Introduction
The client is among one of the top five pharmaceutical companies dedicated to delivering high-quality, branded and generic medications trusted by healthcare professionals and patients across the nation. The company has a state-of-the-art R&D center in Pune. It is a leading global player in the field of Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (ACR-inhibitors and cholesterol-reducing agents). Additionally, it has a notable presence in the areas of diabetes, anti-inflammatory and respiratory therapy.
Challenges
The Existing Particle Size Distribution (PSD) system that the client used wasn’t giving satisfactory results as it was failing to separate agglomerations leading to incorrect information often.
The client had already invested in a microscope and hence was reluctant to try any other solutions. Besides the PSD software not being 21CFRpart11 compliant, the client was also facing challenges on the support front.
Solutions
The ImageProVision experts worked in collaboration with the client and studied extensively their configuration of the existing microscope and suggested they mount an adapter and a digital camera over their existing microscope. Then, they recommended the implementation of their flagship product i.e. Particle Size Analyser and Classifier (ipvPClass) by adding extra features focused on addressing every need of the client.
The ipvPClass isolated the particles and separated the agglomerations. Additionally, new particle algorithms were developed and specific user inputs with manual options were also provided. The IPV experts offered highly customized reports that helped them make informed decisions and save time. With ipvPClass at their disposal, the client was able to make giant strides in terms of progress.
Benefits
→ Tremendous savings on development time and drastic reduction of costs in R&D
→ A new 21 CFR compliant software integrated seamlessly with the new systems
→ Samples for particle classification could be analysed with great ease and in lesser time
→ Identification and Classification of different APIs in mixture delivered a massive advantage to the R&D professionals
→ Bespoke customization provided additional statistics to improve the process by focussed corrections
→ One-on-one training with the client’s researchers and analysts helped them build new skills and learn new things
→ Leveraging the existing microscope setup and ensuring interoperability with the new ipvPClass implementation helped the client to save huge amounts of time and money
→ Online support and frequent on-site visits ensured smooth execution. The negligible downtime helped provide a rich and seamless customer experience