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Aseptic Processing

Aseptic preparation: The weakest link is getting stronger

12 December 2009 | By Gavin Halbert, Director, Cancer Research UK Formulation Unit, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde

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…

article

Disinfectant validation

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…

article

Advanced Aseptic Processing: RABS and Isolator Operations

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)…

Exploring the advantages of PAT for pharmaceutical cleaning

article

Test method validation for cleaning validation samples

19 March 2008 | By Richard Forsyth (Merck)

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…

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Recommended

Aseptic Processing

Aseptic preparation: The weakest link is getting stronger

Disinfectant validation

Advanced Aseptic Processing: RABS and Isolator Operations

Test method validation for cleaning validation samples