- Type I Borosilicate Glass Serum Vial
- Low Particle Cleaned, Depyrogenated, and Sterilized
- Packaged in Plastic Trays with Double Autoclave Bags
- Uncapped and Unstopped.
- Minumim Purchase on 30ml (1,040 units), 50ml (1,029 units), 100ml (1,020 units)
- Your Purchase exceeds any of the limits provided regardless of Size another tier will be assessed for better pricing
- Seals and Stoppers Sold Separately.
1.) Filtration Solutions makes no warranties regarding the material properties or dimensions of the bottles. Filtration Solutions does not manufacture the bottles. Any inquiries regarding the properties of the bottles should be directed toward the manufacturer. Customer agrees to release Filtration Solutions for all liability for the material and physical properties and dimensions of the bottles.
2.) Bottles will be cleaned, depyrogenated, and sterilized using a combination of chemical and thermal methods. Bottles will be cleaned using a proprietary cleaning method which is at the discretion of the manufacturer to select. A final rinse of the bottles will be performed with water meeting resistivity, TOC, and endotoxin requirements for Water for Injection.
The bottles will be processed for low particulate. The bottles will have a particulate level of less than 1 particle per ml larger than 10um when tested with 100ml of filtered DI water, which meets the particulate requirements of USP <788> for small and large volume injectables.
3.) After cleaning, the bottles will be depyrogenated and sterilized. The clean bottles will be sterile. A bottle will have an endotoxin level less than 2EU which meets the endotoxin requirements of less than 20EU per bottle established for medical devices. Lower endotoxin levels are available upon request.
4.) The serum bottles will be bulk packaged in clean corrugated plastic trays to be supplies by manufacturer. The bottles will be packaged in 10 9/16” x 12 7/8” plastic trays.
The trays of bottles will be sealed in an autoclave bag. The trays of bottles will then be sealed in a second autoclave bag.
The trays of serum bottles will be packaged in 14” x 12” x 12” boxes, with four trays of bottles per box. The box of bottles may be over packed in a larger box at the discretion of manufacturer.
The bulk package configuration, which will be at the discretion of manufacturer, will be designed to both preserve the cleanliness of the components and protect them from damage during shipping.
5.) Serum bottles will be tested for particulate per USP <788> by manufacturer using the microscopic particle count test method. Items will be tested by pooling 10 or more samples and testing the internal/wetted surfaces of the components with filtered DI water. For the test, only particles larger than 10um will be recorded. The acceptance criteria will be a particulate level of less than 1 particle per ml larger than 10um when tested with 100ml of filtered DI water per bottle.
6.) All cleaning processes will be performed in a Class 100 to Class 10,000 or better cleanroom per Fed. Std. 209E (ISO 14644-1 Class 5-7).
7.) A certificate of Process will be issued for cleaning, depyrogenation, and sterilization. If further third party testing is selected or required, a certificate of Analysis will be issued for the sterility, LAL and particle count testing at an additional cost to customer.
8.) A shelf life of 6 months will apply to the processed bottles. If a longer shelf life is required, it is recommended that shelf life testing of the bottles is performed.
9.) For a quantity of up to approximately 3,000 bottles, typical delivery time can be up to 20-30 working days after receipt of materials and a valid purchase order, with additional time required for optional testing.
10.) In order to avoid delays in scheduling, purchase orders should be emailed to Matt Morgan @Mattm@filtrationsolutionsllc.com.
11.) Pricing in the table above is based on the specified purchase order quantities. If different quantities of bottles are required, it is recommended that the customer consult with Filtration Solutions LLC for the desired quantity of bottles. Which this could affect pricing per each.
12.) Terms are net 0 terms, until account can be established, F.O.B Michigan, USA.
13.) By accepting the terms of this quote through issuance of a purchase order, Customer acknowledges that the business transaction is occurring solely within the boundaries of the State of Texas, and customer assumes possession of any products shipped to them at the time that they leave the manufacturers facility. The parties agree that Texas Law Controls, and submit to the jurisdiction of the state and federal courts in Harris County, Texas in the event of any disputes between them.
Alternative packaging configurations are available if needed. Additional cleaning services and testing services for the bottles are also available, and can be quoted upon request.