Our instruments and systems test for closure and seal integrity of pharmaceutical products e.g.: sterile products that can be negatively affected by oxygen and/or moisture. Our systems ensure the leak tightness of the tested products through repeatable and reliable measurements. Nolek help customers with the entire scope, from determining if prototypes are constructed in a sufficient way to avoid leaks to inline integrity leak testing with extremely short cycle times. Furthermore, we help our customers through the entire project:
- Product analysis and testing
- Design and Assembly in any of our two manufacturing facilities worldwide; Sweden and Malaysia.
- Issuing of certificates that testing follows the correct standards
- Providing complete documentation according to FDA regulations
- All our software comply with CFR21 part 11
- All our equipment follow other GAMP 5 requirements as well
Nolek recognized the increasing pressures placed upon pharmaceutical operations. We are today the preferred supplier of leak test equipment and validation packages for some of the top global pharmaceutical manufacturers. We aim at becoming more than a supplier; we want to become your partner.
All Nolek products are designed, developed and manufactured in-house to ensure the highest possible quality standard