July 10th 2025
The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.
Innovations in Pharmaceutical Packaging - Smart Blister Packs
January 1st 2003Packaging technology is moving into the 21st century with innovative and cost-effective developments, including sound, moving images and even tracking devices. What was once deemed science fiction is rapidly becoming science fact. This article explores the latest developments in blister pack technology, discussing the range of benefits to both pharmaceutical manufacturers and patients.
Selecting the Right Ultrafiltration Membrane for Biopharmaceutical Applications
December 1st 2002Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.
IMS Limit Test Improves Cleaning Verification and Method Development
October 1st 2002A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
The Usefulness of 0.45 µm–Rated Filter Membranes
April 1st 2002In this study, the authors examine the suitability of 0.45 µm–rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.
Developing Custom Adhesive Systems for Transdermal Drug Delivery
March 1st 2002Adhesives manufacturers can be involved in the development of transdermal drug delivery products by working with pharmaceutical companies on R&D, materials qualification, manufacturing, and other product development tasks.
Microbial Bioburden on Oral Solid Dosage Forms
February 1st 2002Low levels of some microorganisms that are present in oral solid dosage forms are unlikely to present a risk to patients. The amount of water activity in these products can help determine when microbiological testing should be conducted.