READY TO FILL STERILE VIALS

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:

2ml clear 62113S-2 and 2ml amber 62413S-2 : both measure 15x32mm with a standard 13mm OD crimp finish. 2ml ready to fill sterile vials

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

10ml clear 62121S-10 and 10ml amber 62421S-10 : both measure 24x50mm with a standard 20mm OD crimp finish. 10ml ready to fill sterile vials

Gerresheimer RTF Ready to Fill sterile vials – immediate shipping from in stock warehouse centrally located in the USA – we ship sterile Ready to Fill vials to customers worldwide! BUY STERILE VIALS NOW

COMPOUNDING PHARMACY STERILE VIALS VIAL SEALS VIAL STOPPERS & PHARMACEUTICAL FILTERS

Sterile Serum Vials Ready to Fill and Sterile Vial Stoppers – gamma-irradiated – with sterility , CFU bioburden and endotoxin testings reports for all lots sold

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!

CONTACT: sales@ezvialz.com

EZVIALZ Canada Customs Clearance

Bioburden Tested VIAL Stoppers

Ready for Sterilization
Bioburden Tested and Bacterial Endotoxin Tested vial stoppers from EZVIALZ

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

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. 

CLICK HERE TO ORDER

Sold in bags of 1,000 pieces

ISO 10R Vials from EZVIALZ

EZVIALZ now offers ISO 10R dimension vials in both clear and amber. Our ISO 10R vials measure 24x45mm with a standard 20mm crimp finish (13mm hole opening and 20mm outer rim diameter).

62121A2-10, ISO 10R Clear:  https://ezvialz.com/10ml-vials/1027-10ml-clear-shorty-serum-vials-sid-yxp-24x45mm-ream-of-252.html

62421A2-10, ISO 10R Amber:  https://ezvialz.com/amber-serum-vials/1026-10ml-amber-shorty-serum-vials-sid-yxp-24x45mm-ream-of-252.html

Both the above clear and amber 10R style vials are manufactured using USP Type 1 borosilicate glass and are packaged inverted in shrink wrapped plastic trays of 252 pieces per tray.

 

10R Amber 10ml vial 62421A2-10

Molded versus Tubing Serum Vials and Serum Bottles

Tubing vs Molded
Example of a molded 10ml serum bottle and tubing 10ml serum vial

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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.

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Bromobutyl Vial Stoppers VS Chlorobutyl Vial Stoppers

Bromobutyl Vial Stoppers vs Chlorobutyl Vial Stoppers
Bromobutyl Vial Stoppers vs Chlorobutyl Vial Stoppers from EZVIALZ

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

Bromobutyl Rubber

Advantages:

  • 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.

Disadvantages:

  • stabilizers are required in the production of bromobutyl rubber (such as soybean oil).
  • heat sensitivity is a greater concern with bromobutyl stoppers.

Chlorobutyl Rubber

Advantages:

  • better resistance to heat and is the preferred stopper for high-heat sterilization techniques.
  • efficiently produced without the use of stabilizers.

Disadvantages:

  • longer curing times, resulting in higher production costs

Sterile Vial Stoppers

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.

Sold in bags of 1,000 pieces.  CLICK HERE TO ORDER

10ml amber sterile vials – open – ready to fill PYROGEN FREE

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

10ml Open Sterile Pyrogen Free Serum Vials

10mL Sterile Serum Vials, PYROGEN FREE, USP Type 1, Unsealed.

Pyrogen Free Sterile 10mL Serum Vials - Unsealed
Pyrogen Free Sterile 10mL Serum Vials – Open and Unsealed – must be opened in the cleanroom!

 

 

 

 

 

 

 

USP Type 1 Borosilicate Glass – manufactured, washed, depyrogenated and double bagged by Gerresheimer – the true manufacturer and worldwide standard in pharmaceutical packaging. 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