Application Notes
How Clean is Your Syringe?
Test with the OLYMPUS CIX100 Cleanliness Inspection System
CIX100 system: automation, intuitive, step-by-step guidance and user rights management ensure reliable result creation by all operators
With the option to analyze bright contaminants on a dark background, the CIX100 system is an ideal tool for inspecting the cleanliness of medical disposables in the manufacturing process.
Introduction
Syringe filters are widely used in life science, drug delivery, and biomedical applications. To choose the right syringe filter, users must find an optimal combination of filter material and membrane size to accommodate the total volume, viscosity, and solid contaminants in the fluid. Failure to do so can lead to clogging and a large dead volume, i.e., fluid remaining in the filter membrane.
The quality control of syringes and syringe filters is a mandatory and important part of the production process. In this application, checking the technical cleanliness of the filters is critical.
The conventional method used to inspect for particulates in rinse fluid relies on automatic particle counters (APCs). However, this type of measurement does not provide any details regarding the shape of the particles, which is important for distinguishing between fibers and spheres, or whether the particles are reflecting (metallic) or non-reflecting (nonmetallic). Also, laser-based particle counters often overlook transparent particles or may overcount due to bubbles in the liquid.
Because of these complications, the analysis of the quality and quantity of the contaminants in the rinse fluid is limited, and the use of APCs makes selecting the best match of filter membrane material, optimal pore size, membrane size, and syringe filter shape difficult.
The CIX100 system provides a detailed description of the contaminants in syringe filters, including particle morphology.
APC system: For non-spherical particles, the signal can change significantly for the same particle with particle rotation.
OLYMPUS CIX100 Cleanliness Inspection System
The OLYMPUS CIX100 cleanliness inspection system provides a comprehensive overview of contaminants by performing an automatic microscopic particle analysis
The advantages of using the CIX100 system to analyze the cleanliness of syringe filters includes:
- High image resolution (0.63 µm/pixel @10x lens) enables the detection of particles down to a size of only 2.5 µm with an inspection time under 10 minutes.
- Analysis of particle morphology, including the area, shape, and volume.
- Innovative and patented illumination system that automatically distinguishes between reflective and non-reflective particles in a single scan, improving the inspection time.
- Insert your specimen into the CIX100 cleanliness inspector, and the fully automated measurement system reduces the risk of handling errors and contamination while maximizing throughput and the quality of the results.
- Easy and traceable calibration.
- Repeatable and reproducible results for excellent comparability between multiple users and multiple CIX100 systems. The CIX100 system is ideal for reliable and comparable quality control at multiple production sites.
- Thanks to user rights management, a rigid design with a protected optical beam path, maximum automation, and a modern user interface with step-by-step guidance, any operator can produce reliable and comparable results that are automatically stored in the CIX database.
- Selectable scanning mode: show dark particles on a white background or vice versa.
- Filter holders for 47 mm or 25 mm diameter membranes or customizable holders are available.
Complies with international technical cleanliness standards, e.g., USP788:2011 and customizable standards.
The CIX100 system offers access to particle morphology, helping ensure the correct size classification of particles down to 2.5 μm.
A single click changes the scanning mode.
The CIX100 system comes with a large variety of international standards and customization options.
Mount the filter in 3 simple steps: 1) Place the specimen on the membrane holder. 2) Tighten the membrane holder’s clamp to fix it in a flat position. 3) Click the membrane holder into the stage insert.
The analysis is fully automated, minimizing the risk of contaminating the specimen and maximizing throughput.
Step-by-step process for technical cleanliness analysis.
Live scan results: fast decision-making with result monitoring during sample scan acquisition.
Review results: thumbnail images with a live image link.
Reports: automatically create customizable reports that comply with international standards.
Products Used for This Application
CIX100
The CIX100 inspection system is a dedicated, turnkey solution for manufacturers who maintain the highest quality standards for the cleanliness of manufactured components. Quickly acquire, process, and document technical cleanliness inspection data to comply with company and international standards. The system’s intuitive software guides users through each step of the process so even novice operators can acquire cleanliness data quickly and easily.