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A 3-Minute Introduction To Rapid Sterility Testing

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph.Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. A typical sterility test has 14 full days of incubation and uses analyst observations to generate results, whereas a rapid sterility test is reduced to just five days of incubation – a 64% reduction in processing time. Rapid sterility also incorporates more sophisticated, computer-generated results, which eliminate observation bias. Alcami utilizes the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Topics: Thought Leadership Analytical Testing Microbiology Rapid Sterility

ON-DEMAND WEBINAR: The Importance of Microbial In-Use Studies

A microbial in-use (admixture) study is performed to evaluate the growth of low-level microorganisms inoculated into the diluted drug product and tested at several time points over the prescribed administration time. These studies are performed to determine if microbial growth will be supported and/or proliferate in the product during the holding period prior to patient administration in the event of inadvertent microbial contamination during product dilution. It is important to understand and comply with the timelines and deadlines surrounding these microbiological procedures. 

In this webinar, Alcami’s admixture studies expert, Brent Harlow, will guide you through the necessity of these studies and how to successfully perform them for FDA approval. 

Topics: Webinars Microbiology

The Top 8 Most Asked Questions about Microbial In-Use Studies

According to Dr. John Metcalfe, “pharmaceutical companies go to great lengths to manufacture a drug product which is sterile, whether by terminal sterilization or aseptic processing. Equally important to the microbiological quality of the product at the time of product release is its microbiological quality at the time of patient administration.” This Q & A featuring microbial in-use studies with microbiological expert, Brent Harlow, will address the most common questions asked about these studies.

Topics: Analytical Testing Microbiology

Filter Validation – An Interview with Stacey Ramsey

Joining Alcami in 2015, Stacey Ramsey, a senior scientist specialized in microbiology, is a scientific expert on microbial retention. Ramsey’s work focuses on the clinical stages of a drug product which compliments her experience in process development and method development in microbiology. Being part of the development process goes beyond running tests on lab samples, which allows Ramsey to showcase her passion while being a fundamental member of the Alcami development process team.

How would you explain filter validation to someone outside of the pharmaceutical world?
From a big picture perspective, filter validation is filtering out microorganisms from a lab sample. In other words, it’s when you have a drug product that it is sterilized by means of a filter. In order to be able to filter out microorganisms, the filter has to have such small pores that it excludes bacteria and, therefore, you’re filtering out bacteria.

Topics: Thought Leadership Analytical Testing Filter Validation Microbiology