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Pharmaceutical Manufacturing and Packing Sourcer

Evaluating the Impact

What was the strategic driver behind your research?

Julie Suman: Several complex challenges are facing injectables component partners, from increased safety and quality requirements to development of sensitive drug formulations, which necessitate the creation of more inert solutions with greater regulatory standards. Drug product manufacturers need flexibility to select components that meet their sterilisation requirements.

What is the regulatory case for extractables and leachables?

Injections and injectable suspensions have the highest degree of concern associated with the various routes of administration, as far back as the guidance document issued by the FDA in May 1999. Current expectations have increased with new methodology defined in the US Pharmacopeia and Product Quality Research Institute (PQRI) parenteral and ophthalmic guidelines. There is also a high likelihood of packaging component/dosage form interaction, hence the intense scrutiny in this area.

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Julie Suman, RPh, PhD, is the Founder of Next Breath, an Aptar Pharma business, and serves as its President. Julie holds a BS in pharmacy from Duquesne University, US, and a PhD in pharmaceutical sciences from the University of Maryland, Baltimore, US. She is co-editor of the Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, US. Julie is also a member of the Parental Drug Association Visible Particulate Taskforce.
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News and Press Releases

CBIs Global Risk Based Monitoring Event

CBIís Global Risk Based Monitoring Event is approaching, taking place in London on 13 Ė 14 September 2018, designed for benchmarking with international peers to gauge RBM performance, efficiencies, implementation and technologies.
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Time lapse photography to demonstrate the potential antimicrobial abilities of Dycem contamination control flooring

Dycem

A defined volume of bioluminescent reporter bacteria was deposited onto 20 mm x 20 mm coupons of Dycem flooring, vinyl tile and ITW Alma tacky mat. Through monitoring of bacterial bioluminescence, metabolic inhibition was observed on all three surfaces however the effect occurred more rapidly on Dycem flooring than on vinyl or ITW Alma. Recovery counts after three hours of exposure to the floor surfaces showed between a 65% and 100% decrease in the number of viable organisms recovered from Dycem flooring compared to controls. On vinyl and ITW Alma flooring, there were slight increases in the number of viable survivors recovered compared to controls. Dycem flooring inhibited the metabolic activity and reduced the number of viable survivors recovered of Salmonella enterica Serovar Typhimurium DT104 pGLITE. It remains unclear as to whether this effect is attributable to the impregnated biocide or rapid drying of the inoculum on this surface.
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Industry Events

SMiís 9th Annual Biosimilars & Biobetters Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Following the success of our previous events in both London and the US, Biosimilars and Biobetters UK 2018, SMi deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.
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