Solutions for Medical Device Development, Manufacturing and Quality Control -Rapidly Boost Your Productivity

Maximum productivity, accuracy and regulatory compliance are critical success factors in Medical Devices development, manufacturing and quality control. However, you need to be completely confident that you can trust your results all the way through your manufacturing process.

Let Sartorius save you time and increase your throughput by helping you control the quality of your Medical Devices, to produce results you can really rely on.

Introducing our solutions into your Medical Devices manufacturing and QC processes will not only improve your productivity, but also ensure full compliance to the most rigorous standards and requirements. Sartorius solutions enable you to streamline time-consuming, labor-intensive and potentially error-prone manufacturing processes, as well as quality control your workflows.

Solutions for Medical Devices - Get Reliable Results Every Time While Improving Your Productivity

Boost Productivity and Get Reliable Results with Cubis®

Cubis® balances increase throughput of your stent weighing thanks to the speedy stabilization times under real manufacturing conditions.

Enjoy reliable results and premium precision

Cubis® II Ultra-Micro and Micro Balances• The new generation of modular premium laboratory balances• Best-in-class performance for coronary stent weighing• Fastest stabilization time to improve productivity• Integrated motion sensor for touch free opening/closing of the draft

shield

Cubis® High Capacity Micro Balances• High throughput for vascular stent weighing

Stent Holders• Smart accessories for quick, easy and reliable stent weighing

Cubis® – The Right Balance between Precision and Productivity

• High throughput via fast stabilization times

• Accurate and reproducible weighing results

• Convenience of seamless connectivity and adaptable software

• Compliance through complete traceability

Back-Weighing Solutions for Medical Components, like Drug Eluting Stents

HPLC Sample Preparation Solutions

Save Time and Improve Reproducibility with Sartorius HPLC Sample Preparation Solutions

Extend the lifetime of your HPLC columns and avoid ghost peaks for accurate results every time.

Discover Sartorius HPLC Sample Preparation Solutions for Analytical Quality Control in your Medical Devices Manufacturing Process

• Enjoy robust, reliable sample preparation and streamlined workflows

• Get precise, reproducible, interference-free results

• Use best in class sample prep for best in class results

Preparation of Buffers and Dilution of Samples

Ensure consistent baselines and reduce ghost peaks with chromatography grade ultrapure water

Ultrapure Lab Water Systemsarium® mini plus UV with Unique Bagtank Technology& arium® pro UV• ASTM Type 1 water to increase sensitivity of analytical

results• Remove TOC levels down to a minimum and avoid

background noises in chromatograms • Our IQ/OQ service offering ensures regulatory conformity

for GLP/GMP• Produce highly deionized water and minimize chemical ion

interference

Pipetting

Experience ergonomic pipettes and reliable pipetting results of even the lowest volumes

Tacta® Mechanical Pipettes• Effortless pipetting thanks to ergonomic design• Volume lock for reliable pipetting results• Easy calibration and adjustment

Picus® Electronic Pipettes• Accurate and precise pipetting results• Fully electronic operation and easy to use• Light weight pipette for superior pipetting ergonomics

Low RetentionTips • Optimal sample recovery• Purity certified

Preparation of Standards

Benefit from automated preparation and documentation of 100% comparable HPLC standards

Cubis® MSA Dosing System with Q-App Software• Fully automated preparation of standard series• Documentation of test procedures• Reliable and intuitive guidance through simple workflows• CFR21 Part 11 compliant records

Filtration

Protect and extend the lifetime of your HPLC columns by removing particles from samples for consistently reliable analytical results

Claristep® Filtration System • Convenient filtering of 8 HPLC samples simultaneously

saves time• Total ease of use• Maximum chemical resistance and compatibility

Minisart® Syringe Filters• Reliable particle removal, without adding any extractables

or leachables to your samples• Minisart® RC comes with a lot-specific HPLC purity

certificate• Fastest flow of filtered samples without blocking

Microbiological Testing Solutions

Efficient, Reliable, User-Friendly Microbiological Testing Solutions for Medical Devices

Product safety means patient safety – get full confidence in medical device QC testing.

Meet Regulatory Requirements in Your Microbiological Testing

• Achieve accurate, reproducible results for raw material, in-process and final release microbiological testing

• Take advantage of the fully compliant membrane filtration solutions

Air Monitoring Solutions

Continuous active air monitoring solutions for clean room environments

MD8 Airscan®• Reduce risks with convenient 8 hours non-stop active air

monitoring• Be prepared for Annex 1 regulations

Gelatin Membrane Filters• Agar-free filters - no need to change agar plates, no risk of

cross contamination• USP-approved filter retains even smallest viable airborne

microorganisms at the most accurate of levels

Water Testing Solutions and Bioburden Testing Solutions

Keep your microbiological quality under control with processes and procedures compliant with ISO 11737-1. Streamline your workflows and simplify your microbiological testing with user-friendly Sartorius consumables and equipment for microbial enumeration.

Microsart® @Filter Units• Save time and minimize the risk of secondary contamination• Reliable results as no liquid remains after filtration • Ready-to-use, sterile Microsart® @filter units combine a

funnel, a filter base and a gridded membrane filter in one unit

Microsart® @Media Dishes• The innovative active lid enables touch-free membrane

transfer • Eliminate false-positive results • Pre-filled with agar, Microsart® @media dishes are sterile-

packed and ready to use

Microsart® e.motion Membrane Filters & Dispenser• Membrane filters for colony counting, particle testing and

microscopy• Outstanding recovery rates for microorganisms• Individually sterile-sealed filters are packed on a special

pleated band• Convenient dispenser enables automatic, touch-free

membrane filter dispensing

Microsart® Manifolds• Single and multi-branch manifolds for microbiological

analysis of liquid samples in quality assurance• Fully autoclavable stainless steel manifolds are easy to clean

and rinse• High flexibility thanks to quick connections for adapting

filter base and tubing• Ergonomic and intuitive handling of the valves

Microsart® e.jet Pump• Maintenance-friendly and efficient pump• Vacuum flask free, smooth and reliable filtration• Space-saving footprint for benchtop use

Get in Touch with Our Specialists for Expert Advice on a Specific Need, or Discover Our Solutions Here:www.sartorius.com/md

Sartorius Lab Instruments GmbH & Co. KGOtto-Brenner-Strasse 20

37079 Goettingen, Germany

Phone +49.551.308.0info@sartorius.com www.sartorius.com

Specifications subject to change without notice. Copyright Sartorius Lab Instruments GmbH & Co. KG. Ver. 1 | 2019 Apr | EN