Sterile vial stoppers, washed and gamma irradiated, ready to use.
We offer 13mm and 20mm washed and sterilized vial stoppers for use with our open Ready to Fill sterile vials. Compounding pharmacies can save time and money while remaining in compliance with documentation requirements. Our sterile vial stoppers are manufactured from USP quality bromobutyl rubber, washed using purified water, packaged into 1,000 piece bags, and sent to be sterilized by gamma radiation. The manufacturers of our sterile vial stoppers are ISO certified. All production lots have 3rd party sterility and endotoxin testing performed with testing result documentation provided to our distributors and clients worldwide.
Overview Our Amber 30ml Sterile Vials are designed for the pharmaceutical manufacturing and compounding pharmacy sectors, particularly suited for cleanroom environments and Restricted Access Barrier Systems (RABS).
Product Details
Construction Material: USP Type 1 Amber Borosilicate Glass
Dimensions : 20mm crimp finish (13mm hole x 20mm outer rim), with a OD x H dimensions of 37mm (W) x 66mm (H)
Packaging: Arranged in durable plastic trays of 63 vials, hermetically sealed for maximum protection.
Quality Assurance Each vial is thoroughly processed and tested:
Formed and washed with USP Water for Injection (WFI) by Gerresheimer®.
Depyrogenated through heat treatment and sterilized using ethylene oxide by SteriGenics®.
Comprehensive USP sterility and endotoxin testing reports are available for all lots, ensuring compliance with USP and cGMP regulations worldwide.
Additional Components Available We also offer compatible 20mm seals and stoppers, available separately. Choose from washed, ready-to-sterilize options or pre-sterilized closures for your convenience.
Certification & Compliance of Closures Our Ready to Use (RTU) vial stoppers and flip cap seals comply with stringent USP and AAMI standards. Our sterile vial closures are delivered ready to use, having undergone rigorous washing to eliminate particulates, inactivation of endotoxins, and sterilization according to USP and AAMI specifications. Third-party testing documentation by ISO certified testing laboratories is provided for all lots sold. This meticulous process reduces end-user costs and saves valuable time on processing, testing, and validation.
Why Choose Us? We are your trusted source for complete vial packaging solutions tailored to meet the regulatory demands of the biological and pharmaceutical industries. Experience unparalleled quality and service with our products.
Voigt Global Distribution is now offering ISO 6R RTU RTF open sterile nested vials to clients worldwide!
These ISO 6R open nested sterile vials have been washed using purified water, depyrogenated with heat, then sterilized. Full sterility and endotoxin tests are performed for each lot produced.
Close up image of the ISO 6R nested sterile vial tray. Also referred to as an alveolar style nested tray.
The image above is a close up of the unique nested tray. The nested tray design keeps glass vials from touching one another during transportation and storage. This greatly reduces cosmetic imperfections in the glass during transportation and storage.
The small number of vials (96 pieces) in this protective nested vial tray is ideal for smaller batches produced by compounding pharmacies.
ISO 6R dimension is 22mm wide and 40mm in height to the top of the crown rim. Standard 20mm crimp finish (13mm hole opening x 20mm outer rim diameter). These vials meet ISO 8362 for the 6R vial used in injectable preparations.
Since these vials are unsealed, the double bagged tray requires opening in a cleanroom.
20mm seals and stoppers are sold separately. Sterile 20mm vial stopper and sterile 20mm flip cap seals for these sterile nested vials are available upon request.
We now offer convenient single tray sale units of our ISO 10R amber open sterile vials in 96 piece nested trays. USP Type 1 amber glass is the starting material by Gerresheimer AG. ISO 10R dimension 24mm OD x 45mm height with a standard 20mm crimp finish is created from the glass tubing then washed using USP quality water. These ISO 10R amber glass vials are depyrogenated with heat and sterilized using ethylene oxide by SteriGenics. Sterile ISO 10R amber vials are arranged in nested “alveolar” style trays – a benefit to the customer, as the nested tray arrangement keeps glass vials from touching one another while in transit and storage. This protective nested tray is best in class for primary packaging of serum vials used in the pharmaceutical industry.
TO see an example of amber serum vials arranged in a nested tray, see the image below:
ISO 6R Amber Sterile Vials. Open un unsealed sterile vials in a nested tray configuration.
ISO 6R Amber Sterile Open Vials, Depyrogenated, Nested Alveolar Tray of 96 pieces
ISO 6R Amber Open Sterile Vial: 22x40mm with a 20mm crimp finish.
Manufactured and pre-washed by world renowned Gerresheimer, depyrogenated and terminally sterilized by SteriGenics.
Must be opened in the cleanroom – these sterile open vials are unsealed.
UNIQUE: durable plastic alveolar nested trays reduce cosmetic imperfections and damages during transit. These ISO 6R sterile amber open vials do not touch each other during transit and storage. See the second image for clarification.
A completed C of C on Gerresheimer letterhead is available on request for all lots sold. All nested alveolar trays of 96 pieces have a label showing: GERRESHEIMER Our Item No.: 82421S-5 The Lot / Batch Number Quantity per ream This information is then traceable to your paid invoice as well as the Gerresheimer C of C
Sold as a sealed nested alveolar tray of 96 pieces UNSEALED / UNSTOPPERED – must be opened in the cleanroom!
Measure 16x35mm with a standard 13mm crimp finish – unsealed, sterile and ready to fill (RTF). Manufactured and pre-washed by world renowned Gerresheimer, depyrogenated and terminally sterilized by SteriGenics. Must be opened in the cleanroom – these sterile open vials are unsealed. Provided in plastic trays with double bagging.
UNIQUE: Our ISO 2R amber sterile vials are arranged in durable plastic nested trays (alveolar trays) which reduce cosmetic imperfections and damages during transit. These ISO 2R sterile amber open vials do not touch each other during transit and storage. See the below image for clarification:
ISO 10R 10ml open sterile vials in nest and sterile tub packaging
ISO 10R 10mL STERILE VIALS – READY TO FILL – READY TO USE
VOIGT GLOBAL DISTRIBUTION offers the highest quality ready to fill open sterile vials at to customers worldwide. Our latest addition to our complete ready-to-use complete vial kit packaging components are sterile ISO 10R 10ml vials, which have the following characteristics:
manufactured using clear USP Type 1 borosilicate FIOLAX® glass tubing
washed with USP WFI water
depyrogenated with heat
sterilized with ethylene oxide
tested for USP sterility and endotoxin compliance
Full USP sterility and endotoxin testing reports are available to all customers for cGMP and State regulatory compliance requirements. USP Type 1 clear FIOLAX® borosilicate glass is used to manufacture these vials to ISO-8362 specification.
Dimensions: 24mm diameter x 45mm height to the top of the crown opening with a standard 20mm finish. 20mm sterile vial flip cap seals and 20mm sterile vial stoppers are also available (sold separately).
BENEFITS OF ISO 10R 10ml OPEN STERILE READY TO USE – READY TO FILL VIALS
Lowered costs to the user by providing a pre-washed, sterilized, depyrogenated 10ml sterile vial. No additional preparation supplies necessary.
Documented USP sterility and endotoxin testing showing compliance to USP <71> and USP <85> standards.
Advanced preparation speeds delivery of the product to market distribution
The alveolar style tray prevents glass-on-glass contact during transportation and storage, thereby reducing the risk of cosmetic imperfections and damage during transit.
ISO 10R dimensions are compliant with ISO 8362-1 standards, and are suitable for clients worldwide
Small tray size of 96 pieces reduces waste associated with larger trays, making these ideal for pilot prototype R&D applications, as well as small batch production by compounding pharmacies, cGMP outsourcing manufacturing facilities and CDMO.
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:
DESCRIPTION
CURRENT
ISO REPLACEMENT
2ml clear and amber
15x32mm
16x35mm
5ml/6ml clear and amber
22x40mm
remains the same
10ml clear and amber
24x50mm
24x45mm
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.
Ready to fill sterile vials in 2ml 5ml and 10ml sizes in both clear and amber.
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.
