Are you struggling with inconsistent accuracy or compromised cell viability during low volume dispensing? Even well-established, traditional pump technologies find it challenging to maintain repeatable results, streamline setup, and maintain a contamination-free fluid path.
Introducing the Cole-Parmer® Single-Use Dispensing Pump powered by i-FILL®, a hybrid technology engineered for unmatched, repeatable accuracy over thousands of cycles. Presented by Intellitech and Cole Parmer, this webinar will walk you through pump operation and performance specifications, key applications, and the comprehensive support and resources available exclusively through Cole Parmer, so you can have confidence in every fill.
Questions & Answers from the live event
What is the pump accuracy?
Pump accuracy depends on the kit size and dispensing volume. For both the 1 mL and 10 mL kits, accuracy is specified at ±2% at the lower end of the defined operating range. Within the mid-to-upper range of each kit, performance improves significantly, achieving ±0.25% accuracy across continuous runs of 100 dispenses.
For example, the 10 mL kit demonstrated ±2% accuracy at volumes as low as approximately 0.5 mL, while accuracy tightened to ±0.25% at mid and higher volumes (up to ~19.3 mL). Testing was performed using water-like fluids, with no special temperature controls, and results reflect consistent, repeatable performance rather than single-point claims.
How is viability of cells measured from the pump?
Cell viability was evaluated using multiple protocols and time-based studies. Testing included circulation periods of 5 minutes, 15 minutes, 2 hours, and up to 2 days. Assays such as Trypan Blue staining and other established methods were used.
Initial studies focused on basic viability, determining whether cells survived, live vs. dead. Ongoing studies extend beyond survival to assess metabolic health, including whether cells remain capable of replication and growth. Each study follows a defined protocol, and summary results are available upon request.
How easy is it to prime the pump?
Priming the pump is designed to be straightforward and quick. The user mounts the appropriate single-use kit and selects a predefined priming recipe based on kit size. After placing the intake tubing into the source container, the user initiates priming with the push of a button.
Within three to four dispenses, air is expelled from the tubing set and the system is ready for operation. The process does not involve complex tubing paths or manual adjustments.
Is the pump compliant to 21 CFR 11?
Here are some things to consider:
The pump supports key elements required for 21 CFR Part 11 compliance, including user access controls. Users must log in to modify pump parameters, ensuring controlled access to configuration settings. Operators can run pre-configured recipes without altering parameters, while administrative changes require appropriate credentials.
These features support regulated environments where electronic access control and traceability are required.
Can the pump be validated?
Yes. The pump can be validated, and it is currently used in validated environments by existing customers. Validation protocols are available and align with the performance testing demonstrated during the webinar.
Validation typically involves identifying the pump, recording operating parameters, running samples, and measuring dispensing results over time to confirm repeatability and consistency.
Does the pump need to be calibrated?
The pump itself does not require routine calibration or annual factory recalibration. However, best practice is to perform a benchmarking step for each new single-use kit.
After priming, users are encouraged to run the pump onto a balance and verify the dispense volume. If needed, piston stroke length can be adjusted to fine-tune the volume. Once this initial adjustment is made, the kit can be considered set for use. This process accounts for minor kit-to-kit variability and ensures target volumes are met.
Does the pump require specialty tubing?
No specialty tubing is required. Standard kits use platinum-cured silicone tubing, supported by material certifications. However, tubing can be customized if a different material, length, or configuration is required for a specific application.
Customization options are available through the Cole-Parmer, allowing users to select tubing that meets their process or regulatory needs without requiring proprietary or uncommon materials.
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