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5 pages/≈1375 words
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Biological & Biomedical Sciences
Research Paper
English (U.S.)
MS Word
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What are the considerations for validating single use systems? (Research Paper Sample)


Harvard style. 1.5 line spacing.gone through turnit in process.
Note: the project must be written using pubmed or other research journals and books


Considerations for Using Single-Use Systems
Due Date
Considerations for Using Single-Use Systems
The concept of cost reduction, increase in speed to the market as well as the drive to meet regulatory requirements calls for the pharmaceutical companies to consider single-use technology, pre-sterilized, and plastic equipment systems as some of the alternatives towards the stainless steel process lines. In this case, the application of a single-use system ensures that the bio-manufacturing process becomes efficient at a lesser cost. The single-use system can easily be of help since the equipment can be used and ultimately disposed of, thereby, eliminating any form of capital investment as well as the development time required towards validation of the cleaning and sterilization processes. There is also the aspect of reducing market time through the removal of process validation steps, thereby, making the elimination of downtime required for the undertaking of such processes possible. Such actions could be very significant in enabling an increase in productivity. Notably, there are a number of approaches applicable to validation that could be easily adopted. These may include but not limited to user requirement specification, installation qualification, operational qualification, design qualification as well as performance qualification (Pahl et al., 2019).

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