Automated Visual Inspection
Parenteral drug products are required to be 100% visually inspected. As each product and its packaging define their specific inspection task, standardized inspection setups may lead to a high level of false rejects and underperforming visual inspection. A highly customized solution, in contrast, provides the opportunity to significantly improve detection rates and to reduce false reject rates.
AVI of BFS cards
Visual Inspection of BFS ampoules - CUBE CAPA
To complement the 100% leak testing of Blow-Fill-Seal (BFS) ampoules, we have developed a station for automated visual inspection. This makes your product inspection even more comprehensive and helps to achieve better packaging quality.
Our solutions for integrity testing of BFS containers enable full compliance with regulatory requirements. If you would also like to integrate an automated visual inspection for the BFS ampoules, our CUBE CAPA offers the ideal combination for leak testing.
Visual Inspection
Modul for optical control of cosmetic defects and liquid level
Leak Detection
LFC method® inspects the entire container
Turning unit
Orients the BFS cards for further processing
Inspection of cosmetic defects on BFS ampoules
In the manufacturing process of BFS ampoules, underfilling or cosmetic defects can occur. Testing with an optical inspection station can detect various defects on the contour of the container such as black dots or plastic residues as well as analyse the fill level. Our approach is a modular camera station, which is integrated into the line in front of the CCIT machine. This ensures BFS ampoules are inspected 100% replacing manual inspection and thereby reducing costs while improving quality.
Leak testing of BFS and FFS
Annex 1 of the EU GMP Guideline requires a 100% leak test of fused sterile drug containers. This includes blow-fill-seal ampoules and vials, and form-fill-seal ampoules. Since manufacturers have a very high variety of products to be inspected on a line, an inspection method that offers a high flexibility is extremely valuable. The LFC method® from WILCO is suitable for different packaging sizes and shapes with a wide variety of ingredients. A proactive forced gas exchange is generated by means of a vacuum drop. This highly sensitive inspection method is equally suitable for the laboratory and for the production line.
Advantages of the LFC method® for BFS
Vacuum decay and in specific the LFC method® provide several advantages for 100% high speed integrity testing of fusion sealed containers such as BFS and FFS containers.
Next to the high sensitivity, a big advantage is that the entire BFS or FFS sample is tested non-destructively at once while for instance, the HVLD methods allow only a partial measurement and therefore do not provide fully accountable test results. The LFC method® is very flexible on the drug product. It is suitable also for oily and non-conductive liquids.
Reliable object handling
For best inspection of BFS cards, WILCO integrated a card turning unit for optimized inspection. In order to ensure a continuous BFS process there are several control functions integrated such as bypass function, jam control and overload clutch.
Features
- Troughput up to 220 cards per minute
- Integrated LFC method®
- Sensitivity of down to 5 microns
- Testing of entire BFS container at once
- Applicable for various shapes and sizes of BFS containers
- Applicable for oily and non-conductive liquids in BFS containers
- Applicable for BFS with low filling volume
- Non-destructive test method
- Deterministic test method preferred acc. USP<1207>
- Test method according ASTM – F 2338
- Design according GMP guidelines
- Data Handling in compliance with 21 CFR part 11
- Reliable product handling
- Easy and tool-less format changeover
Would you like to learn more about our combined CCIT and visual inspection solutions for BFS ampoules?
We would be happy to advise you personally.
