Epsilon 4 Pharmaceuticals & cosmetics
Trust your product quality
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.
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.
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.
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.
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.
Fast and sensitive
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.
|Sample handling||X-ray tube||Detector||Software|
|10-position removable sample changer||Metal-ceramic side window for maximum stability||High-resolution silicon drift detector (SDD), typically 135 eV @ Mn-Kα||Elemental screening with Omnian standardless analysis solution|
|Spectrometer can accommodate samples (loose powders, liquids, slurries and solids) up to 52 mm in diameter||50 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 time||PASS/FAIL analysis with FingerPrint solution|
|Spinner is included for more accurate results of liquids, slurries and powders||Ag anode X-ray tube for best performance of P, S and Cl analysis||Thin-entrance detector window for high sensitivity||Audit trail software option for enhanced data security in compliance with FDA 21 CFR Part 11|
Standards (Reference materials)
Epsilon software is the XRF analysis software platform that is used with PANalytical’s range of Epsilon 1 and Epsilon 4 benchtop EDXRF systems.
Omnian software enables users to achieve the best possible analysis when dedicated methods or certified standards do not exist.
Enhanced Data SecuritySecuring your data and satisfying regulators.
A FingerPrint software module combined with an Epsilon EDXRF system is ideal for material testing when analysis speed is important but the actual composition is not of interest.
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.
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
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
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:
- Pressed powders
- Loose powders
- Fused beads
- Films and coatings