Quality management is an increasingly important focus for biopharmaceutical manufacturers looking to avoid production problems and failures. And it’s increasingly becoming a multifaceted, industrywide concern as regulators take a closer look. With this in mind, it’s useful to see how the industry is approaching quality management in terms of the initiatives being pursued.
While the entire pharmaceutical industry must be aware of combustible dust from API and excipient ingredients, the production of oral solid dosage (OSD) drugs is the most at risk.
Chemical procedures commonly require the introduction of heat. This is typically in the form of a hot plate or open flame. While the best place to perform these types of chemical procedures is inside a chemical fume hood, most people are unaware of heat’s effect on the airflow through the fume hood, and the potential impact on containment. By Luke Savage, LEED Green Associate, Sales Engineer, Labconco Corporation
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 10-20 microsiemens of conductivity, or, it can be used in polishing systems to produce water with a 16-18 megohm resistivity level. By Bob Applequist, Labconco Product Manager
After 15 years of telling customers not to fill their freeze dry flasks to the rim, and not to place their freeze dry flask straight up and down in the freezer, and not to put the lids on their freeze dry flasks during pre-freezing, guess what I did? By Jenny Sprung, Product Manager
By Brian Garrett, LEED Green Associate, Product Manager