NIBSC experts will be discussing how control materials are relevant

Join us and @IBMScience at our upcoming webinar where NIBSC experts will be discussing how control materials are relevant. Book now: https://t.co/GJKm6FqYdm pic.twitter.com/BNCozPkSfu

— NIBSC_MHRA (@NIBSC_MHRA) October 29, 2018

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Advanced Technologies are Tackling the Global Lyme Epidemic

More than 300,000 new cases of Lyme disease, the most common tick-borne illness in the United States, are diagnosed each year. In a new interview with CMRubinWorld, Dr. Brian Fallon, Director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center reveals that despite the challenges to find a cure for this complex, debilitating disease, precision medicine and biotechnology are accelerating the discovery of new tools with which doctors will be able to diagnose it and treat patients.

In an authoritative new book, Columbia University Medical Center physicians Brian Fallon and Jennifer Sotsky explain why there is much cause for optimism. “Through rapid genetic sequencing, scientists can identify many different strains of Borrelia burgdorferi (causative agent of Lyme disease) as well as new tick-borne microbial infections, such as Borrelia miyamotoi, Borrelia mayonii, and the Heartland virus,” says Fallon. The discovery of these new microbes inside ticks has significantly helped researchers since it “provides a starting point for the study of pathogenesis, vaccine development, and treatment.” Fallon notes that researchers have also been able to screen thousands of drugs to determine which have the ability to destroy Borrelia.

Read the full article here

Brian Fallon, MD, MPH is the Director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center and the author with Jennifer Sotsky of Conquering Lyme Disease: Science Bridges the Great Divide, published in 2018 by Columbia University Press.

CMRubinWorld’s award-winning series, The Global Search for Education, brings together distinguished thought leaders in education and innovation from around the world to explore the key learning issues faced by most nations. The series has become a highly visible platform for global discourse on 21st century learning, offering a diverse range of innovative ideas which are presented by the series founder, C. M. Rubin, together with the world’s leading thinkers.

For more information on CMRubinWorld

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Importance of Microbial Contamination Control

Tim Sandle has written an editorial of the special edition of the Journal of GxP Compliance, dedicated to pharmaceutical microbiology.

This special edition captures some of the current themes and issues relating to pharmaceutical microbiology and contamination control, and many of the points required to develop a control strategy.

The importance of microbiological control in relation to the manufacture of pharmaceutical and healthcare products is the theme of this special compilation for IVT Network. The articles selected highlight the twin themes of maintaining control through the assessment of risk and the use of sound, scientific methods to assess risk. This latter area includes the use of rapid and alternative methods.

While microbiology plays a role in drug development, through the application of biotechnology (including the development of anti-infective agents and with the manufacture of pharmaceutical products), a considerable part of the role of the pharmaceutical microbiologist is with protecting pharmaceutical and healthcare products from spoilage by microorganisms and thus protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.

The reference is:

Sandle, T. (2018) Editorial: Importance of Microbial Contamination Control, SPECIAL EDITION: Essential Microbiology for GXP Compliance: 3-6 - http://www.ivtnetwork.com/article/essential-microbiology-gxp-compliance 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Disinfectant Efficacy Testing for Fungi on Non-Porous Surfaces: A Case Study

An important aspect of the selection and evaluation of disinfectants is the disinfectant qualification programme. After a disinfectant has been chosen based on its chemical properties and expected performance/effectiveness, each disinfectant should be assessed to ensure its efficacy (and for European Medicines Inspectorate and U. S. FDA regulated premises this is mandatory). Efficacy is demonstrated through performance testing to show that the disinfectant is capable of reducing the microbial bioburden in either suspension (planktonic state) or from cleanroom surfaces to an acceptable level. The disinfectant efficacy validation should provide documented evidence that the disinfectant demonstrates bactericidal, fungicidal, and/or sporicidal activity necessary to control microbial contamination in the facility. This chapter summarises the test requirements and the different standards that are currently available.

A new paper of interest:

Regulatory agencies expected the users of disinfectants within cleanrooms to evaluate the efficacy of disinfectants. Various standards are available to guide the microbiologist through this process. What is more difficult is the content of some of the standards themselves because they have not been written specifically for the healthcare sector or the pharmaceutical industry (more typically they have evolved from the food, cosmetics or environmental control sectors). It may be necessary for the microbiologist to adapt the standards to suit practical situations (backing this up with a well-thought out rationale). Another point to be considered before embarking on such validation is whether all of the standards are to be replicated or whether experimental work required by some of the standards can be provided by the manufacturer of the disinfectants.

Given that most regulators and microbiologists regard the surface test as the most meaningful of the laboratory methods, this paper addresses this test. This paper outlines and approach taking for the assessment of a disinfectant to kill fungi on a surface. Of the different disinfectant efficacy studies, surface studies are generally regarded as the most challenging and representative of actual cleanroom conditions. For this, one organism is used as an example – the fungus Cladosporium, which as presented here was an environmental isolate from a pharmaceutical cleanroom. Cladosporium is one of the most commonly detected fungi from the as-built environment.

Surface tests, however, are not straightforward. The approach presented here is based on European surface test requirements; while other approaches differ slightly, the overall methodologies are similar. Hence the approach here can be used as a case study for others to evaluate against.

The reference is:

Sandle, T. (2018) Disinfectant Efficacy Testing for Fungi on Non-Porous Surfaces: A Case Study, Journal of GxP Compliance, 22 (4): 1-12

For details see: Disinfection

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Webinar: In Vitro Pyrogen Detection, the new trend

Want to know more about in vitro Pyrogen detection? Find out about our new Monocyte Activation Test ready-to-use kit. Discover the benefits of the PyroMAT™ System, learn how to use it and go through a real-life case study.

The PyroMAT™ system is the only cell-line based Monocyte Activation Test (MAT) provided as a ready-to-use kit on the market: a new solution for sensitive, robust, and easy-to-perform pyrogen test

Make the move to the monocyte activation test—the only method that detects the full range of endotoxin and non-endotoxin pyrogens and contributes to the reduction of animal consumption for testing purposes.

Want to know more about our solutions? Join our live webinar on October the 25^th and find out more about the new PyroMAT™ System. Register now

Pharmaceutical Microbiology Resources

Webinar: Best Practices for Cleaning and Disinfection of Cleanrooms and Disinfection Validation

Cleaning and disinfection of cleanrooms is of great importance as part of a contamination control strategy. For this to be effective, correct disinfectants need to be selected, rotation between biocides must in place, a sporicidal agent needs to be selected, disinfectants need to be qualified cleaning frequencies need to be established, and appropriate training given. This is hampered by the lack of a global approach to satisfy regulatory agencies. This webinar provides an overview of the focal points required to achieve a global approach for cleanroom disinfection.

Webinar details:

Date: Thursday, 18 October 2018 | Time: 10:00 AM PDT, 01:00 PM EDT | Duration: 60 Minutes

Presenter: Dr. Tim Sandle, see: https://www.onlinecompliancepanel.com/webinar/Global-Best-Practices-for-Cleaning-and-Disinfection-of-Cleanrooms-and-Disinfection-Validation-505381

Points covered:

• What is cleaning and disinfection?
• How to select disinfectants?
• Global guidelines for disinfection in cleanrooms
• EU GMP (& draft Annex 1), USP <1072>, FDA aseptic processing guidance, PIC/S
• How to use disinfectants effectively
• Points for success
• Approaching disinfectant validation: Differences between European and U.S. standards
• Practical approach to disinfectant validation: what is best for pharma?Legal requirements for disinfectants: Europe and U.S.

For further information see: Online Compliance Panel

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

PyroMAT™ System: Have you heard about the latest solutions for pyrogen detection?

PyroMAT™ System: Have you heard about the latest solutions for pyrogen detection?

The PyroMAT™ system is the only cell-line based Monocyte Activation Test (MAT) provided as a ready-to-use kit on the market: a new solution for sensitive, robust, and easy-to-perform pyrogen test

Make the move to the monocyte activation test—the only method that detects the full range of endotoxin and non-endotoxin pyrogens and contributes to the reduction of animal consumption for testing purposes.

Want to know more about our solutions? Join our live webinar on October the 25^th and find out more about the new PyroMAT™ System.

Register today