All posts by vialpacks

Compounding Pharmacy, Open Sterile Depyrogenated Vials

Amber ISO 6R Clear and Amber Sterile Vials, Open Sterile Ready to Fill / Ready to Use, in Nested Trays

IO 6R Open Sterile Nested Vials
IO 6R Open Sterile Nested Vials

Clear or Amber USP Type 1 borosilicate sterile glass vials with a standard 20mm crimp finish (13mm hole opening x 20mm outer rim diameter). Outside diameter x height: 22x40mm

USP Type 1 borosilicate glass vials are formed and then washed using USP Water for Injection (WFI) by Gerresheimer®. The washed vials are depyrogenated using heat, and then sterilized using ethylene oxide by SteriGenics®. The finished vials are arranged in durable nested plastic trays and hermetically sealed.

ISO 6R 5ml 6ml open sterile vials in a alveolar style nested tray of 96 pieces
ISO 6R 5ml 6ml open sterile vials in a alveolar style nested tray of 96 pieces

NESTED TRAYS: unique nested tray (alveolar style tray) keeps glass vials from touching one another during transit and storage. This designs greatly reduces the chances of scratches or damages. The nested tray can also serve as a sterile vial rack during the filling process in your cleanroom.

With each paid order, IVPACKS customers will receive a certificate of conformance will be prepared. The certificate of conformance will contain the following elements:

▪ EtO residual determination, ISO 10993-7, Current Edition.

▪ Sterilization process conformance, ISO 11135, Current Edition.

▪ Sterility testing conformance, USP <71>, Current Edition

▪ Bacterial endotoxins, NMT 0.125 EU/mL, USP <85>, Current Edition

▪ Commercial information (order, date of production, quantity, glass tubing, etcetera).

Single sealed nested tray of 96 pieces

ORDER ISO 6R CLEAR OR AMBER NESTED STERILE VIALS AT IVPACKS

Compounding Pharmacy, Open Sterile Depyrogenated Vials

ISO 2R Amber Sterile Vials in Nested Trays

ISO 2R amber sterile vials, open, ready to fill, in nested trays of 228 pieces.

Amber ISO 2R Amber Sterile Vials, Open Sterile Ready to Fill / Ready to Use, in Nested Trays 

Amber USP Type 1 borosilicate glass vials with a standard 13mm crimp finish (7mm hole opening x 13mm outer rim diameter).

Outside diameter x height: 16x35mm

USP Type 1 borosilicate glass vials are formed and then washed using USP Water for Injection (WFI) by Gerresheimer®. The washed vials are depyrogenated using heat, and then sterilized using ethylene oxide by SteriGenics®. The finished vials are arranged in durable nested plastic trays and hermetically sealed.

NESTED TRAYS: unique nested tray (alveolar style tray) keeps glass vials from touching one another during transit and storage. This designs greatly reduces the chances of scratches or damages. The nested tray can also serve as a sterile vial rack during the filling process in your cleanroom. 

With each paid order, IVPACKS customers will receive a certificate of conformance will be prepared. The certificate of conformance will contain the following elements:

▪ EtO residual determination, ISO 10993-7, Current Edition.

▪ Sterilization process conformance, ISO 11135, Current Edition.

▪ Sterility testing conformance, USP <71>, Current Edition (Method: Direct inoculation).

▪ Bacterial endotoxins, NMT 0.125 EU/mL, USP <85>, Current Edition.

▪ Commercial information (order, date of production, quantity, glass tubing, etcetera).

Single sealed nested tray of 228 pieces 

ORDER ISO 2R AMBER NESTED STERILE VIALS AT IVPACKS

Compounding Pharmacy, Open Sterile Depyrogenated Vials

STERILE NESTED VIALS

BUY STERILE NESTED VIALS FROM IVPACKS

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

  1. Lowered costs to the user by providing a pre-washed, sterilized, depyrogenated 10ml sterile vial
  2. Advanced USP sterility and endotoxin testing with documented compliance to USP <71> and USP <85> 
  3. Reduction in the time of preparation to speed delivery of the product to the client(s) and market distribution
  4. 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. 
  5. ISO 10R dimensions are compliant with ISO 8362-1 standards, and are suitable for international clients worldwide
  6. 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.

BUY STERILE NESTED VIALS AT IVPACKS NOW

Uncategorized

Ready to Use Sterile Vials – Ready to Fill Sterile Vials – Unsealed Open Sterile Vials

Ready to Use – Ready to Fill Sterile Vials by IVPACKS

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.

STERILE VIALS – READY TO USE – ORDER NOW

STERILE VIAL STOPPERS – READY TO USE

IVPACKS also offers STERILE VIAL STOPPERS – ORDER NOW

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.

Order STERILE VIAL STOPPERS – READY TO USE

Compounding Pharmacy, Open Sterile Depyrogenated Vials, Stoppers Ready for Sterilization

Compounding Pharmacy Sterile Vials and Ready to Sterilize Vials

10ml sterile open depyrogenated vials
10ml sterile open depyrogenated vials

COMPOUNDING PHARMACY SUPPLIES by IVPACKS LLC

IVPACKS LLC offers compounding pharmacy customers sterile vials, ready to sterilize “pre-washed vials”, vial stoppers, sterile vial stoppers and pre-washed “ready to sterilize / ready for sterilization” vial stoppers, vial seals, West Pharmaceuticals FLIP OFF and Matte Seals, vial crimpers, and pharmaceutical grade sterilization filters.  CLICK HERE FOR COMPOUNDING PHARMACY VIAL PACKAGING

Uncategorized, Vial Stoppers Technical Information

VIAL STOPPERS – Bromobutyl Rubber vs Chlorobutyl Rubber

Bromobutyl vs Chlorobutyl Vial Stoppers
Worldwide sales of chlorobutyl and bromobutyl vial stoppers from IVPACKS LLC

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
Open Sterile Depyrogenated Vials

10ml Serum Vials Sterile Pyrogen Free Unsealed

  • 10ml sterile open depyrogenated vials
    10ml sterile open depyrogenated vials
  • 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:
GERRESHEIMER
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.

Sold as a case of 435 pieces: CLICK HERE TO ORDER OPEN STERILE VIALZ

Stoppers Ready for Sterilization

Vial Stoppers – Pre Washed Ready for Sterilization

VALIDATED CFU AND ENDOTOXIN TESTED PRE-WASHED VIAL STOPPERS

ready-to-sterilize-stoppers
Tested Validated Washed Vial Stoppers

A). Reduce preparation time compared to using “raw” stoppers.  B). Eliminate the need to perform CFU and Endotoxin testing  C). Testing and documentation performed by a US FDA certified facility

NOW AVAILABLE: 20mm Round Bottom, 20mm Lyophilization and 13mm Round Bottom Stoppers pre-washed, CFU/Endotoxin tested vial stoppers. CLICK HERE

Open Sterile Depyrogenated Vials

2ml Open Sterile Depyrogenated Serum Vials

Buy 2ml Open Sterile Depyrogenated Injection Serum Vials 

Sterile 2ml Injection Vials - open and ready to fill
Sterile 2ml Injection Vials – open and ready to fill

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:
GERRESHEIMER
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