news
Metformin oral solution recalled due to nitrosamine impurity
A Class 2 recall notice for one batch of Rosemont Pharmaceuticals metformin hydrochloride 500mg/5ml oral solution has been issued by the MHRA.
List view / Grid view
QA/QC
article
QA/QC & Environmental Monitoring In-Depth Focus 2021
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.
article
Scrubbing up the environment
Here, colleagues from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) share the beneficial impact of reduced cleanroom environmental contamination following an upgrade to their facilities and procedures.
article
Bacterial Endotoxin Test using LAL methodology: overcoming interfering factors
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…
whitepaper
Worksheet: ARMM technology comparison
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
webinar
Adopting technology in the quest for digital transformation
13 August 2021 | By MasterControl
Watch our on-demand webinar to discover how MasterControl Manufacturing Excellence™ augments and enhances worker performance as part of digital transformation.
webinar
Leveraging extended reality (XR) technology to drive laboratory productivity
12 August 2021 | By Thermo Fisher Scientific
Learn how SampleManager XR software and Microsoft HoloLens can support implementing a digital strategy and drive forward digital transformation.
whitepaper
Whitepaper: How digital modelling supports cleanroom design
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
news
FDA releases guidance for near infrared (NIR) analytical procedures
New final guidance will aid drug developers in developing, validating, applying and submitting near infrared (NIR) spectroscopy-based analytical procedures.
news
Understanding limitations of microbial detection methods is key, says expert
Microbial detection methods are inherently flawed by three key factors, here we summarise Tim Sandle’s explanation of the concerns surrounding microbial methods and sampling.
video
On-demand webinar: The art of changing QC testing methods
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
webinar
Improve efficiency and return on investment by adopting molecular spectroscopy techniques in pharma manufacturing
3 August 2021 | By Thermo Fisher Scientific
In this on-demand webinar, discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimised costs.
news
Are your disinfectant validation protocols fit for purpose?
In a review, Tim Sandle sets out what disinfectant validation studies should assess and why those factors are important when choosing cleanroom disinfectants.
whitepaper
Case study: RMM to reduce plate counts
See how a pharma company maintained product quality and reduced risk by using an RMM analyser, while also meeting their goal of reducing plate counts by 25 percent.
news
Microbial air sampler market to value $545mn by 2028
Research suggests the adoption of microbial air samplers to overcome COVID-19, as well as the growth of the pharmaceutical sector will both drive market development.
