Saturday, 23 September 2023

Pharmig disinfectant guide updated


 

The Pharmig guide to disinfectants has been completely revised and re-written to provide a roadmap to regulatory compliance for cleaning and disinfection.

 

The new text will walk the user through the steps needed to design, validate, and implement an effective cleaning and disinfection programme. Including:

 

  • Identifying and assessing risks associated with cleaning and disinfection
  • User requirements for cleaning agents and disinfectants
  • Supplier qualification
  • Disinfectant efficacy testing and validation
  • Controls for routine use – including application methods, in-coming QC testing, and periodic review of the programme

 

The reference is:

 

Kirkham, R., Guardi, L., Moorwood, K. and Sandle, T. (2022) A guide to cleaning and disinfection of pharmaceutical facilities – a road map to regulatory compliance, Pharmig, Stanstead Abbotts, UK

 

To order see: Pharmig

 

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

Future horizons: Evolutions and revolutions in rapid microbiology


 

Rapid microbial tests should be risk-based so the stakeholder can select the preferred technology for their intended use and balance user requirement specifications including time to result, specificity, limit of detection, sample size, and product attributes. Many rapid methods produce signals not based on a colony forming unit (CFU), and that some non-CFU based rapid methods may detect and quantify viable cells that may not be effectively detected using conventional methods, media or incubation parameters. Data integrity remains an important consideration for rapid microbiological methods and not all technologies have been developed with the more exacting requirements of pharmaceuticals in mind. To have integrity, data must be attributable, legible (permanent), contemporaneous, original and accurate, principles known as ALCOA.

 

These standards apply whether a laboratory is using a conventional or rapid microbiological method. This review article assesses some recent developments with rapid microbiology… some of the technologies presented may feature in the pharmaceutical microbiology laboratory of tomorrow.

 

Sandle, T. (2022) Future horizons: Evolutions and revolutions in rapid microbiology, Pharming News, Issue 89, pp8-10

 

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

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