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Container closure integrity (CCI) is a critical factor every drug manufacturer and compounder is required to achieve. To achieve CCI, one must consider factors such as vial material, blowback, and stopper design. One vital factor – too often an afterthought – is the aluminum seal.
Example of a good crimp and seal
Although considered a secondary component (since it does not contact drug product), the importance of a proper seal and crimp cannot be overstated. Three aspects of achieving a proper crimp are: skirt length, compression force, and cosmetics.
Skirt Length: This is the length of the aluminum part of a seal. Ideal skirt length is determined based on the stopper flange height, the vial crown height, and the percent compression used. If a skirt is too short, CCI may be risked. If the skirt is too long, the appearance of the system may cause the perception of lack of CCI.
Compression Force: This is the force used during the crimping process to push seals down onto the stopper/vial system. If systems are not sufficiently compressed during fill/finish, CCI may not be achieved. Excessive compression can cause the stopper to push through the hole in the top of the seal.
Seal Cosmetics: This relates to the appearance of the aluminum skirt of the seal post-crimping, particularly around the bottom of the crown of the vial. This appearance ought to be smooth, with no visible “wrinkles.” Wrinkles may pose a CCI risk and may result in rejected product.
West is able to offer both preliminary and detailed recommendations to help companies select seals. West’s Integrated Solutions lab team can help prepare a closure container system to meet FDA guidelines. Contact us today for more information.
When the COVID-19 Pandemic shut down the ability for in-person tradeshows and events, we worked to find an alternative solution with a new virtual exhibit designed to replicate the West experience without the risk of in-person interactions. Our team members quickly turned the idea of a booth replacement into an interactive experience for customers to use – both during trade shows and any time there’s a need to connect with us.
Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?
Advanced therapies are rapidly becoming a reality, targeting unmet patient needs and treatments for diseases with limited therapeutic options. Some advanced therapies, such as gene therapy and mRNA, require frozen storage due to their fragile nature at ambient temperature, putting unprecedented expectations on the vial-stopper-seal combination to maintain container closure integrity (CCI) during storage at low temperature conditions. The quality, patient safety, and high value of these therapeutics can be jeopardized if the chosen vial-stopper-seal combination doesn’t maintain a sterile barrier from when the drug is packaged through to administration to the patient. During cooling from ambient temperature to temperatures below -80°C, packaging components such as glass vials, elastomeric closures, and aluminum seals exhibit contraction and changes in physico-mechanical properties. These changes in material properties and component dimensions may affect their ability to maintain CCI, resulting in the formation of transient leaks.
Ophthalmic drug products (ODPs) present a special challenge for the measurement of extractables and leachables (E&L) due to the presence of multiple leachables sources. ODPs typically are packaged in labelled, semipermeable polymer (e.g., low density polyethylene) containers (i.e., primary container) and stored in cardboard containers (i.e., secondary container) along with instructions for use. The polymer, label, cardboard and paper are all possible sources of leachables.
Twelve weeks, 60 days, or 480 hours is all that I have in the summer of 2014 to showcase my talents as the Pharmaceutical Delivery Systems (PDS) Marketing and Innovation Ambassador Intern. To many, that might seem to be a rather extensive amount of time to become familiar with an organization, meet respective colleagues, learn about products and operations, and develop a means to an end for the designated project assignment that all Ambassadors receive every summer.
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