Established in 1997, B&W Tek first developed a comprehensive OEM laser product line based on diode lasers in its first four years before adding an array-based spectrometer product line for OEM customers in 2001…
“In answering customers’ needs, we developed a Raman system that was portable and started to provide custom portable Raman systems and set a record of shipping around 8,000 portable Raman spectrometers in less than four years,” says Jack Zhou, Chief Operating Officer at B&W Tek. “Moving from the portable system to handheld products was a natural and logical progression for the company. We found competitive advantages and application opportunities in the pharmaceutical industry. As a major player in the portable Raman industry, the IPs developed by B&W Tek, our technical knowledge and development experience in the field as well as our mass manufacturing capability greatly benefited our handheld device development and manufacturing. We had a solid foundation to introduce successful handheld products quickly and efficiently.”
So what are the benefits of handheld Raman? “The NanoRam® is a handheld device whose primary application is aimed at identifying pharmaceutical raw materials,” Zhou explains. “This is useful for 100 per cent raw material identification in accordance with regulatory requirements. A handheld Raman instrument can offer on-site identification that confirms or disputes that what is inside the packaging is what the labels claims. A recent customer was trying to differentiate between two very similar materials that were giving close signatures that couldn’t be separated by the instruments he was using. With the NanoRam®, we used statistical tools in the software to give very precise readings of ‘pass’ and ‘fail’ that separated the two materials. This type of scenario is frequent in pharmaceuticals, as many companies use excipients that are chemically very similar. With our algorithms, we can draw statistical confidence limits to discriminate between closely matched materials. The NanoRam® offers a quick, qualitative pass/fail result that can save time and offers a clear ROI. When developing handheld units, it’s important to remember that handheld and portable Raman tools offer different capabilities, based on the needs of the user. Portable Raman offers fuller capabilities similar to that of a full grade research instrument such as data mining, while the handheld tool has a touch screen interface that can be used for quick qualitative analysis and can be run by any type of operator in any scenario. Miniaturisation is key, as well as maintaining the performance that is found in portable Raman.”
“The NanoRam® is the only handheld Raman spectrometer in its class to offer a user friendly touch screen and high brightness display,” Zhou continues. “It employs a cooled detector with enhanced operation stability and sensitivity which results in a fast measurement time and short library / method development time. Its built-in, powerful and statistic-based software makes it possible to differentiate close materials that other devices on the market may have difficulty with. It also supports easy notes entry, account management and statistical data analysis all through the handheld touch interface. The NanoRam® has a wide variety of sampling accessories available for various application needs, making it flexible for being used in variety of environments. B&W Tek also provides the NanoRam® in full compliancy with the regulatory requirements specifically for gov – erning the use in pharmaceutical industries. We provide full product documentation as well as IQ/OQ with execution, method validation protocol and SOP training. Guidelines, on-site training service, library/method development service, annual service package and many more options are also available.”
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Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
And what innovations are the company looking to introduce in the future? “B&W Tek is committed to continuing its innovations in providing the pharmaceutical industry with easy to use and high performance solutions,” Zhou says. “At the moment, our handheld Raman tool offers a simple qualitative analysis of pass or fail. For a quantitative analysis, we offer a portable Raman tool so that customers can perform more sophisticated chemometric analyses on, for example, whether a tablet has a sufficient API content or if something found on the market is authentic. We have the capability to provide our portable equipment with a more sophisticated analysis, and we are looking to develop handheld Raman capabilities to include some of the tools we use in portable Raman, enabling quantitative analyses on handheld Raman for different appli – ca tions. From a hardware point of view, we are looking to expand the use of handheld Raman in different types of scenarios by accessorising it to enable its use in other areas, while maintaining the convenience of a handheld unit. Because of our unique design for handheld Raman, we can respond to the needs and requirements of the industry and develop accessories that are suitable for a wider range of applications.”
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