OVERVIEW

• Lightweight, compact, easy to mount
• GmP friendly with smooth surfaces
• Accurate and reliable Diode Array NIR technology
• Internal wavelength and intensity reference
• Lowest cost of ownership
• WiFi connected and battery powered
• Embedded PC for instrument control and data buffering
• Full GmP support for instrument and
• Optional Interfaces to OPC, SiPAT, SynTQ or PharmaMV

Applications

Bin Blending Sentronic PAT solutions are widely used in pharmaceutical powder blending to increase process understanding and support process and product release

More Information

SentroPAT DA

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.

 

High Performance Diode array spectrometer

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.

 

Understand and control the blending process

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.

 

Flexibility and easiest handling

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

• Mains adapter, internal and external charger and a hot swappable battery are providing a handling and possibilities as known from mobile PC or any other battery operated device
• The 3D orientation sensor allows software adjustable and reliable measurement synchronization to the blender rotation.
• The smooth cGMP-friendly unit can be easily cleaned, as it is required for use in GMP production facilities.

Highest data integrity

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.

 

Comprehensive support

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.

 

 

 

 

 

 

 

 

 

 

 

 

Technical Data

 

SentroPAT Analyzer
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
SentroProbe
Spot size	5mm diameter / 20mm² surface
Light source	2 internal 5W bulbs for redundancy Lamp modules user replacable Lifetime 14,000hrs
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
Software interfaces
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