Aseptic processing plays an important role in rendering sterile formulations that cannot be terminally sterilized. However, terminal sterilisation is considered to be the method of choice in the manufacture of sterile products due to the enhanced sterility assurance that it affords. To ensure that there is no recontamination of the sterilised product after aseptic processing, process validation is required before, during, and after manufacturing.

Process validation is defined as the action taken to demonstrate and to provide documented evidence that a process will, with a high degree of assurance, consistently achieve the desired and intended results. The prevalidation phase is about Equipment Qualification so all subsequent validation step results are not tainted by equipment issues. Installation Qualification demonstrates and certifies that a piece of equipment is properly installed, is provided with all necessary services, subsidiary equipment, and instruments, and is capable of performing in accordance with its basic design parameters. Operational Qualification demonstrates that the equipment will perform consistently and within pre-defined limits, as specified and installed.

Validation can occur before, during, and after routine production: – Prospective Validation, Concurrent Validation, and Retrospective Validation. Prospective Validation applies to new processes and new equipment; Concurrent validation applies to existing processes and equipment; and retrospective validation applies to existing processes and equipment and Retrospective Validation applies to existing processes and equipment and is based solely on historical information.

Validation studies are required for every single step of aseptic processing and should have their data evaluated by qualified individuals against protocol criteria and judged as meeting or failing the requirements. Media fill studies are used to simulate the aseptic process using a sterile, nutrient-rich medium instead of the actual product to assess the effectiveness of aseptic techniques and equipment in preventing contamination. The nutrient medium used should meet the criteria of having low selectivity and be supporting growth of the widest range of microorganisms that might reasonably be encountered; be clear in appearance to allow for the observation of any evidence of growth following incubation; and be capable of being filtered through the same grade and type of microbial retentive filter as that through which the actual product is, or will be, filtered.

A manufacturer’s contamination control strategy must include validation of sterilisation processes. By applying prospective, concurrent, and retrospective validation methods, pharmaceutical manufacturers can comprehensively assess and confirm the efficacy of their aseptic techniques. Media fill studies are pivotal in demonstrating the capability of the process to consistently prevent contamination, thereby safeguarding product sterility. MesaLabs offers sterilisation cycle development and uses their expertise to meet current regulatory requirements and overcome unique sterilisation challenges. MesaLabs is a Bronze Sponsor of the Innovatrix ‘3rd Aseptic BioPharma Processing Summit’ in Vienna, Austria, on October 29–30, 2024. Connect with them to discuss your process validation needs as well as being able to network with peers and industry experts in Vienna, visit our website or email us at info@innovatrix.eu for the event agenda.