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 DevicesGet Reliable Results Every Time While Improving Your Productivity

For more information, please visit www.sartorius.com/md

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® High Capacity Micro Balances:- High throughput for vascular stent weighing

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

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

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

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

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

HPLC Sample Preparation Solutions

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

Preparation of Buffers and Dilution of Samples

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

Ultrapure Lab Water Systems:- Arium® 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

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

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

For more information, please visit www.sartorius.com/md

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

Efficient, Reliable, User-Friendly Microbiological Testing Solutions for Medical Devices. Product Safety Means Patient Safety – Get Full Confidence in Medical Device QC Testing

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

Microbiological Testing Solutions

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

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

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® 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® @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

For more information, please visit www.sartorius.com/md

Minimize Risks in Endotoxin Testing with Smart Pipetting Solutions. Guarantee Consistently Reliable Endotoxin Testing Results with Purity-Certified Pipette Tips

Endotoxin Testing Solutions

Optifit Pipette Tips

Optifit pipette tips are tested and certified to be endotoxin free, so they fit into workflows of medical device QC labs. Sartorius manufactures pipette tips according to ISO 14644-1 in a certified ISO 8 cleanroom environment to maintain the highest quality and purity standards.

- Optifit tips are packed in single tray racks with an air-tight wrapping to protect the tips from endotoxins- The highest quality pure polypropylene is used as raw material to ensure material purity- A lot-specific purity certificate is supplied with tips- Optifit tips ensure perfect fitting and leak-tight sealing on Sartorius pipettes for maximum pipetting accuracy and reproducibility

Tacta® Mechanical Pipettes – Perfectly Balanced

Tacta® is the new premium mechanical pipette with superb comfort and reliability. Tacta® makes pipetting effortless and safe, while producing accurate and reliable results time after time.

- Fully autoclavable pipette for best contamination removal- Controlled and smooth tip ejection with the new Sartorius Optiject technology- Easy to clean, with only three parts to disassemble

Perform Reliable Testing of Endotoxin Levels on Medical Devices with Smart Pipetting Solutions

- Use purity certified and endotoxin-free pipette tips- Sartorius pipette tips are tested for endotoxin content with a limit of 100 times lower than the regulatory requirement- Sartorius pipettes provide you with consistently accurate and precise results and they are easy to use and clean

Picus® NxT Electronic Pipettes – Highly Sophisticated and Ergonomic

Picus® NxT is the lightest and smallest electronic pipette on the market. Its ergonomic design, fully electronic operation, and advanced functionalities ensure an easy and comfortable pipetting experience.

- User-definable protocols speed up routine pipetting sequences and add reliability on standard curve pipetting- Certificate of accredited 3-point calibration (ISO 17025 and ISO 8655) conforms to the strictest regulations- Maintenance and calibration reminders alert you when service is required- Possibility to lock the pipette and prevent the use, for instance, in case of contamination

For more information, please visit www.sartorius.com/md

Product Safety Means Patient Safety.Get Consistently High Quality Results Compliant to ASTM Standard D6980 with Smart Sartorius Moisture Analysis Solutions

Moisture Analysis for Medical-grade Plastics

Sartorius Mark 3 HP is the perfect solution for plastic moisture content analysis in medical device manufacturing. It operates on the principle of loss on drying. Mark 3 HP finalizes on a programmed rate of weight change compared to the actual initial weight of the sample over a programmed window of time, and it features a built-in temperature and weight calibration function to ensure advanced moisture analysis.

- Economical and reliable alternative to the Karl-Fischer titration and drying oven methods- Multi-module operation enables parallel measurements of up to 4 different samples on one single device- Easy-to-use, intuitive, single button operation - Robust and fast; optimal for routine operation- An extensive range of security settings guarantees reliable results and 100% traceability- Mark 3 can measure the minimum moisture content down to 0.005% (50 ppm) moisture

Mark 3 HP Moisture Analyzer – The Genuine Alternative to Karl-Fischer Titration

Sample Testing Services - The Convenient and Reliable Way to Obtain Correct Results

Complex medical device production processes and products place high demands on fast, reliable, and highly precise moisture analysis. Moisture Analysis Individual is an innovative concept that exactly meets these requirements with the moisture analyzer Mark 3. Our application specialists support you to create a customized, reliable and traceable method with the highest possible comparability to your reference method by utilizing our library of over 7000 plastic resins. If needed, our application labs can support you further and use your sample for comparative measurements. Just start measuring – with the simple touch of a button.

- Minimize risks, and get precise and reproducible measurements of even the least amount of moisture - Get consistently high quality results compliant to ASTM standard D6980- Mark 3 is a genuine alternative to Karl-Fischer titration because it is easy-to-use without any harmful chemicals

Sartorius Offers Smart Solutions and Services to Determine Even the Lowest Moisture Content in Plastic Resins within Minutes

For more information, please visit www.sartorius.com/md

Specifications subject to change without notice. Copyright Sartorius Group. Version 2020 / 04

Sales and Service ContactsFor further contacts, visit www.sartorius.comGermany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0

USA Sartorius Corporation 565 Johnson Avenue Bohemia, NY 11716 Phone +1 631 254 4249 Toll-free +1 800 635 2906