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In a <a href="/pt-pt/blog/2017/july/new-technology-for-delivery-of-vaccines">previous blog post</a>, we discussed various devices and solutions used to overcome the challenges associated with Intradermal (ID) injections. These challenges are mainly associated with the Mantoux Technique, a manual ID injection using a needle and syringe. Lacking the skill needed for this technique creates a risk of injecting the product too deep or not sufficiently deep and rendering the dose either less or potentially ineffective. Previous posts also touched on some of the potential benefits associated with ID delivery when compared to the more familiar Subcutaneous or Intramuscular type injections. Two of the benefits we look at closer in this post are dose sparing and improved immune response. Additionally, we will see how these two benefits can be related. <br />
The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products<sup>1</sup>. FDA Draft Guidances<sup>2, 3</sup> help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.
In 2023, West turned 100. As I look back across the year, I am proud to be part of this amazing organization. Our 100th year in service was a time to reflect on our heritage, celebrate everything we have achieved and look forward to our future with a renewed sense of determination.
A container closure system (CCS) is comprised of packaging components, such as a vial and stopper, that together, contain and protect the drug product. There are many different packaging formats that you can select for your CCS, so it is important to have a thorough understanding of the various components included in the CCS, their required function, storage temperature and conditions, and the overall administration of the drug product.
On December 1, 2013, revisions to USP Ch. <1> Injections, Labeling on Ferrules and Cap Overseals will go into effect for all drug products sold in the United States, including veterinary products. Now is the time to ensure that your product packaging is compliant.
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