1. What recent changes in the pharmaceutical industry led to an increase in handheld usage?
Increased government regulations for QbD/PAT led by the US and Europe that mandate 100% testing of incoming raw materials have been a major driver for the adoption of handheld units. In addition, the competitive pressures on pharmaceutical companies to reduce costs and implement LEAN manufacturing processes has created the need for handheld instruments that can be used by QA/QC technicians to screen raw materials in the warehouse and at the loading dock without sending samples for analysis in laboratories.
2. How, in your opinion, have handheld solutions shifted since inception?
Handheld instrumentation has greatly expedited the analysis of incoming raw materials by moving verification from the lab to the warehouse. The recent launch of the NanoRam handheld Raman spectrometer has pioneered two major shifts in handheld solutions. The first is unparalleled laboratory grade performance in the palm of your hand by utilizing TE Cooling, a VBG stabilized laser and a high power touch screen computer. The second is a revolution in ergonomic software capabilities, which have allowed for the development of simple and intuitive user interfaces. The NanoRam OS is specifically designed with both the non-technical user and highly skilled user in mind. The simple work flow expedites training procedures while advanced features such as method development, reporting, and wi-fi allow the administrator to more effectively manage their inspection process.
3. What notable challenges do handheld spectrometers overcome with regard to materials verification?
The main advancement is being able to bring the materials analysis to the sample in the containers by handheld instruments. The new generation of products like the NanoRam, are fast and easy to use by non-specialists for a wide range of gels, liquids, powders and solids. Onboard analysis software and reference libraries provide accurate identification and verification of the materials being tested. The handheld device can be validated and configured to meet a pharmaceutical company’s standard operation procedures and FDA compliant processes.
4. What is currently the single largest trend with respect to material verification in cGMP facilities?
The single largest trend in material verification in cGMP facilities is the move toward 100% testing of raw materials. In order to keep up with this demand, pharmaceutical companies will need to deploy more instruments at multiple facilities. This is becoming more feasible with the decreasing cost of ownership of handheld instruments, as well as new wi-fi capabilities that support easy management of multiple units simultaneously.
The deployment of numbers of handheld instruments within the global operations of pharmaceutical companies is increasing to meet cGMP requirements. These instruments can be programmed remotely and updated with new software and reference libraries.
5. How have government regulations and guidelines provided by U.S. and international pharmacopeia influenced these trends?
The key driver in the US and other major pharmaceutical manufacturing regions is the ever-growing list of FDA and EU regulations for QA/QC processes. Many countries that manufacture pharmaceuticals export the majority of their products to the US and Europe, so adherence to these requirements is critical. Many other countries base their regulations on the FDA guidelines, most notably the Chinese SFDA. US and European pharmacopeia have led the way in developing guidelines for the use of FT-IR, NIR and Raman instruments. The new generation of handheld products like the NanoRam are fully compliant with 21 CFR Part 11 requirements and can be validated within pharmaceutical QA/ QC environments.
6. What unique qualities of the NanoRam allow users to comply with recent regulatory specifications?
The NanoRam comes operational with B&W Tek’s proprietary NanoRam OS software, which is compliant with both cGMP and 21CFR part 11 certifications and meets all regulatory requirements for the major global testing agencies. Specifically related to the pharmaceutical industry, the NanoRam is fully compliant with regard to the integrity, safety and traceability of all data generated in the identification and testing of drug compounds and the raw materials as set down by the United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and all other major regulatory pharmacopoeia. In compliance with 21 CFR Part 11 requirements for computerized systems, NanoRam OS fulfills all requirements in order to allow for electronic signatures and records in lieu of paper records.
7. Which country or region do you view as leading the way in LEAN Manufacturing (in reference to handhelds)?
The US is leading the adoption and expansion of LEAN processes within the pharmaceutical industry. Competitive pressures between the large pharmaceuticals and also with the generic drug manufacturers, together with the loss of patent protections, is forcing companies to reduce manufacturing costs and risks by enhancing QA/QC procedures. In these ways, pharmaceutical companies can offer competitive drug prices and avoid product liabilities.
8. How will B&W Tek expand handheld spectroscopic capabilities over the next few years?
Currently, our Raman handheld instruments are utilized for incoming material identification and verification, at-line sampling, and final inspection. In the near future, B&W Tek will expand its handheld capabilities to include quantitative mixture analysis and trace detection. Over time, we plan to incorporate several orthogonal sensing technologies into our handheld portfolio, such as NIR and FTIR, allowing you to analyze any material in any environment.