CASE STUDYUNITEDWITHINNOVATION& INSIGHTSHigh precision syringe labeling
Thermo Fisher Scientific develops innovative approach to enable high precision labelingof pre-filled syringes
Innovative syringe labeling capabilities forcomparator blinding

The sponsor however, could find no supplier in the market that
could meet the level of labeling precision required to blind thecomparator or to similarly label its investigational product.

A large pharmaceutical company was planning to conduct aninfectious disease trial for the treatment of Hepatitis C. The global
trial would cover over 40 countries and require the labeling anddistribution of more than 250,000 pre-filled syringes over thecourse of the study. The investigational drug product had to be
maintained at a temperature of 2 to 8° Celsius, with a maximum
time out of environment (TOE) of 6.5 hours. Only one comparator
drug was suitable for use in the study. The comparator productcame in a single use prefilled syringe, with a ½ inch needle anda needle-stick protection device (NSD). The comparator syringe
could accommodate 180-mcg, 135 mcg, 90 mcg and 45 mcg
dosing regimes.
The sponsor faced two significant hurdles in executing
its trial:• The comparator had to be blinded using a label that met
the exact dosage specifications of the branded product.
• Thesponsor

company

hadtomatch

itsowninvestigational product packaging and labeling to thecomparator. This required not only same size syringes
but also labels that contained similarly precise dosing
regimens for patients.

The sponsor had experience with Thermo Fisher in the past andapproached Thermo Fisher project management team to discusspossible solutions to the hurdles it was facing. The Thermo
Fisher team felt that they could develop an innovative approachthat would meet the specified level of labeling precision the trial
required. To do so, Thermo Fisher assembled a global teamrepresenting its engineering expertise from the United States,
United Kingdom and Switzerland, to convene and develop asolution. This team was able to engineer high-precision labeling
equipment and labels that could be used to meet the exacting
dosage requirements of this, and future trials, where labels requireprecision dosing graduation.
The High-Precision labeling capability was designed to include
vision system verification of label position. To ensure precisionlabeling, the equipment had to be programmed for the exact
dimensions of the pre-filled syringe as well as the label. In
coordination with packaging engineers and the sponsor team, alabel was designed that would achieve the best possible blinding
against the comparator product and could be placed on thepre-filled syringe within a detectable tolerance level of +/-0.7mm.

Together with the sponsor, the team developed acceptable
precision standards and conducted extensive testing whereextractable volumes were compared to the measured distance on
the label, to ensure the level of precision was met. The complete
system was ultimately qualified according to the co-developed
precision standards.
Since 2011, 19 production runs have been executed and morethan 50,000 syringes have been successfully shipped to over 40
countries. Thermo Fisher global team of engineers was able todevelop a first-in-industry capability that is now available to allsponsors requiring varying level of precision dosing graduationon labels.

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