As the global demand for open sterile vials increases, so does the requirement for manufacturing standardization and distribution efficiency. To achieve the utmost efficiency and reproducible quality while maximizing global standardization in vial size, new automated manufacturing systems and equipment will be implemented in the coming 2-3 years. Once fully implemented, there will be a slight dimensional change to some of the open sterile RTF vials we offer.
International Standards Organization (ISO) – Vial Dimensions
Below is a table of the open sterile vial dimensions we offer now VS what the ISO replacement will be in 2-3 years:
2ml clear and amber
5ml/6ml clear and amber
remains the same
10ml clear and amber
NOTICE: the same size seals and stoppers you order will also work with the ISO version. Only the vial OD x H changes (NOT the crimp finish).
You can immediately order samples of non-sterile ISO 2R, 6R, and 10R vials to review ahead of time. If your pharmacy is applying labels to the vials, you may want to order a few sample pieces to make sure the labels and other packaging (eg: vial boxes, etc) will work with the new ISO vial dimensions. For a visual illustration of our 62121S-10 and 62421S-10 in comparison to an ISO 10R vial size, please see the image below:
If you have any questions, please send us an email: sales@VGDINC.com The implementation of this new ISO standard production line will probably be in 2024 or 2025.
Voigt Global Distribution Inc offers worldwide sales and distribution of open sterile Ready to Fill sterile vials to compounding pharmacies, outsourcing manufacturing facilities and CDMO. Our cGMP compliant Ready to Fill open sterile vials offer several process advantages and cost savings to the pharmacist and sterile compounding technician, including:
Lessen the documentation burden associated with analytical testing of raw materials
Reduce or eliminate the cost and maintenance of vial washing and sterilization equipment
Reduce the space in your facility required for vial processing equipment
Eliminate the need for expensive WFI (water for injection) for vial processing
Reduce or eliminate the training required for laboratory technicians on appropriate vial washing and sterilization protocols
Only order what you need when you need it – perfect for smaller compounding pharmacy operations or pilot drug trial manufacturing requirements
Voigt Global Distribution Inc also offers validated sterile vial stoppers and sterile vial seals, with 3rd party sterility and endotoxin testing performed by an ISO certified facility here in the USA. This documentation is provided free of charge to all our paid customers of sterile vial packaging.
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.
Voigt Global Distribution Inc provides customers worldwide with sterile, ready to fill vials in sizes of 2ml, 5ml (ISO 6R), and 10ml sizes. Our open (unsealed) ready to fill sterile vials are manufactured by world recognized Gerresheimer AG, with subsequent sterilization performed by Sterigenics, an industry leader in sterilization technology.
VGDINC offers 13mm and 20mm round IVA Foil Seals – intranvenous admixture seals to help prevent duplicated additions or withdraws from IV bags and serum vials. VGDINC and IVPACKS LLC ship sterile IVA foil seals to clients worldwide and can assist you with Customs clearance brokerage services
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
Now offering Customs clearance in Canada and much of Europe! Buy any item from VGDINC and let us clear your goods through Canada Customs using our own GST account for Canada Customs clearance. Save time and money by consolidating your procurement and brokerage clearance services through one provider! For customers in Europe, we have affiliated resellers that can clear your goods through Customs in Europe using their EORI. Please contact us for additional information.