Pharmaceutical Microbiology Resources

Pharmaceutical Microbiology offers access to numerous free technical papers covering a wide range of topics in microbiology, pharmaceutical manufacturing, and quality control. The collection is refreshed frequently. Some of these papers are authored by Tim Sandle, while others have been contributed by visitors to the site.

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Articles

Aseptic Process Simulations: A look at the essential features

2 weeks ago | pharmamicroresources.com | Tim Sandle

Aseptic processing (image by Tim Sandle)In terms of sterility assurance, aseptic processing is a more hazardous pharmaceutical process to conduct compared with terminally sterilised products since should microbial contamination occur during dispensing the product, due to its inherent nature, cannot be subjected to a post-filling sterilization process.
AI-Driven Calibration Tools Are Transforming Sterility Assurance

2 weeks ago | pharmamicroresources.com | Tim Sandle

Sensor. Image by Filya1 - Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=6304562New sensor technologies offer greater accuracy than ever when verifying sterility in pharmaceutical environments. However, issues like calibration drift stand in the way of that reliability. Even the most sophisticated monitoring tools can slowly become less precise over time. Calibration is the obvious solution, but it is not a foolproof process, so errors are still possible.
Means, Ranges and Replicates: Improving Microbial Plate Counting

3 weeks ago | pharmamicroresources.com | Tim Sandle

A microbial colony is a visible cluster of microorganisms growing on the surface of or within a solid medium. This may be from a single cell or an amalgam of the same organism of more than one cell or a mix of different organisms. Bioburden levels are commonly measured when conventional methods are deployed in terms of colony-forming units (CFUs).
From Flat to Functional: Recreating Human Microbial Environments with 3D Bioprinting

3 weeks ago | pharmamicroresources.com | Tim Sandle

Image: Bioprinting of 3D Convoluted Renal Proximal Tubules on Perfusable Chips.Source: Homan K, Kolesky D, Skylar-Scott M, Herrmann J, Obuobi H, Moisan A, Lewis J (2016). "Bioprinting of 3D Convoluted Renal Proximal Tubules on Perfusable Chips". Scientific Reports. DOI:10.1038/srep34845Not all microorganisms are harmful. In fact, our body naturally hosts tiny organisms like bacteria, viruses, and fungi that play essential roles in maintaining our health.
How Vaccines Are Shaping the Global Public Health Landscape

1 month ago | pharmamicroresources.com | Tim Sandle

Vaccines have long stood as one of the most powerful tools in the arsenal of public health. From eradicating smallpox to curbing the spread of polio and mitigating the devastating effects of COVID-19, immunizations continue to transform the health trajectories of entire populations. As the 21st century unfolds, vaccines are not only protecting billions from infectious diseases but are also reshaping global healthcare systems, economies, and policy frameworks.
CGMP Requirements For Automated Facility Monitoring Systems

1 month ago | pharmamicroresources.com | Tim Sandle

Monitoring systems (image by Tim Sandle)In pharmaceuticals and healthcare, “facility” refers to the operational space, such as a cleanroom. The critical controls that maintain the facility are delivered through key utilities like air handling systems. To assess facility control, most organizations use facility monitoring systems (FMSs) to monitor the manufacturing workspaces continuously.
Addressing human factors in decontamination

1 month ago | pharmamicroresources.com | Tim Sandle

Ensuring that surgical processing departments are well-run is of great importance, as these departments are responsible for decontaminating reusable surgical equipment and for delivering it, as required, to operating theatres. Decontamination involves several processes, occurring within dedicated facilities, including cleaning, disinfection and sterilisation, which ensures reusable surgical instruments are safe for further use on patients.
Small Steps to Giant Leaps: Advancing Data Integrity in Sterility Testing

1 month ago | pharmamicroresources.com | Tim Sandle

With Sterility Testing serving as the final critical data point for product release to the public, the Pharmaceutical Industry is continually looking to methods which will increase efficiencies and reduce errors. What if there was a software that could work with your existing Steritest® Symbio pump and also allow you to digitally capture every step of the Sterility test?
Pharmaceutical Microbiology

1 month ago | pharmamicroresources.com | Tim Sandle

As the therapeutic landscape grows more complex, so too must the analytical techniques for cleaning validation to ensure the utmost cleanliness is achieved. Within the bio/pharma industry, there is a certain expectation for companies to maintain required levels of cleanliness within their facilities to ensure products that are manufactured are at minimal risk of contamination. All cleaning processes must also be validated for effectiveness and reproducibility.
Pharmaceutical Water and Its Critical Role in Biopharmaceutical Manufacturing

2 months ago | pharmamicroresources.com | Tim Sandle

Pharmaceutical water is a vital component in biopharmaceutical manufacturing, playing a critical role in various processes, from drug formulation to cleaning and sterilization. Water quality directly impacts the safety, efficacy, and consistency of pharmaceutical products. The stringent regulatory standards set by agencies such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and the World Health Organization (WHO) underscore the importance of maintaining high purity levels.