Multiple materials are involved in the packaging of drug products in prefillable syringes. Multiple materials are involved in the packaging of drug products in prefillable syringes. With regards to ...

Extractables and leachables assessment is a critical facet of biopharmaceutical development and quality control, ensuring that medicines remain safe, effective and uncontaminated by substances ...

Standardized risk assessment and analysis protocols facilitate the comparison of processing equipment components. The National Institute for Bioprocessing Research and Training (NIBRT) assessed the ...

Diane Paskiet, Director, Scientific Affairs, West Pharmaceutical Services, elaborates on the key quality considerations when designing drug product compatibility studies There are multiple types of ...

DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/25jkl3/leachables_and_ext) has announced the addition of John Wiley and Sons ...

Drug manufacturers spend significant amount of time and money in characterizing, identifying, minimizing the impurities in a drug product so that regulatory bodies make accurate decisions with respect ...

The article provides a detailed overview of the process used to determine leachables and extractables from plastics. This process is mostly preferred for plastics employed in food contact applications ...

In this interview, AZoM talks to Dr Mark Jordi, President of Jordi Labs, about extractables and leachables, and how they relate to the pharmaceutical industry. What are Extractable and Leachables?

The International Council for Harmonization (ICH) has released a draft Q3E guideline that offers a harmonized framework for assessing and controlling extractables and leachables (E&L) in ...

Dr Bettine Boltres, Product Manager, Pharmaceutical Tubing, SCHOTT, Germany in this white paper, touches on a risk-based approach of the evaluation and describes important facts to consider when ...