Patient safety is at the heart of the Ompi Stevanto Group EZ-Fill® vial and container design. By separating all containers in the secondary packaging, the EZ-Fill® sterile vial ensures maximum integrity of the container during transportation and ensuring no glass-to-glass contact.
The SG Ompi EZ-Fill® sterile vial is packaged in double bagged trays of 96 pieces. This smaller than conventional quantity per tray allows for more efficient processes in your facility (compounding pharmacy, CDMO, etc).
(above) When removed from the double bag pouch, each tray of the EZ-Fill® sterile vials will be sealed with a sterile sheet.
These steps must be performed in the cleanroom environment.
Simply peel back this added protective barrier and remove the second sterile barrier beneath it (see above).
Each of the Stevanto Group-OMPI Ez-Fill® vial is arranged in its own segmented alveolar compartment to avoid glass-on-glass contact. Lot identification is found in dot-matrix font on one end of the partitioned alveolar tray (see below).
Open RTF sterile vials for compounding pharmacies, outsourcing manufacturers and CDMO facilities. Manufactured and washed using WFI by Gerresheimer, with sterilization processing and documented validation by SteriGenics. These Ready to Fill Gx® RTF ready to fill sterile vials are available in the following sizes:
5ml (6ml) clear 62121S-5 and 5ml (6ml) amber 62421S-2: both 22x40mm with a standard 20mm OD crimp finish. This dimension is an ISO 6R sized vial (the dimension matches what is colloquially referred to as a 5ml shorty). 5ml ready to fill sterile vials
EZVIALZ is a worldwide supplier of primary vial packaging for compounding pharmacies, biologicals manufacturers and medical development research facilities. Ready to Fill sterile vials, sterile vial stoppers and numerous vial seals are available in numerous options READY TO SHIP. Unlike most suppliers, we have immediate stock available in both small and bulk volumes for rapid worldwide delivery.
CUSTOMS CLEARANCE TO CANADA – EZVIALZ is able to ship to clients in Canada and clear the goods through Customs in advance ! You dont need to hassel – we do the work for you!
EZVIALZ offers both 13mm and 20mm vial stoppers that are Bioburden Tested and BET Tested (Bacterial Endotoxin Tested) by a US FDA and ISO 17025 certified facility in the USA. Our “Ready to Sterilize / Ready for Sterilization” (RFS series) vial stoppers are double bagged in autoclave ready sterilization bags with lot traceability for cGMP documentation compliance.
Bioburden Testing determines the number of colony forming units (CFU / microorganisms) present on a surface that has not yet been sterilized (autoclave sterilization, Ethylene Oxide, gamma-irradiation, etc). The US Code of Federal Regulations Chapter 21 211.110 (a)(6) clearly states that bioburden testing must be outlined and conducted according to written procedures during the processing of drugs. Click Here for Bioburden and BET Tested Stoppers
Bacterial Endotoxin Testing (BET) is an in vitro assay for detection and enumeration of bacterial endotoxins, a component of the cell wall of gram-negative bacteria. The BET must be performed for medical devices with direct or indirect contact to the cardiovascular system, lymphatic system, or cerebrospinal fluid. Also, the BET must be performed when manufacturing injectable pharmaceutical products. THe EZVIALZ RFS13 and RFS20 series stoppers have BET performed by a US FDA and ISO 17025 facility. Click Here for Bioburden and BET Tested Vial Stoppers.
Sterile 20mm Lyophilization Stoppers, “2-Leg Style”, gamma-Irradiated at a minimum 25 kGy (Cobalt-60).
Independent 3rd party testing for CFU and Endotoxins. Packaged in a double-polyethylene bag with gamma-irradiation indicator on each bag. Each bag is lot labeled for traceability to both your CFU/Endotoxin testing paperwork and invoice. Document traceability on this product helps you to stay compliant with cGMP requirements.
One of the issues that customers routinely get confused with when ordering is the difference between a molded vs tubing vial. Both of these styles are listed on our website, so make sure your staff is aware of the difference before placing an order.
A molded serum vial (aka: molded serum bottle) is made from molten glass that is dropped into a mold, compressed, and then released when hardened. Molded serum vials (serum bottles) have a thicker wall compared to tubing vials, and a convex bottom (vs flat in a tubing vial). There is also a faintly visible vertical seal running along the side of a molded serum bottle.
A tubing serum vial is made from long glass tubes with a rigidly defined wall thickness; the tubing is then cut to appropriate lengths to make the vial. The advantage to tubing vials is that the wall is uniform in thickness and the bottom of the vial is flat (vs convex in a molded vial). Tubing vials are the better option for use in lyophilization applications.
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
20mm Round Bottom Bromobutyl Stoppers, gamma-Irradiated at a minimum 25 kGy (Cobalt-60). Independent 3rd party testing for CFU and Endotoxins. Packaged in a double-polyethylene bag with gamma-irradiation indicator on each bag. Each bag is lot labeled for traceability to both your CFU/Endotoxin testing paperwork and invoice. Document traceability on this product helps you to stay compliant with cGMP requirements.
10mL Amber USP Type 1 Borosilicate Glass – manufactured and washed by Gerresheimer, depyrogenated and sterilized by Sterigenics. Sold both in reams of 179 and full cases of 716 (4 reams of 179). Lot labeled, double bagged sterile, depyrogenated vials are arranged in plastic trays for easy handling in the cleanroom. Full documentation for sterilization and 7 day sterility assurance testing is available for all lots sold. CLICK HERE TO ORDER
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