Pouch Leak Test – Non-Destructive Leak Inspection
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 7400XS - Sachet, stickpack, pack, lidded cups…
The ASC 7400XS is an integrity test instrument designed for small flexible packaging, in compliance with Good Manufacturing Practices (GMP). The inspection process is conducted without damaging the packaging or the product, ensuring no risk of contamination, under controlled conditions, and without operator influence.
Capable of detecting leaks as small as a few microns, the ASC 7400XS enables early identification of sealing issues, allowing corrective actions to be taken before large quantities of poorly sealed packaging are produced, minimizing production losses.
Test chamber dimensions: 212 x 162 mm.
Test method
The product to be tested is placed inside a test chamber, in which a vacuum is generated in a controlled way. The surrounding vacuum causes the packaging to inflate. It comes into contact with a sensor located in the lid.
This sensor measures the internal pressure of the pack and records its variation over a short period. In a correctly sealed package, the pressure loss will be near zero. A pressure decay beyond a programmable tolerance indicates a leak.
Major leaks are detected in the first phase of the test, as the package either does not inflate or inflates insufficiently.
Benefits
- Fast
- Non operator-dependant
- Ergonomic
- Non-destructive
- Measured value of airtightness
- 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 components validate that the integrity test reliably detects all possible defect scenarios.
ASC Instrument has developed a validation method using several Calibrated Leaks, a highly robust approach, confirmed through numerous inspections.
- These Reference Parts are prepared using actual Customer components
- They are fitted with a connector for Calibrated Leaks
- Each Reference Part is delivered with its Certificate
- They allow for quick and simple instrument verification
