The Thermo Scientific IonicX Portable XRF Analyzer helps pharmaceutical and biopharmaceutical manufacturers ensure the quality of materials by providing fast and accurate material identity verification of ionic salts.
Here are some frequently asked questions and answers about the IonicX Portable XRF Analyzer.
A: The IonicX Portable XRF Analyzer is an X-Ray fluorescence spectrometer. XRF is a non-destructive analytical technique used to determine the elemental composition of materials. XRF analyzers determine the elemental composition of a sample by measuring the fluorescence (or secondary) X-ray emitted from elements in a sample when those are excited by a primary X-ray source. Each of the elements present in a sample produces a set of characteristic X-ray lines ("a fingerprint") that is unique for that specific element, which is why XRF spectroscopy is an excellent technology for qualitative analysis of material composition. (For more information about XRF, download this ebook: Portable XRF Technology for the Non-Scientist.)
A: Pharmaceutical manufacturers employ the IonicX for raw material analysis of ionic salts in the manufacturing of pharmaceutical products. A non-expert operator can use a portable IonicX to accurately verify the identity of ionic salts far faster than conventional bench-based techniques. The efficient use of IonicX streamlines material verification and renders 100% material inspection cost-effective while maintaining high quality standards.
A: No knowledge of underlying analysis technology (XRF theory) is necessary to successfully implement the IonicX Portable XRF Analyzer following method validation. Operation requires only a general familiarity with the interface. However, given the nature of the device, it is recommended that all operators receive radiation safety training to minimize any risk associated with improper handling of the IonicX Portable XRF Analyzer.
A: Each year plant personnel spend considerable resources moving materials to be sampled in a controlled location, performing analysis with trained personnel in a laboratory setting, documenting samples, and moving materials into a quarantine area to await laboratory results. With the IonicX Portable XRF Analyzer, incoming materials may be verified in the warehouse, by-passing all the traditional central laboratory testing steps – saving time and manufacturing resources such as personnel, plant space, and inventory costs.
QC laboratory testing is also resource intensive. Highly qualified lab personnel spend numerous hours preparing and analyzing samples, reviewing data, and documenting procedures and results. Identity testing occupies valuable instrument time that could be used for other analyses. Chemical disposal fees add to laboratory costs. Using non-destructive, portable XRF analyzers like IonicX, pharmaceutical manufacturers minimize these costs.
A: When the IonicX Portable XRF Analyzer is in use, the instrument emits a directed radiation beam when the tube is energized. Reasonable effort should be made to maintain exposures to radiation as far below dose limits as is practical. This is known as the ALARA (As Low as Reasonably Achievable) principle. Three factors will help minimize an operator’s radiation exposure: time, distance, and shielding. While the radiation emitted from the IonicX Portable XRF Analyzer in unprotected conditions is similar to the exposure received in a conventional medical or dental X-ray, the IonicX test stand provides a means of mitigating the radiation, keeping any exposure at safe levels.
A: Unlike comparable ionic salts RMID analyzers (e.g. LIBS), the IonicX does not require the preparation of a compressed pellet to operate. Instead, the IonicX utilizes widely available sample cups of marginal cost, which are simply filled without prior preparation or alteration of the sample itself. These cups are composed of an assembled plastic frame and a polypropylene film, which forms a ‘window’ through which the analysis takes place.
A: Yes, the IonicX Portable XRF Analyzer can be mounted in two distinct test stands: the Portable test stand, which allows increased stability for maximized workflow, and the Mini test stand, which provides a small footprint while maintaining complete functionality. Images and further descriptions of each test stand are available on the IonicX Portable XRF Analyzer product page here.
A: Yes, the IonicX Portable XRF Analyzer is rugged, splash resistant (IP54 compliant), and has a dustproof housing for harsh environments, commensurate with the device’s intended capability to provide laboratory-quality results anywhere in the manufacturing plant.
A: Weighing just 2.8 lbs (1.3kg), the IonicX Portable XRF Analyzer can be moved throughout operating facilities without the need for recalibration or modifications. With data transfer over secure Wi-Fi, the instrument can be used at any location.
A: The area of analysis is typically 8mm in diameter, ensuring homogeneous representation of raw material.
A: The IonicX Portable XRF Analyzer uses batteries that are designed to be hot-swappable. In order to allow battery substitution with no down time, capacitors in the analyzer maintain instrument functionality for 5-10 seconds after the battery has been removed.
A: Yes. Wi-Fi is used to connect the IonicX Portable XRF Analyzer to public and private wireless networks through wireless access points (WAPs) such as Wi-Fi routers and other hotspot devices. Unsecured networks are not supported.
Bluetooth connectivity is enabled from the Settings Page of the analyzer’s Touch Screen and can be used to establish a wireless connection between the IonicX Portable XRF Analyzer and a portable printer or barcode scanner.
A: The IonicX Portable XRF Analyzer comes with a locking shielded carrying case, two lithium-ion battery packs, one 110/220 VAC battery charger/ AC adaptor, check samples, a safety lanyard, and a PC connection cable (USB).
A: Yes. The IonicX Portable XRF has enhanced 21 CFR part 11 compliance security features, such as user access restricted by user names and passwords, password aging and complexity, full audit trail features, and the ability to securely sync data.