December 2009 Editor's Picks: Products from Sepha and AdvantaPure - Pharmaceutical Technology

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December 2009 Editor's Picks: Products from Sepha and AdvantaPure

Equipment and Processing Report

Featured products from Pharmaceutical Technology's monthly newsletter, Equipment & Processing Report

product Sepha
Leak-testing machine reduces waste

Sepha’s (Belfast, Northern Ireland) Blisterscan is a nondestructive, noncontact leak-testing machine for blister packs. The machine scans blister packs with a laser beam before and after applying a vacuum to them. It examines the difference between scans to determine the size of the hole in the blister pack. The instrument detects leaks as small as 7 µm in diameter and locates the exact pocket that leaks.

Because the Blisterscan method is nondestructive, packs that pass the test can be returned to the production line. If a pack fails the test, an operator can empty its contents for repackaging. The Blisterscan unit thus reduces the amount of wasted product. In addition, the unit can be fully validated, unlike the blue-dye test, which requires a subjective operator decision about whether a pack passes or fails. The Blisterscan machine is intended to automate the quality-assurance process and facilitate compliance with current good manufacturing practices standards.


productAdvantaPure
Identification method improves trackability

AdvantaPure (Southampton, PA) has introduced its DocuLink method of distinguishing silicone manifolds after installation. The company assigns each manifold a unique identification number and permanently molds a silicone-encased label with this information within the manifold’s silicone connector. This method can be applied to T, Y, cross, reducer, or molded Tri-Clamp connectors. Operators can use a manifold’s identification number to view its related documents such as certificates of compliance, component specifications, and validations on an online data-management site.

AdvantaPure’s DocuLink labels and silicone manifolds withstand autoclaves, gamma irradiation, clean-in-place, and steam-in-place sterilization processes. The DocuLink labels do not contact the products within the manifolds. The DocuLink method is designed to facilitate manifold trackability and ease users’ safety concerns. Because the unit eases document retrieval, it could reduce the time and expense related to audits and validations.

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Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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