Monday, 31 May 2021

An Anatomy Of A Contamination Control Strategy For Sterile Manufacturing

 


A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event).

It is recognized that any contamination control strategy represents a cyclical process, designed to prompt the manufacturers to identify and resolve risk, and hence one that requires periodic review and update. While contamination control strategies are foremost discussed in relation to sterile manufacturing, most of the elements are applicable to non-sterile processing as well.

This article, in considering the key features and components, presents an anatomy of a contamination control strategy. This primarily in relation to sterile manufacturing (although there will no doubt be elements of interest to non-sterile manufacturers). The aim is to provide a framework that can be used by pharmaceutical and healthcare organizations for benchmarking purposes.

The reference is:

Sandle, T. (2021) An Anatomy Of A Contamination Control Strategy For Sterile Manufacturing, Journal of GxP Compliance, 25 (2): https://www.ivtnetwork.com/article/anatomy-contamination-control-strategy-sterile-manufacturing

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

Friday, 28 May 2021

Microneedle patch delivers antibiotics locally in the skin


 

MRSA skin infections are often treated with intravenous injection of antibiotics, which can cause significant side effects and promote the development of resistant bacterial strains. To solve these problems, researchers at Karolinska Institutet in Sweden are developing a microneedle patch that delivers antibiotics directly into the affected skin area. New results published in Advanced Materials Technologies show that the microneedle patch effectively reduces MRSA bacteria in the skin.

 

MRSA (methicillin resistant Staphylococcus aureus) skin infections are potentially lethal, especially in patients with compromised immune systems. Vancomycin is one of the main treatments and is given as an intravenous injection. The reason the antibiotic is not given locally is because of its low ability to penetrate the skin. It is not given orally either because of poor absorption through the gut. The problem with systemic administration is that it often results in significant side effects. Moreover, even when relatively high doses are administered, the local concentration of vancomycin in the skin remains low, which may promote the development of antibiotic resistant strains. Thus, there is a clinical need for local delivery of vancomycin to the skin.

 

 

The patch is placed on the skin at the site of infection. The barely visible microneedles are so small that they do not reach the pain receptors, which makes the treatment relatively painless. The microneedles' ability to penetrate the skin was studied in skin tissue from piglets and excised human skin. The results show that the drug was effectively delivered into the skin, and most importantly, significantly reduced the MRSA bacterial population.

 

Microneedles were voted one of the top 10 emerging technologies by World Economic Forum in 2020. They are already in clinical use for administering vaccines and there are many ongoing clinical trials for other uses such as treating diabetes, cancer and neuropathic pain.

 

See:

 

Jill Ziesmer, Poojabahen Tajpara, Nele‐Johanna Hempel, Marcus Ehrström, Keira Melican, Liv Eidsmo, Georgios A. Sotiriou. Vancomycin‐Loaded Microneedle Arrays against Methicillin‐Resistant Staphylococcus Aureus Skin Infections. Advanced Materials Technologies, 2021; 2001307 DOI: 10.1002/admt.202001307

 

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

Thursday, 27 May 2021

COVID-19 wastewater testing proves effective in new study


 

Wastewater testing is an effective way to identify new cases of COVID-19 in nursing homes and other congregate living settings, and it may be particularly useful for preventing outbreaks in college dormitories, a new University of Virginia study finds.

 

The research, a collaboration of UVA's School of Medicine and School of Engineering, was led by UVA Health's Amy Mathers, MD. It offers some of the first clear guidance on the most effective methods to perform testing to detect COVID-19 in wastewater.

 

The researchers evaluated and compared sampling and analysis techniques by testing them within buildings with known numbers of positive cases. They were then able to determine wastewater testing's strengths and limitations as a tool for monitoring COVID-19 in a building population. For example, the technique proved better at detecting initial infections than determining the number of occupants infected or how long they had been infected.

 

One important answer revealed by the research: Wastewater testing can detect even small numbers of asymptomatic cases, something not previously documented.

 

See:

 

Lisa M. Colosi, Katie E. Barry, Shireen M. Kotay, Michael D. Porter, Melinda D. Poulter, Cameron Ratliff, William Simmons, Limor I. Steinberg, D. Derek Wilson, Rena Morse, Paul Zmick, Amy J. Mathers. Development of wastewater pooled surveillance of SARS-CoV-2 from congregate living settings. Applied and Environmental Microbiology, 2021; DOI: 10.1128/AEM.00433-21

 

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

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