제약 QBD에서 NIR기술을 이용한 PAT(Process Analytical Technology) 장비
Complete PAT solution for pharmaceutical solid dose manufacturing
High Shear Wet Granulation
Tablet press feed frame
Fluid bed coating
Hot melt extrusion
Sentronic solutions for process analysis comprise the SentroPAT FO platform, the probe and the corresponding analyzer management software. The result is a powerful, proven package that can be tailored to your specific process-monitoring needs.
SentroPAT FO is a compact analyzer for direct monitoring of production processes for solid-dose pharmaceuticals. It is an extremely versatile system that can be quickly and easily integrated into existing production equipment and processes. It offers extremely valuable insights into practically all process steps, such as blending, granulation, drying and compressing. It delivers precise data on input materials, process progress, product homogeneity, and the ideal process end-point. The combination of high-speed measurement and highly robust, innovative probe technology creates an exceptionally reliable tool for improved process understanding and measurement.
NIR infrared spectroscopy is the most versatile PAT technology available, with a proven track record in laboratory applications. It can be deployed to capture both physical and chemical process parameters, often rendering additional particle measurement equipment unnecessary.
This specific NIR technology is ideal for analyzing fast-moving samples, without compromising accuracy. Measurements can be performed in milliseconds, allowing the prompt elimination of spectra with poor sample presentation.
A key focus of design and development from the very outset was minimum maintenance effort and cost of ownership. The system continuously and automatically monitors all key instrument parameters, operating reliably for extended periods without user intervention. The only regular maintenance required is light source replacement, generally at intervals of one to two years. This simple task can be performed without special tools or skills.
Sentronic has implemented end-to-end, fully compliant documentation across the entire product life cycle for many customers, and for many projects. We are an experienced, flexible partner. We understand that each customer has specific needs and imperatives, and we develop made-to-measure answers to the challenges of each PAT project. We are happy to play a supporting role within your existing organizational structures, providing vital input. You can be sure of effective communications, and quick, easy access to expert advice.
|Technology||Multiplexed Diode Array spectrometer
with up to 4 measurement channels
|Wavelength range||1100-2100nm (full specification
within 1150 - 2100nm)
|Wavelength aacuracy||+-1nm over full specification range|
|System noise||<50µAU RMS within 1150-2150nm at 1s measurement|
|Embedded PC||Intel Atom based, Windows 7 professional|
|Communication||Ethernet (OPC, TCP/IP, SiPAT)|
|Housing||GmP friendly (smooth surfaces
IP65 / NEMA4
|Dimensions||160 x 220 x 240mm|
|Operating conditions||10° ... 30°C
10% ... 90% relative humidity
|Spot size||5mm diameter / 20mm² surface|
|Light source||2 internal 5W bulbs for redundancy
Lamp modules user replacable
|Internal reference||Internal micro-mechanical white reference direct behind process window|
|Process window||Welded in sapphire|
|Probe shaft||3/4" (19mm) diameter, length 65, 100, 200, 300 or 500mm|
|Approvals||ATEX zone 20/21, CE|
|Self monitoring||Internal controller and sensors to monitor probe function and status|
|Operating conditions||0° ... 80°C probe tip
up to 150°C for CIP processes
|Data pretreatment||bad spectra rejection, mathematical pretreatments, noice monitoring|
|Analyzer management||Health status monitoring, data sequrity, user management, audit trail|
|Chemometric interfaces||Unscrambler, SIMCA, GRAMS, Calibration Workshop|
|Technology||.NET based application|
|Communication protocol||Ethernet based TCP-IP, OPC-Server, SiPAT driver|