Our customer manufactures renal and hospital products in the UK. Historically, they have used Magnaflux EMEAR’s visible red penetrant SPOTCHECK® SKL-SP2 to detect seal failures in intravenous therapy (I.V.) bags when setting up their production line and during In Process Controls (IPC).
When carrying out the tests, our customer puts an amount of SKL-SP2 into the I.V. bags and inflates them under pressure. After 15 – 20 minutes, they check the bags for any obvious signs of leaks.
The colour contrast of the red penetrant makes it easy to see any faults along the seams or in any other part of the bag. They had evaluated fluorescent penetrants for this purpose but the testing showed that the visible red penetrants offered far better contrast, and therefore the ability to determine pass/fail situations.
Strictly speaking, this counts as ‘destructive testing’ as no tested I.V. bags are filled with the final product.
Our customer wanted a safer alternative to SKL-SP2. The red dye used in SKL-SP2, while used at a concentration of < 6%, carried the statement ‘suspected of damaging fertility’. Their company policy states that they should have no chemicals of concern on-site.
They voiced their concerns and we were able to reassure them that, as part of our programme of continuous improvement, we had already taken steps to replace the red dye with one that had no issues regarding fertility.
In making this change, Peter Pritchard, Magnaflux EMEAR Product & Marketing Manager, commented:
“We also took this opportunity to ensure that the new red dye did not contravene the German Azo Ban on azo dyes which led to a widespread, yet unsubstantiated, statement about potential carcinogenicity that stemmed from the leather making industry.”
Our customer raised two concerns about the new version of SKL-SP2:
- Would its performance match that of the previous product version?
- How would they know when they had received the product manufactured using the modified formula?
Whilst Magnaflux EMEAR took the upgraded version of SPOTCHECK® SKL-SP2 to market in October 2015, we were able to provide our customer with a sample for evaluation ahead of this time.
We also adopted a version control system for our Safety Data Sheets and labels, which tells customers when we have made necessary changes to product formulations.
One thing that was very important to our customer was that the surface energy of the new formulation was the same, or very similar to, the old formulation, so that the penetrant has the same tendency to wet the surface of the I.V. bag.
All testing on SKL-SP2 with the new dye deemed that it was suitable for use. Coupled with this, the Magnaflux EMEAR Safety Data Sheet and labelling management system allowed them to establish when new product was on-site.