This whitepaper from Beckman Coulter explores GMP cleanroom routine environmental monitoring and data integrity.
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Maintaining Data Integrity. Did you know that lack of data integrity has been a top reason for FDA Drug GMP warning letters?
The new MET ONE 3400+ Series PortableAirborne Particle Counter automates environmental monitoring for GMP cleanroom compliance.
The Sievers Eclipse* Bacterial Endotoxins Testing (BET) Platform empowers users to be conscious of today’s needs to protect valuable natural resources while still complying with the strict analytical and regulatory requirements drug and device manufacturers must meet.
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
High data quality and integrity is critical to ensure successful manufacturing of a drug. This whitepaper discusses how utilisation of software systems such as SampleManager LIMS enables and promotes compliance with regulations for the manufacturing of a drug.
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.
This whitepaper introduces the ReFIBE™ brand of wipes – a recycled polyester cleanroom wipe providing a sustainability story in a single-use world. Made from recycled plastic water bottles, these wipes are made from 100 percent knitted standard weight polyester with heat sealed edges.
In this whitepaper, bioMérieux describe the potential application of BioFire® FilmArray technology – a well-recognised technology used in infectious disease diagnostics – for rapid at-line detection of mycoplasmas in the pharmaceutical industry.
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
Application note: Impurity analysis in pharmaceutical products with the advanced photodiode array detector SPD-M40
The accurate determination of trace impurities is of great importance in both pharmaceutical drug development and drug manufacturing. This application note showcases the new photodiode array detector SPD-M40, which measures the concentration of impurities in pharmaceutical products.
Application note: Application of flow cytometry for microbiological monitoring of pharmaceutical grade water
As the main excipient for the pharmaceutical industry, water is integral to patient safety and the quality of pharmaceutical products.
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.