Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
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The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
Explore the cost comparisons, risk reduction, and increased support that arise when using Sievers Certified Reference TOC Standards.
Optical spectral measurement tools are extremely useful both for in-line measurements in process analytical techniques (PATs) as well as for evaluating the composition of finished substances. Here, CPI’s Lukas Kuerten and Rachel Findlay demonstrate a valuable method for gaining useful information from spectral data.
Here, EPR summarises a review of some of the benefits and disadvantages for spectroscopic techniques used to characterise the structure of therapeutic proteins in solid dosage forms.
In this in-depth focus, learn how to overcome interfering factors when using LAL for endotoxin testing and discover how the implementation of a new scrubs system benefited an aseptic production facility.
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
In our latest issue, features explore the use of nano formulations to improve skin and nail drug delivery, how to take cell and gene therapies from concept to commercialisation and what strategies you can use to overcome interfering factors in LAL bacterial endotoxin testing. Also in this journal, find out…
A new paper reveals how combining flow cytometry with other analytical techniques can provide a wealth of information on bacterial viability and thus enhance sterilisation processes.
A new paper shows thermal imaging (infrared thermography) can detect E. coli and S. aureus bacteria after just six hours of incubation, long before it is visible to the human eye.