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Module Overview

Pharmaceutical Facilities, Utilities and Research Methods

This module provides the students with a comprehensive understanding of the types of Non-Aseptic Pharmaceutical Manufacturing Equipment, with emphasis on the Qualification of the same. This is combined with is an introduction to pharmaceutical facilities and the main types of pharmaceutical utilities and the validation of the same.  In addition the module introduces the students to research design, and research methodologies

Module Code

PVT9016

ECTS Credits

10

*Curricular information is subject to change

Indicative syllabus covered in the module and / or in its discrete elements; 

EQ (Non Aseptic) 

  • Description of selected main types of non-aseptic processing equipment 

  • Steps in qualification of non-aseptic pharmaceutical aseptic manufacturing equipment: -Design, Risk analysis, procurement, FAT, Installation, SAT, commission, and calibration.  Responsibilities and purpose of each 

  • Preparation and Execution of DQs and IQs 

  • Preparation and execution of OQs 

  • Non-conformances/deviations 

  • Hand-over of equipment to production 

  • Change control 

 

Facilities and Utiliities 

  • Pharmaceutical plant layout and design 

  • Aspects of Design/Construction,  cleanability, materials of construction, surface finishes, piping design and construction, vessel design, equipment design and sampling 

  • Pharmaceutical water systems, design and regulatory requirements, hot and cold water, potable water, purified water (PW), water for injection (WFI), their generation, storage and distribution systems 

  • Clean steam generators, steam sterilisation in place (SIP) and clean-in-place 

  • Cleanrooms:  regulatory requirements,  layouts,  area classification protection, design considerations,  HVAC system (air supply, air changes, air filtration), contamination control, personnel, barrier technology 

  • Clean steam generators, steam sterilization in place (SIP), Clean-in-place (CIP) 

  • Heating - Ventilation - and Air Conditioning (HVAC) for sterile and non-sterile manufacturing 

 

Research Studies 

  • Research design and methodologies 

  • Dissertation Review 

Webinars, Lectures, Videos, Discussion Boards, Workshops

Module Content & Assessment
Assessment Breakdown %
Other Assessment(s)100