Advanced filling” operation mode under different production modes
Infeed Star-wheel System
100% IPC Check Weighing System
Stoppering System
Peristaltic Pump Filling System
Discharge Star-wheel System