A range of tubular glass serum vials, rubber stoppers and seals supplied ready-to-use in one complete kit, certified to European Pharmacopoeia and US Pharmacopoeia, and available off the shelf. The components are also available to be purchased separately.
Ready-to-use clear tubular glass serum vials, rubber stoppers and seals
18 month shelf life from date of processing
Comes with critical USP and EP certifications, and product conforms to requirements outlined in the current versions EP 3.2.1 and EP 3.2.9
PARTICULATE - lot certified to current versions of USP <788> using Method 2, and EP 2.9.19 Microscopic Particle Count Test
STERILITY - lot certified to current versions of USP <71> and EP 2.6.1
ENDOTOXINS - Lot certified to current versions of USP <85> and EP 2.6.14, lot was tested and is certified to <0.25 EU/mL, Kinetic Turbidimetric LAL Method, FDA Guideline
Container Closure Integrity (CCI) certification available upon request
Complete manufacturing traceability
Aseptic filling of injectable drug products
Drug research]Freeze drying / lyophilisied drug products
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:
Products supplied ready-to-use to improve workflow
Single source options reduce lead times & Simply administrative effort
Focuses your efforts on core competencies
Eliminates capital investments in sterile processing equipment
Frees up valuable clean room space
Validated processes & Certificate of Analysis Traceability assures quality production outcomes
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.
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
Pre & post sales support
Complimentary product offering
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.
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.