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2023 Guide to Medical Devices Quality Control and Testing

2023 Guide to Medical Devices Quality Control and Testing
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2023 Guide to Medical Devices Quality Control and Testing

Introduction To remain competitive in the medical device market, you need to be able to reduce costs while improving quality. Sartorius offers a variety of solutions for your medical device manufacturing and quality control processes—options that can improve your productivity and help you meet rigorous compliance standards. Some of our solutions include: GxP Pipetting Compliance Air Monitoring in Cleanroom Environment Weighing Compliance to US FDA - Data Integrity Principles Accurate Weighing Results for Medical Stents Ultrapure Water for HPLC Analysis Partner with Sartorius to streamline...

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GxP Pipetting Gxp History Compliance GxP Pipetting Compliance Are You GLP/GMP Compliant When It Comes to Pipetting? Are you following methods for current Good Laboratory Practice (cGLP) or current Good Manufacturing Practice (cGMP)? Our new application note introduces tools and principles that can help you with these demanding requirements, especially when it comes to your pipetting practices. A pipette is a precision measuring apparatus that has a significant influence on your lab results, but it can also be your companion in ensuring compliance. Accurate Weighing for Medical Stents...

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GxP Pipetting History Compliance Accurate Weighing for Medical Stents Air Monitoring in Cleanroom Environments Air Monitoring in Cleanroom Environments according to EN 17141 and ISO 14698 Biocontamination control strategies are a key requirement of recent standards and guidelines, such as the EN 17141 and the revision of the EU GMP Annex 1. The Annex E chapter of EN 17141 details guidance on culture-based microbiological monitoring methods and sampler verification. This Application Note focuses on viable microbial monitoring and demonstrates that microbial air monitoring by Gelatin Membrane...

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GxP Pipetting History Compliance US FDA Weighing Compliance Advanced Weighing Compliance for Use in Regulated Medical Devices Industry Sartorius’s Cubis® II balance is designed to follow US FDA data integrity principles for accurate, legible, contemporaneous, original, and attributable (ALCOA) data. The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Achieve full compliance with additional procedural controls and systems for long-term data storage. Download White Paper Accurate Weighing for Medical Stents

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GxP Pipetting History Compliance Accurate Weighing for Medical Stents Accurate Weighing for Medical Stents How to Achieve Accurate Weighing Results for Medical Stents Download our handbook to discover four steps to highly accurate and reproducible weighing results with the Cubis®II balance -the perfect choice for stent manufacturers in the Medical Devices industry. Ensure high-throughput and boost your productivity via fast stabilization times, regardless of the stent size or weighing conditions in your facility. Ultrapure Water for HPLC

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GxP Pipetting History Compliance Ultrapure Water for HPLC Ultrapure Laboratory Water for HPLC Analysis in Medical Devices The presence of trace contaminants in your solvent during gradient elution can result in “ghost or phantom peaks,” so the quality of your solvent is often decisive in the reliability of your HPLC analytical run. However, deionized or distilled water still contains quantities of organic substances, which can cause ghost peaks. Water of the quality required for HPLC can be either purchased from a manufacturer or produced on site with a water purification system. Our...

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GxP Pipetting History Compliance More Resources | Contact Us Visit Our Website For More Information Additional Resources Discover More Accurate Weighing for Medical Stents Ultrapure Water for HPLC

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Germany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0 F or further contacts, visit www.sartorius.com Specifications subject to change without notice. Copyright Sartorius Lab Instruments GmbH & Co. KG. Status: 02 | 2023

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