Surgical Instruments – Safe, Effective & Compliant Precision Tools
Robust, Simple and Reliable Quality Control (QC) Solutions
Surgical instruments (scissors, stethoscopes, scalpels, forceps, clamps, retractors, etc.) are high-precision tools engineered and manufactured in compliance with stringent quality specifications.
New instruments designed for advanced minimal-invasive and single-incision surgeries – and made of different materials (such as stainless steel, titanium, nylon, teflon, silicon or fiberglass) must make smaller incisions in favor of smaller scars and fewer post-operative complications.
Long-lasting quality and robust performance with low susceptibility to retain bioburden are among the many elements to consider while designing these instruments. During manufacturing, many components must be refined, surface-treated and sometimes assembled by hand.
Stringent QC is a key factor for successful commercialization of surgical instruments. It offers the potential to de-risk projects, increase success rates, significantly reduce costs and accelerate time-to-market. Deviations or fluctuations can be detected in time to avoid higher production costs, downtimes or product recalls.
Let Sartorius help you reach full QC potential!
A Deeper Look into the Process Steps for Medical Device QC
Medical Device Manufacturing Workflow
R&D and Process Development
Improvements in minimally-invasive surgery is transforming the patient experience by reducing recovery times and post-surgery trauma. Single-use ancillaries and instruments limit the risk of nosocomial infections.
It all starts in the design and development phase.
Discover R&D and Process Development solutions for your application:
- Density Check of Solid Material & Liquids
- Chemical Characterization - Biocompatibility
- Cytotoxicity - Biocompatibility
- Data Analytics
Raw Material Testing
The quality of the final product depends on the quality of the raw materials. To ensure device performance and patient safety, your raw materials must be stable and safe for use and meet stringent ISO, USP, EP, ChP, JP, and ARTG testing standards.
Discover the Raw Material Testing solutions for your application:
- Density Check of Solid Material & Liquids
- Moisture Determination of Raw Material
- Particulate Matter Analysis
- Chemical Characterization - Biocompatibility
- Microbial Testing: Water & Bioburden Testing
In-Process Control
In-process quality control tests are performed at regular intervals to verify product quality and specifications at every stage of production.
Evaluate the correct amount of Titanium Nitride (TiN) for black coatings on forceps. Test moisture content on fluoropolymer-coated blades or particulate matter on ablation tools. Ensure proper assembly of all parts in a scissor.
Discover the In-Process Control solution for your application:
- Check Coatings – Application of Correct Amounts
- Moisture Determination
- Particulate Matter Analysis
- Continuous Microbial Air Monitoring
- Rinsing & Sterile Preparation
- Data Analytics
- Counting with Reference Weight
Final Release Testing
Final tests are required to guarantee error-free assembly, avoid malfunction, prevent defects, and ensure robust performance during surgery.
Discover the Final Release Testing solutions for your application:
- Check Coatings Application
- Error-Proof Packaging
- Density Check of Solid Material & Liquids
- Moisture Determination of Packaging Material
- Microbial Testing: Bioburden & Sterility
- Chemical Characterization - Biocompatibility
Featured Products
Cubis® II Microbalance
Weighing by difference solutions are your best fit to verify coating systems have applied the exact amount of medical grade polymer or API.
Arium® Comfort II Ultrapure Water System
Sartorius Water Purification Systems provide ultrapure water for impurity-free and safe operation
Microsart® @filter
Membrane filtration solutions for standard microbial enumeration protocols facilitate accurate detection of potentially pathogenic or spoilage microorganisms.
Featured Resources
Frequently Asked Questions
You may have heard the term Six Sigma used in conjunction with lean manufacturing, a Kaizen approach or continuous quality improvement. Six Sigma is not only applicable to large-scale business operations.
If you're looking for a way to improve production processes or solve a quality control problem, Six Sigma might be the answer. Discover more in our Science Snippets Blog.
Prior to sterilization, bioburden testing to determine total number of viable microorganisms on all or part of a medical device surface, is one of the most-used microbiological tests in the Medical Device industry.
As required by industrial standards such as ISO 11737-1, microorganisms should be suspended in the proper liquid, captured using membrane filtration and grown on a culture medium. Thus, using the right products and procedures to determine bioburden is essential and helps reduce risks which could impact patient safety.