Epsilon 4 Pharmaceuticals & cosmetics

Trust your product quality

  • Multi-functional benchtop XRF analyzer 
  • Non-destructive elemental analysis of impurities in APIs
  • Compliant with ICH Q3D, USP<232>, <233> and <735>

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Overview

The Epsilon 4, an energy dispersive X-ray fluorescence (EDXRF) benchtop spectrometer, offers non-destructive elemental analyses of impurities in active pharmaceutical ingredients and excipients in line with the recommendations in ICH Q3D, USP<232>, USP<233> and USP<735>. 

Applications that have traditionally been performed by ICP and AAS are now possible without the need for time-consuming and costly sample preparation.

Features

  • 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.

  • 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.

  • 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.

  • 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.

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.

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.

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.

Key applications

Epsilon 4 spectrometers can handle a large variety of sample types, weighing from a few milligrams to larger bulk samples. Samples can be measured as:

  • Solids
  • Pressed powders
  • Loose powders
  • Liquids
  • Fused beads
  • Slurries
  • Granules
  • Filters
  • Films and coatings

Universal and reliable device.

Jakub Nowak — ComerLab Dorota Nowak

Specification

Sample handling

Sample capacity 10-position removable sample changer
Sample size Spectrometer can accommodate samples up to 52 mm (2 inch) in diameter
Features Spinner is included for better accuracy of air filter analysis

X-ray tube

Features Metal-ceramic side window for maximum stability
50 micrometers thin beryllium window for high sensitivity for light elements (Na, Mg, Al, Si)
Tube setting Ag anode X-ray tube for best performance of P, S and Cl analysis

Detector

Detector type High-resolution silicon drift detector (SDD), typically 135 eV @ Mn-Kα
Features Max count rate of 1,500,000 counts/s at 50% dead time
Thin-entrance detector window for high sensitivity

Software

Software
  • Elemental screening with Omnian standardless analysis solution
  • PASS/FAIL analysis with FingerPrint solution
  • Audit trail software option for enhanced data security in compliance with FDA 21 CFR Part 11

Accessories

Software

Epsilon software

Analytical EDXRF software package for Epsilon benchtop systems

Epsilon software is the XRF analysis software platform that is used with PANalytical’s range of Epsilon 1 and Epsilon 4 benchtop EDXRF systems. The software offers all the functions required to set up and operate an Epsilon benchtop system. The analytical program assembly is greatly facilitated by the high degree of intelligence built into the software, allowing users to benefit from half a century of applications expertise. Daily XRF analysis is a routine task that can be readily carried out by inexperienced personnel after a minimum of instruction. Many features are present to enhance the usability of the software.

Omnian

Standardless analysis of all types of samples

Omnian enables users to achieve the best possible analysis when dedicated methods or certified standards do not exist. A trendsetting standardless analysis package, Omnian incorporates state-of-the-art software and setup samples that transcend technologies. Available for Epsilon 1, Epsilon 4 and Zetium spectrometers, Omnian delivers fast and reliable results regardless of sample type or matrix.

Enhanced Data Security

Securing your data and satisfying auditors

The Enhanced Data Security (EDS) module is a software option that provides enhanced trust in results for users of the Zetium XRF spectrometer (through the SuperQ software) and the Epsilon XRF spectrometer. With capabilities including advanced user management, action logging, data protection, and application status assignment, EDS helps you strengthen your audit trail, minimize the risk of error, and prove that your XRF instrument is working as expected.

FingerPrint

Instant material identification

A FingerPrint software module combined with an Epsilon 4 EDXRF system is ideal for material testing when analysis speed is important but the actual composition is not of interest. FingerPrinting generally involves little to no sample preparation and is non-destructive.

Standards (Reference materials)

CRMs

Certified reference materials, including XRF calibration modules and reference materials

More information

User manuals

Software downloads

Please contact support for the latest software version.

Support

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
  • 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
Trust your product quality.

Trust your product quality.

Compliant, low cost, non-destructive elemental analysis of impurities in active pharmaceutical ingredients. Upgrade your lab today.

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