제약 QBD에서 NIR기술을 이용한 PAT(Process Analytical Technology) 장비
is a dedicated NIR analyzer for non-invasive online monitoring of pharmaceutical powder blending. The system provides valuable process insight from product development to operations and can also be used to control blend time. The system fits to any size of bin blenders and containers.
The heart of the instrument is a rugged and proven InGaAs diode arrey spectrometer. High spectral resolution and wavelength accuary combined with low noise enable the use in demanding applications. Superior system to system comparability simplifies method transfer between different instruments. Highest long term and temperature stabiliy is supported by internal intensity and wavlength references.
Besides determination of blending end point by statistical methods, quantitative analysis of API and other formulation ingredients applying chemometric calibrations is possible, too. Based on the gained process data it is possible to optimize blending time, avoid faulty batches and prevent blends from being segregated due to over-blending. There is no longer need for conventional thief sampling and laboratory analysis which retard manufacturing processes and therewith raise production costs. Fully implemented and applied the online monitoring of blend uniformity is a key element for real-time release.
A key focus of design and development from the very outset was ease of use and minimum maintenance effort:
Mounting can be done by means of a simple 2" or 4” hygienic flange
Highest data safety is guaranteed by the use of the internal embedded PC, since all generated data are buffered locally on the analyzer, before transmission through the wireless network. tandard PC periphery can be directly attached for service or IT administration. WiFi connectivity and optional OPC server are provided for the process environment.
Sentronic enjoys a unique skill set, with many years experience in development and production of spectrometer systems and probes, combined with in-depth knowledge of pharmaceutical production processes. With our engineering capabilities we are able to provide comprehensive support in any aspect of system integration into designated process environment.
Attachment to the process is made by a separate process flange with an integrated sapphire window. This flange is welded into the bin wall or into the bin lid.The inside surface is smooth and flush and will not generate any disturbancy to the blending process. We provide all necessary integration support to make that necessary modification to the equipment.
|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|