Introduction
The client is a progressive contract development & manufacturing organization dedicated to topical semi sold formulations located in Mumbai, India. They have the largest single-site facility dedicated to topical formulations in the Asia Pacific region.
Challenges
The measurement of particle size distributions and the requisite knowledge of how they influence the products and processes is pivotal to the manufacturing business. The client was in constant search of o high-quality customizable solution to achieve not only accurate but quick results for particle size analysis in their R&D and Production facilities.
The client’s aggressive timeline was closing in for the introduction of their new drug. They employed Laser Diffraction Technology, but it didn’t prove to be useful as getting accurate results in the gel was difficult. The results from Laser Diffraction were varying batch-to-batch and the results were not verifiable.
Another challenge was the inconsistency of results at R&D and the production stages. In addition, there was virtually no support from the existing software vendor, thus delaying the development work.
Solution
The IPV experts analysed the situation and worked very closely with the client to develop a completely new methodology to identify the particle sizes. IPV’s Particle Size Analyser and Classifier (ipvPClass) with Z-Stack management were used to provide dynamic visualizations which uniquely enabled the identification of particles at different focal lengths.
Besides enabling the separation of isolated particles and agglomerations, the Z-stack method also helped devise new particle classification algorithms. Import/export options were developed to avoid any kind of duplication of parameter settings at the R&D and production stages. ImageProVision, in alignment with the client requirements, developed customizable reports and provided continuous online support and on-site visits to both the facilities.
Benefits
→ Rapid analysis of new drug sample loading to increase productivity
→ Simplification of day-to-day batch clearance reports
→ Improved Accuracy
→ Standardisation of method and parameters in the R&D and production stages
→ Additional statistics to improve processes by focussed corrections
→ Efficiently saving time and money helped rapidly advance the drug development project
→ Incessant online support assisted with frequent on-site presence ensured a smooth and quick execution ensuring negligible downtime
→ Extremely easy to use software enabled quick training of researchers and analysts