List view / Grid view
3 December 2008 | By
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…
2 August 2008 | By
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)…
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…
