Packaging
STELMI LAUNCHES STERILE STOPPERS
Wednesday 11. February 2009 - STELMI has been supplying sterile ready-to-use plungers since 2003. To meet the demand, STELMI is now offering a range of sterile stoppers for vials (antibiotic, infusion and lyophilization vials), which satisfy the requirements of pharmaceutical laboratories both in terms of component quality and regulatory documentation.
In this way, after the transfer of the washing operations for the primary packaging elastomer components, STELMI is now taking on the sterilization operations, so as to give greater flexibility to drug product manufacturers. The stoppers can be used immediately, enabling a better distribution of resources and removing the need for investment in sterilization equipment with all its associated validations.
The highest degree of quality assurance
Insofar as the delegation of a key operation like sterilization requires the highest degree of quality assurance, STELMI combines high-quality components with effective validation and revalidation procedures (in line with ISO standards 11137 and 11607) as well as all documentation certifying compliance – including an FDA-registered type V DMF and a certificate guaranteeing sterility.
Obtaining “ready-to-use” components requires perfect knowledge of all the applicable pharmaceutical requirements, mainly involving the washing and sterilization stages. The level of validation provided by STELMI ensures that the process is controlled and yields products of superior and reproducible quality.
The elastomer-based formulations selected and proposed for the sterile components are compatible with radiosterilization. The sterile components are washed before sterilization using the UltraClean 6 evolution washing process – which complies with the most exacting standards and pharmacopoeias – thereby obtaining the highest level of particle and microbiological cleanliness.
Just like the sterile plungers, sterile stoppers are delivered in double-walled polyethylene bags or containers for use in an isolator, thus limiting the risk of contamination.
Gamma radiation: a safe and effective method of sterilizing stoppers
Stelmi chose gamma radiation as a sterilization method because this method has significant advantages for primary packaging components.
Gamma rays are highly penetrating, allowing the components to be sterilized in their original boxes and an entire pallet to be sterilized in one operation, thus limiting the risk of potential contamination to the transfer of the components to the sterile area, and ensuring traceability.
Sterilization is carried out without moisture, removing the need to dry the stoppers and offering a residual moisture guarantee for stoppers intended for lyophilized products.
The exposure dose is controlled and can be easily recorded.
Supplying “ready-to-use” primary packaging items is the logical follow-up to the supply of “ready-to-sterilize” items developed by STELMI in the 1970s. The validation protocol put in place by STELMI, along with gamma ray sterilization, provides pharmaceutical laboratories with the level of safety they need.