Infusion Pump Testing & Micro-Flow Calibration
Ultra-High Resolution Weighing for Accurate Flow Rate Assessment and Regulatory Compliance
In the critical field of medical device manufacturing, particularly for devices that deliver life-sustaining fluids, precision is paramount. Sartorius understands the importance of ensuring accurate dose administration and sets the standard in precision lab weighing for infusion device manufacturers and testing labs.
Introducing the Perfect Fit for Testing Infusion Pumps
Our Cubis® II Balances are engineered to support accurate dose administration for devices like infusion pumps, supporting your experts in Product Development, Quality Assurance, Regulatory Affairs, and more.
Be equipped with trustworthy data to uphold the integrity of medical infusion pumps throughout their lifecycle with:
- Precision Testing: High-Resolution Cubis® II balances for accurate flow rate and dose assessment
- Regulatory Compliance: Adherence to AAMI TIR 101, IEC 60601-2-24, FDA, MDR, and GMP standards, aiding in product development, design verification, technical investigations, and quality control
- Reproducible and Reliable: Streamlined testing with robust data integrity, in line with 21CFR part 11
- Innovative Technology: Monolithic weighing system to addressing industry challenges, such as balance drift and repeatable measuring values
- Comprehensive Offer: Sustainable Grade 2 water at your fingerprint
Discover the Sartorius difference in ensuring the reliability and integrity of infusion pumps, where every microliter counts.
Example of Test Apparatus
Fluid delivery performance testing for volumetric infusion, insulin, syringe, container, or peristaltic pumps.
Infusion Pump Testing Equipment
Cubis® II Ultra-High Resolution Balances
Sartorius Cubis® II Ultra-High Resolution balances are the premier choice for infusion pump manufacturers aiming for AAMI TIR 101 compliance, offering unparalleled precision in flowrate and accuracy testing. The Cubis® II MCA66S micro balance and MCA225S semi-micro balance stand out with their advanced features, ensuring that technical experts can conduct thorough and reliable tests with confidence. The key benefits include:
- Exceptional resolution, with the MCA66S providing 1 µg sensitivity and a capacity of 61 g for flowrates under 0.1 mL/h and the MCA225S offering 10 µg for flowrates between 10 mL/h and 0.1 mL/h
- A monolithic weighing system of the 4th generation across the range ensures precise, repeatable results with minimal drift, even in challenging lab conditions
- High capacity and fast stabilization allow for longer, uninterrupted testing periods, reducing the need for frequent reservoir emptying
- Robust construction and climate chamber resistance, from +5 to +40 °C, guarantee stable data output and adherence to 21CFR Part 11, making these balances a reliable tool for infusion pump testing
Grade 2 Lab Water
Per AAMI TIR 101 §4.2 and in IEC 60601-2-4, ISO 3696 grade 3 (or better) water or 0,9% normal saline should be used for the test solution.
The Arium® Advance EDI reliably delivers water of consistently high grade 2 water quality. Equipped with three purification stages, the system efficiently removes impurities and other contaminants from tap water.
- Easy to use – Prompt up to 10 L/h of water with unique touch display and intuitive menu navigation
- Sustainable – Get the Grade 2 water you need where you need it, without sourcing or trashing single-use bottles of medical water
- Modular – Various and convenient system configuration with flexible water dispensing system, Arium® Smart Station, and a choice between three dimensions of Arium® Bagtank for intermediate water storage
- Optimized water consumption – Intelligent Arium® software iJust, controls a valve on the concentrate outlet based on hardness data that have been entered
Services for Lab Balances
To be compliant with AAMI TIR 101, FDA, MDR, and GMP laboratory balances should be tested and calibrated regularly. Our Sartorius Service provides the needed certificates for your application.
- Accredited calibration in accordance with ISO | IEC 17025 in many countries
- Traceability of measurement results to national standards
- Regulatory compliance and audit security
Supporting Solutions
Cubis® II Balances Offer:
A monolithic weighing system that empowers flow & accuracy. Cubis® II balances offer exceptional repeatability, high capacities, fast stabilization, and low weighing drifts under real-life conditions.
Increase your efficiency without compromising between long testing periods and high precision. Our Cubis® II High-Capacity Micro balances are designed to let you run a maximum number of shots through high capacities (61g) and a readability of 1 µg with minimum interruption.
The Cubis® II balances achieve high and accurate data transfer rates of 10 Hz (10 measuring values per second) and can achieve even higher transfer rate with specific adjustments.
Infusion Pump Testing Resources
Featured Resources
Frequently Asked Questions
For accurate fluid delivery testing in infusion pumps, it's crucial to select a balance that aligns with IEC 60601-2-24 and TIR 101 standards. Key considerations include:
- Readability: This is the balance's smallest measurable unit and reflects its precision. Choose from precision (1 mg), analytical (0.1 mg), semi-micro (0.01 mg), or micro (0.001 mg) balances based on the required sensitivity and TIR 101's flow rate recommendations.
- Capacity: The balance's maximum load capacity must be sufficient for the test's duration, potentially up to 96 hours as per IEC 60601-2-24, to avoid frequent emptying and maintain measurement accuracy.
- Weighing drift sensitivity: A weighing drift, defined as an unwanted change in the weight value without additional dosing, is a well-known phenomenon that can be influenced by various environmental factors. Temperature fluctuations, which influence the weighing system, play a significant role. Humidity and vibrations also have the potential to cause weighing drift. By choosing a balance with a monolithic weighing system (like all Cubis® II balances) the effect of a drift can be reduced or even prevented.
Opting for the highest balance capacity and resolution ensures reliable pump performance testing.
The Sartorius Cubis® II Balances assist microvolume pump manufacturers in testing flow rates and accuracy. For evaluating microvolume pumps, we suggest employing the latest Cubis® II Ultra-High Resolution Balances, offering resolutions of 0.01 mg (semi-micro balance with a 220 g capacity) or 0.001 mg (high-capacity micro balance with a 61 g capacity). These balances deliver rapid and stable readings and are equipped with an integrated ionizer and a conductive coating on the draft shield to eliminate static interference.
The Cubis® II balances feature a monolithic weighing system that supersedes the traditional 150+ piece systems, significantly diminishing weighing drift and establishing them as the optimal choice for precise applications.
AAMI TIR 101:2021 recommends ASTM Class 3/OIML Class F1 weights. The nominal mass value of your weight should be more than 80% of the maximum capacity of your weighing instrument. Proof of traceability to national standards should be available.
The report from the EMPIR Metrology for Drug Delivery project details various calibration methods for assessing the response or delay time of drug delivery devices using Newtonian liquids for ultra-low flow rates from 5 nL/min to 100 nL/min. The methods explored include gravimetric, optical (meniscus tracking and pendant drop), microPIV/microPTV, and displacement methods. Each method is traceable to specific standards and involves unique model functions and uncertainty components such as volume, time, radius, and stability of motion.
