Analyze accurately and frequently

To comply with regulatory requirements like ICH Q3D and USP<232>, Malvern Panalytical offers a range of cellulose-based system calibration standards for toxic elements, catalyst residues or PGM particles. Support for validation and data integrity requirements is provided through system IQ and OQ packages and Enhanced Data Security software for user authentication and analysis auditing (FDA 21 CFR Part 11). FingerPrint, a positive material identification solution, is available for the analysis of impurities and detection of possible counterfeit drugs.
Illustrated below are the significant added values achievable by Epsilon 4, relative to this single modest investment.

The power of benchtop XRF

Combining the latest excitation and detection technologies and smart design, the analytical performance of Epsilon 4 approaches that of more powerful and floor-standing spectrometers. Selective excitation and careful matching of the X-ray tube output to the capabilities of the detection system underlie the system’s outstanding performance.

The power of benchtop XRF

Low running costs

Epsilon 4 does not require the use of expensive acids, gasses and fume hoods, like in ICP and AAS. The only requirement is mains electricity and in some cases the use of helium to boost the sensitivity for light elements in the sample. Also, the individual components in XRF spectrometers are not exposed to friction or heat and therefore last for many years.

Low running costs

Non-destructive analysis

Measurements with Epsilon 4 are carried out directly on loose powders or end products, like pills and capsules, with little to no sample preparation. Since XRF is a non-destructive technique, the sample can also be measured subsequently by other analytical techniques, if required.

Non-destructive analysis

IQ and OQ documentation

Installation qualification and operation qualification procedures are available for Epsilon 4. These procedures are instrument verification and validation procedures required by companies to meet good laboratory practice (GLP), good manufacturing practice (GMP) and FDA 21 CFR Part 11 regulations.

IQ and OQ documentation

Pharmaceutical setup samples

To comply with regulatory requirements, Malvern Panalytical offers a range of cellulose-based system setup samples for toxic elements, catalyst residues or PGM particles in the groups 1, 2A, 2B and 3. The standards contain 17 elements with concentrations ranging from 0 to 200 mg/kg. The three separate sets contain 5 different standards plus a validation sample.

Pharmaceutical setup samples

Fast and sensitive

Fast measurements are achieved by using the latest silicon drift detector technology that produces significantly higher intensities.
Unique detector electronics enable a linear count rate capacity to over 1,500,000 cps (at 50% dead time) and a count rate independent resolution typically better than 135 eV for better separation of analytical lines in the spectrum. This allows the Epsilon 4 spectrometer to run at full power and therefore realizes a much higher sample throughput compared to traditional EDXRF benchtop instruments.
Fast and sensitive
Sample handlingX-ray tubeDetectorSoftware
10-position removable sample changerMetal-ceramic side window for maximum stabilityHigh-resolution silicon drift detector (SDD), typically 135 eV @ Mn-KαElemental screening with Omnian standardless analysis solution
Spectrometer can accommodate samples (loose powders, liquids, slurries and solids) up to 52 mm in diameter50 micrometers thin beryllium window for high sensitivity for light elements (Na, Mg, Al, Si)Max. count rate of 1,500,000 counts/s at 50% dead timePASS/FAIL analysis with FingerPrint solution
Spinner is included for more accurate results of liquids, slurries and powdersAg anode X-ray tube for best performance of P, S and Cl analysisThin-entrance detector window for high sensitivityAudit trail software option for enhanced data security in compliance with FDA 21 CFR Part 11

Services

Solutions to maximize the return on your investment

To assure that your instrument remains in top condition and performs on the highest level, Malvern Panalytical offers a wide range of services. Our expertise and support services assure an optimal functioning of your instrument.

Support

Service for a lifetime

  • Phone and remote support
  • Preventive maintenance and checkups
  • Flexible Customer Care Agreements
  • Performance certificates
  • Hardware and software upgrades
  • Local and global support

Expertise

Adding value to your processes 

  • Sample preparation development/optimization
  • Analytical methodologies 
  • Turnkey solutions for XRD 
  • Operations via IQ/OQ/PQ, quality assurance (GLP, ISO17025) or round robins/inter laboratory studies
  • Automation of lab processes
  • Consultancy services

Training and education

  • Training on-site or at our competence centers
  • Broad range of basic and advanced courses on products, applications and software

Analytical services and calibration materials

  • Expert (XRF) analyses services
  • Oxides and trace analysis
  • Customized calibration materials