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Brochure: MET ONE 3400+ Air Particle Counter
The new MET ONE 3400+ Series PortableAirborne Particle Counter automates environmental monitoring for GMP cleanroom compliance.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
news
CureVac recieves €75 million loan for vaccine development and manufacturing expansion
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.
whitepaper
Application note: Ozonia Ozone Technology for ultrapure water disinfection
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
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Infographic: Benefits and applications of Ozone Technology
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
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Application note: Pharmaceutical analysis using UV-Vis: compliance with USP Chapter <857> and European pharmacopoeia (Ph. Eur. Chapter 2.2.25)
USP general chapter and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy. This technical note demonstrates how to ensure qualification as per global pharmacopoeias' requirements.
news
bioBoaVista manufactures customised media for COVID nasal diagnostic tests using the Flexicon PF7
bioBoaVista showcases its viral transport medium, that can stabilise samples, for efficient nasal tests for the diagnosis of COVID-19.
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How confident are you that your data is complete, secure and accurate?
Reliable data integrity tools to take control of your equipment and data.
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Application note: Nitrosamines by GC-MS in Valsartan
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
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Application note: Organic acids in solutions by IC-MS
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.
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Application note: Nitrosamines in drug product by HRAM-LCMS
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
news
Global regulatory authorities COVID-19 policy and regulations meeting
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
webinar
Accelerated development of first-in-human (FIH) programmes. Lonza’s SimpliFiH® Solutions
2 June 2020 | By Lonza
In this webinar, Lonza presents its approach to its FiH (first-in-human use) drug substance and technology-enabled drug product development programme, designed specifically to provide customers with a standardised and rapid, phase-appropriate early clinical supply programme (SimpliFiH®).
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Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon, and conductivity data
Cleaning validation is an important element to cGMP manufacturing to ensure purity, quality, and potency of drug product.
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Whitepaper: Rapid sterility testing: a new solution for short shelf life products
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
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On-demand webinar: Microbiological control in a pharmaceutical manufacturing environment
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
