Project managers play a vital role in ensuring the successful development and delivery of pharmaceutical applications. In order to maintain product sterility and ensure patient satefy, vials are sealed with a stopper and a cap. Far too often, the selection of vial stoppers seems to go relatively unnoticed, however, they have a significant impact on the quality and safety of the final pharma product.
Are you considering your different options for vial stoppers? In this article, we will provide an informative checklist for all pharmaceutical project managers to follow when selecting the appropriate stopper for any containment system.
The Significance of Vial Stoppers
The vial stopper is a pharmaceutical rubber component that serves as a barrier between the product inside the vial and the external environment. The design of the vial stopper protects the pharmaceutical product against moisture, air, oxygen, etc., and is fundamental to avoid contamination or product degradation. It is essential for project managers to pay close attention to their selection and use of their vial stopper to ensure project success.
After the vial has been closed with a stopper it is finally sealed with a cap. Caps are offered in different product ranges, including combined aluminum and plastic caps (also known as push-off caps), aluminum caps, lined screw caps, and smartseals. When selecting the type of vial stoppers, it is essential to also consider the selection of caps as the compatibility of the two components is crucial to maintain the sterility, integrity, and functionality of the packaging.
Checklist for Selecting Your Vial Stopper
Pharma project managers must incorporate vial stoppers into their list of considerations to ensure that they meet the highest standards of quality, safety, and compliance for their sealing solution. Below, we will provide an informative checklist to be followed when selecting and considering your different options for vial stopper:
1. Material Selection
Vial stoppers come in different ranges of designs and materials. We recommend all project managers have an open communication channel with the scientists to determine the most suitable material for the specific product that is being packaged.
The monographs of regulatory bodies, such as the Food and Drug Administration (US), European Medicines Agency (EU) or National Medical Products Administration (China) as well as those of national Pharmacopoeias are have to be taken into account.
Common materials of the vial stopper include butyle-based rubber formulations,
2. Compatibility Testing
Once you have decided on a material and design that seems to be the most suitable for your pharmaceutical project, we recommend performing a compatibility test to ensure harmony between the product, vial, and sealing solutions. In a compatibility test, the unity between the material of the vial stopper and the product is evaluated in various studies and tests.
3. Sterility Assurance
Project managers should also work closely with the quality control team during the consideration phase. The quality control team ensures that the vial stoppers fulfill the quality assurances, including that the stoppers are being manufactured under sterile conditions.
4. Container Closure Integrity
Container closure integrity (CCI) is an essential element of a drug product container system as it maintains the sterility and stability of all pharmaceutical products. In order to fulfill CCI, the vial stopper must provide an airtight seal that prevents any containment or escape of the product. CCI can be established through container closure integrity tests which should be performable by all manufacturers.
5. Extractables and Leachables
It is also necessary for project managers to be aware of extractables and leachables in order to establish evaluation and testing to prevent this from happening.
6. Regulatory Compliance
The vial stopper considered for your project needs to stay within compliance and follow all national regulations. It is the project manager's responsibility to ensure that the selected vial stopper complies with regulatory standards set by the Food and Drug Administration (FDA) or European Medicines Agency (EMA).
7. Supply Chain
It is essential for all project managers to closely manage their supply chain. When selecting a supplier of vial stoppers, consider how this new partnership will affect the rest of the supply chain. Prioritize engaging in a partnership with a supplier that can ensure reliability and timely support to avoid any production delays. It is also worth considering the location of the supplier, as local partnerships are known to simplify the process.
8. Sustainability and Environmental Impact
When selecting a supplier of vial stoppers, project managers need to evaluate the environmental impact of the manufacturer as it should align with the eco-responsibility of their own business. Look for concrete sustainability actions and policies that are put in place to fulfill environmental, social, and governance (ESG) policies.
9. Quality Assurance
Implement quality controls and testing to inspect the vial stoppers for defects and ensure quality assurance. The controls will verify the performance of the stoppers and are an important step in producing high-quality end products.
10. Packaging and Labeling
Although it might seem like a small final step, make sure to not skip the inspection of the packaging and labeling of the vial stoppers. Proper packaging and labeling ensure easy identification of the product and traceability to maintain a transparent supply chain.