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A good elastomer stopper for a vial container system needs to have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is crucial, as they determine performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. West understands these issues, and therefore is able to develop formulations to offer maximum performance. An example is the formulation 4040/40, which was designed according to quality-by-design (QbD) principles.
Performance evaluation is governed by standards published by organizations such as International Organization for Standardization (ISO), United States Pharmacopeial Convention (USP), European Directorate for Quality of Medicines (Ph. Eur.), and China National Medical Products Administration (NMPA). Key properties of a stopper are:
Acceptable performance depends upon the standard considered, and the drug product for which the stopper is being used. West Analytical Lab Services has the staff, knowledge, and facility to perform evaluations according to all the standards cited, and offers testing through its Integrated Solutions platform.
Click here for more information on our 4040 LyoTec® stoppers.
Selecting the right stopper and making the right evaluations – West has the expertise. For more, contact an Account Manager or Technical Customer Support (TCS) representative.
LyoTec® is a registered trademark of West Pharmaceutical Services, Inc. in the U.S. & other jurisdictions.
We are pleased to announce that Jennifer Ogden, Director, Global Accounts, has been recognized by the HealthCare Businesswomen’s Association (HBA) as West’s 2015 Rising Star. Jenn is a leader among the sales force and is responsible for developing and driving the execution of account strategies with West’s global biotech customers.
West Pharmaceutical Services, Inc. today announced that Eric M. Green has been appointed the company’s Chief Executive Officer, succeeding Donald E. Morel, Jr., Ph.D., current Chairman and CEO. Eric Green will join West and take on his new responsibilities on April 24, 2015.
The pharmaceutical industry’s focus on extractables and leachables from packaging/delivery systems began during the mid-1990’s. Today’s regulatory agencies are more educated about the process, and drug product formulations have become more complex, which makes the need for robust extractables and leachables programs more critical than ever. In fact, failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the first question to ask is – “where do I start?”
We recently announced our partnership with <a rel="noopener noreferrer" href="https://techin-iitpkd.org/" target="_blank">TECHIN – a Technology Innovation Foundation of IIT Palakkad</a> which focuses on assisting innovation and incubation for growing entrepreneurs, to build a Medtech Research Center of Excellence.
Unanticipated incompatibilities between the drug product and a closed system transfer device (CSTD) delay therapeutic delivery to the patient. Considering the CSTD with the drug product and even co-packaging the drug product with an optimal FDA-approved CSTD will positively impact drug product therapeutic performance and ultimately patient care.
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