9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations
The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.
WHITE PAPERS & CASE STUDIES
Product Development For An Oral Solid Dosage Using Continuous Manufacturing
A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.
Pediatric Dosage Form Considerations For Highly Potent Compounds
The development of pediatric medicine poses numerous challenges to pharmaceutical formulators, particularly products intended for infants and very young children. This white paper describes special considerations for selecting appropriate pediatric dosage forms and the benefits of choosing mini-tablets (e.g., orodispensible) for pediatric formulation, particularly for highly potent compounds.
Extrusion- Spheronization, Engineered For Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of both today’s and tomorrow’s complex OSD therapeutics.
In-Situ, Non-Destructive Surface Area Measurement For The Optimal Application Of Lyophilization
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.
Manufacturer Finds Solution For Transporting HPAPI Product with Containment
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.
Venting Fume Hood Base Cabinets — A Better Way
Frequently, companies have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out.