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Linda Skowronsky

 

Figure 2 Range of growth at water activity (aw) and relative humidity (%ERH) for various classes of microorganisms
Figure 2 Range of growth at water activity (aw) and relative humidity (%ERH) for various classes of microorganisms
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Inhibition of microbial growth in solid dosages at ICH stability storage conditions

Several intrinsic and extrinsic factors influence microbial growth. Two important…

31 August 2011 | By Linda Skowronsky, Senior Microbiologist, GlaxoSmithKline

Several intrinsic and extrinsic factors influence microbial growth. Two important factors include the presence of available moisture and a supportive temperature. The conditions described in ICH Topic Q1A (R2)1 do not allow the organisms of interest in pharmaceutical solids to grow, due to either an unfavourable temperature or humidity. For…

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Microbiological quality for non-sterile drug product for the 21st century

For decades microbiological quality has remain dormant while the pharmaceutical…

22 February 2010 | By

For decades microbiological quality has remain dormant while the pharmaceutical industry has continued to evolve. Compendial methods and limits, while now generally harmonised throughout the world, still reflect the same methods utilised 100 years ago. Although there is more clarification around the number and types of organisms permitted in products…

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A practical approach to microbial testing to support non-sterile product stability

During stability, product testing is performed to ensure the product…

3 December 2008 | By

During stability, product testing is performed to ensure the product will continue to meet specified criteria of quality and strength through its expiration or shelf-life at the temperature and humidity required by specific markets. This article will not address the other stability requirement of continued efficacy during consumer use which…