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Join our subject matter experts in Boston for the 2013 Educational Series, “Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems.”
This full-day event will provide pharmaceutical packaging industry professionals with an overview of container closure and delivery systems for injectable dosage forms along with critical factors for selecting the appropriate container closure or delivery system for applications from development through commercialization
Date:
April 29, 2013
Time:
8:30 a.m. to 4:30 p.m.
Registration begins at 8:30 a.m.
Location:
Charles Hotel
1 Bennett St.
Cambridge, MA 02138
To register to attend, click here.
We are pleased to share that West has received the Distinction Award of the AmCham Singapore CARES initiative, which is a further testament to West’s continued commitment as a good corporate citizen and our contributions on making a positive impact in the communities we serve.
To promote patient safety and the stability and efficacy of protein-based drugs, including mAbs, it is important to store the drugs in compatible container and delivery systems. From the time of storage until the drug reaches the patient, the protein interacts with the surfaces of these systems, which can impact the drug’s stability. The drug also can be affected by the various mechanical stresses and elevated temperatures to which it may be exposed during shipping, handling, and delivery.
<p><em>Lloyd Waxman, Harold Murray and Vinod Vilivalam</em></p><div id="g_93cd4f5a_be87_417c_be5f_5391eae75b241"><div><div><em></em> </div><div><strong>ABSTRACT</strong></div><div><strong> </strong></div><div><strong>Purpose: </strong>The shipment and storage of biopharmaceuticals in prefilled syringes (PFS) places new demands on PFS performance. Studies compared package integrity of glass and plastic PFS: piston movement was evaluated under reduced pressures to simulate transport by air in non-pressurized holds, and container closure integrity was tested on PFS that had been frozen or frozen and thawed, since some biopharmaceuticals are stored and transported in the frozen state. Piston release and travel forces were also measured in plastic PFS since in order to be competitive with siliconized glass PFS, the functional characteristics of plastic PFS must meet or exceed the criteria established for glass PFS.</div></div></div>
Mitigate risk of contamination, enable accurate dosing, while maintaining the stability and sterility of parenteral products
<p>Color has a surprising number of uses in injectables packaging.</p><p>European guidance states that “similarity in packaging which contributes to medication error can be reduced by the judicious use of color on the pack” ¹. Draft guidance issued by the U.S Food and Drug Administration (FDA)² similarly recommends that “sponsors use color prudently to bring attention to the product name, strength, and important warning(s).” Color – when applied thoughtfully and with full awareness of the context in which the drug will be used – can be an important way for manufacturers to help practitioners and patients differentiate products and support their correct use.</p>
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