Isolator Glove Integrity 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 7400SGVV - Glove test
The ASC 7400SGVV is an integrity testing instrument designed for isolator gloves and large flexible envelopes, enabling vertical inspection, while adhering to Good Manufacturing Practices (GMP). The testing process is conducted without affecting the product, under controlled conditions, and without operator influence.
Capable of detecting micro-leaks, the ASC 7400SGVV ensures the inspection of large flexible envelopes with high integrity requirements, such as isolator gloves.
Test chamber dimensions: 1018 x 635 mm.
Test method
The glove to be tested is inserted in a rail-mounted sealing device. The rail is entered in the test chamber, in which a vacuum is generated in a controlled way. The surrounding vacuum causes the glove to inflate. It comes into contact with a sensor located in one of the side panels.
This sensor measures the internal pressure of the glove and records its variation over a set period. In a leak-free glove, 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 glove either does not inflate or inflates insufficiently.
Benefits
- Fast
- Non operator dependant
- Ergonomic
- 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
