Precision Labelling Key to Success for Clinical Trial
A large multinational pharmaceutical company was looking for a partner to help prepare for a new clinical trial in the US and Europe.
The Challenge The Sponsor had pre-filled syringes for this trial which needed to be labeled, packaged and distributed worldwide. A unique solution was required as this trial demanded extremely precise label application on syringes of varying lengths. Manual label application was not considered accurate enough. Full automation of the labeling process was the only option acceptable by the Sponsor. Each label needed to be applied in a certain position on each syringe to reflect the correct dosing information. If not, the patient could receive an incorrect dosage which could put the patient at risk and compromise the trial.
The Solution Fisher Clinical Services initiated a feasibility study to take into consideration all aspects of this complex and unique project. The recommendation was to develop a new machine to eliminate the risk of getting it wrong. Technical specifications were drawn up for this new syringe labeling machine to apply, with very high precision, labels containing a dosing scale. This meant using a special camera system to indicate the bottom of the syringe for precise label application. The permitted deviation of the label position was only +/-0.7mm. In addition, due to the required high precision of the label application, the Fisher Clinical Services team of experts needed to offer a new type of high precision label to ensure better results.
Due to the critical nature of this project, an automatic discharge of the syringes from the machine was required. In the case of rejects, products with a label out of specification, would be sent to a sensor controlled reject exit. All other syringes would go through an automated quaility control which involved re-measuring the zero position of the syringe and checking on exact label position after application.
As the project required variable data to be printed on the label, the machine needed the capability to print and apply data on-line. In order to fulfil this request, the printer needed to be set up to acquire all variable data from the database whenever it was needed. And finally, the system needed to provide the capability to reprint missing or illegible labels and to create a report of rejected labels into an audit trail.
Development The Fisher Clinical Services Engineering Team developed this new equipment to meet the unique requirements of the Sponsor. Due to the demographic reach of the trial, the decision was made to build two new machines – one for Basel, Switzerland for the European sites, and one for Allentown, PA, for the US sites. After labeling and packaging was completed the patient kits were distributed to these sites worldwide. The project took just 5 months from approved customer requirements to equipment build and quality control checks, ensuring First-Patient-In dates were met in Europe and in the US.
Innovation, Efficiency & Cost Savings The first version of the machine was able to define the label position accurately in relationship to the bottom of the syringe, but with a reject rate of circa 10%. The Sponsor, now aware of the Fisher Clinical Services team’s expert capabilities, challenged the team to decrease the rate to below 10%, because the cost of rejected syringes was still quite significant. Further engineering modifciations to the machine dramatically reduced the reject rate from 10% to below 2%. This provided the Sponsor with an 8% saving of time and money. Today the machine runs faster and has very few syringe rejects, if any.
Customer Satisfaction Patient safety is paramount for all clinical trials, but in this instance extreme measures had to be taken to ensure accurate precision labelling of syringes reflecting correct dosage levels. All timelines were met for this trial and the Sponsor is currently planning to use this innovative technology to prepare clinical supplies for future trials, globally.