PHARMACEUTICAL CASE STUDY:
Extreme environment cleanroom labels
This case study customer aspires to be the best healthcare company in the world and is dedicated to providing leading innovations and solutions for tomorrow. Lgi has been a part of enabling this customer to achieve that vision since 2007 with Lgi CleanMark® cleanroom labels. Since 2007, Lgi has been successfully solving a variety of extreme environment cleanroom label identification challenges, resulting in a long, successful partnership. The story began when Lgi identified that this custumer was modifying one of their cleanroom processes to accommodate a cleanroom label that did not support their desired approach.
From Persistence to Resistance
In order to ensure that lab samples would not be contaminated with any foreign particles, technicians thoroughly cleaned lab sample collection vessels with a heavy dose of IPA. The ideal process was to label the sample collection vessel prior to this IPA cleaning. Unfortunately, the old cleanroom label could only withstand a brief wipe with IPA without losing legibility of the cleanroom label that had been placed on the collection vessel. The inability of the cleanroom label’s ability to withstand this extreme environment, dictated a process change. The process was modified such that the collection vessel would first undergo the heavy doses of IPA prior to being labeled. Once the cleanroom label was applied, an additional step was added to wipe down the vessel again with a less aggressive cleaning. Although this new process solved the legibility issues, it added an additional step in their process and also created the possibility of contamination. The need was for an extreme environment class 100 cleanroom label that could be applied to the collection vessel prior to the IPA cleaning so the vessel could be thoroughly cleaned after the cleanroom label had been applied.
THE PROCESS & SOLUTIONS
Collaboration and Exploration
There was no commercially available extreme environment direct thermal printable cleanroom label material that met the class 100 cleanroom label requirements: 1. print the label in order to uniquely identify the collection vessel, 2. apply the label to the collection vessel and then, 3. thoroughly clean the vessel with aggressive amounts of IPA, while not losing legibility of the label’s print. Working closely with engineering, Lgi researched multiple materials and constructions that would meet these requirements. Multiple candidate constructions were developed and tested until the final solution was achieved. This solution also included a print treatment which further improved the performance of this label. Finally, this extreme environment cleanroom label was qualified for use within the process.
Particular, but no particulates
The label solution that Lgi helped create, has led to multiple applications within this company. In addition to the original project, they now use Lgi CleanMark® cleanroom labels to meet a myriad of requirements. Customized adhesive characteristics on various surfaces and varying extreme environment requirements are all met with Lgi CleanMark® cleanroom labels. The most recent project required the Lgi solution to work in a microbe free cleanroom environment. Lgi was able to meet this requirement utilizing gamma sterilized CleanMark®cleanroom labels.