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Aseptic Processing

 

aseptic containment APS
aseptic containment APS
article

Aseptic containment strategies to meet challenges of processing new highly toxic and biologically hazardous sterile medicinal products and therapies

7 March 2019 | By ,

Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…

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Avoiding environmental monitoring ‘false negatives’: overcoming disinfectant residues with culture media neutralisers

6 September 2018 | By

Even with the rise of rapid microbiological methods, most environmental monitoring applications are undertaken using culture media, with many alternative methods also being growth-based. This makes the selection, control and release of culture media an area of great importance, given that the quality of the culture media underpins the environmental…

Figure 1
Figure 1
article

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…

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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)…