Performing QA/QC Tasks within Pharmaceutical Industry

Addressing Modern Laboratory Challenges

In the modern laboratory, one of the main challenges is to reduce the cost of ownership of equipment and to guarantee its reliability without compromising its analytical performance. Moreover, since these instruments get increasingly complex and advanced, it is vital to ensure they are easy to maintain and operate. They should be in a position also to enable compliance with prevalent good laboratory practices and regulatory guidelines.

Addressing Modern Laboratory Challenges

The ABB MB3000-PH FT-IR spectrometer for the pharmaceutical industry has been developed keeping these significant principles in mind. It is the outcome of over three and a half decades of experience in FT-IR spectroscopy and more than a decade of existence in life sciences analytical laboratories.

Experience and Innovation: the Winning Combination

One of the trademarks of ABB FT-IR instruments has always been robustness. ABB is proud to carry on this heritage with the MB3000-PH, which is the most dependable FT-IR spectrometer available in the market. In addition to the excellent stability of the wishbone principle with corner cube mirrors that guarantee reproducible data, the design of the interferometer has been refined further by introducing a novel double-pivot concept derived from ABB’s aerospace technology, thereby ensuring exceptional robustness. Consequently, the permanently aligned optics eliminate the need for alignment and the interferometer comes with a lifetime warranty.

Maximum Simplicity at a Minimum Cost of Ownership

Whether operating in analytical development, QA/QC, formulation laboratory, or R&D, users can benefit from the ease of use and simplicity of the MB3000-PH. The universal sampling compartment of the spectrometer is highly versatile and accommodates a broad array of accessories. The innovative Horizon MB™ FT-IR software suite is a user-friendly and intuitive interface that enables immediate adaptation for new users.

Apart from offering a minimal footprint, the innovative vertical design of the MB3000-PH FT-IR spectrometer reduces the cost of ownership: the pre-aligned source module with electronic stabilization eliminates the need for replacement for a decade, and the innovative diode laser-based metrology module avoids the need for any scheduled maintenance. These distinctive features, in combination with the extensive integrated health monitoring of the instrument, offer the peace of mind a user needs to confidently rely on the MB3000-PH.

Performance Matters

Since it is well known that ease of use and robustness are of little value when achieved at the cost of analytical performance, engineers at ABB have paid great attention to make sure that the MB3000-PH offers the high-quality type of spectra that have contributed to the world-class reputation of ABB spectrometers over the years. The exceptional signal-to-noise specifications of the MB3000-PH illustrates that compromising on performance is not an option for ABB.

An Unrivalled Reliability

Permanently Aligned Optical System

The novel double-pivot interferometer is designed to guarantee optimized robustness. The corner cube mirrors are permanently aligned without the need for dynamic alignment. Reproducible spectroscopy is vital in a highly regulated environment.

Minimal Components

The modular design of the MB3000-PH enables integration of reliable components with lesser effort.

Rugged and Durable Modules

The MB3000-PH comes with a lifetime warranty against degradation or damage due to moisture and demonstrates the optimally increased analyzer service life in the market. Maintenance scheduling is no longer a problem with the MB3000-PH.

ABB MB3000-PH FT-IR spectrometer

Versatility at a Glance

Standard Open Sample Compartment

The MB3000-PH is designed with an Arid-Zone open sample compartment that satisfies all the needs of the modern analytical laboratory. It has the ability to use a wide range of easily swappable ABB or third-party accessories that are pinned in place and eliminate the need for alignment.

Multiple Sampling Options

ABB provides the MIRacle™ accessory with electronic recognition through USB port, a universal ATR sampling kit for the analysis of liquids, solids, gels, pastes and intractable materials, thereby fulfilling the most common sampling demands. Other sampling options provided by ABB are a diffuse reflectance DRIFT accessory, a horizontal ATR kit, specular reflectance accessories with variable and fixed angles, demountable liquid cells, gas cells, and micro-sampling with a beam condenser or microscope.

Simple yet Efficient

A Focus on Ease of Use

The MB3000-PH’s logical and customizable Horizon MBTM FT-IR software interface enables the user to configure the work environment and choose data formats based on the requirements. The several import and export options make data conversion easy.

The Performance You Need

The MB3000-PH satisfies demanding criteria in relation to spectral range and sensitivity. Its exceptional stability sets a world-class standard for FT-IR performance.

The First Maintenance-Free FT-IR Analyzer

No Consumables

Since the MB3000-PH components do not wear out, they eliminate the need for adjustment or replacement. The spectrometer optics are non-hygroscopic by nature, thus avoiding the need for purge.

First Maintenance-Free FT-IR Analyzer

Sources with a 10-Year Average Lifetime

In terms of the MB3000-PH, ABB provides the first maintenance-free FT-IR spectrometer with no downtime, which is really a revolution in the laboratory.

Compliance Made Easy

Secured Data Handling

The MB3000-PH is designed to include the Horizon MB Security software module which allows choosing between two security levels, thereby guaranteeing operations in a 21 CFR Part 11-compliant mode.

Complete Validation Package

ABB’s knowledge of what it takes to implement and validate an analyzer in the life sciences industry has led the company to include a complete set of cGMP IQ-OQ protocols and templates in the package.

Horizon MB FT-IR (default)

Intuitive Software for Daily Operations

The HORIZON MB FT-IR module enables the samples to be acquired, processed and analyzed. It has rendered the managing of analytical results easier like never before.

Horizon MB Library (Default)

A Powerful Search Engine

The HORIZON MB Library module has been developed for efficient searches of multiple libraries and provides full-text and spectrum search capabilities.

Horizon MB Security (Default)

Enabling 21 CFR Part 11 Compliance

The HORIZON MB Security module provides two selectable security setting levels (“Computer” or “Windows”). It offers unique access control to software functions according to permission schemes, electronic signatures, hierarchical access control based on data access roles, traceability of all data manipulations, and activity logging.

Horizon MB Professional (Option)

Advanced Features for Demanding Users

The HORIZON MB Professional module comes with optimized mathematical functions, extended import/export functions, and 3D capabilities. It is also provided with a regulatory module for automated execution and reporting of the instrument verification tests illustrated in pharmacopeia guidelines.

Horizon MB Quantify (Option)

The Modern Chemometrics Toolbox

The HORIZON MB Quantify module includes univariate and multivariate algorithms for data analysis and quantification. It also incorporates the Horizon MB Professional module.

Horizon MB Scripting (Option)

Functionality Customization

The HORIZON MB Scripting module enables users to create their own routines and functions with the help of the robust SAX basic scripting engine.

First Maintenance-Free FT-IR Analyzer

Horizon MB RX (Option)

Real-Time Chemical Reaction Analysis

The Horizon MB RX module has been developed to generate chemical reaction analysis templates and to carry out real-time trending. It facilitates the following operations:

  • Simple real-time and off-line editing of reaction profiles
  • Intuitive set-up using the Reaction Wizard with multi-window layout
  • New template creation from optimized what-if scenarios
  • Quick reaction execution from available templates
  • Possibility of performing off-line reprocessing for chemical run data
  • Evaluation of what-if scenarios and comparison of active run with reference (“Golden batch”)

Horizon MB IR Interpretation (Option)

Spectra Interpretation and Functional Group Analysis

The Horizon MB IR Interpretation module enables the functional groups in molecules to be identified and allows the interpretation of complex spectra based on automated peak table search against a reference library. It is a vital tool in the toolkit of a spectroscopist for routine analysis and chemical research applications.

Horizon QA (Option)

Modern Software for Routine Analysis and QA/QC

The Horizon QA module enables the laboratory staff to perform QA/QC and routine applications in a simple and reliable manner by offering intuitive workflow together with integrated spectrometer and accessory control. The user is guided by the software in every step from gathering reference data to developing QA/QC applications and implementing turnkey techniques. Horizon QA also facilitates plant connectivity by automatically producing a tab-separated file with detailed results and parameter information for the analysis of each sample performed with a procedure. This file can then be imported by a LIMS system.

First Maintenance-Free FT-IR Analyzer

Spectroscopic Performance (Typical at 25 °C with DTGS Detector)

  • Maximum signal-to-noise ratio (root-mean-square, 60 s, 4 cm−1, at peak response): 50000:1
  • Spectral range: 485 to 8500 cm−1
  • Frequency repeatability at 1918 cm−1: <0.001 cm−1
  • Short-term baseline instability: <0.09%
  • Resolution: better than 0.7 cm−1
  • Temperature stability: < 1% per °C
  • Apodized resolution: adjustable from 1 to 64 cm−1, in increments of 2
  • Frequency accuracy at 1918 cm−1: <0.06 cm−1
  • Signal sampling: 24-bit ADC

Application Software (Computer not Included)

  • Standard software: Horizon MBTM FTIR + Horizon MB Library + Horizon MB Security
  • Operating system compatibility: Windows XP Pro
  • Optional add-on modules: Horizon MB RX, Horizon MB Professional, Horizon MB IR Interpretation, Horizon MB Quantify, Horizon QA, Horizon MB Scripting

Optical Bench

  • Optical path fully purgeable
  • Beamsplitter material: ZnSe (non-hygroscopic)
  • Metrology: solid-state laser (no scheduled maintenance required)
  • Interferometer mechanism: high-throughput double pivot Michelson, with protective cover (patent-pending)
  • Open sample compartment configuration: Arid-Zone, center focus
  • Source: ceramic Globar with electronic stabilization, expected half-life, 10 years
  • Sample compartment mounting: 3-point positioning guide or 3-point kinematic adjustable
  • Detector module: DTGS
  • Sample compartment dimensions: 20 cm x 14 cm plate, 8.7 cm beam height

Data Communication

  • Connection: direct-connect or LAN
  • Hardware port: Ethernet, 10/100 Mbps

Instrument Enclosure

  • Size: 43.5 cm (W) x 28.0 cm (D) x 37.2 cm (H)
  • Casting: rugged all-metal with integrated handles
  • Weight: 24 kg

Environmental

  • Operating temperature: 10 to 35 °C
  • Universal power supply: 120-240 VAC, 50/60 Hz
  • Operating relative humidity: 5% to 80%, non-condensing
  • Power consumption: 65 W
  • Regulatory certification and compliance: TUV and CE

Documentation

  • User manual
  • cGMP IQ-OQ protocol templates
  • Quick-start guide

ABB Analytical is one of the major ABB manufacturing centers for laboratory and process analytical systems with over three and a half decades of experience in developing FT-IR and FT-NIR spectrometers for military, industrial and space applications.

As part of ABB’s portfolio of products and services for process optimization, it has the ability to provide a complete range of tailored calibration modeling services and application support for industrial applications.

ABB also offers extensive, globally distributed after-sales support and engineering services, and also a complete customer training program.

IR and NIR Spectroscopy Knowledge Management

  • Calibration and chemometrics development training
  • Application support and spectroscopy training
  • On-site services including hardware and calibration maintenance

Up-Time Insurance Program

  • Customized service contracts
  • Preventive maintenance
  • Chemometrics services
  • Extended warranty services

Installations/Start-ups and Analyzer Life Cycle Program

  • Spectrometer and laboratory/process software exchanges/upgrades
  • Process spectrometer start-ups
  • Extended process and lab spectrometer warrantees
  • Laboratory spectrometer installations

This information has been sourced, reviewed and adapted from materials provided by ABB Measurement & Analytics - Analytical Measurement Products.

For more information on this source, please visit ABB Measurement & Analytics - Analytical Measurement Products.

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