Lyophilization Stoppers
Vial Components
Pharma
Aptar Pharma’s Lyophilization Stoppers are designed to remain stable on the vial in the freeze dryer during the transfer and sublimation phases, as well as maintain excellent performance during freeze-drying process conditions. Our Lyophilization Stoppers ensure high chemical inertness and effective recovery of the reconstituted drug product as well as optimal protection of the lyophilization cake.
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Optimal Stopper Protection for Your Sensitive Lyophilized Drug
Pure quality formulations with low residual moisture
Selecting the right packaging system is important, especially for lyophilized drugs. Thanks to our in-house expertise, we continue to develop innovative elastomeric formulations offering a balance of both mechanical and physical properties with the fewest possible ingredients. This ensures the best results in terms of chemical inertness, which is ideal for our customers’ sensitive drugs including Biotech.
For freeze drying applications, we offer specific elastomeric formulations with intrinsic inertness which also provide a low level of residual moisture, especially important for lyophilized drugs.
Ensuring quality protection of lyophilized drug formulations
Our Lyophilization Stoppers are specifically designed to answer the challenge of freeze-drying and ensure optimal protection of sensitive molecules used by Biotechnology companies. Aptar Pharma developed different designs such as igloo or two-legs for powders, adapting to all freeze-drying cycles.
We offer the lowest moisture formulations providing optimal protection of the lyophilized cake.
Trusted by the world’s leading pharmaceutical companies
Our Lyophilization Stoppers are used by all the major Pharmaceutical and Biotechnology companies worldwide. Our 50+ years of experience, scientific expertise and high quality standards provide customers with a wide range of trusted injectable component solutions as well as support services, including analytical testing, development services, regulatory support and post launch support, for your drug development success.
Premium quality offering accelerating and derisking your drug product development
Our Lyophilization Stoppers are available in standard and textured surface finishes to mitigate compatibility issues and help you get to market faster.
They can be delivered in specific packaging options and different finishings including Ready-to-Sterilize (RTS), Ready-to-Use (RTU) or PremiumFill® for improved quality processes and services, reducing contamination and compatibility issues.
Lyophilization Stopper Advantages
- Optimal Protection of the Lyo Cake
- Perfectly Designed for Lyophilization Processes
- Good Machinability
- Enhanced Cleanliness with PremiumFill®
Low permeability & low level of residual moisture
A product dried to less than 3% of residual moisture will absorb moisture when exposed to an environment with greater moisture than its own level. The stability is then compromised. Our Lyophilization Stopper formulations have been developed to guarantee a very low level of moisture and thus the protection of the lyo product throughout its shelf life.
State-of-the-art design & low temperature resistance
The freeze-drying process is a very specific one. Our stoppers have been developed to answer all of the demanding parameters for lyophilization: ease of pre-positioning of the stoppers on the vials, resistance to very low temperature during the freezing phase, impermeability to facilitate the drying processes, specific shapes to allow smooth closing of the vials and avoid pop-off issues, rough surface and spacers to reduce the risk of sticking to the upper shelf after closing of the vials.
Adapted shapes & surface treatments
Our Lyophilization Stoppers have anti-sticking spacers and come with either matte or rough surface on the flange and at the bottom of the plug. Rough surface reduces the risk of conglutinated stoppers and improves the anti-sticking performance during shelf compression to close the vials.
Comply with the highest quality requirements
Our Lyophilization Stoppers are available in PremiumFill®, our guaranteed specification resulting in lower embedded particles, improved particulate cleanliness and an overall reduction in defects.
Product Details
See Why Our Lyophilization Stoppers Provide Optimal Protection
Find out how our Lyophilization Stoppers provide optimal protection and safety for your sensitive lyophilized drugs.
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