Roots Analysis has announced the addition of ” Pre-Sterilized / Ready-to-Use Primary Packaging Market” report to its list of offerings.
Primary packaging, such as vials, syringes, and cartridges, and their affiliated closures, play a vital role in ensuring the stability, and sterility, and thereby, the overall quality, efficacy and safety of a drug product. Moreover, the packaging bears the product label, which provides information related to the drug and, in certain cases, dosing instructions.[1] Pharmaceutical packaging is typically carried out under controlled conditions; specifically, for therapeutics that are designed for parenteral administration, fill / finish is carried out in sterile and aseptic environments. It is also crucial for innovators (or packaging service providers) to choose the appropriate, high quality primary packaging for their respective products; this is because the packaging material is in direct contact with the drug / therapy.[2] Building and maintaining the necessary expertise and infrastructure to support pharmacological fill / finish is a capital-intensive ordeal. Further, the growing complexity of modern pharmacological interventions, such as monoclonal antibodies, cell and gene therapies (which are typically produced in small batches) and the gradual (but imminent) shift to personalized therapies, has prompted drug developers to look for leaner manufacturing and packaging solutions. In this context, cost optimization is important and one of the available ways to save both time and capital is by bypassing manual processing and sterilization of primary packaging and switching to ready-to-use (RTU) formats.
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Amongst the primary packaging containers, vials and syringes emerged as the most common types of pre-sterilized / RTU containers manufactured by stakeholders engaged in this domain. This can be attributed to the fact that these containers are the most suitable for packaging of small volume of therapeutics, such as biologics, cell therapies, small molecules, vaccines and other potent products.
Further, glass emerged as the most preferred fabrication material used for pre-sterilized / RTU containers. Of these, majority (83%) of the containers are made of type I borosilicate glass, followed by those fabricated using type II treated soda-lime glass (10%) and type III soda-lime glass (7%). This is followed by pre-sterilized / RTU containers fabricated using plastic (29%), primarily cyclic olefin polymer. Examples include (in alphabetical order) ClearVial (MedicoPack), Daikyo Crystal Zenith Insert Needle Syringe Systems (Daikyo Seiko), Daikyo Crystal Zenith Ready to Use Vials (Daikyo Seiko) and SCHOTT TopPac sensitive (SCHOTT).
Sterilization of primary packaging systems is considered to be an essential step in the overall healthcare manufacturing process as it deactivates various forms of contaminating agents (particularly referring to bacteria, fungi, protozoa and viruses). Majority (43%) of the pre-sterilized / RTU containers are sterilized using ethylene oxide, followed by those employing steam sterilization (34%).
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