safc bulk liquid handling capabilities - sigma-aldrich€¦ · safc bulk liquid handling...

SAFC Bulk Liquid Handling Capabilities

A Leading Manufacturer and Supplier of Critical Raw Materials to the Biopharmaceutical Industry

Manufacturing, Packaging and Logistics

sigma-aldrich.com/safc Order: 800-244-1173 | Email: [email protected]

1

Table of Contents

Why Choose SAFC? .................................................................................................................................................... 2

History ........................................................................................................................................................................... 3

Liquid Manufacturing

Capability and Capacity .................................................................................................................................... 4

Global Quality Systems ..................................................................................................................................... 5

Bulk Packaged Water (WFI-grade source) ........................................................................................................ 6

Raw Material Sourcing Program ........................................................................................................................ 7

Scale-up and Support Service

Small Volume Custom Media - imMEDIAte ADVANTAGE™ .............................................................................. 8

Spent Media Analysis ........................................................................................................................................ 9

Standard Bulk Packaging

1 L Bag ............................................................................................................................................................ 12

5, 10 and 20 L Bag .......................................................................................................................................... 13

50, 100 and 200 L Bag .................................................................................................................................... 14

100, 200 and 500 L Bag .................................................................................................................................. 15

FlexStations® .................................................................................................................................................... 16

Shipping and Logistics

Recyclable and Returnable Rigid Outer Containers ....................................................................................... 17


Raw material management is an ever evolving, increasingly complex and crucial part of any manufacturing process in the pharmaceutical and biopharmaceutical industry. As a leading developer and manufacturer of critical raw materials, SAFC understands the challenges a manufacturing input can bring to process performance, regulatory compliance and business security.

Our reputation for safe, productive and consistent raw materials allows customers the confidence needed for component grade, quality and sourcing transparency. SAFC continues to build a progressive portfolio of products and services that contribute to an overall improved process risk profile irrespective of a development, clinical or commercialized stage.

Why Choose SAFC?Critical Raw Material Manufacture and Supply

An Evolution: Biopharmaceuticals and SAFC

3

HistoryLegacy of Expertise

Since 1971, global cell culture-based manufacturing operations have relied on us as a primary supplier for critical raw materials in vaccine, biotherapeutic and diagnostic products. SAFC prides itself on remaining up to date in a dynamic market environment and thus responsive to key industry trends and events:

• Explosive growth in large molecule drug development where a product is defined by its manufacturing process. SAFC provides excellence in critical raw material supply to ensure consistency of process and product.

• Transition of an industry traditionally reliant on serum in production processes to the requirement for animal component free (ACF) raw materials.

• Contamination events leading regulatory bodies to place accountability of raw material sourcing in the hands of the drug manufacturer. SAFC is best positioned to assist with supply chain certainty and safety.


Liquid Manufacturing Capability and Capacity

SAFC continues to progress its cGMP liquid manufacturing facilities and capabilities to meet or exceed current industry requirements. SAFC routinely provides a wide range of bulk liquid lot sizes ranging 50-10,000 L suitable for use in clinical and commercial manufacturing processes.

Dual Liquid Manufacturing Sites

Dual liquid production sites strategically located in North America and Europe have the capacity to support customers with on-going large volume liquid requirements. Both facilities are supported by a single Global Quality System and operated with an aligned local Quality Program.

Global Liquid Media Manufacturing Facilities

Facility Europe – Irvine, Scotland N. America – St. Louis, MO (Broadway)

Function Liquid Manufacturing Site Liquid Manufacturing Site

Employees 98 75

Size 118,000 ft2 / 10,963 m2 98,600 ft2 / 9,160 m2

Warehousing

1,450 m2

1,345 pallet spacesTemperature MappedRoom Temperature (15-30 °C)Cold Storage (2-8 °C)Freezer (-10 to -30 °C)

1,500 m2

2,200 pallet spacesTemperature MappedRoom Temperature (15-30 °C)Cold Storage (2-8 °C)Freezer (-10 to -30 °C)

Production Scale 50-10,000 L in 316# SS tanks 50-10,000 L in 316# SS tanks

Animal Component free (ACF)

ACF Dedicated ACC & ACF (full segregation)

Positive HEPA Pressure Cascade

Grade A - Aseptic Filling Areas (Bottles)Grade C - CleanroomsGrade C - HydrationGrade D - Formulation Closed System Filling Areas (Bags)

Grade A - Aseptic Filling Areas (Bottles)Grade B - 2° CleanroomsGrade C - Hydration & FormulationGrade D - Closed System Filling Areas (Bags)

Filling CapabilitiesBottles: 10 mL - 2 LBags: 1 L - 500 & 1,000 L• Automated high-throughput bag fills

Bottles: 10 mL - 2 LBags: 1 L - 500 & 1,000 L

Cleaning Capability Validated CIP / SIP Processes Validated CIP / SIP Processes

Quality Certification / Standard

21 CFR Part 820ISO9001: 2008ISO13485: 2003

21 CFR Part 820ISO9001: 2008Federal DEAMissouri DEA

Quality Control Laboratory On site On site

5

SAFC’s liquid media facilities are covered under a comprehensive company-wide Global Quality Management System, which assures the highest product consistency, reproducibility and performance. SAFC is committed to staying at the forefront of all relevant guidelines and regulations and maintains multiple FDA inspected facilities around the world. Our quality systems meet stringent regulatory requirements yet flexible enough to allow a certain amount of customization to meet individual customer requirements. Key attributes include:

• Dedicated ACF Production

• Supplier and Material Qualification Programs

• Risk Assessment

• 21 CFR Part 820

• ISO Certifications

Customer Audits

At SAFC we encourage audits by our customers. During your audit we invite you to review and evaluate our many Quality System programs that are designed to maintain product control and allow us to produce high quality products consistently lot after lot.

To schedule an audit please contact your Account Representative.

Quality Control Testing

The SAFC liquid media facilities each have on site Quality Control laboratories. Standard quality control assays for liquid media are conducted using harmonized current compendia methodologies as shown below.

Global Quality Systems

Standard Quality Control Assays for Liquid Media

Finish Product Testing(General) Methodology Europe N. America

Appearance Uniformity/color • •

pH USP 791 • •

Osmolality USP 785 • •

Bioburden USP 61 • •

Endotoxin USP 85 (Kinetic Chromogenic, Gel clot LAL) • •

Cell Growth Multi-passage, minimum density and % control • •

Sterility USP 71 • •


As a principle ingredient in a vast array of process solutions, SAFC has state of the art WFI (Water-for-Injection) systems you can rely on. Whether a bulk liquid solution or the bulk water itself, SAFC produces a range of large volume liquid products designed for industrial biopharmaceutical use. Bulk packaged water from these systems is suitable for the preparation of both Upstream and Downstream process solutions intended for further use in industrial bioprocessing applications.

Bulk Packaged Water (WFI-grade source)

Upstream Application

• Cell Culture Media

• Cell Suspension and Wash Solutions

• Reconstitution of products

Downstream Applications

• Process Buffers

• Cleaning and rinsing agents

• Diafiltration and purification buffers

SAFC Cell Culture Grade water is produced from a validated system conforming to current specifications of USP and EP for Water for Injection (WFI). The WFI systems are single generation systems with separate tanks maintained at 80 °C and loops operated at 24 °C. SAFC WFI systems are maintained and monitored on an ongoing basis to ensure water quality standards.

Continuous Monitoring

• System

– Conductivity – Total Organic Carbon (TOC) – Temperature

• Environmental Program

– Microbial – Endotoxin – Nitrates

Water System Diagrams

Municipal Water Supply

Softening

Carbon Filtration

UV System (Disinfection)


0.2 micron filtration


Double pass RO System

Triple Effects Distillation

10,000 L WFI Storage Tank



Broadway Site

Irvine Site

Softening

Carbon Filtration


Multiple Effects Distillation


Softening

Carbon Filtration






Triple Effects Distillation




Broadway Site

Irvine Site

Softening

Carbon Filtration


Multiple Effects Distillation

7

The Supply Chain and Supplier Quality Management teams within SAFC work in a coordinated effort for the sourcing and management of a Global Raw Material Management Program and to ensure the program is robust, controlled and provides for sustainable consistent material supply. These groups within SAFC have two primary initiatives: Ensuring Security of Supply

• Maintaining active dialog and relationship with suppliers

• Establishing working forecast and inventory levels with key suppliers

• Initiating enhanced Supplier Relationship Management programs

Risk Based Program Mangement

• Used in the quality assessment, qualification and management for materials, manufacturers and suppliers.

• Identifying and mitigating supply chain risk to reduce variability

• Use of subject matter experts to help establish appropriate release criteria and specification

• Comprehensive change notification from our suppliers through to our customers

Raw Material Sourcing Program

Continuous Quality Control

Assay Methodology Specification

Endotoxin Kinetic-chromogenic per USP <85> < 0.25 EU/mL

Bioburden Membrane filtration per USP <1231> < 10 CFU/100 mL

TOC On-line measurement per USP <643> < 500 ppb

Conductivity On-line measurement per USP <645> < 1.0 S/cm

Nitrates Nitrates, EP < 0.2 ppm


Scale-up and Support ServiceSmall Volume Custom Media: imMEDIAte ADVANTAGE™ Service

SAFC offers global services to make the process optimization phase of your biopharmaceutical development a smooth journey. Fast turnaround of small volume custom media and reliable spent media testing services can assist in effectively reducing your timelines and maximizing your titer.

Efficient Process Development

SAFC established the imMEDIAte ADVANTAGE service to support the biopharmaceutical developer with access to small volume custom media. With a fast turnaround (10 business days*) the service is ideal for:

• Prototyping / Troubleshooting / Scale-up Studies

• Upstream / Downstream Materials

• Powder / Liquid Formats

• Concentrates

Material Feasibility – Scalability - Transferability

Over 50 years of small-scale manufacturing expertise with industrially focused development ensures products are scalable and transferable for GMP readiness. The SAFC Raw Material Sourcing Program ensures a robust, secure supply chain and implements risk mitigation strategies to avoid risk due to potential process or raw material variability – all imMEDIAte ADVANTAGE components fall under this global program.

• Scale-down model of cGMP powder mill used

• Compounded from fully released GMP raw materials inventory

• Batch records

• Formulation derivatives tracked and archived for reference

Spent Media Analysis

In practical terms, shortened development time relies on having access to dependable data and answers. SAFC’s spent media analysis service offers reliable testing for nutrients that gives customers the data they require to make effective decisions on further process optimization.

• Results available within 15 business days

• Discuss data with experts in media development

• Develop feeding strategies or optimize media based on results

*Not including shipping

9

Spent Media AnalysisAssay Number Assay Components Tested

Vitamin Analysis (88100-1EA)

Water-soluble vitamins in cell culture and fermentation media can be separated, identified and quantified via HPLC. This method is for the accurate determination and quantification of water-soluble vitamins.

Cyanocobalamin (B12 )Pyridoxamine (B6 )Pyridoxine (B6 )Nicotinamide (B3 )Riboflavin (B2 )Pyridoxal (B6 )Thiamine (B1 )

Lipids/fatty acids (88101-1EA)

Lipids are extracted and analyzed by Gas Chromatography. Lipid classes quantified include phospholipids, free fatty acids, triglycerides, cholesterol esters and total protein. Actual values are reported.

Lipid Profile Fatty Acid Profile

CholesterolEstersPhospholipidsTotal Lipids Triglycerides

Arachidonic, PalmiticLinoleicPalmitoleicMyristicOleic Stearic Lauric

Cholesterol (88102-1EA)

Cholesterol is a critical nutrient utilized during cell growth. Analysis of this nutrient by reverse phase HPLC can provide valuable information to determine cell consumption of cholesterol. Actual values are reported.

--

Free Amino Acids (88103-EA)

Amino Acids in cell culture media, blood plasma and other matrices can be separated, identified and quantified via Hitachi L-8900 Amino Acids Analyzer. This method is for accurate determination and quantification of amino acids.

TaurineL-Aspartic AcidHydroxy-L-Proline L-Threonine L-Serine L-Asparagine L-Glutamic Acid L-Glutamine L-Proline L-Glycine L-Alanine L-Citrullline L-Valine

L-MethionineL-CystineL-IsoleucineL-LeucineL-TyrosineL-PhenylalanineGABAEthanolamineL-TryptophanL-OrnithineL-LysineL-Histidine L-Arginine

Standard Element - ICP (88119)

A Varian Vista PRO™ with a radial torch is used for standard elemental analysis and has a relatively wide linear range for many elements. The nebulizer has a very small orifice ~1 mm or less and is easily clogged by high solids. Generally, samples from spent media frequently contain high solids and are cloudy. The solids content should be about 1%.

Calcium (Ca) Magnesium (Mg) Sodium (Na)

Potassium (K)Phosphate (P)Sulfur (S)

Trace Element - ICP (88120)

A Varian 720-ES™ with an axially mounted torch gives much lower detection limits than the Vista PRO™. The nebulizer has a very small orifice ~1 mm or less and is easily clogged by high solids. Generally, samples from spent media frequently contain high solids and are cloudy. The solids content should be about 1%.

Aluminum (Al)Barium (Ba)Bismuth (Bi)Cadium (Cd)Chromium (Cr) Copper (Cu)Iron (Fe)

Lithium (Li)Manganese (Mn)Molybdenum (Mo)Nickel (Ni)Lead (Pb) Stronium (Sr)Zinc (Zn)

Folic Acid (B9) (88126-1EA)

Water-soluble vitamin in cell culture and fermentation. Media can be separated, identified and quantified via HPLC. This method is for the accurate determination and quantification of folic acid.

--

Vitamin B12 w/ Folic Acid (88128-1EA)

Water-soluble vitamins in cell culture and fermentation. Media can be separated, identified and quantified via HPLC. This method is for the accurate determination and quantification of water-soluble vitamins.

Cyanocobalamin (B12 )Pyridoxamine (B6 )Pyridoxine (B6 )

Riboflavin (B2 )Pyridoxal (B6 ) Thiamine (B1 )Folic Acid (B9 )

Glucose (88202)

Levels are measured by the hexokinase test method. Results provide valuable information regarding glucose consumption during the growth cycle. --

Endotoxin (LAL)

Determined by kinetic chromogenic Limulus Amoebocyte Lysate methodology. Endotoxin is released from the cell membrane of Gram-negative bacteria. This test method can be used to evaluate spent and fresh media samples, serum and raw materials.

--

Osmolality (88206)

Cellular osmolality (pressure) can impact cell performance. Analysis of osmolality in fresh and spent media can assist in optimizing cell culture media for optimal cell performance. Osmolality is determined by freeze-point depression. Results are measured in mOsm/kg H2O. Tests can be performed with or without sodium bicarbonate.

--

pH (88207)

Cell culture systems require specified pH ranges for optimal cellular performance. The pH of fresh or spent cell culture media is measured with a pH meter. Determination of pH is the (−)log10 of the hydrogen ion concentration of the liquid/liquefied samples. pH can be measured with or without sodium bicarbonate.

--

Bioburden (88208)

Bioburden testing is performed to monitor bacterial levels using membrane filtration. Actual values are reported. --

Appearance (88210)

Appearance is determined by a color wheel for liquids and as a standard OP for dry powders. --

Solubility (88211)

This test determines and documents the solubility of raw materials and dry powder media. Satisfactory solubility is defined as fully soluble in water within 30 minutes at approximately 25 °C. The solution is clear and free of particulate. Results are reported as satisfactory or unsatisfactory.

--

11

SAFC Standard Bulk Packaging System

• Bag

• Connectivity

• Recyclable and Reusable Rigid Outer Containers


Standard Bulk PackagingSAFC has selected the industry’s leading biopharmaceutical-grade polyethylene-based film, TepoFlex® provided by Meissner as the premier solution for our bulk liquid packaging systems. Innovative in composition, TepoFlex® breaks with the legacy of prevailing films and is one of the most fit-for-purpose films available for biopharmaceutical applications. Manufactured and extruded in ISO Class 7 cleanrooms, the TepoFlex® film is characterized by a comprehensive Leachable and Extractable assessment available for review under confidentiality.

• Certified animal component-free (ACF)

• Gamma-irradiated to ensure an SAL of 10-6 substantiated (ISO 11137 methodology)

• TepoFlex® Film passes biocompatibility according to USP <87>, USP <88>, USP <661>, ISO 10993 parts 5, 6, 10 and 11, as well as EP 3.1.5

1 L Bag End-ported Application

Supports sample bag requirements as well as providing connectivity for small volume process equipment.

Port 1 Connection to filling manifold

Port 2 Aseptic sampling port provides for pre-use sampling and low flow aseptic connectivity

Port 3• Tubing applicable to pumping operations (size 16)

• 1/8" x 1/4" tubing widely applicable to tube welder applications

• Female Luer termination compliments male Luer fitting provided on port number 2

Rigid Outer Container

Description SAFC Part # Dimensions Tare Weight QTY per Pallet Count / PKG

Blue Orbis FP 182 Tote

500480 21.8" x 15.2" x 12.9" 6.5 lb. 20 8 x 1 L

P1 P2 P3

1/4" x 3/8" PVC Tubing, 3" Length, Sealed End

1/4" x 3/8" 374 C-Flex Tubing, 3" Length

1/4" HB x Female Luer AdapterSwabable Valve / Needleless Injection Site

Male Luer Cap


1/4" x 1/8" HB Reduction Fitting


1/8" HB x Male Luer Adapter

Female Luer Plug

Connectivity

Bag Volume SAFC Part #

1 L 6887B

13

Application

Supports sample bag requirements as well as providing connectivity for small volume process equipment.

5,10 and 20 L Bag End-ported

Port 1 1/8" x 1/4" tubing is widely applicable to tube welder applications - specifically those involving Terumo welders and aseptic sampling


• Generally applicable to feeding small scale bioreactors <100 L via tubing welder

• Female MPC connectivity

Port 3

• Tubing applicable to pumping operations (size 73)

• Generally applicable to feeding small scale bioreactors <100 L via Male MPC connectivity

• 3/8" x 5/8" tubing is widely applicable to tube welder applications

• Port 3 can be connected to Port 2 to form recirculation loop


• Connection to filling manifold

• Port allows for pre-use sampling and/or supplementation of process fluid




500480 21.8" x 15.2" x 12.9" 6.5 lb. 20 2 x 5 L


500480 21.8" x 15.2" x 12.9" 6.5 lb. 20 1 x 10 L


500480 21.8" x 15.2" x 12.9" 6.5 lb. 20 1 x 20 L


Sealing Cap, MPCCoupling Body, 1/4" HB, MPC

Male Luer Cap

Swabable Valve / Needleless Injection Site

1/8" HB x Female Luer Adapter


P4P3P2P1

1/8" x 1/4" 374 C-Flex Tubing, 24" Length1/4" x 1/8" HB Reduction Fitting



Coupling Insert, 3/8" HB, MPC

Sealing Cap, MPC

Connectivity


5 L 6879B

10 L 6885B

20 L 6881B


50,100 and 200 L Bag Drum Compatible Assemblies


Port 2

• Tubing applicable to pumping operations (size 82)• 1/2" x 3/4" tubing is widely applicable to tube welder applications• Female MPX connectivity• Broadly applicable to larger volume mixing and bioreactor applications

Port 3• Tubing applicable to pumping operations (size 73)• 3/8" x 5/8" tubing is widely applicable to tube welder applications• Male MPC provides additional broad applicability to single use systems connectivity

Port 4

• Tubing applicable to pumping operations (size 24)• 1/4" x 7/16" tubing is widely applicable to tube welder applications• Aseptic sampling port allows for pre-use sampling and/or supplementation of process fluid • MPC fittings can be disconnected to provide for applications which require female MPC connectivity



Bergen Drum (50 L)

500628 16" (D) x 27" (H) 8 lb. 5 1 x 50 L

Bergen Drum (100 L)

500656 20" (D) x 31" (H) 10 lb. 4 1 x 100 L

Bergen Drum (200 L)

500613 22" (D) x 35" (H) 23 lb. 4 1 x 200 L


Sealing Cap, MPC


Coupling Body, 1/2" HB, MPX

Sealing Plug, MPX





Male Luer CapSwabable Valve / Needleless Injection Site



Coupling Inset, 1/4" HB, MPC

Coupling Body, 1/4" HB, MPC




P1P2

P3

P4

Connectivity


50 L 6882B

100 L 6898B

200 L 6897B

Application

Incorporates connectivity for the bulk of the larger volume single-use mixers and bioreactors on the market.

15

Application

Incorporates connectivity for the bulk of the larger volume single-use mixers and bioreactors on the market.

100, 200 and 500 L Bag FlexStation® Compatible Assemblies


Port 2• Tubing applicable to pumping operations (size 82)• 1/2" x 3/4" tubing is widely applicable to tube welder applications• Female MPX connectivity is broadly applicable to larger volume mixing and bioreactor applications

Port 3• Tubing applicable to pumping operations (size 73)• 3/8" x 5/8" tubing is widely applicable to tube welder applications• Male MPC provides additional broad applicability to single use systems connectivity

Port 4

• Tubing applicable to pumping operations (size 24)• 1/4" x 7/16" tubing is widely applicable to tube welder applications • Aseptic sampling port allows for pre-use sampling and/or supplementation of process fluid• MPC fittings can be disconnected to provide for applications which require female MPC connectivity

Port 5

• Tubing applicable to pumping operations (size 82)• 1/2" x 3/4" tubing is widely applicable to tube welder applications• Male MPX connectivity is broadly applicable to larger volume mixing and bioreactor applications, can

be connected to port 2 for recirculation mixing/homogenization operations

Rigid Outer Container FlexStation® compatible – refer to specifications.

• ISTA 3H Qualified

P5



Sealing Plug, MPX

Coupling Body, 1/2" HB, MPX



Sealing Cap, MPCMale Luer Cap

Swabable Valve / Needleless Injection Site




Coupling Body 1/4" HB, MPC


1/2" x 3/8" HB Reduction Fitting1/2" x 3/4" 374 C-Flex Tubing, 3" Length




Coupling Insert, 1/2" HB, MPX

Sealing Cap, MPX

P1

P2

P3P4

Ratchet Pinch Clamp, Large

Ratchet Pinch Clamp, Medium

Ratchet Pinch Clamp, Large


100 L 6883B

200 L 6895B

500 L 6904B

Connectivity

Note: A 500 L top-port bag as a top-port discharge option is also available.


FlexStations® Rigid Transport and Shipping Container

Description FlexStation® 100 FlexStation® 200 FlexStation® 500

Volume 100 L 200 L 500 L

Outside Dimensions

Length 31.9” (809 mm) 31.9” (809 mm) 47.2” (1,200 mm)

Width 24.0” (609 mm) 24.0” (609 mm) 31.5” (800 mm)

Height 32.8” (833 mm) 32.8” (833 mm) 36.3” (915 mm)

Collapsed Height 15.9 (403 mm) 15.9” (403 mm) 18.5” (475 mm)

Height (Stacked 2) 64.8” (1,648 mm) 64.8” (1,648 mm) 71.3” (1,810 mm)

Footprint 5.4 ft2 (0.5 m2) 5.4 ft2 (0.5 m2) 10.3 ft2 (0.96 m2)

Container Capacity 661 lb. (300 kg) 661 lb. (300 kg) 2,860 lb. (1,300 kg)

Functional Temperature 0-40 °C 0-40 °C 0-40 °C

Material Polypropylene Polypropylene Polypropylene

Weight (Empty) 66 lb. (30 kg) 53 lb. (24 kg) 225 lb. (102 kg)


These premium rigid transport and shipping containers are available in standard sizes of 100, 200 and 500 liters to fit SAFC’s standard FlexStation® compatible bulk packages. The collapsible containers provide a rugged shipping solution and are also ideal for intra-company use. The durable plastic outer containers are reusable and collapsible for easy storage and handling when not in use. SAFC has qualified for liquid transport in accordance with International Safe Transit Association (ISTA) Series 3 testing.

Accessories

Stainless steel carts and pallet trucks specifically designed for the FlexStation® available. Please inquire with your Account Representative

17

Minimizing waste in your supply chain contributes to improved cost efficiencies, a cleaner environment and helps to meet customer demand for sustainable products and services. All SAFC rigid outer containers qualified for use as secondary packaging and transport of bulk liquid are recyclable contributing to reduced waste generation. SAFC offers a comprehensive inventory management program for large scale bulk liquid requirements utilizing the FlexStation® allowing for return and reuse. The reuse of these containers is defined by the recommended number of uses that define a normal FlexStation® lifespan.

Shipping and LogisticsRecyclable and Returnable Rigid Outer Containers

Recyclable Totes and Drums

• Blue Orbis Tote (NA)

• Bergen Barrel (NA)

Optional use of a dedicated FlexStation® fleet is available through the SAFC Recyclable and Reusable Program. This alternative allows customers to identify and track customer-specific containers allocated to their business offering expanded flexibility and control for continuous large volume supply needs. Please see your local account representative for more information

Inventory Identification and Tracking

• Container Ownership

• Lot-specific Designation

• Track Number of Uses (cycle count)

Maintenance

• Clean Out-of-Place Protocols

• Controlled Storage

Optional Customer-own Containers

• Ideal for Ongoing Large Volume Supply

• Increase Flexibility

• Increased Control

Reusable FlexStation® Container

• FlexStation® (NA & EU)

• Blue Orbis Tote / Bergen Barrel (EU)

sigma-aldrich.com/safc

PWX82605-5098741094

©2013 Sigma-Aldrich Co. LLC. All rights reserved. SAFC and SIGMA-ALDRICH are trademarks of Sigma-Aldrich Co. LLC, registered in the US and other countries. imMEDIAte ADVANTAGE is a trademark of Sigma-Aldrich Co. LLC. CHOZN is a trademark of

Sigma-Aldrich Co. LLC. FlexStation and TepoFlex are trademarks of Meissner Filtration Products, Inc. EPOGEN is a trademark of Amgen. Cerezyme is a trademark of Genzyme Corporation. REOPRO is a trademark of Janssen Biotech, Inc. AVONEX is a trademark of Biogen Idec.

HERCEPTIN is a trademark of Genentech, Inc. Enbrel is a trademark of Amgen. Erbitux is a trademark of Imclone, LLC. Avastin is a trademark of Genentech, Inc. Vista PRO and 720-ES are trademarks of Varian, Inc.

Purchaser must determine the suitability of the product(s) for their particular use. Additional terms and conditions may apply. Please see product information on the SAFC website at www.sigma-aldrich.com/safc and/or on the reverse side of the invoice or packing slip.

SAFC International SitesGlobal Email: [email protected]

Argentina Tel: +54 11 4556 1472 Fax: +54 11 4552 1698 Email: [email protected] Australia Free Tel: 1800 800 097 Free Fax: 1800 800 096 Tel: +61 (0)2 9841 0555 Fax: +61 (0)2 9841 0500 Email: [email protected] Austria Tel: +49 (0) 896 51 31 790 Fax: +44 (0) 129 420 4450 Email: [email protected] Belgium Tel: +31 (0) 78 620 5495 Fax: +44 (0) 129 420 4450 Email: [email protected] Brazil Tel: +55 11 3732 3100 Fax: +55 11 5522 9895 Email: [email protected] Canada Free Tel: +1 800 565 1400 Free Fax: +1 800 265 3858 Tel: +1 905 829 9500 Fax: +1 905 829 9292 Email: [email protected] China Tel: +86 21 6141 5566 Fax: +86 21 6141 5568 Email: [email protected] Czech Republic Tel: +420 (0) 246 00 3280 Fax: +44 (0) 129 420 4450 Email: [email protected]

Denmark Tel: +46 (0) 87 42 4298 Fax: +44 (0) 129 420 4450 Email: [email protected] Finland Tel: +46 (0) 87 42 4298 Fax: +44 (0) 129 420 4450 Email: [email protected] France Tel: +33 (0) 474 82 2920 Fax: +44 (0) 129 420 4450 Email: [email protected] Germany Tel: +49 (0) 896 51 31 790 Fax: +44 (0) 129 420 4450 Email: [email protected] Hungary Tel: +420 (0) 246 00 3280 Fax: +44 (0) 129 420 4450 Email: [email protected] India Tel: +91 80 6621 9400 Fax: +91 80 6621 9650 Email: [email protected] Ireland Tel: +44 (0)1294 20 4490 Fax: +44 (0) 129 420 4450 Email: [email protected] Israel Free Tel: +1 800 70 2222 Tel: +972 8 948 4100 Fax: +972 8 948 4200 Email: [email protected] Italy Tel: +39 (0)23 341 7385 Fax: +44 (0) 129 420 4450 Email: [email protected]

Japan Tel: +81 (0)3 5796 7340 Fax: +81 (0)3 5796 7345 Email: [email protected] Malaysia Tel: +60 3 5635 3321 Fax: +60 3 5635 4116 Email: [email protected] Mexico Free Tel: +01 800 007 5300 Free Fax: +01 800 712 9920 Email: [email protected] The Netherlands Tel: +31 (0) 78 620 5495 Fax: +44 (0) 129 420 4450 Email: [email protected] New Zealand Free Tel: +0800 936 666 Free Fax: +0800 937 777 Email: [email protected] Norway Tel: +46 (0) 87 42 4298 Fax: +44 (0) 129 420 4450 Email: [email protected] Poland Tel: +420 (0) 246 00 3280 Fax: +44 (0) 129 420 4450 Email: [email protected] Portugal Tel: + 34 91 545 3045 Fax: +44 (0) 129 420 4450 Email: [email protected] Russia Tel: +7 495 621 58 28 Fax: +7 495 621 59 23 Email: [email protected]

Singapore Tel: +65 6779 1200 Fax: +65 6779 1822 Email: [email protected] South Africa Free Tel: +0800 1100 75 Free Fax: +0800 1100 79 Tel: +27 11 979 1188 Fax: +27 11 979 1119 Email: [email protected] South Korea Tel: +82 (0)31 329 9010 Email: [email protected] Spain Tel: + 34 91 545 3045 Fax: +44 (0) 129 420 4450 Email: [email protected] Sweden Tel: +46 (0) 87 42 4298 Fax: +44 (0) 129 420 4450 Email: [email protected] Switzerland Tel: +49 (0) 896 51 31 790 Fax: +44 (0) 129 420 4450 Email: [email protected] United Kingdom Tel: +44 (0)1294 20 4490 Fax: +44 (0) 129 420 4450 Email: [email protected] United States Toll Free: +1 800 244 1173 Call Collect: +1 314 289 8454 Toll Free Fax: +1 800 368 4661 Fax: +1 314 652 0000 Email: [email protected]

safc bulk liquid handling capabilities - sigma-aldrich€¦ · safc bulk liquid handling...

Documents