news
One vaccine injection could carry many doses
Engineers have invented a new 3-D fabrication method that can generate a novel type of drug-carrying particle that could allow multiple doses of a drug or vaccine to be delivered...
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Packaging
article
Extractables – leachables correlations for packaging
Plastic materials, widely used in pharmaceutical packaging systems, can interact with the packaged product by transferring leachables. Leaching is important, as foreign leachable impurities can adversely affect the quality, efficacy and safe use of the packaged product, due to their chemical or physical nature, reactivity, and/or toxicity.
article
Developing OTC syrup packaging for the highly regulated EU market
The regulatory environment has a great impact on business, especially in healthcare. Non-compliance exposes companies to the risk of launch delay, delisting products from the market and out-of-stocks. Moreover, it can cause reputational damage affecting staff, consumer and shareholder confidence, reduce market opportunities, and affect the bottom line.
article
Extractables and leachables – safety-based limits
A thorough understanding and control of extractables and leachables in liquid and semi-solid products has long been a regulatory requirement.1,2 Regulatory guidelines require that product contact surfaces are “not reactive, additive or absorptive”.3
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Issue #4 2017 – Digital Version
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
news
Antalis drives forward with new vehicle fleet
Antalis’ customers are set to benefit from a fleet of more technologically advanced vehicles as part of its £5m partnership with fleet provider, Fraikin...
news
Patheon to invest $45 million in spray drying & manufacturing solutions
Patheon expects to invest approximately $45 million at key sites across its network in spray drying capabilities and flexible manufacturing solutions...
whitepaper
Whitepaper: Extractable and leachables studies – designed and performed to meet all intended needs
Following FDA legislation in 1999, scrutinising packaging standards for extractables and leachables has become the norm. In this whitepaper, Eurofins examines the ways in which the evaluation of final packaging components is now carried out including the role of liquid and gas chromatography-mass spectrometry in the process.
article
Personalised medicine, batch size of ONE, the new challenge to fill-finish?
Wenzel Novak PhD gives some considerations on container, environment, process and automation for small batch sizes in the downstream process of fill-finish…
news
Aptar Pharma extends nasal pump manufacturing capabilities
Aptar Pharma has announced the installation of manufacturing capacity for its child-resistant and Senior-Friendly Classic Nasal Pump in their Congers, NY site.
article
Does the Falsified Medicines Directive lead to a European pack coding guideline?
The Directive on Falsified Medicines (FMD, or Directive 2011/62/EU amending Directive 2001/83/EC) and its supplementing Delegated Regulation (DR 2016/161) aim to improve patient safety by preventing falsified medicines from entering the legal supply chain...
article
Strategic aspects of change control for pharmaceutical packaging systems
Plastic materials used in pharmaceutical packaging can interact with the packaged dosage form, causing leachables to accumulate...
article
FMD and supply chain security
Over 12 months ago, the European Union delegated regulation that supplements the Falsified Medicines Directive (FMD) was published in the Official Journal of the European Union, starting the countdown to the deadline of 9 February 2019, when most EU member-states, and three non-members currently, are expected to have implemented all…
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Issue #2 2017 – Digital version
Read the free-to-view digital version of the latest issue of European Pharmaceutical Review...
