Newsletter | July 22, 2014

07.22.14 -- Pfizer To Buy InnoPharma, Acquires Injectables Portfolio

Pharmaceutical Online Newsletter
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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.
» Featured Content
Mitigate Risk With Package Quality
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.
Featured Focus: Packaging
Dangerous Goods Classification Confusion: UN 3373 Biological Substance, Category B
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.
APPLICATION NOTE: Destructive Testing: Does Your Hard Tablet Measure Up?
CASE STUDY: 100% Container Closure Inspection Of Freeze-Dried Drug Product In Quarantine
BROCHURE: Bosch KKX 3900 Universal Capsule Inspection System
BROCHURE: SorbiCap Sorbent Canisters
» Logistics
WHITE PAPER: Staying Current In Cold Chain Management
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.
DATASHEET: Via Prequalified Universal Insulated Shipper
By Sonoco ThermoSafe
BROCHURE: AT&T M2M Business Solutions
» Critical Environments
APPLICATION NOTE: Determination Of Cell Aggregation In Bacteria Cultures With An Automatic And Reliable Method
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.
DATASHEET: Alcotabs: Critical-Cleaning Detergent Tablets
By Alconox, Inc.
BROCHURE: Rotating Load Sterilizers
» QA/QC
The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
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.
BROCHURE: How Efficient Are Your Document Management Processes?
PRODUCT: Pharmaceutical Microbial Detection Systems
» Inspection
ARTICLE: A Process Analytical Technology (PAT) Approach To Automated Container Closure Integrity Testing (CCIT)
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.
PRODUCT: Pharmaceutical Yield Test Rheometer
PRODUCT: Facility Monitoring Software
» Manufacturing
WHITE PAPER: DEA Imposes Extra Layer Of Regulations On Manufacturers Of FDA-Approved Prescription Drugs To Alleviate Pain
BROCHURE: Steris Point Of Use Pharmaceutical Pure Steam Generator Brochure
PRODUCT: Process Control Systems
UPCOMING TRAINING

Building An Effective GMP Training System: A Risk-Based Approach
Date: Wednesday, July 30, 2014 • Time: 1:00 pm to 2:30 pm EST
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