With high potency active pharmaceutical ingredients (HPAPIs) comes a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.
A key focus of this paper is the relevant measurement of surface area, with experimental data demonstrating the performance and value of novel instrumentation for in-situ characterization.
Sticking or picking issues are often not detected until transferring the product from research and development to production. Prevent unanticipated problems during scale up and full-scale production by considering tablet compression issues before tablet designs are finalized.
With proper formulation development and tablet design the tablet press operator should be able to manufacture quality tablets without exceeding the tooling’s maximum compression force rating.
A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of Quality by Design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.
A client was in need of a containment enclosure for an analytical weighing and solution-preparation operation involving Highly Potent Active Pharmaceutical Ingredients (HPAPI) in powder form. Their goal was to transfer product from an enclosure to another enclosure. read how Flow Sciences used a recently developed containment device and augmented to fit the specific needs of the client.
This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.
Fareva offers a one stop shop opportunity for your oral solid dosage, high potent OSD, and sterile injectable needs.
AIM™ Pro Plus Control System Makes Tablet Production Easy
The Natoli AIM™ Pro Plus control system is a flexible software and hardware architecture that is standard on Natoli production tablet presses. This industry-leading package can be retrofitted to almost any production tablet press to increase production, improve tablet consistency, and provide an easier-to-manage production environment.
Natoli Engineering’s NP-P20A single-station hydraulic tablet press is a favorite for the production of injectable micropellets and for marginal formulations requiring deep-fill. The NP-P20A meets the FDA’s requirements for batch reporting and secure data management under CFR 21 Part 11 compliance.
When Time-Reduction, Cost-Savings, Quality And Reliability Matter, Ropack Pharma Solutions Is The Distribution Partner Positioned To Deliver.
Used 24" Thomas Accela Cota coating pan, model 24-III, stainless steel construction, top vented, serial# 24-320.
One (1) used Vectro granulator, mdoel CF360EX, stainless steel construction, 3-5 kg capacity, xp design with controls, 220 volt, serial# CF-110, new 1982.
Used Vector Hi-Coater coating pan, model VHC-1355, stainless steel construction, with 24" and 30" perforated pans, with spray guns, 460 volt, serial# HCT-392 45938, built 2007.
