Form–Fill-Seal (FFS) machines use heat sealable flexible plastic packaging which is then filled and heat sealed. This procedure is commonplace in the medicinal packaging industry, where quality assurance is of paramount importance, and the following of established and validated methods of preparation and procedure is imperative.
Though all filling procedures are carried out in cleanrooms, one cannot exclude potential risks such as:
- Leakage in hydraulic and cooling systems.
- Particle generation possibly compromising air cleanliness standards.
- Leakage in the packaging itself due to mishandling.
In addition, because strips are still predominantly checked manually by pressing each strip by hand, identifying leaks can be both time consuming and subject to human error. No manufacturer within the pharmaceutical industry can afford to make errors that result in expensive recalls and ultimately lead to a bad reputation.
With the LPS micro leak tester, Bonfiglioli provides a solution.
The LPS is an inline machine that can test strips for micro leaks at a rate of 60 strips per minute. The strips are fed in the machine via a conveyor and are tested using a force sensor. This method of testing is non destructive, fast and reliable. The measurement of the resulting force after being pressed repeatedly will determine the seal integrity of the ampoule. This machine is equipped with SCADA platform based software configurable to comply with CFR 21 part 11 norms. Validation documents compliant with FDA protocols are available upon request.