Certificate in Pharmaceutical Manufacturing and Cleanroom Practices
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Course Overview
Provide the learners with the necessary knowledge and understanding of the manufacturing processes, equipment, tools, control systems and cleanroom technologies needed to function effectively in a highly regulated and controlled pharmaceutical manufacturing environment.
Understanding the Industry
Industry has highlighted through SECBA project engagement that there is a significant need for specialised expertise in many fields such as bioinformatics, analytical chemistry and biotechnology. Quality assurance and control are particularly crucial, with industry seeking competent analysts, Qualified Persons (QPs), and professionals skilled in Quality Management Systems (QMS) and ISO standards.
The growing reliance on technology, including computerised information management, automation and digital skills like bioinformatics and statistical analysis, further underscores the need for graduates with strong tech proficiency. Regulatory compliance, especially in Quality Control, validation, and adherence to standards, is also a priority. However, a noticeable talent gap exists, particularly for roles requiring specialised skills (e.g. Bioprocessing). This highlights the importance of ongoing education and training in related fields to address the skills shortage and ensure a steady pipeline of qualified professionals for the sector.
Career Opportunities
Learners could gain employment within the sector (e.g. Wu-Xi Biologics, Pfizer, Almac, MSD, AbbVie, Grifols, Amryt Pharma etc.) and undertake the programme to obtain a recognised qualification.
Some learners may undertake the programme to ‘re-skill’ and move into the area, they are not employed, or perhaps employed in other Biopharmaceutical areas.
Course Delivery and Modules
This course will be delivered using a combination of online and face-to-face (labs), delivered over one semester.
Online Lectures typically take place on Tuesdays and Thursdays with designated lab days scheduled at the end of the semester.
Module Learning Outcomes
- Categorise the manufacturing activities, inputs, outputs etc. using a Generic Process Approach model.
- Examine the key principles and methodologies used in a implementing a Lean/Six Sigma approach to manufacturing.
- Formulate the basic concepts associated with the design, layout, operation and control of clean rooms, how they are applied and used to maintain regulatory conformance.
- Interpret and explain the principles of tablet /capsule production systems and the associated control/measurement systems i.e. Manual, CLAS and CMMS. MLO5 Explain how the principles of Cleaning, Decontamination and Sanitation (CDS), Cleaning In Place (CIP), Fogging are applied and how to provide and distribute Purified Water, Water for Injection and Clean Steam.
- Manufacturing Process Approach
- Definitions, transformation process diagrams i.e.inputs, outputs, activities, deliverables etc. 1.2) Flow Charts and Process Flow Diagrams
- Site Selection and Premises Design
- Criterion, decision and ranking matrix. Material, process and people flow. Weighing & Dispensing area design and environmental control
- Premise and Regulatory GMP
- Impact on and design of Ancillary, Storage, Production and Quality Assurance areas
- Manufacturing GMP and regulatory requirements
- How regulatory requirements impact personnel , premise and equipment,
- Clean Rooms
- Definitions and standards. Turbulent and Laminar flows. Layouts and design, including air locks, air showers and stepover benchs. Factors affecting effectiveness i.e. rest and occupancy. Air supply, distribution and filtration. Zone control and clean room clothing.
- Water purification and distribution
- Classification types and uses of water. Multistep purification process, Distillation and Reverse Osmosis, Distribution systems for WFI and PW.
- Principles of steam generation – steam equipment, boilers.
- Utility and Cleam steam. Generation and distribution of Clean Steam
- CDS – Cleaning, Decontamination and sanitation
- Cleaning, Decontamination and Sanitation (CDS). Clean In Place (CIP) and Fogging
- Tablet Production Systems
- Tablet forms and formulations, Physical propertie i.e. shape, size and strength. Granual an Dry compression mixes. Wet and Dry cranulation.
- Eccentric and Rotary presses. powder and granual delivery systems. Weight control systems i.e. Manual, CLAS and CMMS.
- Correlation betwen compaction force and weight.
- Tablet Coating systems
- Acid resistant v non resistant coatings. Types of coating processes
- Capsule Filling Systems
- Generic Filling steps. Filling methodologies, Plate, Auger, Tamping, Compression and Drug-pack
Education Progression
Graduates may progress to the Higher Certificate/ Diploma in Science in Biopharmaceutical Manufacturing or similar level 8 programmes. Graduates of the Higher Diploma will be able to progress to level 9 taught postgraduate and Level 9 and 10 research programmes, including Level 9 and 10 research opportunities in DkIT.
Certificate in Science in Biopharmaceutical Manufacturing New course
Higher Diploma in Science in Biopharmaceutical Manufacturing
Fees and Funding
This programme is funded through the South East Cross Border Alliance (SECBA) project, supported by PEACEPLUS, a programme managed by the Special EU Programmes Body (SEUPB).
Fees
Entry requirements
Standard Entry Requirements
- Applicants should have a level 8 major award in Engineering / Science (or equivalent)
or - a Level 7 award in a cognate Science discipline (or equivalent)
or - a Level 7 award in Engineering with a minimum of 2 years’ experience in the Pharmaceutical / Biopharmaceutical Industry (or equivalent)
- Applicants for whom English is not their first language must have English level of IELTS 6.0 or equivalent.
Non-Standard Entry Requirements
Any non-standard entries will be covered by Recognition of Prior Learning.
The part-time programmes are not available to international applicants (the programme includes delivery of practical content on campus, part-time programmes do not fulfil visa requirements).
Recognition of Prior Learning
Applicants who do not meet the standard academic entry requirements but have significant relevant experience (certified and/or experiential) may apply to access this programme via the Recognition of Prior Learning (RPL) route. Learn more about RPL at DkIT
How to apply
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Disclaimer: All module titles are subject to change and for indicative purposes only. All courses are delivered subject to demand and timetables are subject to change. Elective Module options will only run subject to student numbers. The relevant Department will determine the viability of each elective module option proceeding depending on the number of students who choose that option. Students will be offered alternative elective modules on their programme should their preferred elective option not be proceeding. Award Options for Common Entry Programmes: The relevant Department will determine the viability of each award option proceeding depending on the number of students who choose either option. If the numbers for one of the Award options exceed available places, students for this option will be selected based on Academic Merit (highest grades).