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According to the Code of Federal Regulations Title 21 Food and Drugs Part 211.94(a) Subpart E Control of Components and Drug Product Containers and Closures, drug containers must not react or add to a drug product in a way that alters the drug’s safety or quality.
Concerns related to the packaging system can include:
– Poor chemical durability
– Use of silicone lubricants and impact to product quality
– Compatibility concerns related to biopharmaceuticals
– Potential for leaching and interaction with drug products
– Drug product shifts in pH due to glass dissolution
– Reduced potency from adsorption of drug product onto glass surface
– Breakage, scratches or particles resulting from packing, transport and filling
To help assure proper package selection and avoid potential incompatibilities between product and closure systems, a screening comparison study can be completed. This typically includes an 8-week investigational study that will help manufacturers determine the best elastomer selection for their drug product.
First, a study questionnaire is completed by the manufacturer to help the selected lab gain knowledge of the drug product. From this information, a list of potentially suitable elastomeric formulations is chosen for the study.
A gross compatibility study is designed to accelerate any incompatibilities that may exist between the drug product and the potential packaging. To accomplish this, the customer must supply bulk product or placebo for testing. Processing of components is then simulated and sample vials are inverted to maximize contact between the elastomer and the drug product. Accelerated conditions are used to help speed the analysis.
A thorough analysis may include the following screening techniques:
Appropriate sample preparations for these analyses will also need to be established as part of the study.
*These screenings involve the use of a general method, which may qualitatively uncover extractables that are present. West recommends a more thorough leachable analysis be performed on the chosen closure candidate during later evaluations.
The Japanese Pharmacopeia (JP) has updated chapter 7.03 “Test for Rubber Closures for Aqueous Infusions” and the last date to transition to the new version is <strong>September 30, 2015</strong>.
On July 3, 2013, Novartis issued a <span style="color: #0000ff;">voluntary recall</span> of its Menveo<sup>®</sup> vaccine. Menveo is a lyophilized meningococcal vaccine used against <em>Neisseria meningitidis</em>, a bacterium that causes meningitis, meningococcemia and septicemia, and rarely, carditis, septic arthritis or pneumonia.
<p><em>Part 2 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director,</em><em> Xavier University. This is the second installment in a four-part series on supply chain management.</em></p><p>In my previous blog, I mentioned the three overarching themes that need to be addressed to help ensure the integrity of the materials supplied throughout the pharmaceutical and medical device supply chains through the development of Good Supply Practices (GSPs).</p>
<p style="margin: 0in 0in 10pt;"><span>When the first Generic Drug User Fee Act (GDUFA I) was enacted in 2012, The FDA’s Office of Generic drugs (OGD) was trying to manage a growing backlog of regulatory applications. The introduction of user fees to the generic drug approval process permitted FDA to increase resources to address the increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a 5-year span, resulting in reductions in both the generic drug application backlog and application review times. </span></p>
Primary packaging components come in intimate contact with drug products – they can affect both drug product and patient safety. Many elastomer components are offered with a FluroTec<sup>®</sup> film that serves as a chemical barrier to minimize the migration of compounds from the elastomer into the drug product. FluroTec film comprises an ethylene-tetrafluoroethylene co-polymer (ETFE) – selected based upon flexibility, ability to be laminated to an elastomer, and of course, permeability resistance.
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