Examples of using Extractables in English and their translations into German
{-}
-
Colloquial
-
Official
-
Ecclesiastic
-
Medicine
-
Financial
-
Ecclesiastic
-
Political
-
Computer
-
Programming
-
Official/political
-
Political
Minimal extractables and leachables.
We have not detected any extractables.
Extractables profiling inorganic and organic extractables.
Our services for extractables studies include.
Investigations on biocompatibility leachables, extractables etc.
Very low extractables mean less contamination from reactive ions.
High flow rates, low pressure drops, long life and low extractables.
Chemically inert; no extractables except at extreme pH; DMSO resistant for HTS.
Development of a tailored study design for extractables and leachables.
Characterization of extractables by chromatographic and spectroscopic investigations.
Thermal bonding process eliminates adhesives and ensures minimal extractables.
Customizable workflow for quantitative extractables studies simulation studies.
The selection and qualification of a container for a pharmaceutical product includes extractables.
The assessment of extractables and leachables in bio/pharmaceutical products is an important step in drug product development.
No resin binders-thermal bonding process prevents media migration and ensures minimal extractables.
Extensive tests with different organic solvents andbuffers didn't show any extractables according to USP< 661> even for storage over longer time and at elevated temperatures.
PE-binding technology results in very low levels of particles,non volatile residue and ion extractables.
Whether you're dealing with degradation products, genotoxic impurities,or leachables and extractables: we are very skilled at finding the right structures.
All products are supported by validation guides detailing test protocols including ISO,USP and extractables.
Extractables& Leachables The selection and qualification of a container for a pharmaceutical product includes extractables& leachables testing as per international regulations.
Thermal welding processes seal all components, eliminating adhesives and extractables and optimising cartridge integrity.
Other restrictions include potential leachables and extractables[Jenke 2007], size limits, higher costs for consumables, lack of standardization or categorization, supply security, and the current lack of sensor technologies in automation.
Aurelie Mannella continues:"A series of actions have been implemented in order toassure no impact on extractables and leachables.
Because of their high purity and minimal ion extractables, GD/XP syringe filters are recommended for analysing ion content that would otherwise experience interference from glass-based extractables.
Any filters used should be validated with respect to pore size, compatibility with the product,absence of extractables and lack of adsorption of the API or any of the components.
Moreover, there are no tests to assess the integrity of SUS prior to implementation, nor are there regulatory requirements for SUS for the complete biotechnology process, nor evalua-ted analytical methods with acceptance criteria for leachables and extractables.
Solvias provides expert testing and consultingservices to assess the safety and integrity of extractables and leachables in pharmaceuticals, single-use production process materials, container closure systems, and medical devices.
In some cases, such as for a nasal spray, the packaging materials need to be biologically evaluated to USP Parts 87 and 88 much in the same way as for the most invasive medical devices such as catheters,where the potential for leachables and extractables is a key concern.
Where the labelling does not specify the type of containers, compatibility(with respect to parameters such as appearance, pH, assay, levels of individual and total degradationproducts, sub visible particulate matter and extractables from the packaging components) should be demonstrated in glass, PVC and polyolefin containers.
Additional services to help customers more easily comply with local regulatory requirements include documentation support in line with FDA guidelines, covering relevant product safety and compliance documentation andinformation on potential leachables and extractables.