spacer
home >
PUBLICATIONS

 
 
 

spacer

 

Industry Events

SMi Presents the 4th Annual: Highly Potent Active Pharmaceutical Ingredients (HPAPI)

11-13 May 2020, Copthorne Tara Hotel, London, UK

SMi is delighted to announce its 4th Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 11th – 12th May 2020. HPAPI 2020 conference focuses on the growing landscape driven by the demand for highly potent drugs in oncology, diabetes and autoimmune disease treatment. This event will address the biggest challenges the industry is facing with regards to determining toxicology limits, assessing hazards, implementing risk procures, translating risk assessment into facility engineering, preventing and dealing with cross-contamination and adhering to GMP regulatory guidelines.
More info >>

 
News and Press Releases

Nova Biomedical Launches BioProfile® FLEX2 On-Line Autosampler for Fully Automated Sampling, Analysis, and Feedback Control of up to 10 Bioreactors

Waltham, MA – Nova Biomedical is pleased to announce the launch of the BioProfile FLEX2 On-Line Autosampler (OLS), a modular system that connects as many as 10 bioreactors to one FLEX2 analyzer for up to 3 weeks of walkaway, automated sampling, analysis, and feedback control of key cell culture analytes. The FLEX2 measures up to 16 tests including pH, gases, metabolites, osmolality, cell density, and cell viability.
More info >>

 
White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement