XRF is typically used in the pharma industry to validate and verify critical stainless steel components and other alloy components, for example for on-site installation and operational qualifications.
Jim Martin, a spokesman for Innov-X, noted that new biopharmaceutical engineering (BPE) specifications in the drug industry require complete traceability of critical stainless steel components.
"Mill certification and heat stamps are often used to ensure traceability of parts. However, during the manufacturing processes mix-ups can occur," he said. Meanwhile, reports are generated from companies providing raw materials but are no guarantees of material validity.
The capability to test items like piping and valves on-site can save rework, valuable time and costs," added Martin, as certification by tracking materials validation certificates can take lots of time and does not guarantee accurate results.
The Alpha Series design uses an X-ray tube in a compact, ergonomically designed handheld unit with a pocket PC for what the company describes as 'unprecedented flexibility in a portable analyser'. Testing is nondestructive and reporting is fast and accurate on the chemical composition, X-ray spectra and alloy identification, it added.
Importantly, there are no radioactive isotopes used in the analyser, which circumvents the cumbersome regulatory issues, such as costly disposal and monitoring requirements, associated with this type of detector technology. The unit has a built-in high-resolution colour PDA and features a removable handle that allows it to fit into tight spaces.
Martin told In-PharmaTechnologist.com that in addition to not using radioactive isotopes, Innov-X' product is differentiated from others on the market - including those from rivals Niton and Oxford Instruments (Metorex) - because it is the only one to incorporate a PDA, which provides features such as the ability to transmit data, as well as remote printing and reporting.
Overall, the global marketplace for XRF spectroscopy analysers is valued at around $500 million, with 'a large piece' of that total going into the pharma sector, according to Martin. The Alpha series comes with a price tag in the $30-$40,000 range, he added.