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Aseptic Processing - Articles and news items
In this free-to-view in-depth focus: How to deal with non-sterile results in aseptic processing, Risk Profiling and Proactive Response (RPPR) to Bio-contamination in GMP classified and controlled areas, Microbiology Roundtable…
The manufacture of sterile products attracts the greatest regulatory scrutiny of all product types, since manufacturing failures can be fatal and manufacturers are required to utilise the most robust sterilisation method possible to limit the probability of this occurring. However, aseptic preparation, which is the last resort manufacturing method, continues to be employed since for sensitive products this is the only feasible route. Aseptic preparation has always suffered from the potential for undetected, or undetectable, microbial ingress occurring during the manipulation of sterile components. The implementation of isolator systems have provided an advance over standard clean rooms technologies and the weakest link of aseptic preparation is getting stronger.
The design, validation and implementation of a documented and approved disinfectant programme must form a key part of any pharmaceutical production area qualification. There is significant regulatory interest in this area as it forms a fundamental part of any production facility maintenance schedule. European pharmaceutical companies are required to implement the necessary measures in order to comply with the requirements set out in EudraLex Volume 14 of the “Rules Governing Medicinal Products in the European Union”1. These guidelines are more commonly known as the EU Guide on GMP (EU-GMP). Pharmaceutical companies who supply to the United States are also required to comply with the GMP requirements of 21 CFR 211.56 “Sanitation” and 21 CFR 211.67 “Equipment cleaning and maintenance”.
Advanced Aseptic Processing (AAP) is a term referenced in the recently published ISPE RABS definition1 to cover the spectrum of Restricted Access Barrier Systems (RABS) and isolator systems. In general, AAP techniques are physical barrier methods of product protection and containment that are used during manufacturing operations to separate (primarily) operators from the process. These methods are most often used during open processes or other critical process steps to ensure the product is not exposed to viable organisms and particulate contamination. While there are many methods to choose from, there is no argument that AAP techniques are widely used.
Testing cleaning validation samples requires a validated method. The extent of validation is dependent upon the type of method employed, the capabilities of the method, the scientific and regulatory needs of the resulting data and the anticipated outcome of the testing. A number of test method options are reviewed for their analytical capabilities, along with their method validation parameters.