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2020 Guide to Medical Devices Quality Control and Testing

The importance of quality control in medical devices companies cannot be underestimated. To ensure product quality and remain competitive, you need to be able to reduce costs while improving quality.

Medical device product development is a complex process. Quality managers need to ensure quality control at every stage of the process and trust the results.

Sartorius offers a variety of solutions for your medical device manufacturing and quality control processes. Maintain compliance and improve processes with a range of trusted laboratory equipment.

The guide covers the main stages in the quality process:
 

  • Microbiological Testing Solutions
  • Back-weighing Solutions for Medical Stents
  • HPLC Sample Preparation and Analysis Solutions
  • Endotoxin Testing Solutions
  • Moisture Analysis Solutions for Medical-grade Plastics

Streamline your testing and quality processes by using best-in-class laboratory equipment to produce trusted and reliable results.

Table of Contents

Chapter 1

How to Accurately Measure the Moisture Content of Plastic Resin?

Read more below...

Chapter 2

Are You GLP/GMP Compliant When It Comes to Pipetting?

Read more below...

Chapter 3

Continuous Microbial Air Monitoring in Clean Room Environments

Read more below...

Chapter 4

Do You Know How NASA Detects Airborne Microbes in the International Space Station?

Read more below...

Chapter 5

Advanced Weighing with Compliance for the Regulated Medical Devices Industry

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Chapter 6

How to Achieve Accurate Weighing Results for Medical Stents

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Chapter 7

Improved Sample Preparation for HPLC Analysis

Read more below...

Chapter 8

Ultrapure Laboratory Water for HPLC Analysis in Medical Devices

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Chapter 9

How to Avoid Endotoxin Contamination in Pipetting When Testing Medical Devices

Read more below...

Chapter 10

Did You Know That Endotoxin Contamination of Lab Consumables Can Influence Your Assay Results in Medical Device Testing?

Read more below...

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Chapter 1

How to Accurately Measure the Moisture Content of Plastic Resin?

Moisture content is an important variable that must be monitored for and controlled during the production of plastic medical device parts. ASTM standard D6869 is the benchmark for measuring the moisture content of plastic resin, and stipulates the use of Karl Fischer titration as the applicable standard method. Herein, we show that the Sartorius Mark 3 High Performance Moisture Analyzer correlates well with Karl Fischer titration standards for a number of plastic resins commonly used in medical device manufacture.

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Chapter 2

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.

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Chapter 3

Continuous Microbial Air Monitoring in Clean Room Environments

Download our application note and start preparing for Annex 1 regulations. Find out how you can implement continuous microbial air monitoring throughout your entire medical device manufacturing and quality control systems.

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Chapter 4

Do You Know How NASA Detects Airborne Microbes in the International Space Station?

You must continuously monitor airborne microbes in your medical device manufacturing clean room facilities, just as they do in the International Space Station. See how NASA uses Sartorius’s MD8 Airscan® technology to catalog and characterize potential disease-causing microorganisms—thousands of miles above Earth.

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Chapter 5

Advanced Weighing with Compliance for the 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 the Pharma package, has all the technical controls you need for compliance with common regulations. Achieve full compliance with additional procedural controls and systems for long-term data storage.

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Chapter 6

How to Achieve Accurate Weighing Results for Medical Stents

Download our handbook to discover four steps for highly accurate and reproducible weighing results, and see why the Cubis® II balance is the perfect choice for stent manufacturers in the medical devices industry. Ensure high-throughput and boost your productivity via fast stabilization times, regardless of your stent size or facility weighing conditions.

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Chapter 7

Improved Sample Preparation for HPLC Analysis

HPLC sample preparation is easier than ever with Sartorius’s Cubis® MSA Dosing System. The Cubis MSA individual system with Q-App software eliminates the need to reach a precise target weight by automatically calculating the solvent volume to the appropriate value. The software then uses compound weight(s) and solvent volumes to calculate your verified standard solution concentration(s). 

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Chapter 8

Ultrapure Laboratory Water for HPLC Analysis in Medical Devices

The quality of your solvent is often determines the reliability of your HPLC analytical run; the presence of trace contaminants in your solvent during gradient elution can result in ghost or phantom peaks. However, deionized or distilled water still contains quantities of organic substances, which can cause these ghost peaks. High-quality HPLC water can be purchased from a manufacturer or produced on-site with a water purification system. Our application note evaluates water purification systems as an alternative to commercially sold ultrapure water for the preparation of high-purity eluents for HPLC analysis.

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Chapter 9

How to Avoid Endotoxin Contamination in Pipetting When Testing Medical Devices

Preventing contamination during pipetting is paramount to achieving reliable medical device test results. Aseptic pipetting requires knowledge of potential contamination mechanisms. Our application note discusses the three contamination types that originate from pipetting: pipette-to-sample contamination, sample-to-pipette contamination, and sample-to-sample contamination.

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Chapter 10

Did You Know That Endotoxin Contamination of Lab Consumables Can Influence Your Assay Results in Medical Device Testing?

Pipetting errors are a common source of variance in testing procedures. For example, variance in endotoxin testing standard curves can have a deleterious effect on the reliability of test results.

To minimize potential sources of endotoxin contamination when pipetting, use endotoxin-free consumables, such as pipette tips, within the testing workflow. Our poster is a handy reference with tips and tricks for contamination-free pipetting. 

Our application note discusses a pipette quality control program for your lab so you can keep pipetting variance low.

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