Whitepaper: Does QRM + RMM = Better EM
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
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Whitepapers & App Notes
Application note: BioCapt® Single-Use – Microbial Impactor
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.
Application note: APSS-2000 – Automated Parenteral Sampling System
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.
Whitepaper: Recent advances in pharmaceutical regulations for viable environmental monitoring
Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly.
Application note: MiniCapt – Portable Mircobial Sampler
The MiniCapt Portable Microbial Sampler enables collection of biocontamination samples throughout cleanrooms and clean air facilities.
Whitepaper: Manage Your Risk: Monitoring the Environment of Aseptic Processes
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.
Scientific poster: Chromatography essentials for performing perfect separations
This free poster compiles all basic chromatography principles needed to develop and run flash and prep HPLC methods.
Application note: Rapid Analysis of Genotoxic Nitrosamines by HPLC-MS/MS
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.
Article: Tips & tricks: sensitivity gains in LC-MS
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.
Whitepaper: Stability testing blister packs inspected with Sepha’s VisionScan test method
It is a requirement of both US and EU regulations that pharmaceutical packaging operations demonstrate integrity. As technology-based solutions remain somewhat of an unknown quantity, this whitepaper tests the hypothesis that Sepha’s VisionScan test method is considered non destructive.
Journal article: Validation of Milliflex quantum for bioburden testing of pharmaceutical products
Pharmaceutical drug products must fulfill specified quality criteria regarding their microbial content in order to ensure patient safety. Drugs that are delivered into the body via injection, infusion, or implantation must be sterile (i.e., devoid of living microorganisms).
Whitepaper: Supelco preparative HPLC products for pharmaceutical development and production
There is an increasing need for purified materials in the development and production of pharmaceutical products. FDA and other regulatory agencies continue to require more stringent purity requirements on active pharmaceutical ingredients (API), including most recently chiral purity.
Whitepaper: Remediation requires transparency: A process for managing quality and compliance
Standardization and alignment of the drug development and manufacturing process allow high-performing companies to globally source and efficiently produce pharmaceutical and biopharmaceutical products.
