Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment.
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The United States Pharmacopeia (USP) is a scientific non-profit organization that sets standards used worldwide for the identity, quality, purity and strength of medicines, food ingredients and dietary supplements.
The Lasair III Particle Counter sets the standard for portable aerosol particle counters, and fully meets the requirements of ISO 14644-1 (including the new 2015 revision) and ISO 21501-4.
Application note: FacilityPro® Environmental Monitoring Systems – Data Processing and System Control
The FacilityPro® processor provides the central hub for an environmental monitoring system.
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
The BioCapt® Single-Use Microbial Impactor is a lightweight, integrated air sampler designed to be used with both portable and remote monitoring systems in remote sampling settings.
The APSS-2000 syringe sampling system sizes and counts suspended particulate matter in a wide range of liquids and meets or exceeds all current USP, EP, and JP requirements.
Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly.
The MiniCapt Portable Microbial Sampler enables collection of biocontamination samples throughout cleanrooms and clean air facilities.
Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
Case study: Merck Leverages Data and Analytics to Support New Continuous Drug Manufacturing Processes
Over the past couple of years, the European Medicines Agency and US Food and Drug Administration have given approvals to a handful of pharmaceutical companies to manufacture drug products using continuous manufacturing processes.
This free poster compiles all basic chromatography principles needed to develop and run flash and prep HPLC methods.
Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
Whitepaper: Impact of the Claristep® Filtration System on recovery and adsorption of various therapeutic proteins at low sample volumes
Comparison of the Sartorius Claristep Filtration System with standard sample preparation using syringe filters.
The prerequisite of any highly sensitive analysis via HPLC-MS (high performance liquid chromatography coupled to mass spectrometry) is the use of ultrapure solvents and reagents and careful handling of all associated materials, consumables, and systems.