Friday, 31 December 2021

Happy New (microbial) Year!








Thank you for supporting Pharmaceutical Microbiology Resources over the past year!

 

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

Saturday, 25 December 2021

Medical facemask research: Lessons for the cleanroom manager


 

No face mask is 100% effective. Masks are a trade-off between bacterial and particle efficiency and user comfort, with a 97.5% bacterial filter efficiency the typical rating. Achieving this is dependent upon the mask integrity and worn correctly. This paper covers cleanroom contamination control, more recent research within the medical field has been completed and this can be applied to the pharmaceutical sector.

 

One reason for the lack of information pertaining to face mask release in terms of droplets as well as the combination of factors that influence the duration of face mask wearing in the cleanroom context is because most of the research has been in the medical field.

 

Sandle, T. (2021) Face Mask Controls and Duration of Wearing: What Medical Research Can Teach the Cleanroom Manager, Journal of GxP Compliance, 25 (3): https://www.ivtnetwork.com/article/face-mask-controls-and-duration-wearing-what-medical-research-can-teach-cleanroom-manager     DOI: 10.1080/21506590.25352021TS-FMCDW

 

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

Friday, 24 December 2021

Happy Microbial Holidays!



Thank you for supporting Pharmaceutical Microbiology on LinkedIn and the Pharmaceutical Microbiology Resources webpage - Happy Micro Holidays!

Regards,

Tim Sandle

 

 

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

Monday, 20 December 2021

Are You Approaching LIMS Validation Correctly?



Two LIMS related articles of interest:

 Laboratory information management systems (LIMS) are an established part of larger laboratories. While all LIMS are based on the application of information to improve laboratory productivity, efficiency, and compliance, different systems vary in their scale, functionality, and quality. It is important that systems are appropriately validated, for it does not matter how good a system is if the validation is not conducted to an applicable standard. For example, errors can occur in terms of tracking data associated with samples, or acceptance criteria may be attributed to the wrong sample.

This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.

Read Tim Sandle’s new article on LIMS validation here:

Sandle, T. (2021) Are You Approaching LIMS Validation Correctly?, Pharmaceutical Online, at: https://www.pharmaceuticalonline.com/doc/are-you-approaching-lims-validation-correctly-0001

Also see:

Laboratory information management systems (LIMS), as well as providing workstream value within the laboratory, are inevitably the subject of regulatory focus and audit. This is due to the criticality of the data and the pivotal role LIMS play in the batch release process.

 

An audit of a LIMS is an examination of the procedures used in a computer system to evaluate their effectiveness and correctness and to recommend improvements. The scope of an audit will vary, and audits of LIMS are often wider for new systems than with established systems that have been subject to multiple audits. In addition, since LIMS will generate data used for batch release, issues relating to the data integrity of batch records will be arguably of greatest concern.

 

 

This is the subject of a new article from Tim Sandle.

 

This article considers what to audit and how to audit a LIMS, presenting a framework that will be useful to those planning to undertake a LIMS audit and for laboratory managers who need to prepare for such an audit.

 

The reference is:

 

Sandle, T. (2021) A LIMS Audit Framework: What To Audit & How To Prepare, Outsourced Pharma, at: https://www.outsourcedpharma.com/doc/a-lims-audit-framework-what-to-audit-how-to-prepare-0001

 

Also published on Pharmaceutical Online: https://www.pharmaceuticalonline.com/doc/a-lims-audit-framework-what-to-audit-how-to-prepare-0001

 

Also published on BioProcess Online: https://www.bioprocessonline.com/doc/a-lims-audit-framework-what-to-audit-how-to-prepare-0001

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

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