PRODUCT 제품소개

QbD/PAT

근적외선 공정분석 [ SentroPAT FO ]
  • 제품명
    Multichannel diode array NIR Analyzer
  • 제조사
    SENTRONIC
  • 상세내용

제약 QBD에서 NIR기술을 이용한 PAT(Process Analytical Technology) 장비


OVERVIEW


Complete PAT solution for pharmaceutical solid dose manufacturing

  • fast and long term stable results
  • superior spectroscopic performance
  • reflectance probes with internal reference
  • large spot size (5mm diameter)
  • best spectra quality with moving sample conditions
  • GmP friendly hardware design
  • GAMP compliant analyzer management software
  • OPC connectivity
  • interfaces to SiPAT (Siemens), SynTQ (Optimal ltd.) and PharmaMV (Perceptive Engineering Ltd.)
  • Predictor interfaces: Simca, Unscrambler



Applications



Continuous Manufacturing
PAT-Applications in continuous pharmaceutical manufacturing processes

High Shear Wet Granulation
Introduction to the Application of NIR based PAT to monitor High Shear Wet Granulation

Tablet press feed frame
Potency & Blend/Granule Uniformity measurement with NIR probe in the feed frame of tablet presses

Fluid bed coating
Online NIR spectroscopy tablet and granule coating thickness measurement

Roller compaction
NIR can be used to measure ribbon density and porosity

Hot melt extrusion
NIR based inline monitoring for pharmaceutical hot melt extrusion




More Information


A complete solution, a customizable solution

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

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.

 

The NIR advantage

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.

 

Fast diode array technology

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.

 

Low maintenance

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.

 

Partnership with Sentronic

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.

 

 

 

 

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