BIO09013 2008 UTILITIES FOR BIOPHARMA PROCESSES
This module aims to provide the student with a fundamental understanding of the key utilities that are a pre-requisite for the manufacture of pharmaceutical and in particular biopharmaceutical products. Furthermore the student will understand the means and methodologies for the provision of the different utilities that are required by the biopharmaceutical industry.
On completion of this module the learner will/should be able to;
Distinguish between the different types of utilities that are required for the manufacture of biopharmaceutical products.
Identify the critical utilities such as Purified Water, Water for Injection, Clean Steam, Clean gases etc.
Identify and discuss the means for the generation, treatment, storage and distribution of Purified Water and Water for Injection. Also, describe the methods for the validation of these processes.
Identify and discuss the means for generation and distribution of other biopharmaceutical utilities such as Clean Steam, Compressed Air, Process Gases etc.
Discuss the methods for routine monitoring, quality control and validation of utility systems to ensure their ongoing integrity in operation is maintained.
The following is a summary of the main topics included in this particular module: The different types of utilities that may be required as follows; water systems - Potable Water, Purified Water, Water for Injection; Water treatment systems - pre-treatment, treatment and post-treatment; water distribution systems; Clean steam systems; Compressed air - its generation and distribution; Gases required and their purity levels.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQs, project assignments, practical work, essays, oral presentations, vivas etc.||Continuous Assessment||UNKNOWN||100 %||OnGoing||1,2,3,4,5|
Part Time Mode Workload
|Independent Learning||UNKNOWN||Self Study||7||Weekly||7.00|
ISPE, Water and Steam Systems, Vol. 4., ISPE Baseline Guides., 2001
AWWA and ASCE, Water Treatment Plant Design., McGraw-Hill Professional., 2004