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Closing Non-Viable Particle CAPA Investigations in aseptic processing areas

by | Mar 29, 2023

Closing CAPA’s with root cause solutions is a requirement of the regulatory bodies especially now that annex 1 guidance has gone into effect. Investigating root causes of non-viable particle contamination in parenteral drugs can be a challenging task, especially when only a few vials are impacted and the difficulty collecting non-viable particles from all the equipment in the aseptic processing areas. However, the use of gamma irradiated PolyCHECK sample collection wipers and state-of-the-art analytical equipment in a cleanroom environment can assist in finding solutions to these types of issues.

The PolyCHECK sample collection wiper is a specialized tool designed to effectively collect large quantities of sample material for analysis. These wipers are gamma irradiated to ensure that they are free of contaminants and can be used in sensitive aseptic processing environments. With a Sterility Assurance Level (SAL) of 10e-6, the PolyCHECK wiper has a very low risk of introducing additional contaminants into the sample. PolyCHECK wipers allow for 10-to-100-fold improvements in sample collection productivity which is critical if lot disposition decisions are pending.

In addition to the PolyCHECK wiper, using a materials science lab equipped with advanced analytical equipment such as a Scanning Electron Microscope (SEM) with Energy Dispersive X-ray (EDX) and Fourier Transform Infrared (FTIR) spectroscopy can provide valuable insights into the nature and origin of the non-viable particle contamination. The SEM allows for high-resolution imaging of the particles, while the EDX can provide elemental analysis of the particles. The FTIR, on the other hand, can identify the chemical makeup of the particles, including the specific polymer used in the fiber contamination.

By combining the capabilities of the PolyCHECK wiper and the materials science lab, it is possible to identify the root cause of the non-viable particle contamination and implement effective corrective actions to prevent future occurrences. This is especially important in the pharmaceutical industry, where regulatory bodies such as the European Medicines Agency (EMA) require that CAPA investigations be closed with root cause solutions. The new annex 1 guidance from the EMA further emphasizes the importance of finding and addressing the root cause of contamination issues to ensure the quality and safety of parenteral drugs.

In summary, the use of the gamma irradiated PolyCHECK sample collection wiper and a state-of-the-art materials science lab with advanced analytical equipment can assist in closing CAPA investigations into non-viable particle contamination in aseptic processing areas, providing a root cause solution and helping to prevent repeated failures in GMP facilities.

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