Laser Drilling Positive Control
Fill in the information
Fill in the information
Typical Applications
New Method Development
Establishes a scientific and compliant sensitivity baseline for your CCIT detection strategy.
Regulatory Audits
Provides objective, regulator-recognized proof of your method's detection capability.
Routine System Suitability Testing (SST)
Quickly verifies that the entire CCIT system is in a validated and sensitive state prior to each testing batch.
Core Value
01
Meets Key Standards: Designed to support compliance with USP <1207> and other global regulatory guidelines.
02
Science-Driven Decision: Enables the selection of more appropriate detection method and limits of conformity based on precise data.
03
Quality Assurance: Guarantees the accuracy and authority of your CCIT test results at the core.
Customized Your Products
We offer more than just standards; we provide an end-to-end service—from instrument performance calibration and method validation support to final compliance reporting—ensuring the integrity and credibility of your entire testing chain.
Zholion provides both standard and customized CCIT Positive Control Samples based on your container type, target defect size, test method, and validation purpose.
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 |
| Container Type | Vial / Ampoules / Prefilled Syringe / Cartridge / IV bag / BFS |
| Pore Size | 1 / 2 / 3 / 5 / 8 / 10 / 15 / 20 / 50 / 100 µm |
| Hole Position | Up / Middle / Bottom / Neck |
| Qty | 1–100 / 101–400 / >400 |
In pharmaceutical package integrity testing, a validated method must prove that it can detect defects at the required sensitivity level. Zholion Laser Drilled Positive Controls provide a measurable and repeatable reference standard with controlled pore size, location, and container format.
These Positive Controls for CCIT can be used with vacuum decay testing, pressure decay testing, high voltage leak detection, helium leak detection, gas analysis, microbial ingress comparison, and other CCIT methods. They help quality teams build stronger validation evidence and reduce the risk of false negative results in package integrity testing.
Zholion specializes in pharmaceutical and medical device container closure integrity testing and gas analysis. Our Laser Drilling Positive Control solutions are designed to support the full CCIT lifecycle, from method development and performance verification to validation support and compliance documentation.
With traceable data, customizable sample design, and technical support for CCIT method selection, Zholion helps pharmaceutical manufacturers build a more reliable and compliant package integrity testing process.
Need Reliable Laser Drilling Positive Controls for CCIT?
Contact Zholion to get customized Laser Drilling Positive Control samples with traceable calibration certificates, standard or custom pore sizes, and support for USP <1207> compliant container closure integrity testing.
More Information
Are traceable calibration certificates available?
Yes. Zholion Laser Drilling Positive Control samples can be supplied with traceable calibration certificates to support validation records and quality documentation.
What container types can be customized?
Zholion can provide CCIT Positive Control Samples for vials, ampoules, prefilled syringes, cartridges, IV bags, BFS containers, and other pharmaceutical packaging formats.
Can Laser Drilling Positive Control samples support USP <1207>?
Yes. Zholion Positive Controls for CCIT are designed to support pharmaceutical package integrity testing and help users build documentation aligned with USP <1207> expectations.
What are Laser-drilling Positive Control used for?
Laser Drilling of Pharmaceutical Packaging are used for CCIT method development, equipment qualification, routine system suitability testing, validation studies, and regulatory documentation.
What is a Laser Drilling Positive Control?
A Laser Drilling Positive Control is a pharmaceutical package sample with a precisely created micro-hole. It is used as a known defect sample to verify the sensitivity and reliability of leak test methods.
Why Choose Zholion?
Traceable Data
Every orifice is precision-calibrated, ensuring fully traceable data.
Simplified Compliance
Helps meet the requirements of international audit standards like FDA, WHO, CMA and other regulations.
End-to-End Partnership
From selecting the right standard to integrating it with your equipment and processes, we are your reliable partner in container closure integrity.
