2ml clear open sterile vials, double bagged tray of 417 pieces PLUS a separate double bagged quantity of 1,000 13mm sterile vial stoppers.
Gerresheimer USP Type 1 borosilicate glass vials measuring 15x32mm with standard 13mm crimp finish. Arranged in double bagged plastic trays of 417 pieces per tray. Each double bagged tray will have a corresponding lot label for traceability to your cGMP compliant paperwork showing glass certification and sterility assurance testing. Manufacturing and washing with USP WFI is made by Gerresheimer; sterilization and USP sterility testing is managed by Sterigenics.
13mm bromobutyl stoppers that meet USP specifications are manufactured in a facility that maintains a DMF registration with the US FDA. Stoppers are washed with USP WFI and sent for gamma-irradiation sterilization in an ISO Certified government facility. Each bag of sterile, ready to use stoppers has a gamma-irradiation indicator and lot traceability label for your cGMP compliance documentation.
13mm and 20mm sterile vial stoppers from Voigt Global Distribution Inc. Pre-washed, gamma-irradiated sterile vial stoppers are available from Voigt Global Distribution Inc in convenient bags of 1,000 pieces. Manufactured by an FDA – DMF registered facility and tested in the USA for compliance with USP Sterility Testing and Endotoxin standards. Irradiation procesing and production lot traceability labelling is each double bagged 1,000 piece sale unit. See: https://voigtglobal.com/237-sterile-vial-stoppers
Compounding pharmacies that operate under the auspices of cGMP (503b compounding pharmacies) must use validated pharmaceutical grade sterilization filters. PALL KLEENPAK pharmaceutical sterilization filters are validated as a true pharmaceutical sterilizing grade filter; we have 3 immediately available. CLICK HERE TO ORDER PALL KLEENPAK PHARMACEUTICAL STERILIZING FILTERS
On December 1, 2013, the new United States Pharmacopeial Convention (USP) labeling standards for ferrules and cap overseals were adopted. Unless a notation is explicitly required for safe use on the vial cap ( eg: dilute before using ), words cannot appear embossed in a vial seal. Words such as “FLIP OFF” cannot be present in the plastic cap of a flip off seal under these new USP standards. The top of a “flip off / flip cap” style seal must be blank (no logos, no words, etc). To maintain compliance with this new standard, your facility should be using either our West Pharmaceuticals brand Matte flip off style seals or our 13mm West Smooth Gloss flip cap vial seals. The West Pharma Matte flip cap seals have a textured matte finish, while the West Smooth Gloss seals have a smooth glossy finish. Both of these flip cap style seals have no words or logos embossed in the plastic, and are available in numerous colors. Send us an email to see what colors are available. CLICK HERE TO ORDER WEST MATTE FLIP OFF SEALS
VGDINC offers both pre-sealed and unsealed sterile serum vials in clear and amber glass. Sealed sterile vials range in size from 2ml to 100ml; unsealed open sterile vials are available in 2ml, 5ml (6ml) and 10ml. USP sterility certification, endotoxin testing and other documentation required for cGMP compliance are available for every lot sold. Ideal for compounding pharmacies, both 503A and 503B. CLICK HERE TO ORDER STERILE VIALS