PDA Journal of Pharmaceutical Science and Technology

PDA Journal of Pharmaceutical Science and Technology
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Abstract Contamination with foreign particulate matter continues to be a leading cause of parenteral drug recalls, despite extensive control and inspection during manufacturing. Glass is a significant source of particulate matter contamination; however, the mechanism, source, and quantification have not been extensively analyzed. Quantification of...

Abstract A new major chapter dealing with container closure integrity (CCI) was released by the United States Pharmacopeial Convention (USP). Chapter <1207> provides a significant amount of education and guidance concerning test methodologies to prove that a system is integral and safe for use. The test method used is only one of the major...

Abstract Microbial quality control of non-sterile drug products is a concern to regulatory agencies and the pharmaceutical industry since the 1960's. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related...

Abstract The development of mass spectrometry-based leak detection for pharmaceutical container integrity was undertaken to provide an alternative to microbial challenge testing. Standard 10-mL vials were modified to contain pinholes (0.5 to 10 microns) by affixing micropipettes with epoxy into 2-mm vial side wall holes. The absolute leak rate was...

Background During the commercial manufacturing phase of the product lifecycle, specific elements of the PQS are used to identify and manage PACs. Per ICH Q10, these include management responsibilities, the four quality system elements—process performance and product quality monitoring (PPPQM), corrective and preventive action (CAPA), change...

As Congress currently struggles with legislation around Obamacare, I had the privilege of speaking with John Sculley, legendary marketing genius and former CEO of Pepsi and Apple. “The healthcare industry is the only technology-driven industry where we spend more each year and get less for our money. I intend to do something about it.” With those...

Abstract We propose a new index and graphical display for quantifying and visualizing process performance in the pharmaceutical industry. These tools can provide management a comprehensive, high level overview of the process performance of a global manufacturing network suitable for risk ranking, by which is meant: identifying those processes at...

Abstract The interior surface of prefilled syringes is typically coated with silicone oil for lubrication to aid in free plunger movement. This article discusses the impact and interaction of formulation variables with silicone oil within the interior surface of the barrel. Characterization techniques including syringe glide force, break loose...

Abstract The development of protein therapeutics requires stabilization of these labile molecules during shipment and storage. Biologics, particularly monoclonal antibodies, are frequently packaged at high concentration in prefillable syringes traditionally made of glass. However, some biologics are unstable in glass due to sensitivity to silicone...

Abstract Marketed drugs and devices possess specifications including critical microbiological quality attributes purposed to assure efficacy and patient safety. These attributes are legislated requirements intended to protect the recipient patient. Sampling, microbiological testing, interpretation of data for final products, raw materials and...