Inspection Module automated solution is developed by Tema Sinergie to guarantee maximum protection and sterility of the radiopharmaceutical during the production phase. The system, through a quality control procedure, ensures that each dose complies with quality standards.
Given the evolutionary phase that theranostics is going through, characterized by a strong increase in production and a consequent increase in safety standards, we have developed the Inspection Module to respond to new quality control needs and a new workflow.
The effectiveness of the process and its validity also depend on accurate and complete data management. Consequently, each vial is initially identified by a QR code and subsequently labeled, in order to be traceable at each step of the process and within its entire production center, avoiding any mismatch risk. To manage the complexity of the data, the zenon software has been integrated: this system allows you to manage all the reporting directly within the customer’s corporate network and track the process phases, thus facilitating the sharing of information and the structuring of data.
The Inspection Module process is divided into four phases:
1. Vial Tightness Verification
The first phase of the process begins after the lead pot – with the vial containing the radiopharmaceutical – is inserted into the control system and consists of the tightness verification test. This is a crucial step to ensure that each unit is perfectly closed and it is essential to prevent the risk of contamination both internally and externally to the radiopharmaceutical. Through the CCIT (Container Closure Integrity Testing) system, the integrity of the drug and the sealing of the vial are verified, and they represent essential prerequisites for the next steps.
2. Verification of Foreign Particles Presence
The second step is dedicated to Visual Inspection. This check is carried out using VI++, our specific solution for visual inspection and labeling of vials for radiopharmaceuticals. During this phase, the operator is able to inspect the vial and subsequently ensure that the radiopharmaceutical is actually free of impurities.
3. Radioactivity Measurement
In this stage, the dose is subjected to a radioactivity measurement. Thanks to a technology now consolidated on the market (dose calibrator), it is guaranteed that the vial complies with the radioactivity parameters, thus ensuring that the product is compliant with clinical use.
4. Vial Labeling and Final Lead Pot Labeling
Immediately afterwards, the operator transfers the vial to the lower part of the Inspection Module via an automatic lift, where a printer applies a label to the vial to be able to identify it again. Finally, the labeled vial is reinserted into the lead pot, ready to be extracted from the Inspection Module. Once outside, the operator applies the second label on the lead pot, identifying it uniquely and definitively.
Thanks to this technology, radiopharmaceuticals can be administered with the certainty that all quality standards have been respected during the production phase. This new automated quality control solution represents a concrete example of how starting from the customers’ needs, it is possible to achieve highly efficient solutions able to respond to the new market needs. Thanks to this approach, it has been possible to solve specific problems in this field – that requires ever greater precision – by anticipating any future need.