CCIT FOR VIALS – Non-destructive integrity test
Product Info
Reference documents
USP 1207
This chapter of the United States Pharmacopeia provides an overview of various container integrity testing methods, both probabilistic and deterministic.
It outlines the advantages and disadvantages of each approach, helping users select the most suitable method for their specific needs.
21 CFR part 11
This text outlines the various precautions to follow to ensure the secure processing and storage of electronic data.
ASC 7400F – Vials, syringes, ampoules, cryotubes…
The ASC 7400F is an integrity test instrument designed for rigid packaging, aligned with Good Manufacturing Practices (GMP). Testing is performed without compromising the container or product, eliminating any contamination risks, under predefined conditions, and without operator influence.
The ASC 7400F was developed to replace traditional integrity testing methods with a deterministic, non-destructive alternative. Its precision allows the detection of leaks smaller than those identified by dye testing.
Additionally, this instrument conducts inspections in approximately ten seconds, providing a significant time advantage over conventional dye tests.
The test methods
The ASC 7400F utilizes pressure decay and vacuum decay test methods.
These techniques involve placing the container inside a sealed chamber, where either pressure or vacuum is applied. The detection of leaks is achieved by measuring pressure variations.
If a defect is present, a small amount of air will pass through the leak, causing a change in pressure within the chamber. The measured variation exceeds the programmed limit, the container is rejected.
Benefits
- Fast
- Non operator dependant
- Results validated instantly by internal Calibrated Leak
- Ergonomic
- Non-destructive
- Quantification of defect
- Traceability
- Smooth qualifications
Positive controls
An essential part of our service is the supply of Reference Parts, including both positive and negative controls. These crucial items validate that the CCIT test reliably detects all possible defect scenarios.
ASC Instrument has developed a validation method based on 7 Reference Parts, a highly robust approach, confirmed through numerous inspections.
- These Reference Parts are prepared using actual Customer components
- Each Reference Part is delivered with its Certificatetificat
- They allow for quick and simple instrument verification
