Certificate in Cleanroom Manufacturing Practices

Cork Institute of Technology (CR_ECLMP_6)
Key Programme Details
Award

Special Purpose Award

NFQ Level

Level 6 About NFQ

Delivery Method

Online, Blended

Mode

Part Time

ECTS Credits

10

Department

Process Energy and Transport Engineering

General Information
Contact

Department Secretaries Elaine McCarthy / Tammy Browne

Email

Cert.CleanManu@cit.ie

Phone

021 4335150

Address

Department Secretaries Elaine McCarthy / Tammy Browne
Dept. of Process, Energy and Transport Engineering
Cork Institute of Technology,
Bishopstown,
Cork,
Ireland.

T12 P928

Role

Administration

Important Dates
Application Deadline

28/08/2020

Start Date

28/09/2020

End Date

28/05/2021

About this Course

This industrially relevant course in Cleanroom Manufacturing Practices is a level 6 accredited programme (10 credits) that is designed for existing employees to upskill and build on their professional experience and introduce potential new recruits in the Biopharmaceutical, Pharmaceutical, Medical Devices and Food industries.

This one-year capacity-building programme is delivered one evening per week over two semesters. It is focused on equipping the learner with fundamental knowledge and skills to work within highly regulated cleanroom environments.

The course comprises of two modules:

Contamination Control (September - January)
Key topics addressed include: understanding the importance of contamination control; sources of contamination within the manufacturing environment; contamination control strategies; cleaning validation; detection and identification of contaminants; effective sterilisation methods.

The module content will be delivered online on Monday evenings with an site laboratory element (6 lab practical workshops) delivered over three Monday evenings.

Cleanroom Management (January - May)
The focus of this module is to gain an understanding of cleanroom classification and standards (e.g. ISO14644); cleanroom design and construction; cleanroom garbing and behaviour; control, monitoring and validation of cleanrooms. A workshop in Cork ETB BioPharma Training Centre in Carrigaline, Co.Cork.is provided for learners.

The theory for this module will be delivered online if social distancing measures continue to be in place and onsite otherwise on Monday evenings. Laboratories and group activities will be delivered on site to engage students with current practices in cleanrooms.


Integral elements of this course are the strong laboratory focus in microbiological, sterilization and detection methods, environmental monitoring, gowning practices as well as completion of industrial documentation and communicate experimental results in accordance with current technical report methodology used in industry.

Objectives

This industrially relevant course in Cleanroom Manufacturing Practices is a level 6 accredited programme (10 credits) that is designed for existing employees to upskill and build on their professional experience and introduce potential new recruits in the Biopharmaceutical, Pharmaceutical, Medical Devices and Food industries.

This one-year capacity-building programme is delivered one evening per week over two semesters. It is focused on equipping the learner with fundamental knowledge and skills to work within highly regulated cleanroom environments.

Entry Requirements

Individuals under the age of 23 must have obtained at least 5 passes at Ordinary Grade D3 in the Leaving Certificate Examinations to include English and Mathematics. Alternative Mathematics does not qualify applicants on this basis.
Applications are welcome from mature students over 23 years of age by 1st January of year of entry. Leaving Certificate is desirable but not essential. Relevant work experience; skills gained through experiential learning; and other qualifications, will be considered through our well established RPL process when assessing applications.

Long Description

This industrially relevant course in Cleanroom Manufacturing Practices is a level 6 accredited programme (10 credits) that is designed for existing employees to upskill and build on their professional experience and introduce potential new recruits in the Biopharmaceutical, Pharmaceutical, Medical Devices and Food industries.

This one-year capacity-building programme is delivered one evening per week over two semesters. It is focused on equipping the learner with fundamental knowledge and skills to work within highly regulated cleanroom environments.

The course comprises of two modules:

Contamination Control
Key topics addressed include: understanding the importance of contamination control; sources of contamination within the manufacturing environment; contamination control strategies; cleaning validation; detection and identification of contaminants; effective sterilisation methods.

The theory will be delivered online. The laboratory element (6 lab practical workshops) delivered onsite in CIT over three Monday evenings.

Cleanroom Management.
The focus of this module is to gain an understanding of cleanroom classification and standards (e.g. ISO14644); cleanroom design and construction; cleanroom garbing and behaviour; control, monitoring and validation of cleanrooms. A workshop in Cork ETB BioPharma Training Centre in Carrigaline, Co.Cork is provided for learners.

If social distancing measures continue to be in place lectures will be online and laboratories and group activities to engage the student with current practices in cleanrooms will be delivered onsite in CIT.

Integral elements of this course are the strong laboratory focus in microbiological, sterilization and detection methods, environmental monitoring, gowning practices as well as completion of industrial documentation and communicate experimental results in accordance with current technical report methodology used in industry.

Why Choose This Course

The biopharma/pharma/MedTech manufacturing operations sector in Ireland is rapidly changing with new roles as Manufacturing Engineers and Operators; Manufacturing Science and Technology Scientists, Bioprocess Engineers and Technicians, Quality Assurance and Quality Control staff and Research and Development are being created (EGFSN report, 2016). All these roles involve operations within aseptic and sterile manufacturing environments with clean utilities which are the core focus of this Cleanroom Manufacturing Practices course.

MSD views this course as “giving people great opportunities to upskill in what is critical and continuously changing aspects of Pharms business”, see attached letter of support. “Cleanroom skills and capabilities are consistently identified as a critical skills required for all entry-level and successive roles across the pharma/biopharma/med-device and food sectors” as stated by Siobhán Bradley, Regional Skills Manager, South-West at Department of Education and Skills - Ireland.

Career Opportunities

Employment prospect is strong as numerous positions are currently advertised in Irish jobs.ie looking for personnel with experience or familiarity with cleanrooms in roles such as production technicians and operatives, cleanroom operatives, dispensing technicians, stores operatives, mechanical fitters and process technicians.

Timetable Info

Semester 1
Online delivery - Monday evenings + 3 evenings in CIT for labs

Semester 1
Online delivery (if current social distancing measures continue to be in place) or onsite lectures - Monday evenings + labs Monday evenings

Delivery Location

Semester 1
Lectures - online
Labs - CIT, Bishopstown, Cork

Semester 2
Lectures - online or onsite in CIT
Labs - CIT Bishopstown, Cork

Delivery Notes

Blended

Admissions Contact Details
Contact Person

Department Secretaries Elaine McCarthy / Tammy Browne

Address

Department Secretaries Elaine McCarthy / Tammy Browne
Dept. of Process, Energy and Transport Engineering
Cork Institute of Technology,
Bishopstown,
Cork,
Ireland.

T12 P928

Phone

021 4335150

Email

Cert.CleanManu@cit.ie

RPL Information

Cork Institute of Technology - https://www.cit.ie/rpl

Application Procedures

online VIA Springboard

Media
Cleanroom Manufacturing Practices

This industrially relevant course in Cleanroom Manufacturing Practices is a level 6 accredited programme (10 credits) that is designed for existing employees to upskill and build on their professional experience and introduce potential new recruits in the Biopharmaceutical, Pharmaceutical, Medical Devices and Food industries.

https://www.cit.ie/course/CRECLMP6