Upon meeting the requirements for the initiation of exhibit batches, the Quality Assurance (QA) department shall grant approval to proceed with the execution of the exhibit batch. The execution of exhibit batches will take place, and samples will be collected at various stages of manufacturing and packing, as outlined in the protocol. Any non-conformances identified … Read more
The process of developing new products varies significantly across different industries, and there is no universal or standardized procedure that can be applied to all sectors and organizations. Drawing from the comprehensive literature on the phases involved in the new product development process (Booz et al. (1969), Cooper (1979), Rosenthal (1992)), the new product development … Read more
Technical awareness of a new product involves understanding its key features, functionalities, design, technology stack, and potential applications. It also includes knowing how the product integrates with existing systems, its performance benchmarks, and any technical challenges or innovations involved To ensure the timely facilitation and planning of the product launch, it is essential to prepare … Read more
Typically, it is anticipated that process validation should be finalized before the distribution of a finished product intended for sale (prospective validation). In cases where this is not feasible, it may be essential to validate processes during regular production (concurrent validation). Additionally, processes that have been operational for a considerable duration without any major modifications … Read more
Tablet compression machines are designed with consideration for the types of dies and punches that will be utilized on them. The arrangement of dies and punches on a compression machine is referred to as tooling, which is primarily classified into B and D categories. The B tooling dies and punches can further be specified as … Read more
PAN COATING OVERVIEW Functions of the parts Inlet & Outlet System of a Pan Coater Inlet of the Pan Outlet of the Pan FLUID BED COATING (WURSTER COATING) FBC is a technique for coating pellets, spheres, particles or granules using a spray of solution inside a column. The spray nozzle is installed in the base … Read more
Most coating processes typically utilize one of the general coating systems, such as the standard coating pan, perforated coating pan, and fluidized bed coater. A notable advancement in the efficacy of standard coating pan systems has been marked by the introduction of the Pelligrini pan, immersion sword, and immersion tube systems, where coating solutions are … Read more
Following are the critical parameters in Coating operation Gun Geometry and Calibration Gun geometry and Calibration refers to the position of spray guns which includes ‘Gun Calibration’, ‘Gun to bed distance’, ‘Gun to gun distance’, ‘Gun to side of pan’, ‘choked guns’ and ‘anti bearing technology’. Gun to bed distance: Gun to Bed Height: Gun … Read more
Cryopelletization is a technique in which droplets of a liquid formulation are transformed into solid spherical particles or pellets through the use of liquid nitrogen as the fixing medium. This technology, originally developed for the lyophilization of viscous bacterial suspensions, is capable of producing drug-loaded pellets in liquid nitrogen at -1600C. The process allows for … Read more
Melt Spheronization is a technique in which a drug substance along with excipients is transformed into a molten or semi-molten state, and then shaped using suitable equipment to create solid spheres or pellets. Initially, the drug substance is mixed with the relevant pharmaceutical excipients, including polymers and waxes, and then extruded at a specific pharmaceutical … Read more
