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8 August 2018 | By SUEZ
The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…
Market leaders in temperature-controlled microscopy and leaders in sample characterisation solutions, Linkam Scientific Instruments, reports on the research of Dr Jamie Wilkinson of the Natural History Museum in London where he uses temperature-controlled microscopy to characterise mineral deposits...
Taking advantage of technology developed in recent years, MECO announces smartANALYTICS® as a means of connecting its water purification machines and systems with big data analytics and in house expertise...
The 66th American Society for Mass Spectrometry (ASMS) Conference was held 03 - 07 June in San Diego, California.
6 June 2018 | By Abbott Informatics
In this webinar, we’ll introduce you to laboratory information management systems (LIMS) and demonstrate how this software can help you achieve regulatory compliance, quality data management throughout your product’s lifecycle...
Wickham Laboratories CEO, Dr John McKenzie, will be presenting at the Cleanroom Technology Conference on the 16 May at 2:30PM, at the National Conference Centre in Birmingham...
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
In this in-depth focus: Compressed gases - an important component of an environmental monitoring programme; The people factor - contamination of cleanrooms caused by personnel...
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.
New ISPE guidance provides a scientific, risk-based approach for managing cross-contamination risk within shared facilities ...
This scientific poster reviews numerous scientific literature related to microbial survival under a broad range of environmental pressure conditions, and the resilience of microorganisms under variable compression and decompression environments.
A new technical report has clarified best practice on visual inspection for visible particles in parenterals.
The US Food and Drug Administration (FDA) has advised manufacturers of non-sterile, water-based drug products that there have been recent product recalls due to Burkholderia cepacia complex (BCC) contamination.
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
