A good elastomer stopper for a vial container system should have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is important, as they determine the stopper performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. Huaren understands these issues and therefore is able to develop formulations to offer maximum performance. As a recognized development partner of pharma elastomer stopper industry leaders, we know the technologies, customer needs. We use this experienced know-how to ajust the formulation according to the drug properties to ensure safety and stability.
Stoppers Performance assessment is governed by standards published by organizations such as ISO, USP, European Directorate for Quality of Medicines (Ph. Eur.), and China National Medical Products Administration (NMPA). Key properties of a stopper are:
Penetrability: force required to penetrate with a needle –
Fragmentation: number of fragments causedsed by needle penetration (essential to understand for multi-use stoppers)
Self-Sealing: The ability to reseal after multiple needle penetrations
Container Closure Integrity: ability of assembled container system to protect drug product
Compatibility performance depends on the standard considered, and the drug product contacting with teh stopper directly. Huaren Pharmaceutical lab service has the staff, knowledge, and facility to perform evaluations according to all the standards cited, and offers testing through its Integrated solutions platform.
Huaren pharma elastomeric stoppers using category:
Selecting the right stopper and making the right evaluations – Huaren stopper can satisfy all your needs, please contact us to get more information!