TEST BETABAG - 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 7400BB - Test Betabag
The ASC 7400BB is an integrity testing bench designed for Betabags and extra-large envelopes, complying with Good Manufacturing Practices (GMP). The inspection process is conducted without affecting the product, under controlled conditions, and without operator influence.
Capable of detecting micro-leaks, the ASC 7400BB allows for testing of empty Betabags either at the end of production or before filling, ensuring the integrity of these single-use packaging solutions.
Test chamber dimensions: 1670 x 655 mm.
Test method
The bag is placed flat inside the chamber, and the operator closes the lid. Closing this triggers the start of the test. The chamber is gradually put under vacuum, which causes the betabag to “inflate.” A non-intrusive pressure sensor in the lid records the internal pressure in the betabag. Once the desired pressure is reached, the machine stabilizes it and measures how it changes.
This change is compared to a Pass/Fail limit, and the instrument either validates or rejects the tested item based on the measured value. A label printer prints a label stating the test result.
Benefits
- Non operator-dependant
- Capable of detecting leaks in the micron range
- Ergonomic
- Suitable for cleanroom use
- Non-destructive
- Measured value of integrity
- 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 products
- They are fitted with a connector for Calibrated Leaks
- Each Reference Part/Calibrated Leak is delivered with its Certificate
- They allow for quick and simple instrument verification
