Solutions for Medical Device Development, Manufacturing and Quality … · Maximum productivity,...
Transcript of Solutions for Medical Device Development, Manufacturing and Quality … · Maximum productivity,...
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 [email protected] www.sartorius.com
Specifications subject to change without notice. Copyright Sartorius Lab Instruments GmbH & Co. KG. Ver. 1 | 2019 Apr | EN