Profile: A look at Sartorius

Using your product formulation under simulated ‘worst-case’ process conditions, we work with you to evaluate your process and provide test protocols for Bacterial Challenge Testing, Chemical Compatibility Testing and Extractables Analysis. We offer a complete array of testing services using your actual product formulation, including USP testing and stability tests. We also provide tests using profiling solvents. Extractable testing for non-filter items such as tubing, stoppers, bags and container/closures is also available. Sartorius also offers a filtration system optimization program, technical training, seminars and Key Accounts Management. Our customers are our number one priority and as a worldwide company, we will help you optimize your processes and maximize your resources.

For additional information on Sartorius products, please contact Sartorius Tech Service at 1.800.368.7178 or visit www.sartorius.com.

Sartorius North America, Inc., 131 Heartland Boulevard, Edgewood, NY 11717

BIOSTAT® Aplus series– A new range of compact bioreactor | fermentor systems from Sartorius

In today’s biotechnology environment it has become commonplace to produce a wide range of proteins using genetically manipulated microorganisms or animal cells.
However the efficiency of traditional small scale laboratory production systems i.e.Shaking flasks, T-Bottles or Spinner flasks is limited due to the fact that oxygen input is low and pH levels cannot be controlled.

Up to now, standard bioreactor | fermentor and with in-built control of temperature, agitation speed, dissolved oxygen, pH and Foam or Level in a reactor vessel have a relatively high initial investment cost.

With the introduction of BIOSTAT®Aplus, Sartorius has created a range of very compact autoclavable bioreactor | fermentor systems with working volumes of up to 5 l that are within the reach users having limited budgets.

In part, this has been made possible by transferring the controlling “Human-Machine Interface” to standard Notebook-PC which is delivered with the BIOSTAT® Aplus. This concept has the additional benefit of enabling the user to operate the system and transfer measured data to an additionally installed MFCS/DA SCADA software package for further evaluation.

An additional cost saving has been realised by developing “Application Specific” configurations for both microbial and animal cell cultivation. These configurations are available with a choice of 1, 2 or 5 l working volume vessels as well as additional add-on options and weight measurement. Each system is supplied with detailed information guides describing recommended experimental conditions, media composition, controller set points etc. for the most commonly encountered expressions systems.

Visit our website to experience our 3D viewer with additional product information.
http://www.sartorius.com/biostat_aplus/

Sartorius Offers Standard, In Stock, Filter and Bag Assemblies


As a direct result of the partnership between TC Tech and Sartorius, Sartorius now offers the Gammasart Biosystem SA line of standard presterilized filter and bag assemblies. Gammasart Biosystem SA’s are in stock, eliminating the lead-time and complications of coordinating a custom designed filter and bag assembly. Each assembly features a 0.2 µm Sartopore 2 Capsule Filter, with an extremely hydrophilic double layer PES membrane construction giving outstanding total throughputs and flow rates. Gammasart Biosystem SA’s are available in sizes from 1 to 200 liters, for a wide variety of process applications.

Single-use systems significantly reduce cross contamination risk, cleaning and cleaning validation. Gamma sterilized filter and bag assemblies eliminate cross and foreign contamination risks during aseptic processing of biopharmaceutical solutions. Now, standard, off-the-shelf filter and bag assemblies simplify the procurement too.

For additional information on Sartorius products, please contact Sartorius Tech Service at 1.800.368.7178 or visit www.sartorius.com.

Sartorius North America, Inc., 131 Heartland Boulevard, Edgewood, NY 11717

Disposable Mixing Systems Enable The Use Of Disposable In More Applications

LevTech Disposable Mixing systems, available from Sartorius allow processors to implement the use of disposable technology in process steps previously reserved for stainless steel. The superconductive, levitated impellor allows traditional impeller based mixing with no contact, friction or particle generation in closed, sterile mixing bags. Primary applications include sterile liquid-liquid mixing for final formulation, resuspension of long-term stored solutions, viral inactivation among many others. 500 liter mixing studies show that homogeneous solutions may be achieved in as little as 45 seconds. Typical volumes are from 30 to 500 liters with up to 2,000 liter applications possible.

Market Introduction MidiCaps®

Sartorius announces the market introduction of MidiCaps® - its new capsule design for the biopharmaceutical industry. MidiCaps® are launched as the company’s contribution to implement innovative and efficient disposable process solutions into the industry. Featuring a broad range of connectors and various filter sizes, MidiCaps® allow for highest flexibility and choice. The GMP compliant, easy-to-use, vent- and drain-valve design, including an integrated hose barb for fluid containment, allows you to perform aseptic operations and provides optimal operator protection. The unique, easy-to-read labelling of MidiCaps® simplifies secure identification of the filter elements and helps to avoid operator errors for overall improvement of manufacturing security. MidiCaps® will become available for all filter materials offered by Sartorius to be used in various applications. The market introduction of MidiCaps® started in March 2005 with the company’s Sartopore 2® product line.

Scalable High Performance Membrane Chromatography

Sartobind® Membrane Chromatography devices from Sartorius offer significant advantages over traditional column chromatography for many applications. Advantages include high flow rates with excellent dynamic binding in a ready to use, durable, disposable format that permits easy scalability from lab to production. Removal of contaminants such as DNA, endotoxin, viruses and host cell proteins are typical applications. Sartobind Membrane Chromatography devices are also used for concentration and capture steps at flow rates unimagined by traditional column chromatographers.

To learn more about Sartobind Membrane Chromatography and all Sartorius products visit our website at www.sartorius.com or contact Customer Service at 1-800-368-7178.

Sartorius North America, Inc., 131 Heartland Boulevard, Edgewood, NY 11717

Sartocheck 4 – Filter Integrity Testing

The Sartocheck 4 filter integrity testing unit is a fully-automated, microprocessor-controlled integrity test used to check the integrity of membrane filter systems. The system can measure a variety of parameters including configurable bubble point testing for difficult to test oil-based products, diffusion testing, and water intrusion testing. Every user action is recorded in an audit trail in full compliance with the FDA’s 21 CFR Part 11 regulations. A total of 350 test programs and 500 test results can be held within its internal database, with a unique data access security system built into the unit.

Sartorius Introduces Sterisart® NF Systems

Sartorius’ Sterisart® NF system is a new alternative for batch release. Sterisart NF is a complete disposable and closed sterility test system. It is based on the membrane filtration method as recommended by the international pharmacopeias for sterility testing.

Sterisart NF is a complete closed system preventing secondary contamination. A special clamping technique and low adsorptive membrane specifically designed for sterility testing known as Sartochem® allows for the elimination of inhibitors which could impede culture growth and generate false negatives.

For additional information on Sterisart NF systems, please contact Sartorius Tech Service at 1.800.368.7178 or visit www.sartorius.com.