the flex mixing system - sentinel process

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1” Powder Port 1 2 3 4 In keeping with its goals to provide customers with affordable bio-handling processes, Flex Concepts, Inc. has developed The Flex Mixing System. This single-use bag system creates a completely sterile mixing and recirculation process from start to finish. There is no longer a need for expensive stainless steel mixers, blades, and containers. Complicated and burdensome equipment is a thing of the past! The Flex mixing bag and system is designed to store, recirculate and mix all types of media within a sterile Flex Concepts single-use bag. With the properly fitted bag, in a Flex Concepts conical shaped, durable and reusable polyethylene barrel, your mixing requirements are met. The rapid recirculation design will mix almost any components to a homogeneous mixture within 5-15 minutes. The Flex Mixing System A Complete Recirculation & Mixing Process System Flex Concepts’ mixing bags and associated components are sterilized using Gamma Irradiation between 25- 40 kGy unless requested otherwise. Leachable & extractable data available for all contact materials. Full traceability for all materials. Certificates of Analysis provided for each lot. Flex Concepts is cGMP compliant. Method of Operation Flex Mixing System Applications Flex Concepts’ mixing and recirculation system uses a disposable mixing nozzle to direct the recirculating fluids and powders throughout the Flex single-use bag which has been fitted inside a Flex rigid polyethylene barrel. Using the mixing nozzle design, multiple tubing sizes and a conical shaped bottom barrel, the Flex system creates either a gentle or robust vortex which sweeps and lifts the contents from the container bottom. Note: There are no moving parts in the system. Fluid and other media recirculation is accomplished via an external pump. • Liquid to Liquid • Powder to Liquid • Recirculation of Homogeneous Solutions Sampling Port Peristaltic Pump Recirculation Loop Bag Interior Barrel Mixing nozzle Flex Recommended Peristalic Pumps • Cole-Parmer B/T • Watson-Marlow Series 700 (Standard Recirculation System)

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1” Powder Port

1 234

In keeping with its goals to provide customers with affordable bio-handling processes, Flex Concepts, Inc. has developed The Flex Mixing System. This single-use bag system creates a completely sterile mixing and recirculation process from start to finish. There is no longer a need for expensive stainless steel mixers, blades, and containers. Complicated and burdensome equipment is a thing of the past! The Flex mixing bag and system is designed to store, recirculate and mix all types of media within a sterile Flex Concepts single-use bag. With the properly fitted bag, in a Flex Concepts conical shaped, durable and reusable polyethylene barrel, your mixing requirements are met. The rapid recirculation design will mix almost any components to a homogeneous mixture within 5-15 minutes.

The Flex Mixing SystemA Complete Recirculation & Mixing Process System

Flex Concepts’ mixing bags and associated components are sterilized using Gamma Irradiation between 25-40 kGy unless requested otherwise. Leachable & extractable data available for all contact materials. Full traceability for all materials. Certificates of Analysis provided for each lot. Flex Concepts is cGMP compliant.

Method of Operation

Flex Mixing System Applications

Flex Concepts’ mixing and recirculation system uses a disposable mixing nozzle to direct the recirculating fluids and powders throughout the Flex single-use bag which has been fitted inside a Flex rigid polyethylene barrel. Using the mixing nozzle design, multiple tubing sizes and a conical shaped bottom barrel, the Flex system creates either a gentle or robust vortex which sweeps and lifts the contents from the container bottom.Note: There are no moving parts in the system. Fluid and other media recirculation is accomplished via an external pump.

• Liquid to Liquid • Powder to Liquid • Recirculation of Homogeneous Solutions

Sampling Port Peristaltic Pump

Recirculation Loop

Bag Interior

Barrel

Mixing nozzle

Flex Recommended Peristalic Pumps

• Cole-Parmer B/T • Watson-Marlow Series 700

(Standard Recirculation System)

355 West 1400 NorthLogan, UT 84341Web: www.flexconcepts.com

Phone: 435-755-6113 Fax: 435-755-6521eMail: [email protected]

Results: The test data demonstrates rapid mixing of the test media achieving 99% homogeneity within 5 minutes and 100% or complete mixture within 15 minutes.

©2010 Flex Concepts, Inc. All rights reserved. Specifications are subject to change. See your Flex Concepts Sales Representative for pricing, custom designs, and other details.

Flex Material & Construction Highlights (3 ply bag)

• Inner ply-contact material (LDPE)• Intermediate ply-safety layer (LDPE)• Outer ply-tensile strength & gas barrier (EVOH/Nylon)• All contact material is USP Class VI approved• All contact material available in ADCF (upon request)• Validation certificates available for all contact materials• Customized sizes and configurations available upon request• Optional films available

Flex Products

Single-Use Bags Flex Part # Barrels Flex Part # 50 Liter FSE00419.01 50 Liter FSF00019.01100 Liter FSE00419.02 100 Liter FSF00019.02200 Liter FSE00419.03 200 Liter FSF00019.03

Tank Liner (one size fits all, 50L - 200L) FV0120019.03Drum Dolly (one size fits all, 50L - 200L) FSF00010.03

mixing study - Powder to Liquid

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3265 Sunset Lane, Hatboro, PA 19040 (215) 675-5700 - www.sentinelprocess.com
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