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Drug products such as biologics, vaccines and products whose chemical and physio-chemical stability depends on temperature put an added emphasis on pharmaceutical manufacturers to ensure proper handling, storage, transportation and dispensing. Maintaining a secure “cold chain” during the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products not only assures product quality and integrity for the benefit of the patient, but also helps to keep the manufacturer, hospital, pharmacist, physician and nurse in compliance with various laws, regulations, guidelines and codes.
Cold chain products need to be packed in such a way that ensures that the required temperatures are maintained throughout their labeled shelf-life. Any deviation from the ideal environment can affect safety and jeopardize the drug’s quality, resulting in loss of potency, efficacy, or even the need to discard the product entirely.
Examples of drugs that require refrigeration may include:
West’s contract manufacturing group offers drug handling and cold chain solutions for pharmaceutical manufacturers that are looking for a complete integrated approach to device manufacturing and assembly to help ensure that drugs are stored within the desired temperature range throughout the cold chain.
Contact us today to determine how West Contract Manufacturing can support cold chain solutions.
<p><span style="background: white;">Working at West means being part of a culture of giving and working by the side of the communities where we operate</span><span style="background: white;">. Our team members are passionate about making a difference and donate considerable time and resources through our corporate giving and volunteer programs. West’s giving strategy focuses on three elements: corporate giving through direct charitable gifts made by West Pharmaceutical Services, Inc., scholarships and matching gifts awarded through the Herman O. West Foundation, an independently managed 501(c)(3) entity and our team member-led giving program, West without Borders*.</span></p>
ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline <em>Q12</em> <em>Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.
The U.S. Food and Drug Administration recently issued a draft guidance, <a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM346181.pdf"><span style="text-decoration: underline;">“Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations to Supplement International Organization for Standardization (ISO) Standard 11040-4 (Draft).” </span></a>The document relates to issues encountered with glass Luer lock syringes when connecting to Luer fittings, including needles, needle-free Luer connectors, adapters and transfer units.
In a <a href="/zh-cn/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 level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).
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