Access Biologicals is a biologics manufacturing company with a comprehensive portfolio of diagnostic plasma-derived serums, reagents and cell culture products. These products are filtered and packaged in bottles with technically advanced labels used for branding, compound identification and sterility indication. Access was experiencing various quality issues related to ink smearing and general material inefficiencies with these labels. Unfortunately, their current supplier couldn’t accommodate correcting these issues on schedule. CleanMark connected with Ernie Schrepfer, Associate Director of Quality at Access Biologicals, and after a quick introduction call, presented a way for them to acquire labels in a timely manner but also identified an opportunity to make major change to the existing label construction which resulted in a more efficient labeling process.
The Challenge & Requirements
First, Access needed to find a label with better ink properties to enhance the appearance of the company’s logo and brand. Secondly, their product had to include visual proof that it successfully completed a cycle of gamma irradiation for sterility assurance. This process was performed by hand applying a small, circular indicating label to the (already) existing printed label which changes colors to indicate the had been gamma irradiated. Next, the label adhesive needed uphold its integrity and remain adhered to the bottles in extreme temperatures below -70°C. Lastly, the printed information on the label needed to survive harsh chemical interaction in order to remain legible.
The Process & Solution
CleanMark utilized their state of the art Flexographic print process with color matching technology to create an exact match of Access’s specific shades of blue used for the label. This was paired with a special varnish layer to protect the print from harsh cleaning chemicals as well. Then, CleanMark’s Engineering Team identified an alternative way for this label to include the gamma indicating feature without having to apply a secondary gamma dot. First, CleanMark’s Art Department manipulated Access’s current label blueprint which created additional space on the cleanroom label. This additional space allowed room to include a gamma-indicating strip directly onto the label itself and eliminated the need to apply a separate gamma dot. This new design caused one side of the label roll to be thicker than the other (due to the addition of the gamma strip). CleanMark’s sampling process was so fast that Access Biologicals was able to implement a minor process change to accommodate this major improvement. This change was remedied by decreasing the number of labels per roll and changing the way that the rolls were wrapped and handled by the filling group. To top it all off, CleanMark used their premium cryogenic adhesive which withstands negative service temperatures as far down as -196°C!
CleanMark’s collaboration with Access Biologicals resulted in a simplified process that no longer required adding a hand applied gamma dot. Delivery times were cut in half while also improving the overall print quality. Most importantly, Access Biologicals now has trusted partner that is responsive to their needs and provides them with solutions that actually work.
CleanMark offers gamma sterile indicator labels that either have an indicator strip built into them, or we can do precision placed gamma dots. Learn more about the gamma labels we offer and how we might be able to help.