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A single-use frozen storage

solution from Charter Medical


Charter Medical’s Freeze-Pak™ Bio-Containers are
designed for use in ultra-low temperature applications.
This film is a single web 12 mil polyolefin monolayer that
does not contain an integral gas barrier. Freeze-Pak™
offers robust performance at temperatures as low as
-196°C and is suitable for long-term storage of both cell
and non-cell based materials. A registered DMF# is
available upon request.

Freeze-Pak™ Film and Bags:


• Offer robust performance as low as -196°C
• Remain pliable in frozen state
• Designed to fit off-the-shelf freezing and
storage cassettes

Standard Applications Include:


• Cell therapies
• Regenerative medicine
• Working and master cell banks

General Product Design

Polyolefin
12 mil

Single
Layer

*Custom designs available upon request


FP-50ML FP-250ML FP-500ML FP-750ML
Ordering Information
Catalog # Vol @ -196°C Freeze-Pak™ Bag Description Dimensions (includes ports) Case QTY
FP-50ML 10 – 30mL 50mL max fill volume, 1 EVA line with 2 PVC leads 3" (7.6cm) W x 8.4" (21.3cm) L 25
(4" L ; 0.118" ID x 0.160" OD) and female luers
FP-250ML 30 – 70mL 250mL max fill volume, 1 EVA line with 2 PVC leads 5.1" (13cm) W x 7.3" (18.5cm) L 25
(4" L ; 0.118" ID x 0.160" OD) and female luers
FP-500ML 55 – 100mL 500mL max fill volume, 1 EVA line with 2 PVC leads 5.1" (13cm) W x 8.9" (22.6cm) L 25
(4" L ; 0.118" ID x 0.160" OD) and female luers
FP-750ML 80 – 190mL 750mL max fill volume, 1 EVA line with 2 PVC leads 5.1" (13cm) W x 9.9" (25.1cm) L 25
(4" L ; 0.118" ID x 0.160" OD) and female luers

Film Physical Test Data (pre-gamma irradiation)


Property Test Protocol Typical Values
Tensile Strength at Break (Mpa) ASTM D882 17
Elongation at Break, MD/TD (%) ASTM D882 250
Elastic Modulus (Mpa) ASTM D882 17
Oxygen Permeability cm /100in /24 Hrs. @ 25ºC, 0% RH
3 2
ASTM D3985 180
Carbon Dioxide Permeability cm /100in /24 Hrs. @ 25ºC, 0% RH
3 2
ASTM F2476 1477
Water Vapor Transmission Rate g/100in /24 Hrs. @ 25ºC
2
ASTM F1249 1.1
Density (g/cm )3
ASTM D792 0.92
Tg (Glass Transition) DSC -48°C
Break at Cold Temperature ISO 8570 Below -80°C
Particulates USP <788> Pass

Film Physical Test Data (post-gamma irradiation)


Property Test Protocol Value
USP Class VI USP <88> Pass
Cytotoxicity USP <87> Pass
Hemolysis ISO 10993-4 Pass
Heavy Metals USP <661> Pass
Buffering Capacity USP <661> Pass
Non-Volatile Residue USP <661> Pass
Residue on Ignition USP <661> Pass

Gamma Irradiation Level: *minimum 25 kGy

Freeze-Pak™ is a trademark of Charter Medical, Ltd.


All data and statements concerning these products may be considered as being indicative of
representative properties and characteristics obtainable. We make no warranty, express or implied,
concerning actual use or results because of industry specific influences.

3948-A Westpoint Blvd.  |  Winston-Salem, NC 27103, USA  |  Toll Free: 866.458.3116  |  Fax: 336.714.4241  | www.chartermedical.com
FP-2015-REV1

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