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In a product’s development lifecycle, the importance of packaging can sometimes be overlooked until a packaging specialist becomes involved and can elucidate whether the packaging design is suitable and meets the tests for form, fit and function. Some companies that may not understand or emphasize the critical elements of a good package in the design phase may find out too late that the package is unsuitable after sustaining one or more failures during validation testing.
Once company experts have established the right packaging around the product configuration, then it must adhere to the design requirements. This is where preliminary testing through design of experiments (DOEs) or packaging engineering studies comes in.
Several items need to be considered before package testing can begin such as sample size, test method(s), acceptance criteria, dunnage[1] material or product, use of controls, thermal conditioning (hot and/or cold), transportation simulation testing and cost to name a few. What combination of variables you choose in a packaging test validation procedure can be based on a properly done risk assessment. So to arrive at that perfect combination is just the beginning.
So what if your packaging fails to perform as expected? Just because you had a test failure does not automatically mean that the packaging is inadequate. It does, however, demand evaluation and adjustments. A great place to start investigating a packaging failure is with the four most common failure points encountered in sterile barrier packaging validations.
[1] Dunnage was originally defined as loose materials used to support and protect cargo in a ship’s hold. That was when shipping vessels were the only form of international shipping. In the packaging industry it is material that provides padding in a shipping container that may or may not be representative of .
West’s Kinston, NC facility was recently recognized with an Honorable Mention at the 2016 International Society for Pharmaceutical Engineering’s (ISPE) Facility of the Year Awards’ ceremony on June 7, 2016, in Bethesda, Maryland. The award acknowledged the West team’s creativity and innovation during the Ready-to-Sterilize (RS) Expansion project, which was completed in June 2015.
On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.
Experimental characterization of an elastomer plunger in a particular pre-filled syringe system is essential to help pharmaceutical manufacturers determine whether that plunger is suitable for intended use. The strategy for a characterization study must consider relevant factors, in particular, compatibility with drug product and the ability to enable consistent delivery of drug product (dosage and time), by a clinician or by an autoinjector.
Register today for West’s free educational series <strong>“Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems”</strong> on March 20, 2014, at the Renaissance Raleigh North Hills Hotel in Raleigh, NC.
A key element of West’s commitment to a safe and efficient delivery of drug products is staying abreast of industry developments, and being prepared to help customers navigate them. Recently Dow Corning introduced a new product - Dow Corning® 366 35% Dimethicone NF Emulsion.
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