We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
On January 1, 2018, new USP standards became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients – aligning with ICH Q3D, which provides limits for the amount of elemental impurities in drug products. New USP General Chapters, USP <232> (Elemental Impurities – Limits) and USP <233> (Elemental Impurities – Procedures) have replaced USP <231> (Heavy Metals). USP <231>, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn. However, the heavy metals testing in USP <381> (Elastomeric Closure for Injections), which is used for testing of elastomeric closures, still references USP <231>.
A proposed change for the USP <381> extractable elements was made in March 2017, but has not yet been approved or published. Due to this, USP issued a Revision Bulletin on December 29, 2017 indicating that the Packaging and Distribution Expert Committee had revised USP <381> to include the historic USP <231> heavy metals tests to enable continued use. The revision became effective on January 1, 2018, and will remain in effect until the USP <381> extractables elements proposal can be approved and published. The Revision Bulletin can be found here.
According to Desmond G. Hunt, Ph.D., Principal Scientific Liaison, USP, “USP is currently reviewing the comments obtained from the Pharmacopeial Forum (PF) 44 (3) revision proposal of <381> and is still working to include an updated method for the testing of extractable metals from elastomeric components for injectable drug products. The Committee is working to have a revised chapter, based on stakeholder comments, republished in PF by the end of the year.”
West follows this very closely. For more information, contact a Technical Customer Support (TCS) representative.
Innovation in manufacturing involves a spectrum of evolutionary improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers as “Absolute Quality.” Recent continuous improvement efforts from Daikyo focused on the manufacturing environment, including a move from ISO 8 to ISO 7 cleanrooms and 100% automated vision inspection with enhanced inspection limits. The result helped Daikyo achieve even higher levels in cleanliness of elastomer products.<br />
<span>Manufacturers of parental drug package/delivery systems must be up-to-date on the ever-changing regulatory landscape. At Pharmapack 2017, Fran DeGrazio, Vice-President of Scientific Affairs and Technical Services, spoke on the topic of metal impurities in a presentation entitled: <em><span>The Changing Regulatory Environment Concerning Elemental Impurities and Container Closure Systems</span></em></span><em><span>. </span></em><br>
It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises both knowing of proposed changes as soon as announced and being well prepared to accommodate them. USP Chapter <381> is changing, and Chapters <382>, <1382> and <1381> are being created. The Pharmacopeia Forum for final comments has been published.
On Friday, May 29, team members from West’s Exton headquarters hosted the 10th annual West without Borders picnic. In keeping with this year’s theme of honoring veterans, Exton team members selected the Travis Manion and No Barriers foundations, which support US veterans and their families, as the beneficiaries of the fundraising efforts.
The other West Ambassador interns and I can all agree that this experience is far from what we imaged, in fact it is much more. From the West without Borders picnic to being assigned various projects, we are learning there are many aspects of a being part of a team in a global company.
English
Chinese
