Micropipette Positive Control
Micropipette Positive Controls consist of a precision-bored capillary glass tube, hermetically sealed within a container. They simulate a defined leak path with specific length and internal diameter, making them the most widely used tool for routine CCIT quality assurance.
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Typical Applications
System Suitability Testing (SST)
The pharmacopeia-recommended choice (e.g., USP <1207>) for daily or per-batch performance verification.
Method Comparison & Transfer
Their stability and calculable nature make them perfect for harmonizing methods across labs or equipment platforms.
Package Process Assessment
Helps define the safety margin of your packaging process by testing against controlled leak rates.
Core Value
Unlike simple pinholes, micropipettes offer capillary models that better reflect certain real-world failure modes.
○ Leak Rate Quantification: Enables estimation of actual flow rates using fluid-dynamics principles, translating "hole size" into practical "leak performance."
○ Comprehensive Range: Available in internal diameters from 1 µm to over 50 µm, covering risk levels from potential microbial ingress to visible product loss.
○ Long-Term Stability: Manufactured from inert glass, these standards deliver consistent performance over time and are ideal for permanent QC reference sets.
We offer not just individual standards, but a complete QC package—including SST protocol guidance, frequency recommendations, and data-tracking templates—to help you implement an efficient, audit-ready daily monitoring system.
Zholion provides both standard and customized Micropipette Positive Control samples for different pharmaceutical packaging formats and validation requirements.
You can choose what you need from the normal standards, or let us know what else you want. We will contact as soon as possible.
| Customization | Options |
| Pore Size | 0.1/0.3/0.5/1/2/3/5/8/10/15/20/50/100μm |
| Implantation Position | Up/Middle/Bottom/Neck |
| Qty | 1-100/101-400/＞400 |
In pharmaceutical package integrity testing, a reliable CCIT method must be able to detect leakage risks that may affect sterility, product composition, or package performance. Zholion Micropipette Positive Control samples provide controlled leak standards to help users verify method sensitivity, equipment performance, and testing repeatability.
These Positive Controls for CCIT can be used with vacuum decay testing, pressure decay testing, gas analysis, helium leak detection, microbial ingress comparison, and other container closure integrity testing methods. They help pharmaceutical manufacturers build a more measurable, traceable, and audit-ready CCIT validation process.
Zholion specializes in pharmaceutical and medical device container closure integrity testing and gas analysis. Our Micropipette Positive Control solutions help users establish a reliable CCIT reference standard for routine quality assurance, method validation, and compliance documentation.
With customizable sample design, traceable calibration support, and technical guidance for CCIT method selection, Zholion helps pharmaceutical manufacturers improve package integrity control throughout the product lifecycle.
Need Micropipette Positive Control Samples for CCIT Validation?
Contact Zholion to get standard or custom Micropipette Positive Control with traceable calibration certificates, controlled pore sizes, and support for USP <1207> compliant container closure integrity testing.
More Information
Are traceable calibration certificates available?
Yes. Zholion Micropipette Positive Control samples can be supplied with traceable calibration certificates to support quality records, validation studies, and regulatory documentation.
Can Zholion provide custom Micropipette Positive Control Samples?
Yes. Zholion can customize pore size, implantation position, according to your CCIT method and validation requirements.
How is Micropipette Positive Control different from Laser Drilling Positive Control?
Laser drilling creates a micro-hole directly on the package material, while Micropipette Positive Control uses a controlled capillary glass tube to simulate a defined leakage path. Micropipette samples are especially useful when stable, calculable leak performance is required.
What are Micropipette Positive Control samples used for?
They are used for system suitability testing, method development, method comparison, method transfer, equipment qualification, and package process assessment.
What is a Micropipette Positive Control?
A Micropipette Positive Control is a pharmaceutical package sample with a precision-bored capillary glass tube sealed inside the container. It is used to simulate a defined leak path for CCIT validation and routine system checks.
Why Choose Zholion?
Audit-Ready Compliance
Easily satisfy pharmacopeia SST requirements, reducing audit preparation effort.
Proactive Risk Management
Regular monitoring helps detect system drift before it impacts product quality.
Actionable Quality Metrics
Turns seal integrity into a measurable, routine QC parameter for clearer operational oversight.
