Safc Biosciences - Rapid Bulk Media
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Process Development
Rapidly scaled-up bulk cGMP liquid media
www.safcbiosciences.com
Member of the Sigma-Aldrich Group
QUICK SCALE™ liquid media • cGMP liquid media rapidly scaled-up • Consistent and reliable performance • Focused on industrial process development customers
Process development groups in the biopharmaceutical industry are under dynamic timelines which require flexibility and responsiveness. When you do not have the time to wait for bulk cGMP liquid media, we offer you QUICK SCALE™. Bigger
Better
• Catalog and custom media formulations available in standardized 10 L, 20 L, 50 L, 100 L and 200 L bag packaging
• cGMP production with cGMP media specifications
• 200 L to 2,000 L cGMP lot sizes • Scaleable package options support small to large lot sizes
• Single-use disposable bags, in Polyethylene (PE) or Ethyl Vinyl Acetate (EVA) films • Consistent and scaleable media packaging systems “on the shelf” and ready to fill • Rigging sets compatible with a variety of applications
Features
Specifications
Lot Size (Liters)
200 L - 2,000 L
Quality Status
cGMP
Bag Sizes
10 L, 20 L, 50 L, 100 L and 200 L
Bag Films
PE or EVA
Connectors
1⁄4” and 3/8” Male Quick Connect and weldable Size C16 C-Flex ®*
Sample/Supplementation
Yes, spike or medicinal port
Additional Connectivity
Yes, see table of additional rigging sets
cGMP Media Specifications
Yes**
Documentation
cGMP batch records
Validated Manufacturing
Yes
* 1/4" for 10 L and 20 L bags and 3/8" for 50 L, 100 L and 200 L bags. Additional rigging sets are available through BIOEAZE™. Please contact your Business Development Manager or Customer Service for details. ** Custom specifications require customer sign-off and approval prior to production.
SAFC Biosciences 10 L SAFCB PE Bag Item #2288B
Faster • Same lead times as 500 mL and 1 L bottles SAFC Biosciences 10 L SAFCB EVA Bag Item #2720B
• Manufacturing/distribution sites in both the US and Europe • Rapid sampling and supplementation through spike port
QUICK SCALE™ lead times
10
8
6 Weeks
4
2
0 Media in standard QUICK SCALE™ or custom bags
Benefits • Responsive solution: consistent and scaleable • Speed to market: reduce validation time associated with switching bag film and packaging size • Convenience and connectivity with weldable and quick connection fittings
• Time saved by filling bioreactors with media from a single bulk bag • QC testing records sooner to provide data for specifications • Saving time equals more time for formulation/concentrate development and optimization
Item No.
Product
Purpose
2720B
10 L Ethyl Vinyl Acetate (EVA) Bag Sterile
10 L EVA film bag
2721B
20 L Ethyl Vinyl Acetate (EVA) Bag Sterile
20 L EVA film bag
2286B
10 L Polyethylene (PE) Bag Sterile
10 L PE film bag
2287B
20 L Polyethylene (PE) Bag Sterile
20 L PE film bag
2321B
50 L Polyethylene (PE) Bag Sterile
50 L PE Film Bag
2320B
100 L Polyethylene (PE) Bag Sterile
100 L PE Film Bag
2319B
200 L Polyethylene (PE) Bag Sterile
200 L PE Film Bag
2675R
Female Quick Connect to Aseptic Connecting Device (ACD) Sterile
Fluid transfer for weldable application
2674R
Female Quick Connect to Male or Female Luer Lock Option Sterile
Versatile transfer set for Quick Connect to luer lock applications
2676R
Female Quick Connect to Dual Quick Connects Sterile
Single to Double Quick Connect
2677R
Female Quick Connect to Dual Sanitary Fittings Sterile
Transfer set with sanitary fitting options
2671R
Dispensing Bell Tube Set Sterile
Female Quick Connect to filling bell for dispensing
2672R
Female Quick Connect to Steam-Thru™ Connection Sterile
Steam-in-Place fluid transfer set
1336R
BIOEAZE™ Rigging Set 1⁄4” with Male-Female Quick Connects Sterile
1⁄4” fluid transfer set 10 ft. length
1337R
BIOEAZE™ Rigging Set 3/8” with Male-Female Quick Connects Sterile
3/8” fluid transfer set 10 ft. length
1520R
BIOEAZE™ Rigging Set 3/8” with Male-Female Quick Connects Sterile
3/8” fluid transfer set 10 ft. length
1654R
BIOEAZE™ Dispensing Tube Set Sterile
Bottle/flask fluid transfer or dispensing applications
Responsive Expertise SAFC Biosciences is the world’s leading supplier of cell culture reagents to producers of marketed biological products. We are committed to supplying high-quality critical raw materials and specialized cell culture products and services to the global healthcare industry. By providing the broadest range of highly customized products and services possible to cell culture-based manufacturing companies we demonstrate our commitment to being responsive experts.
Contact us United States SAFC Biosciences, Inc. 13804 W. 107th Street Lenexa, Kansas 66215 USA Tel: +1 913-469-5580 Toll Free - USA: 1 800-255-6032 Fax: +1 913-469-5584 E-mail: [email protected]
Europe SAFC Biosciences Ltd. Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Tel: +44 (0)1264-333311 Fax: +44 (0)1264-332412 E-mail: [email protected]
Asia Pacific SAFC Biosciences Pty. Ltd. 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Tel: +61 (0)3-9362-4500 Toll Free - AUS: 1 800-200-404 Fax: +61 (0)3-9315-1656 E-mail: [email protected]
BIOEAZE™ is a trademark of SAFC Biosciences, Inc. C-Flex® is a registered trademark of Consolidated Polymer Technologies, Inc. Steam-Thru™ is a trademark of Colder Products Company. © 2006 SAFC Biosciences, Inc. Issued November 2006
www.safcbiosciences.com
G051
Member of the Sigma-Aldrich Group
Rapidly scaled-up bulk cGMP liquid media
www.safcbiosciences.com
Member of the Sigma-Aldrich Group
QUICK SCALE™ liquid media • cGMP liquid media rapidly scaled-up • Consistent and reliable performance • Focused on industrial process development customers
Process development groups in the biopharmaceutical industry are under dynamic timelines which require flexibility and responsiveness. When you do not have the time to wait for bulk cGMP liquid media, we offer you QUICK SCALE™. Bigger
Better
• Catalog and custom media formulations available in standardized 10 L, 20 L, 50 L, 100 L and 200 L bag packaging
• cGMP production with cGMP media specifications
• 200 L to 2,000 L cGMP lot sizes • Scaleable package options support small to large lot sizes
• Single-use disposable bags, in Polyethylene (PE) or Ethyl Vinyl Acetate (EVA) films • Consistent and scaleable media packaging systems “on the shelf” and ready to fill • Rigging sets compatible with a variety of applications
Features
Specifications
Lot Size (Liters)
200 L - 2,000 L
Quality Status
cGMP
Bag Sizes
10 L, 20 L, 50 L, 100 L and 200 L
Bag Films
PE or EVA
Connectors
1⁄4” and 3/8” Male Quick Connect and weldable Size C16 C-Flex ®*
Sample/Supplementation
Yes, spike or medicinal port
Additional Connectivity
Yes, see table of additional rigging sets
cGMP Media Specifications
Yes**
Documentation
cGMP batch records
Validated Manufacturing
Yes
* 1/4" for 10 L and 20 L bags and 3/8" for 50 L, 100 L and 200 L bags. Additional rigging sets are available through BIOEAZE™. Please contact your Business Development Manager or Customer Service for details. ** Custom specifications require customer sign-off and approval prior to production.
SAFC Biosciences 10 L SAFCB PE Bag Item #2288B
Faster • Same lead times as 500 mL and 1 L bottles SAFC Biosciences 10 L SAFCB EVA Bag Item #2720B
• Manufacturing/distribution sites in both the US and Europe • Rapid sampling and supplementation through spike port
QUICK SCALE™ lead times
10
8
6 Weeks
4
2
0 Media in standard QUICK SCALE™ or custom bags
Benefits • Responsive solution: consistent and scaleable • Speed to market: reduce validation time associated with switching bag film and packaging size • Convenience and connectivity with weldable and quick connection fittings
• Time saved by filling bioreactors with media from a single bulk bag • QC testing records sooner to provide data for specifications • Saving time equals more time for formulation/concentrate development and optimization
Item No.
Product
Purpose
2720B
10 L Ethyl Vinyl Acetate (EVA) Bag Sterile
10 L EVA film bag
2721B
20 L Ethyl Vinyl Acetate (EVA) Bag Sterile
20 L EVA film bag
2286B
10 L Polyethylene (PE) Bag Sterile
10 L PE film bag
2287B
20 L Polyethylene (PE) Bag Sterile
20 L PE film bag
2321B
50 L Polyethylene (PE) Bag Sterile
50 L PE Film Bag
2320B
100 L Polyethylene (PE) Bag Sterile
100 L PE Film Bag
2319B
200 L Polyethylene (PE) Bag Sterile
200 L PE Film Bag
2675R
Female Quick Connect to Aseptic Connecting Device (ACD) Sterile
Fluid transfer for weldable application
2674R
Female Quick Connect to Male or Female Luer Lock Option Sterile
Versatile transfer set for Quick Connect to luer lock applications
2676R
Female Quick Connect to Dual Quick Connects Sterile
Single to Double Quick Connect
2677R
Female Quick Connect to Dual Sanitary Fittings Sterile
Transfer set with sanitary fitting options
2671R
Dispensing Bell Tube Set Sterile
Female Quick Connect to filling bell for dispensing
2672R
Female Quick Connect to Steam-Thru™ Connection Sterile
Steam-in-Place fluid transfer set
1336R
BIOEAZE™ Rigging Set 1⁄4” with Male-Female Quick Connects Sterile
1⁄4” fluid transfer set 10 ft. length
1337R
BIOEAZE™ Rigging Set 3/8” with Male-Female Quick Connects Sterile
3/8” fluid transfer set 10 ft. length
1520R
BIOEAZE™ Rigging Set 3/8” with Male-Female Quick Connects Sterile
3/8” fluid transfer set 10 ft. length
1654R
BIOEAZE™ Dispensing Tube Set Sterile
Bottle/flask fluid transfer or dispensing applications
Responsive Expertise SAFC Biosciences is the world’s leading supplier of cell culture reagents to producers of marketed biological products. We are committed to supplying high-quality critical raw materials and specialized cell culture products and services to the global healthcare industry. By providing the broadest range of highly customized products and services possible to cell culture-based manufacturing companies we demonstrate our commitment to being responsive experts.
Contact us United States SAFC Biosciences, Inc. 13804 W. 107th Street Lenexa, Kansas 66215 USA Tel: +1 913-469-5580 Toll Free - USA: 1 800-255-6032 Fax: +1 913-469-5584 E-mail: [email protected]
Europe SAFC Biosciences Ltd. Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Tel: +44 (0)1264-333311 Fax: +44 (0)1264-332412 E-mail: [email protected]
Asia Pacific SAFC Biosciences Pty. Ltd. 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Tel: +61 (0)3-9362-4500 Toll Free - AUS: 1 800-200-404 Fax: +61 (0)3-9315-1656 E-mail: [email protected]
BIOEAZE™ is a trademark of SAFC Biosciences, Inc. C-Flex® is a registered trademark of Consolidated Polymer Technologies, Inc. Steam-Thru™ is a trademark of Colder Products Company. © 2006 SAFC Biosciences, Inc. Issued November 2006
www.safcbiosciences.com
G051
Member of the Sigma-Aldrich Group
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