ISO 10R 10mL NESTED STERILE VIALS – READY TO FILL – READY TO USE
IVPACKS brings the highest quality open sterile vials at the lowest prices to customers worldwide. Our latest addition to our complete ready-to-use complete vial kit packaging are sterile ISO 10R 10ml vials that have been
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.
10ml ISO 10R 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 sold separately on this website.
BENEFITS OF OUR 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
Advanced USP sterility and endotoxin testing with documented compliance to USP <71> and USP <85>
Reduction in the time of preparation to speed delivery of the product to the client(s) and market distribution
Unique alveolar style tray prevents glass-on-glass contact during transportation and storage. This greatly reduces the risk of cosmetic imperfections and damage during transit.
ISO 10R dimensions are compliant with ISO 8362-1 standards, and are suitable for international 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.
IVPACKS offers Ready to Fill – Ready to Use sterile vials to CDMO, compounding outsourcing facilities, compounding pharmacies and other cGMP regulated facilities worldwide. USP Type 1 glass is used by Gerresheimer AG to manufacture and wash the vials, while depyrogenation, sterilizationand sterility testing is performed by SteriGenics. Both Gerresheimer AG and SteriGenics are recognized as leaders in the pharmaceutical industry worldwide.
13mm and 20mm sterile vial stoppers from IVPACKS are washed with purified water, then gamma irradiated for sterility. Both sterility and endotoxin testing reports are available for all lots sold by IVPACKS.
VIAL STOPPERS – Bromobutyl vs Chlorobutyl – ORDER HERE
In the US and European markets, serum vial stoppers are commonly available in both bromobutyl and chlorobutyl rubber for use in pharmaceutical packaging. Vulcanization (heating and curing) of natural rubber results in the cross-linking of individual polymer chains that forms a copolymer of isobutylene, and to a smaller extent, isoprene. The incorporation of a halogen (bromine or chlorine) in the vulcanization process results in the vulcanization rate being improved, blending and curing performance is improved, and the cross-link bonding property has also significantly improved. Each specific halogen offers its own unique characteristics to the finished product.
Bromobutyl Rubber: is a terpolymer of isobutylene, isoprene and brominated Isoprene.
Chlorobutyl Rubber: is a terpolymer of isobutylene, isoprene and chlorinated Isoprene.
Processing with Bromobutyl vs Chlorobutyl
When bromine is used as the halogen for producing bromobutyl rubber, it is generally added at a concentration of 2%; chlorine is added at a concentration of 1.1 – 1.5% in chlorobutyl rubber.
Bromine is more reactive than Chlorine, so a stabilizer is often added to the rubber (such as soybean oil at 1.3%). Chlorine, being more inert, does not require the use of any stabilizers.
The use of antioxidants (such as BHT) is approximately equal in both bromobutyl rubber and chlorobutyl rubber.
Advantages and Disadvantages: Bromobutyl vs Chlorobutyl
lower hygroscopicity and is a better choice for freeze dried / lyophilization product applications. Higher stability and generally have a longer shelf life.
faster cure rates and a shorter scorch or cure induction period (more efficient production)
requires lower levels of curatives and enables one to use a wider range of accelerators.
stabilizers are required in the production of bromobutyl rubber (such as soybean oil).
heat sensitivity is a greater concern with bromobutyl stoppers.
better resistance to heat and is the preferred stopper for high-heat sterilization techniques.
efficiently produced without the use of stabilizers.
longer curing times, resulting in higher production costs
10mL Clear Sterile Open Serum Vials – Washed, Depyrogenated, double bagged with plastic lid and tray. Sterilzed by Ethylene Oxide.
Case of 435 pieces (3 separate bagged trays of 145pc each).
Measure 24x50mm with a standard 20mm crimp finish – not sealed and are not stoppered. Manufactured, pre-washed, depyrogenated and terminally sterilized by world recognized Gerresheimer.
Must be opened in the cleanroom.
IDEAL FOR COMPOUNDING PHARMACY USE
A completed C of C on Gerresheimer letterhead is available for all lots sold.
All cases of 435 pieces have a label showing:
Item No.: 62121S-10
The Lot / Batch Number
Quantity per ream
This information is then traceable to your paid invoice as well as the Gerresheimer C of C.
2mL Clear and Amber Sterile Open Serum Vials, Depyrogenated
Measure 15x32mm with a standard 13mm crimp finish
Manufactured, pre-washed, depyrogenated and terminally sterilized by Gerresheimer.
Must be opened in the cleanroom – these sterile open vials are unsealed.
Provided in plastic trays with double bagging.
A completed C of C on Gerresheimer letterhead is available on request for all lots sold.
All reams of 417 pieces have a label showing:
Our Item No.: 62113S-2 (clear) or 62413S-2 (amber)
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 ream of 417 pieces
UNSEALED / UNSTOPPERED – must be opened in the cleanroom! ORDER 2ml OPEN STERILE INJECTION VIALS ONLINE NOW