A typical cleaning validation (CV) programme consists of three phases: Design, Validation and Continued Verification.
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Syringe membrane filter selection/validation methods to assess analyte loss due to membrane filter adsorption in pharmaceutical quality control tests.
Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
This whitepaper from NSF looks at the key causes of drug shortages and what we can do to stop them.
Case study: How to maximise performance and productivity of existing pharmaceutical sterilisation lines?
New trends in automation and process control for sterilisation systems by integrating robotised loading and unloading technology.
Based on a study of the pharma industry’s remediation projects, this white paper from NSF looks at the key issues behind GMP non-conformance. It also includes questions to ask yourself when making changes to your processes and systems.
When performing chromatography separation, it is essential to determine the precise point when a substance is eluted from the column or cartridge to achieve optimal fractionation.
Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane.
Successful completion of product development for active pharmaceutical ingredients (APIs) is a tremendously challenging task, in large part due to the amount of analytical data collected.
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
Partnering for product characterisation can streamline drug development and create efficiencies in moving from concept to clinic.
Application note: TOC for cleaning validation: swab recoveries of worst-case compounds (feasibility testing)
THE PARENTERAL Drug Association Technical Report No. 49 serves as a resource to help guide the development and evaluation of a cleaning validation programme.
Vapour-compression-based WFI production has a total cost of ownership that is less than or equivalent to that of a membrane-based system and significantly less than that of a typical multiple-effect-based system. The following whitepaper provides examples that illustrate system designs that are relatively basic, yet typically sufficient.
Application note: Non-targeted host cell protein monitoring in downstream process samples using micro Pillar Array Columns combined with mass spectrometry (μPACTM-MS)
This whitepaper reports on the use of μPAC™ in combination with MS for the characterisation of HCPs and their monitoring during downstream processing.
WITH THE RISE of metabolites/molecules production using complete living cells or their components (bacteria, enzymes, chloroplasts, etc), which is also termed bioprocessing, it has become increasingly important to control the different production steps and analyse the different biological materials.