07.22.14 -- Pfizer To Buy InnoPharma, Acquires Injectables Portfolio
PMMI has joined forces with ISPE to introduce Pharma EXPO 2014. Making its debut in November 2014, Pharma EXPO will bring together as many as 10,000 pharmaceutical, biopharmaceutical, and medical device manufacturers for conference sessions and a bustling exhibit floor. Co-locating with PACK EXPO International, Pharma EXPO answers the demand for a show focused on solutions for the entire pharmaceutical and biopharmaceutical life cycle. Learn more.
By Oliver Stauffer, VP/COO, PTI Packaging Technologies & Inspection
Package testing and container closure integrity are cornerstones for quality. Now, more than ever, innovative package designs are being used to differentiate and simplify pharmaceutical product delivery and end use. When defining package quality for your specific application there are two questions to answer.
By Michael Gotz, QuickSTAT
In the previous blog post, "Infectious Biologicals Category A and B — Classification Guidelines," I provided definitions of Infectious Biologicals Category A and B and some basic guidelines on how to classify your shipments. These definitions are clear and helpful when you know that your shipment contains pathogens. In that case, it is either on the list for Category A, or if it is not, then it is classified as Category B.
By Paul Daniel and Piritta Maunu, Vaisala, Inc.
Our aim with this article is to explore the latest revision of Chapter <1079> from the U.S. Pharmacopeial Convention (USP) and to address questions that Vaisala, as a creator of systems used in cold chain applications, receives from customers and contacts who manage temperature-controlled supply chains.
By Andres Lobeiras, Beckman Coulter, Inc
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as the electrical sensing zone (ESZ) technique. The ISO International Standard 13319 describes this technique.
By Milton Boyer, president, OSO Biopharmaceutical Manufacturing
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization.
By Andrea Simonetti, TASI Group: Bonfiglioli Engineering and Sepha
This article provides the overview of the process analytical technology (PAT) methodology application to an automated equipment developed for 100 percent container closure integrity testing (CCIT) of pharmaceutical items.