By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Any good quality manager knows that assumptions about an instrument can lead to unpleasant surprises during the calibration cycle. Test and measurement equipment play a critical role in most production and development processes. These instruments are used to make decisions regarding the effectiveness of processes and to ensure product quality.
By Matt Hicks, COO, Federal Equipment Company
The loss of a patent for a branded drug product leads to opportunities for generic-biopharmaceutical manufacturers. Once a blockbuster drug reaches the end of its branded life cycle, generic manufacturers will gear up to produce lower-margin "copies."
By Kevin Ward, Biopharma Technology Limited
Probiotic bacteria have long been used in probiotic yogurt drinks or provided in tablet form. People have often taken these 'friendly' bacteria to help boost their own systems’ internal flora and fauna; friendly bacteria can help protect our immune system and aid digestion. Bacteria have been known to survive a variety of conditions; however, storage in yogurt drinks or tablet form is often not enough.
By Robert Rosen, Filamatic
There are a few questions to ask yourself when determining which liquid filling machine is right for your project. As each machine is unique in its filling techniques and performance abilities, certain questions that are asked will help to narrow down the choices and to select a machine that will best suit your application.
By Bob Applequist, Labconco Product Manager
Water purity supplied to a laboratory glassware washer for rinsing has been the subject of debate in regards to the end result of producing clean glassware. It should be noted that the term "deionized water" does not reference any specific water purity level. The deionization of water produces water within a wide range of purity levels. The deionization process can be used to make medium-grade water at 10 to 20 microsiemens of conductivity, or, it can be used in polishing systems to produce water with a 16 to 18 megohm resistivity level.
By Christof Kundel, Segment Manager Water Treatment, Bürkert Fluid Control Systems
Reverse osmosis systems play a central part in water treatment. In industrial applications, for example, reverse osmosis is used for purifying process water, producing drinking water, and desalinizing seawater as well as for producing ultra pure or pharmaceutical water. In addition to these processes that aim at reducing the concentration of the substances dissolved in the water, the beverage industry also uses reverse osmosis systems for increasing concentrations, e.g. in the manufacture of fruit juice concentrates or for concentrating the must in wine production.
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
"Please tell me how to map this chamber!" This is a plea we hear at every Vaisala Good Manufacturing Practice seminar. The question deals with environmentally-controlled chambers, everything from small refrigerators or freezers to walk-in chambers, or even large warehouses regulated under cGMP guidelines. Attendees who ask the question are usually interested in how to map a chamber for maximum reliability or effectiveness, as opposed to meeting the U.S. Food and Drug Administration (FDA) regulations.
By Michael Gotz, Director of Dangerous Goods Quick Group of Companies
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 Andre Petric, President, Kraemer USA
There are a number of things to consider when integrating a deduster into your manufacturing line. Before contacting a supplier, be sure to assess your needs by gathering the following four pieces of data.
By David A. Loy, Senior Director of Quality and Regulatory Affairs, Aphena Pharma Solutions
With every recurrence of confirmed counterfeit drug product in the pharmaceutical supply chain, the pressure increases to establish a national standard for pharmaceutical track-and-trace solutions. Although a universal standard has yet to emerge, there is one set of requirements that is currently driving action: the California Board of Pharmacy's ePedigree.