Single-Use BioProcess Systems - Saint-Gobainppl.saint-gobain.com/uploadedFiles/SGppl-global/Documents/Saint... · Single-Use BioProcess Systems ... It is the user’s responsibility

Single-Use BioProcess Systems Single-Use Bags 50 ml to 3,000 liters

Validated Materials • Proven Designs • Leading Service

Capabilities• cGMP manufacturer• QSR and ISO 9001:2008 compliant• Certified ISO class 7 clean room• Validated materials, processes and designs• Fast delivery

Custom products to meet your timeline

©2013Saint-GobainPerformancePlasticsCorporation

Small Volume Bags50 ml to 20 liters• Integrated handle• Integrated hanging capability• Needle-free sampling port• May be used with sterile welder• Available as manifold system

Bags for Cylindrical Tanks50 liters to 750 liters• 2D and 3D designs• Top or bottom drain• Available as liner• Recirculation loops• Available as manifold system

Bags for Rectangle Tanks50 liters to 3,000 liters• Designed to fit your existing tank• Top or bottom drain• Available with 1" ID tubing• Recirculation loops• Integrated sampling systems

Single-Use BioProcess Systems• Consultative customized solutions• Standard product from stock 50 ml to 500 liters• Industry-leading materials and components• Sterilized by gamma irradiation (SAL 10-6)• Full validation information• Delivery assurance

Custom products to meet your timeline

©2013Saint-GobainPerformancePlasticsCorporation

FLS-5158A-PDF-0913-SGCS ©2013Saint-GobainPerformancePlasticsCorporation

Formorethanfour

decades,Saint-Gobain

PerformancePlasticsand

itsfamilyofcompanies

havesuppliedthe

worldwithinnovative,

high-performance

polymerproductsfor

themostdemanding

applications.Our

traditionofexcellence

goesbackalmost350

yearsthroughourparent

company,Compagnie

deSaint-Gobain,one

oftheworld’stop100

industrialcorporations,

withoperationsin64

countries.Thissuccessful

corporationhasbeen

builtwiththesingle

purposeofserving

thecustomeranda

commitmenttoquality

andleadershipineachof

theindustriesserved.

IMPORTANT: It is the user’s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics materials for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication, or application of the products into which the materials are incorporated.

SAINT-GOBAINPERFORMANCEPLASTICSDISCLAIMSALLIMPLIEDWARRANTIESOFMERCHANTABILITYANDFITNESSFORAPARTICULARPURPOSE.

www.biopharm.saint-gobain.com www.appliedbpc.com

biopharmaceutical products manufacturing facilitySaint-GobainPerformancePlastics15301Highway55Plymouth,MN55447Tel:(763) 398-1560Fax:(763) 398-1589

Contact us today for:Consultations • Samples • Quotes • Orders • On-time Deliveries

From Design to DeliveryWe Provide Quality Products Tailored to Your Exacting Specifications

Saint-Gobain single-use bags are constructed of multilayer films optimized for bioprocess production applications. Film materials are consistent throughout the product range, and are certified to be free of materials of animal origin. Offering outstanding biocompatibility, chemical compatibility, barrier and strength properties, Saint-Gobain films meet the most demanding bioprocessing applications.

Fluid Contact Layer - Low Density Polyethylene (LDPE) Provides outstanding biocompatibility with broad chemical compatibility for safe handling of a wide range of biopharmaceutical liquids.

Gas Barrier Layer - Ethyl Vinyl Alcohol (EVOH) Provides excellent barrier to the transmission of oxygen and carbon dioxide.

Strength Layer - Nylon Provides outstanding impact and tear resistance, optimizing overall toughness of the bag.

Tie Structure Multiple materials provide bonding between layers and add to overall performance of the bag.

Multilayer Film Thickness 50 ml to 1 liter bags: 7 mil 2 liter to 2,500 liter bags: 12 mil

Technical BulletinMultilayer Film Structure

FLS-5165a-1113-SGCS www.biopharm.saint-gobain.com ©2013 Saint-Gobain Performance Plastics Corporation

www.appliedbpc.com

IMPORTANT: It is the user’s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics products for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication or application of the products into which the materials are incorporated.SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WARRANTY: For a period of 12 months from the date of first sale, Saint-Gobain Performance Plastics warrants this product to be free from defects in materials and workmanship. Our only obligation will be to replace any portion proving defective, or at our option, to refund the purchase price thereof.

Saint-Gobain Performance Plastics 15301 Highway 55 Plymouth, MN 55447 Tel: (763) 398-1560 Fax: (763) 398-1589

Nylon

Tie

EVOH

Tie

LDPE

Technical BulletinBag Chambers

Animal-Derived Components All chamber materials are free of animal-derived components.

Materials Multilayer film construction with LDPE fluid contact layer, EVOH gas barrier and nylon outer layer.

FLS-5166a-1113-SGCS www.biopharm.saint-gobain.com ©2013 Saint-Gobain Performance Plastics

Saint-Gobain Performance Plastics 15301 Highway 55 Plymouth, MN 55447 Tel: (763) 398-1560 Fax: (763) 398-1589

Physical PropertiesASTM1 Units Typical Value

Thickness 50 ml - 1 liter Chamber 2 liter - 500 liter Chamber

N/A N/A

mils mils

7.0 12.0

Tensile Strength (MD) D882A psi 5300

Tear Resistance D1922 grams >800

Seam Strength D882 lbs/in >25

Dart Impact D1709 grams >1600

Operating Temperature N/A °C -80 to +60

O2 Transmission Rate F-1927 cc/100 in2 / 24 hr 0.02

CO2 Transmission Rate2 N/A cc/100 in2 / 24 hr <0.06(1) ASTM test results reported using 7.0 mil chamber construction (2) CO2 transmission rate reported using raw material performance data

Biological & Particulate TestingTest Protocol Result

Cytotoxicity, In Vivo ISO-10993-5 Pass

Biological Reactivity, In Vitro (USP Class VI) USP <88> Pass

Pyrogen USP <85> Pass

Particulate Matter USP <788>EP <2.9> Pass

Polyethylene with Additives for Containers EP <3.1.5> Pass

Physicochemical Tests for Plastics USP <661> Pass

Sterile Purified Water (Oxidizable Substances) USP <1231> Pass

SterilizationTest Protocol Result

Microbiological Validation of 25kGy Radiation Sterilization

ANSI/AAMI/ISO 11137 10-6 SAL2 YearExpiry

www.appliedbpc.com

IMPORTANT: It is the user’s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics products for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication or application of the products into which the materials are incorporated.SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WARRANTY: For a period of 12 months from the date of first sale, Saint-Gobain Performance Plastics warrants this product to be free from defects in materials and workmanship. Our only obliga-tion will be to replace any portion proving defective, or at our option, to refund the purchase price thereof.

Saint-Gobain Performance Plastics Corporation 15301 Highway 55 • Plymouth, MN 55447 • USA • Tel: (763) 398-1560 Fax: (763) 398-1589

Validation Information

Table of Contents

1. ABC Technical Bulletin_1012F_Confidential

2. 5Mil_Cytotoxicity

3. 7Mil_Cytotoxicity

4. 5Mil_USP_Systemic_Toxicity

5. 7Mil_USP_System_Toxicity

6. 5Mil_USP_Class_VI

7. 7Mil_USP_Class_VI

8. 5Mil_USP_Intracutaneous

9. 7Mil_USP_Intracutaneous

10. 5Mil_USP_Muscle_Implantation

11. 7Mil_USP_muscle_Implantation

12. 5Mil_ EP_7.5_ 3.1.5

13. 7Mil _ EP_7.5_3.1.5

14. Extractables_Toxicon

15. 10‐2293‐N2 Risk Assessment

16. Mocon_Transmission_Data

17. Pyrogen_Lab_Data

18. ABC_LAL_TEST

19. SGS Cert of Analysis

20. USP_661

21. USP_788 7mil Film

22. USP 788 12mil Film

23. USP_1231

Single-Use BioProcess Bags 50 ml to 20 Liters

Saint-Gobain single-use bags provide broad chemical

•• Bioreactor feed and harvest• Intermediate product hold• Chromatography feed •• Product sampling• Final product hold

Ease of UseSaint-Gobain standard single-use bags incorporate a variety

• Integrated handle (2 liter-20 liter)• Integrated hanging capability• Needle-free sampling port• May be used with sterile welder

Materials and ComponentsSaint-Gobain

materials are consistent throughout the product range,

animal derived components.

Saint-Gobain widely accepted test methods.

ISO 10993-5 Cytotoxicity, In Vitro

USP <88> Class VI, In Vivo

ISO 11137 Bioburden

Extractables and Leachables

Single-Use BioProcess Bags: 50 ml to 20 Liters

Dimensions 50 ml – 20 LiterVolume 50 ml Bag 150 ml Bag 250 ml Bag 500 ml Bag 1 L Bag

Length 5.22" (13.26 cm)

7.72" (19.61 cm)

9.72" (24.69 cm)

10.22" (25.96 cm)

13.50" (34.29 cm)

Width 3.85" (9.78 cm) 3.85" (9.78 cm) 3.85" (9.78 cm) 5.35" (13.59 cm) 6.48" (16.46 cm)

Internal Surface Area

26.00 in2

(167.74 cm2)43.50 in2

(280.64 cm2)57.00 in2

(367.74 cm2)86.21 in2

(556.13 cm2)145.42 in2

(935.48 cm2)

Volume 2 L Bag 3 L Bag 5 L Bag 10 L Bag 20 L Bag

Length 15.55" (39.37 cm)

18.05" (45.72 cm)

18.34" (46.48 cm)

27.70" (70.36 cm)

28.12" (71.37 cm)

Width 9.35" (23.75 cm)

9.35" (23.75 cm)

12.35" (31.24 cm)

12.35" (31.24 cm)

18.35" (46.48 cm)

Internal Surface Area

226.40 in2

(1458.06 cm2)271.40 in2

(1748.38 cm2)364.52 in2

(2348.38 cm2)587.44 in2

(3787.09 cm2)887.98 in2

(5722.57 cm2)

1

2

3 Port 1

Port 2

Port 3With Clear C-Flex® 374 Tubing, MPC

Lock with Needle-Free Sampling Port

Standard Bags, MPC & Luer Lock Connectors®

50 ml – 1 Liter

Standard Bags, MPC & Luer® Lock Connectors 50 ml – 1 Liter 6" Tubing Length, All Ports

Part # Tubing Port 1 Port 2 Port 3 Qty/Box

BP0050M 50 ml Bag, STD 3 ports

Clear C-Flex® 374

1/4" x 7/16" x 6" (6.35 mm x 11.11 mm

x 15.24 cm)MPC Insert, Port Cover,

Pinch Clamp

1/4" x 7/16" x 6" (6.35 mm x 11.11 mm


Pinch Clamp

1/8" x 1/4" x 6" (3.175 mm x 6.35 mm

x 15.24 cm)LL Female + Needle-Free Sampling

Port, Luer Cap, Pinch Clamp

20

BP0150M 150 ml Bag, STD 3 ports 20



BP0001L 1 L Bag, STD 3 ports 20

6" Tubing Length, Ports 1 & 2 20" Tubing Length, Port 3

BP0050MC 50 ml Bag, STD 3 ports

Clear C-Flex® 374

1/4" x 7/16" x 6" (6.35 mm x 11.11 mm


Pinch Clamp

1/4" x 7/16" x 6" (6.35 mm x 11.11 mm


Pinch Clamp

1/8" x 1/4" x 20" (3.175 mm x 6.35 mm

x 50.80 cm) LL Female + Needle-Free Sampling


20

BP0150MC 150 ml Bag, STD 3 ports 20



BP0001LC 1 L Bag, STD 3 ports 20

20" Tubing Length, All Ports

BP0050ML 50 ml Bag, STD 3 ports

Clear C-Flex® 374

1/4" x 7/16" x 20" (6.35 mm x 11.11 mm


Pinch Clamp

1/4" x 7/16" x 20" (6.35 mm x 11.11 mm

x 50.80 cm)

MPC Insert, Port Cover, Pinch Clamp

1/8" x 1/4" x 20" (3.175 mm x 6.35 mm

x 50.80 cm)LL Female + Needle-Free Sampling


20

BP0150ML 150 ml Bag, STD 3 ports 20



BP0001LL 1 L Bag, STD 3 ports 20

Port 1

Port 22

1

With Clear C-Flex® 374 Tubing, Male Luer Lock, Female Luer Lock with Needle-Free Sampling Port

Standard Bags,Luer® Lock Connectors

12" Tubing Length, Both Ports

Part # Tubing Port 1 Port 2 Qty/Box

BP0050MS 50 ml Bag, STD 2 ports

Clear C-Flex® 374

1/8" x 1/4" x 12" (30.48 cm)


1/8" x 1/4" x 12" (30.48 cm)


20

BP0150MS 150 ml Bag, STD 2 ports 20



50 ml – 500 ml

Standard Bags, MPC & Luer®Lock Connectors,


Part # Tubing Port 1 Port 2 Port 3 Qty/Box

BP0002L 2 L Bag, STD 3 ports

Clear C-Flex® 374

1/4" x 7/16" x 6" (6.35 mm x 11.11 mm x 15.24 cm) MPC Insert,

Port Cover, Pinch Clamp


Port Cover, Pinch Clamp1/8" x 1/4" x 6"

(3.175 mm x 6.35 mm x 15.24 cm)

LL Female + Needle-Free Sampling Port, Luer Cap, Pinch Clamp

20


BP0005L 5 L Bag, STD 3 ports 3/8" x 5/8" x 6" (9.53 mm x 15.87 mm x 15.24 cm) MPC Insert,




20



6" Tubing Length Ports 1 & 2 20" Tubing Length, Port 3

BP0002LC 2 L Bag, STD 3 ports

Clear C-Flex® 374





(3.175 mm x 6.35 mm x 50.80 cm)


20


BP0005LC 5 L Bag, STD 3 ports 3/8" x 5/8" x 6" (9.53 mm x 15.87 mm x 15.24 cm) MPC Insert,




20




BP0002LL 2 L Bag, STD 3 ports

Clear C-Flex® 374





(3.175 mm x 11.11 mm x 50.80 cm)


20


BP0005LL 5 L Bag, STD 3 ports 3/8" x 5/8" x 20" (9.53 mm x 15.87 mm x

50.80 cm) MPC Insert, Port Cover, Pinch Clamp



20



Port 1

Port 2

Port 31

2

3

With Clear C-Flex® 374 Tubing, MPC

Lock with Needle-Free Sampling Port

2 Liter – 20 Liter

biopharmaceutical products manufacturing facilitySaint-Gobain Performance Plastics 15301 Highway 55 Plymouth, MN 55447 Tel: (763) 398-1560 Fax: (763) 398-1589

IMPORTANT: It is the user’s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics products for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication or application of the products into which the materials are incorporated.

SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

WARRANTY: For a period of 12 months from the date of first sale, Saint-Gobain Performance Plastics warrants this product to be free from defects in materials and workmanship. Our only obligation will be to replace any portion proving defective, or at our option, to refund the purchase price thereof.

www.appliedbpc.com www.biopharm.saint-gobain.com

FLS-5167 a-1113-SGCS ©2013 Saint-Gobain Performance Plastics Corporation

Contact us today for:

Single-Use BioProcess Bags 50 to 500 Liters

Designed for the preparation, collection, storage and transport of biopharmaceutical liquids

For Use With• Cylindrical tanks

• Stainless tanks

• Drums

• Plastic totes

With Clear C-Flex® 374 Tubing,

Female Luer®Lock with Needle-Free Sampling Port

Port 4

Port 1 Port 2 Port 3

Port 4

Standard 3D Bags for Rectangular Tanks 200 Liters - 500 Liter

3D Bags for Rectangular Tanks 30" Tubing Length, All PortsPart # Tubing Port 1 & Port 2 Port 3 Port 4 Qty/Box

BP0200LB 200 L 3D Bag, STD 4 ports

Clear C-Flex® 374

1/2" x 3/4" x 30" (12.70 mm x 19.05 mm

x 76.20 cm) MPX Insert, MPX CAP, Pinch Clamp

1/8" x 1/4" x 30" (3.175 mm x 6.35 mm

x 76.20 cm) LL Female + Needle-Free Sampling


1/2" x 3/4" x 30" (12.70 mm x 19.05 mm

x 76.20 cm) MPX Body, MPX Plug Pinch Clamp

4

BP0500LB 500 L 3D Bag, STD 4 ports 4

Saint-Gobain single-use bags provide broad chemical

•• Bioreactor feed and harvest• Intermediate product hold• Chromatography feed •• Final product hold

Flexibility Saint-Gobain standard single-use bags incorporate a variety

• 2D & 3D designs• • • Needle-free sampling port• May be used with sterile welder

Materials and Components

materials are consistent throughout the product range, with contact material and EVOH as the gas

derived components.

widely accepted test methods.

ISO 10993-5 Cytotoxicity, In Vitro

USP <88> Class VI, In Vivo

ISO 11137 Bioburden

Extractables and Leachables

Single-Use BioProcess Bags: 50 to 500 Liters

barrier layer.

UPS <788>, EP <2.9> Particulate matter injectables

Standard Bags for Cylindrical Tanks 50 liter - 500 liter

2D Bags for Cylindrical Tanks 30" Tubing Length, Both PortsPart # Tubing Port 1 Port 2 Qty/Box

BP0050LP 50 L Bag, STD 2 ports

Clear C-Flex® 3743/8" x 5/8" x 30"

(9.52 mm x 15.87 mm x 76.20 cm) MPC Insert, Port Cover, Pinch Clamp

3/8" x 5/8" x 30" (9.52 mm x 15.87 mm x 76.20 cm)


10

BP0100LP 100 L Bag, STD 2 ports 10

BP0200LP 200 L Bag, STD 2 ports 10

3D Bags for Cylindrical Tanks 30" Tubing Length, All PortsPart # Tubing Port 1 Port 2 Port 3 Qty/

Box

BP0050LD 50 L 3D Bag, STD 3 ports

Clear C-Flex® 3741/2" x 3/4" x 30"

(12.7 mm x 19.05 mm x 76.20 cm) MPX Insert, MPX CAP, Pinch Clamp

1/2" x 3/4" x 30" (12.7 mm x 19.05 mm x 76.20 cm)

MPX Insert, MPX CAP, Pinch Clamp

1/8" x 1/4" x 30" (3.18 mm x 6.35 mm x 76.20 cm) LL Female + Needle-Free Sampling Port,

Luer Cap, Pinch Clamp

10

BP0100LD 100 L 3D Bag, STD 3 ports 10




Port 1 Port 2Port 1 Port 2

With Clear C-Flex® 374 Tubing, MPC Insert

2D Pillow

With Clear C-Flex® 374 Tubing, MPX Insert

Luer®Lock with Needle-Free Sampling Port

Port 1 Port 2 Port 3Port 1 Port 2 Port 3

Standard Bags for Cylindrical Tanks: 50 to 500 Liters

200 L55 Gal

180 L

160 L

140 L

120 L

100 L

80 L

60 L

40 L

20 L

Standard 3D Liners for Cylindrical Tanks 20 liter - 500 liter

3D Liners for Cylindrical Tanks

Part # Base O.D. Height Qty/Box

LR0020L 20 L Liner, STD 3D 11.00" (27.94 cm) 15.13" (38.43 cm) 20









FLS-5168a-1113-SGCS ©2013 Saint-Gobain Performance Plastics Corporation

For more than four

decades, Saint-Gobain

and its family of

companies have

supplied the world

with innovative,

high-performance

polymer products for

the most demanding

applications. Our

tradition of excellence

goes back almost 350

years through our parent

company, Compagnie

de Saint-Gobain, one

of the world’s top 100

industrial corporations,

with operations in 64

countries. This successful

corporation has been

built with the single

purpose of serving

the customer and a

commitment to quality

and leadership in each of

the industries served.

IMPORTANT: It is the user’s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics products for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. Saint-Gobain Performance Plastics assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication or application of the products into which the materials are incorporated.

SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

WARRANTY: For a period of 12 months from the date of first sale, Saint-Gobain Performance Plastics warrants this product to be free from defects in materials and workmanship. Our only obligation will be to replace any portion proving defective, or at our option, to refund the purchase price thereof.

www.appliedbpc.com www.biopharm.saint-gobain.com

biopharmaceutical products manufacturing facilitySaint-Gobain Performance Plastics 15301 Highway 55 Plymouth, MN 55447 Tel: (763) 398-1560 Fax: (763) 398-1589

Contact us today for:

Saint-Gobain Plymouth 15301 Highway 55 • Plymouth, MN 55447 • USA

Tel: (763) 398-1560 Fax: (763) 398-1589

In order to apply, maintain, and demonstrate proper control processes throughout the organization, Saint-Gobain Plymouth has developed a Quality Management System fully compliant with the requirements of International Standard ANSI/ASQ/ISO Q9001‐2008 and, as appropriate, the FDA Quality Systems Regulation (21CFR820). The QMS is fully defined, and includes processes related to: Documentation Requirements

Document and change control system

Record control system

An established quality manual, policy & objectives

Management Responsibility

Formal review and communication involving the quality manual, policy & objectives, and developing quality planning

Focus on satisfying customer needs by integrating requirements into the ABC processes

Utilizing formal QMS management review meetings and follow through

Clearly defined responsibilities, authority, and communication (organization structure)

Resource Management

Competent team of professionals and staff

Provision of ongoing training for quality and professional development

Infrastructure and work environment suitable for the manufacture of disposable containers for the biopharmaceutical and biologics industries.

Product Realization

Incorporating customer requirements, including formal review and approval

Product design and development

Purchasing, incoming inspection, and supplier approval

Production controls including process and equipment validation

Equipment calibration and maintenance

Measurement, Analysis & Improvement

Product conformity through inspection and testing, measurement, and customer feedback

Utilization of internal audits for QMS conformity

Process conformity

Control of nonconforming product

Data analysis and trending of product and processes providing continual improvement

Corrective action including customer complaint processing and investigation

Preventive action