With the push towards 100% inspection and lean manufacturing, pharmaceutical manufacturers need efficient ways to reduce costs and risks associated with raw material identification, while complying with regulatory requirements. Rigaku Raman Technologies vice-president and general manager Bree Allen discusses the advantages of implementing handheld Raman analysis.
What challenges does the industry face that could impact the future of drug production?
Bree Allen: In recent years, pharmaceutical manufacturers have faced many challenges that will impact the drug development and production workflow in years to come. As costs and regulations increase, the focus on lean manufacturing to produce products that meet stringent guidelines, in a timely manner, is critical to the success of a drug company. Without quality management systems (QMS) to ensure compliant products are produced using the most cost-effective method, production growth will not be sustainable.
How can managers obtain the most efficient QMS?
A core part of the manufacturing process is the analysis of raw materials. Traditional quality control involves sending an incoming shipment of material to quarantine while a sample is sent to an off-site laboratory for identification analysis before it can be released to manufacturing. This can be costly and time-consuming. By implementing an identification method at the point of receipt that involves a tool that can be used by any warehouse employee, companies will benefit from a process that is much more efficient.
How has Rigaku Raman Technologies revolutionised raw material identification (RMID)?
We have taken an accepted lab-based technology – Raman spectroscopy – and developed a customisable, handheld Raman analyser – Progeny. Designed for seamless integration into an existing workflow, Progeny delivers what truly matters in a customer’s mind: error-free operation, repeatability, ease of use, and the widest range of sampling capabilities – all in a handheld form.
The new method will involve changing standard operating procedures (SOPs) – a potentially lengthy process. How will Progeny face this challenge?
Until now, software on handheld devices has not allowed great flexibility in the customisation of SOPs and analysis of report formats. Progeny offers complete customisation. It can mimic existing SOPs by following logical steps similar to a smartphone set-up procedure. Another option is to take advantage of Progeny’s powerful report generator and write entirely new SOPs. The integrated barcode reader with camera allows for sample image documentation to improve data tracking. In addition, Progeny’s digital signature capability completes its 21 CFR Part 11 compliance requirement.
How can the results be shared?
Progeny has been made to serve multiple markets and, because each has different needs, the instrument incorporates multiple ways to achieve this task. Wi-Fi and Bluetooth represent the most modern and convenient way to send data to a server for remote archival purposes. However, in regulated environments where data security is mandatory, Progeny ensures wired connectivity and compatibility with laboratory information management systems.
Are there any indirect advantages to implementing this technology for RMID at the point of receipt?
We live in a ‘do more with less’ world, where productivity must be optimised with fewer resources without compromising quality. Handheld RMID improves the percentage of material testing while lowering the cost of laboratory analysis for such a task. Once RMID is deployed, laboratory resources can be shifted to focus on higher-value tasks, providing an additional layer of safety, productivity and quality.
Why have some pharmaceutical companies not yet adopted a handheld analysis technique?
Change only makes sense when benefits exceed costs. Until now, handheld Raman has had the ability to identify a wide range of materials, with the exception of problematic compounds such as coloured substances and others that naturally fluoresce. Progeny expands material analysis capabilities and simplifies workflow integration, which may result in a highly profitable change.
