Wheaton COMPLETEPAK Kit Clear Sterile Vial 5ml Lyo Stopper Red seal

What is CompletePAK®?

CompletePAK® consists of ready-to-use packaging components that can be custom configured via our product configurator. CompletePAK® was developed to assure that there is a solution for every application.

Top 7 reasons why you should choose CompletePAK for your application:

1. Products supplied ready-to-use to improve workflow
2. Single source options reduce lead times & Simply administrative effort
3. Focuses your efforts on core competencies
4. Eliminates capital investments in sterile processing equipment
5. Frees up valuable clean room space
6. Validated processes & Certificate of Analysis Traceability assures quality production outcomes
7. Saves valuable time and money while maintaining a high quality product and streamlining process

The beginning of a new product line:

The lack of ready-to-use vials, stoppers and seals all in one kit, including USP certificates and Container Closure Integrity (CCI) testing leaves drug manufacturers, developers and compounders with limited sterile traceability and compatibility. Researchers in the pharmaceutical industry and compound pharmacies are left with long lead times and the lack of sterile traceability which results to a decrease in time-to-market.

For this reason DWK Life Sciences developed a product line known as CompletePAK® which is a range of primary packaging components that come ready-to-use and off the shelf which are customizable for any application. This reduces customer’s supply chain due to our one source solution capability. Each kit comes with specific United States Pharmacopeia (USP) certificates showing that the products meet or exceeds critical USP standards that are enforced by the Federal Drug Administration (FDA). This kind of solution allows for our customers to focus on their core competency which is manufacturing, compounding and developing drug products.

Core Benefits

• Vial assemblies are sterilized and ready-to-use
• Off-the-shelf product → reduced lead times
• Custom configuration → kit for any application
• Variety of component options

Level II Benefits

• Comes with critical USP certifications
• Container Closure Integrity (CCI) is available upon request
• Equal amounts of components all in one box
• Open vials, not evacuated

Level III Benefits

• Quality management system
• Face-to-face relationship
• Pre & post sales support
• Complimentary product offering

Uses

Research/Drug Discovery

During the research and drug discovery stages for drug development there could be a possible delay time due to the limited availability of vials, stoppers and seals for direct filling options which decreasing the overall drug development market and delays time-to-market.

CompletePAK® is the perfect solution for the research and drug discovery stages because it allows for a consistent reduction of time-to-market and cutting cost related to manufacturing process. Each kit will go through particulate cleaning, depyrogenation and sterilization so researchers can receive the product ready-to-use which will accelerate their time to market. The vials are packaged in a sterile polypropylene (PP) tray which is ideal for manual filling. As each kit was designed to fit in a standard fume hood there will be a smooth filling process for aseptic processing applications.

Compund Pharmacy

The FDA has implemented tighter controls within the compounding pharmaceutical industry. Compounders are moving to become 503b compliant, meaning they will need to satisfy cGMP and are capable of producing sterile product EVERY time. Therefore, it is critical to work with a packaging vendor that has complete manufacturing traceability along with high quality products.

CompletePAK® simplifies sterile processing for compounders as each kit will come with the three certificates that meet or exceeds the USP chapters below, enhancing their ability to become 503b compliant.

1. USP <788> Particulate Matter in Injections
2. USP <85> Bacterial Endotoxin Test
3. USP <71> Sterility Test