Tuesday 19 March 2024

Best practices for pharmaceutical microbial data investigations


 Investigating. Image designed by Tim Sandle

Assessing microbiological data and undertaking investigations into the origins of contamination, establishing root causes, and setting appropriate preventative actions constitutes a core part of the contamination control strategy. Despite the importance of this process, regulatory findings frequently cite poor quality microbial investigations.

 

This article looks at the main steps involved for conducting investigations and provides some best practice advice for the company microbiologist. The goals here are to help to structure investigations that are:

 

  • Simple:            Easy to execute and to understand,
  • Effective:        Producing the correct result.

 

The advice is presented as a series of phases. While the phases represent activity blocks, they should not necessarily be thought of as discrete entities for they can run concurrently or may overlap. This is especially useful in order to complete a detailed and thorough investigation within a reasonable timeframe (as with other investigations undertaken within pharmaceuticals, a target of 30 days is often applied).

 

Sandle, T. (2023): Assessing microbial contamination: Best practices for pharmaceutical microbial data investigations, American Pharmaceutical Review, 26 (3): 20-26: https://www.americanpharmaceuticalreview.com/Featured-Articles/596293-Assessing-Microbial-Contamination-Best-Practices-for-Pharmaceutical-Microbial-Data-Investigations/?cid=26759

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday 18 March 2024

Disinfectant efficacy: Getting the temperature right


 Apart from a few exceptions, disinfection processes are considerably slower at low temperatures than at higher temperatures. This carries consequences for the use of disinfectants, especially in cold rooms where ‘cold-loving’ microbes present a contamination risk. To address this, either concentrations or contact times need to be increased, or an alternative disinfectant agent used. In this article, we take a look at the science.


Read the article for fre online:


Sandle, T. Disinfectant efficacy: Getting the temperature right, RRSL Life Sciences Series, 20th March 2023 at: https://www.rssl.com/insights/life-science-pharmaceuticals/disinfectant-efficacy-getting-the-temperature-right/

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Sunday 17 March 2024

Identifying origin of fungi in cleanrooms


 Image: Tim Sandle

Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms, cold rooms and other controlled areas. Species of filamentous mould include: Cladosporium, Penicillium, Aspergillus, Alternaria, Fusarium, and Paecilomyces).


Read the article free online:


Eckford, C. and Sandle, T.(2023) Identifying origin of fungi in cleanrooms, European Pharmaceutical Review, 22 March 2023: https://www.europeanpharmaceuticalreview.com/news/180833/identifying-origin-of-fungi-in-cleanrooms-fungi-contamination/

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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