Wheaton CompletePAK: Enhancing the Efficiency of Drug Discovery and Drug Compounding
DWK Life Sciences introduces the first stocked, ready-to-use or customizable vial assembly that can be configured for any application.
The lack of a single kit that includes ready-to-use vials, stoppers and seals can limit the small batch drug product packaging options available to drug manufacturers, developers, and compounders. Researchers and compounding pharmacies can face extended lead times when purchasing packaging that does not meet their project specifications, and as a result, project timelines suffer.
DWK Life Sciences presents Wheaton CompletePAK, a range of primary packaging components that are stocked ready-to-use and are customizable for most drug applications. This single source focus can reduce your supply chain delays and speed time to market. Batch-specific certificates of analysis that document compliance with relevant USP standards are included in each kit. The customizable features of CompletePAK allow you to focus on your core competencies: developing, manufacturing, and compounding drug products.
Product Benefits for Compounding Pharmacies
Following 64 deaths in 2012 that resulted from inadequate processing controls, the FDA tightened oversight of compounding pharmacies. These new demands place additional burdens on pharmacy management and staff. Many of these facilities are working toward compliance with Section 503b of the Food, Drug and Cosmetic Act, which requires compliance with all cGMP requirements for large batch, sterile pharmaceutical drugs.
CompletePAK simplifies the sterile packaging supply chain by providing high-quality, ready-to-use drug packaging with complete manufacturing traceability, customized for your process.
Certificates of analysis in each kit document are compliant with:
- USP <788> Particulate Matter in Injections
- USP <85> Bacterial Endotoxin Test
- USP <71> Sterility Test
Product Benefits for Research and Drug Discovery
Drug development can be delayed by the limited availability of sterile vials, stoppers, and seals in lab batch quantities; this can affect development costs and schedules. CompletePAK is a unique, sterile packaging solution for research and drug discovery stages, since it promotes cost control and improves time-to completion scheduling.
Each kit component is cleaned of particulates, depyrogenated, and sterilized, and arrives ready-to-use in the lab. Vials are packed in sterile polypropylene trays, and can be used as filling aids. Kit packaging is sized to complement manual aseptic filling processes.
What is CompletePAK?
The CompletePAK consists of 13 components, including various sizes of vials, serum stoppers, lyo stoppers, and seals. By including specific components in a kit, you can configure the packaging solution that best fits your processing needs.
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