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West’s Peg Frandolig and Lynn Lundy share how vision inspection systems can help drug product manufacturers and packaging suppliers work together to regulate foreign and particulate matter in finished drug products in the December/January issue of Pharmaceutical Formulation & Quality.
Manufacturers of sterile drug products are confronted with increasing quality standards to produce defect-free products, reduce process/product variation, and minimize product rejects. Parenteral drug products intended for injection must meet requirements set forth in the United States Pharmacopeia (USP) Chapter <1> Injections, including the following specifications regarding foreign and particulate matter:
“Each final container of all parenteral preparations shall be inspected to the extent possible for the presence of observable foreign and particulate matter … in its contents. The inspection process shall be designed and qualified to ensure that every lot of all parenteral preparations is essentially free from visible particulates.”1
Particulate matter in finished pharmaceuticals can come from multiple sources, such as the ingredients in the drug product, processing equipment, or the container closure system. Manufacturers of sterile drug products should consider a means to reduce or exclude particulate matter and container closure defects in products.2
1. U.S. Pharmacopeia. USP 34–NF 29 General chapter <1> Injections, labeling of ferrules and cap overseals section. Aug. 4, 2010. USP website. Available at: www.usp.org/USPNF/notices/ferrulesCapOverseals.html. Accessed Nov. 22, 2011.
2. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Office of Regulatory Affairs. Guidance for industry: Sterile drug products produced by aseptic processing – current good manufacturing practice. September 2004. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf. Accessed Nov. 22, 2011.
As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.
The rise in type 2 diabetes has sparked a variety of treatment options, including glucagon-like peptide-1 (GLP-1) receptor agonists. GLP-1s are a class of injected drugs (additional oral options are currently in development) that “mimic the action of GLP-1 and increase the incretin effect in patients with type 2 diabetes, stimulating the release of insulin.”<sup>1</sup> Commonly used when oral treatment alone is not enough, the benefits of GLP-1s include a reduction of glucagon and glycosylated haemoglobin (HbA1c), weight loss and a low risk of hypoglycemia.<sup>2</sup>
We are pleased to present the newly designed Westpharma.com. Our passion for customers goes beyond just the products and services we offer. Our website redesign brings to life our 90+ years of expertise and focuses on simplifying our customers journey to help them find the right solutions for their drug packaging and delivery challenges. Take a fresh look at how our solutions can help you.
<span style="color: #333333;">Today, we are more connected than ever before. We rely on the Internet to stay informed and to perform our day-to-day jobs. It’s hard to imagine our lives without the Internet; yet for all of its advantages, increased connectivity brings increased risks for cybercrime. Recognizing the importance of cyber security, President Obama designated October as National Cyber Security Awareness Month (NCSAM), as has the European Network and Information Security Agency (ENISA). At West, we are committed to ensuring the ongoing success of our business processes and operations, which requires information that is accurate, complete, consistent and, above all, secure. This makes cyber security one of West’s most important priorities.</span>
<span>Before an injectable biologic can be formulated and manufactured, an extensive series of pre-formulation checks are necessary to ensure that developers avoid formulating an unstable, non-viable product¹. Developers must determine whether the injectable biologic will break down within the intended formulation or the manufacturing process. The drug must be thermally stable, possibly resistant to oxidation, tolerate variations in light, and other environmental stresses placed on it during manufacturing and packaging.</span>
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