EPM: What do you see as the main challenges faced by the pharmaceutical industry when it comes to raw material identification?
FI: Raw material identification (RMID) is a crucial part in the pharmaceutical manufacturing process and is essential to ensuring quality control and compliance with industry regulations. Materials can be ‘out of specification’ due to a variety of factors, including incorrect formulation, contamination, counterfeiting or even the mislabeling of their containers. If out-of-spec materials are not promptly identified and rejected they can lead to additional costs as a result of material waste, re-processed work, time delays – or ultimately, product recalls. While protecting patients from being exposed to below standard products, recalls always have an implication on a company’s brand. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme now requires 100% inspection of incoming raw materials (in most countries) which means every container must be analyzed.
The traditional RMID workflow includes material sampling for laboratory testing purposes. This can lead to bottlenecks since the lab testing process is rarely real-time and quality control laboratories are often located off-site. This also means that material needs to be held in a quarantine area before confirmation of the results and that valuable space is taken up by materials waiting for clearance.
EPM: How can handheld Raman spectroscopy technology help meet these challenges?
FI: Raman spectroscopy is a recognised technique in the US Pharmacopoeia (USP), and the European Pharmacopoeia (EP) and, for RMID purposes handheld Raman devices are as analytically effective as conventional lab-based methods.
With the push towards 100% inspection and lean manufacturing, handheld Raman optimizes the RMID process in a number of ways. Handheld Raman devices provide the ability to analyse, identify and qualify materials against specific criteria on the spot. This removes the delay in waiting for lab results, improving cycle time, optimizing material movement, and the need for quarantine. Handheld Raman instruments can also identify substances through bags and other types of packaging, eliminating the risk of compromising the integrity of the contained materials.
All of these factors result in an improved workflow, reduction in space and inventory, as well as time and cost savings.
EPM: What do you believe the future holds for raw material identification technology?
FI: There is currently a cultural preference in the pharmaceutical industry towards laboratory benchtop equipment, but as more handheld devices become available and the level of confidence and efficiency they deliver is proven, I believe we will see a dramatic shift in a move towards the use of handheld devices for RMID. At that point, laboratory personnel could focus on higher valued tasks, including root cause analysis of failed material.
EPM: What does Rigaku offer customers in the pharmaceutical industry?
FI: Before we launched Progeny, users of handheld Raman devices with 785nm or 532nm visible range excitation lasers were not able to identify coloured substances, materials through coloured containers or samples with high fluorescence interference, such as sodium carboxy methoycellulose, xantum gum, or gelatin. Progeny’s 1064nm excitation laser enables users to broaden their analysis range thanks to minimal fluorescence.
Ease of use is a key consideration and Progeny has been engineered to be quickly and easily implemented into customized RMID workflows with features such as a touchscreen user interface inspired by modern smartphones. Users also benefit from Progeny’s single hand operation and angled display meaning that the device can quite literally ‘point and shoot’ at the container being analysed while the user simultaneously checks the measurements on screen. In order to ensure accurate data entry tracking and compliance, Progeny has an integrated digital camera and 21 CFR Part 11 compliant electronic signature capabilities.