10.03.13 -- Making Peace With Plastic Packaging: Fear Of The Unknown In Pharma
This Isn't Your Daddy’s Documentum
Twenty years after the launch of Atari, IT provider EMC debuted Documentum in 1992. Documentum has certainly faced challenges from competitors in the last 21 years, but has kept an eye on the needs of its market in an effort to remain on top. If Atari is a good example of how not to manage a dominant product, Documentum might be an example of how to properly evolve it. Learn more.
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
While there are plenty of advantages of using plastic packaging instead of glass, some pharmaceutical manufacturers still won't consider it for liquid pharmaceuticals because of the long history and tradition of using glass. However, is this because it's not a good choice for pharmaceutical packaging, or is it because we just don't know enough?
By Ewart T. Cole, Dominique Cadé, Hassan Benameur, Capsugel
The encapsulation of liquids and semi-solids provides solutions for convenient delivery through improved oral absorption of poorly water-soluble drugs. In addition, low-dose (content uniformity), highly-potent (containment), low-melting-point drugs; those with a critical stability profile; and those for which a delayed release is required are all candidates for liquid or semi-solid formulations.
By Max Blomberg and Christian Julien, Meissner Filtration Products, Inc.
Integrity testing of single-use systems, such as biocontainer and tubing assemblies used in the processing of biopharmaceutical solutions, continues to emerge as one of the most sought-after means to ensure "integrity" at the point of use.
By Gary Partington, Walker Barrier Systems
Isolators have been around the pharmaceutical industry since the early 1980s, and in the nuclear industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product.
By Michael Gotz, Director of Dangerous Goods Quick Group of Companies, QuickSTAT Transportation of biological substances and infectious materials has become increasingly challenging. Understanding the dangerous goods classification requirements is critical to ensure that your shipments are in compliance with the law.
By Michelle Stevens MOCON, Inc.
Shelf life is the length of time that foods, beverages, pharmaceutical drugs, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption. Permeation greatly influences the shelf life of these products, as the loss or gain of oxygen, water vapor, carbon dioxide, and odors and aromas can rob the product of flavor, color, texture, taste, and nutrition. Oxygen, for example, causes adverse reactions in many foods, for example, potato chips. By measuring the rate at which O2 permeates through the package material, one can begin to determine the shelf life, or amount of time the unopened package will still provide "good" chips.
By Patrick Jackson, Vindon Scientific
Anyone in business in the current economic climate knows that it is a constant struggle. Financial constraints, limitations on capital budget spend, and the ever-increasing need to reduce costs are all adding to the burden of trying to stay in business — and stay competitive. Inevitably, we all share some common challenges.
By Cathy L. Burgess, Donald E. Segal, and Guillermo Cuevas, Alston & Bird LLP
Last month, the FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements." The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the "Owner") and third parties that perform some or all of the manufacturing operations for the product (the "Contracted Facilities"). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements.
By Dr. Dorian Dixon, Nanotechnology and Advanced Materials Institute, University of Ulster
A new white paper by a leading packaging expert from the University of Ulster, Dr. Dorian Dixon, on the integrity of pharmaceutical packaging, has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer, technology-based test equipment.