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The purpose of this Technical Communication is to establish how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.
The MiniCapt Mobile Microbial Air Sampler allows the user to perform viable air sampling in cleanroom environments for classification and monitoring purposes.
PharmaIntegrity™ is the definitive solution for managing the collection, analysis, and trending of environmental monitoring data, ensuring timely detection of problems in production, facilitating product release and reducing risks and costs associated with product loss and recalls.
Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment.
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.
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.
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.
