When developing a successful combination product, the examination of risk of extractable and leachable
contamination and container interaction is key to ensuring correct and safe drug delivery.
The method development & validation segment is further classified as extractable & leachable
, impurity method, technical consulting and others.
Multiple 1-hour leach tests confirmed the leaching of 100% of the lithium leaving behind most of the leachable
elements from other acids such as potassium (K).
With the new facility joining the company's growing network of sites across the UK, Concept Life Sciences' pharmaceutical manufacturing support services now comprise API process research and development and cGMP, quality control release testing, stability studies, out-of-specification investigations, extractables, leachable
and sorption studies, cleaning verification and validation, occupational hygiene, and environmental monitoring.
They may also include heavy metals, Other contaminants and have high leachable
Chemical characterization (also called extractable leachable
testing, or E&L) is a series of analytical tests that quantitates the chemicals that can leach out, or be extracted, from the device.
The CRL also raised CMC-related questions on extractable and leachable
data provided in the NDA.
Morgan Advanced Materials (Worcestershire, England) has developed a proprietary leachable
material which significantly cuts investment casting times in turbine engine blades by up to 20%.
Extractable and leachable
concerns apply mostly to process contact materials (PCM) components, especially in the downstream part of the biopharma process after the filtration step.
In 2017, the FDA confirmed reports that some traditional ceramic pottery (in particular earthenware, a porous form of clay) made in Mexico and labeled "lead free" does in fact contain lead and exceeds the "leachable
" lead limits--meaning that lead could get into food/drink that makes contact with the pottery.
substances may also be generated by erosion and degradation caused by photo, thermal, mechanical, or chemical influences (5).
He covers analytic techniques, principal components and bulk compositions, additives, reserve engineering and product de-formulation, curing and cure state studies, characteristics of rubber process fumes, compliance with food-contact regulations, extractable and leachable
studies on rubber products, analyzing surface blooms and contaminants, and analyzing rubber latices.