FEP

What is FEP?
It is fluorinated ethylene propylene which is a fully fluorinated fluoropolymer

Why is FEP good for cryogenic storage?
FEP has an extremely wide continuous service temperature is remains flexible even at liquid nitrogen temperatures (-196°C)

What are the mechanical properties of FEP?
The tensile strength is 2500 psi (minimum) and the elongation at break is 250% (minimum) per ASTM D882

What is the chemical resistance of FEP?
FEP has excellent resistance to all common chemicals, including DMSO and DM

What are the permeability properties of FEP?
Typical values for permeability are as follows:

(1) Transmission rates measured on 5 mil FEP film, the thickness of film used in bag construction

Is FEP optical clear?
Yes, FEP material is optically clear.

What wavelengths of light does FEP transmit?
FEP material can transmit UV, Visible, and IR light. This is especially useful for those who want to UV or IR irradiate the contents of the bags without breaking sterility.

Is the FEP film used in Saint-Gobain bags USP Class VI?
Yes, the FEP material Saint-Gobain uses is USP Class VI compliant.

What is the thickness of FEP material used in the Saint-Gobain bags?
5 mil (0.005 in). Other custom material thicknesses are available: contact us.

Is your FEP film Animal-Derived Component Free (ADCF)?
Yes, the FEP Saint-Gobain uses is ADCF.

What components are made out of FEP in Saint-Gobain bags?
Film and ports.

Manufacturing of Saint-Gobain FEP Bags

What size and shape bags can be produced?
Our manufacturing process currently allows us to produce bags with nominal internal volumes from ~1 mL to ~50L in a variety of shapes.

Do you manufacture in clean room?
Yes, our manufacturing facility is a Class 100,000 Cleanroom, and FDA registered/inspected.

How are Saint-Gobain FEP bags sterilized?
Currently, all Saint-Gobain FEP bags are steam sterilized and every lot is provided with a certificate of conformity demonstrating a Sterility Assurance Level (SAL) of 10-6.

Do you have data on leachables and extractables?
Yes. Link to validation guide in documentation center

Have your bags tested under USP<661>?
Yes. Link to validation guide in documentation center

How are Saint-Gobain FEP bags identified?
Every bag has a laser engraved product code and lot number and, if desired, bags can be serialized as well.

What regulatory approval do these bags have?
VueLife® and KryoSure® bags are FDA 510(k) cleared and are intended to be used for the containment of fluids and suspensions during transportation, processing, incubation, storage and cryopreservation. Please inquire about our referenceable device master file. 

VueLife® Standard Culture Bags (“C” Series)

What are the standard sizes offered for VueLife® Standard Culture Bags (“C” Series)?

Standard bags are available in a variety of standard sizes.

Are other sizes available?

Yes, custom sizes are available

What are the typical uses of VueLife® “C” Bags?

VueLife® bags can be used for the culture of many primary cell types including, but not limited to: T cells, NK cells, B cells, and monocytes.

Can your bags be used for the culture of cells that require constant agitation?

The bags may be used with shaker and rocker platforms.

What kind of systems can you provide for the transfer of cells and materials?

The VueLife® “C” and “AC” series of bags are “closed systems” and come standard with sterile-dockable tubing, to allow sterile addition or transfer of materials. Their interior will remain sterile even if the bag is removed from the autoclave pouch in an open laboratory environment.

What are ways to do an expansion culture in one bag?

Utilize Saint-Gobain clamps.

How do you seal the bags?

What is the best position of the bag when culturing cells?

It is strongly recommended to use a culture rack in order to maximize the gas permeability through the bottom of the bag.

VueLife® Adherent Culture Bags (AC)

What are the standard sizes offered for VueLife® Adherent Culture Bags (“AC” Series)?

Standard bags are available in a variety of standard sizes

Are other sizes available?

Yes, custom sizes are available.

How are the VueLife® “AC” bags different from VueLife® “C”bags?

VueLife® AC bags are made with the same FEP film with proprietary surface treatment that allows the film to have a higher surface energy.

What are the typical uses of VueLife® “AC” bags?

The proprietary surface treatment on VueLife® AC bags is meant to better promote cell and protein adhesion to the surface of the bag. Due to this, the bags can be used when a protein layer is needed (e.g. for transfection) or for culturing of cell types that may require adhesion.

How are cells released from adherent cell bag?

Cells may be removed by conventional methods (e.g. trypsin) or by physical measures. This will depend on the level of adhesion to the bag.

Can your bags be used for the culture of cells that require constant agitation?

The bags may be used with shaker and rocker platforms.

What kind of systems can you provide for the transfer of cells and materials?

The VueLife® “C” and “AC” series of bags are “closed systems” and come standard with sterile-dockable tubing, to allow sterile addition or transfer of materials. Their interior will remain sterile even if the bag is removed from the autoclave pouch in an open laboratory environment.

How do you seal the bags?

What is the best position of the bag when culturing cells?

It is strongly recommended to use a culture rack in order to maximize the gas permeability through the bottom of the bag.

KryoSure® Cryopreservation Bags

What are the standard sizes offered for KryoSure® Cryopreservation Bags?

Standard bags are available in a variety of standard sizes.

Are other sizes available?

Yes, custom sizes are available.

Why are KryoSure® bags good for cryopreservation?

KryoSure® bags are made from FEP material which stays flexible at liquid nitrogen temperatures. Additionally, the bags are specifically designed with rounded corners and port protectors for durability during freezing.

How are the KryoSure® bags different than other Saint-Gobain FEP bags?

Ports are protected with FEP flaps to prevent any liquid nitrogen contamination during cryopreservation. Additionally, most KryoSure® bags have a label pocket to allow the user to insert a label.

How are samples from KryoSure® bags identified?

The samples can be identified with the unique number engraved into the label pocket and etched into the fill tube in three places which provides unalterable segments for cross-identification. The label pocket can be utilized for additional identification.

What options do you have for extremely valuable products that need to be cryopreserved?

Saint-Gobain offers FEP KryoSure® overwraps for added protection. Additionally, Saint-Gobain manufactures FEP KryoSure® bags to fit metal cassettes.

KryoVue®

What is a KryoVue® “Peel-Pouch”?

It is a peel-pouch designed to be used as an overwrap for the protection of valuable samples stored in liquid nitrogen.

How is a KryoVue® “Peel-Pouch” different from the KryoSure® FEP overwrap?

KryoVue® products are made using a Kapton® film which consists of a FEP fluid contact layer and polyimide outer layer.

----Kapton® is a registered trademark of E.I. du Pont de Nemours & Co.

What are the KryoVue® Sterility covers used for?

KryoVue® Sterility covers are made of the same Kapton® material as the KryoVue® “Peel-Pouch”. They are used to provide a barrier between a bag and a sealer, which provides a sterile environment to contain the bag-to-be-sealed. They are provided non-sterile but can be steam sterilized by the end user.

----Kapton® is a registered trademark of E.I. du Pont de Nemours & Co.

Fluid Transfer Assemblies

What options does Saint-Gobain offer for sampling?

Saint-Gobain offers a wide range of Fluid Transfer assemblies for different sampling applications. Options include but are not limited to: tubing assemblies, syringe assemblies, and sampling manifolds. Other custom assemblies are available upon request.