Certificate in the Cleanroom Manufacturing Practices

Cork Institute of Technology (CR_ECLMP_6)
Key Programme Details
Award

Special Purpose Award

NFQ Level

6 About NFQ

Delivery Method

Classroom - Evening

Mode

Part-Time

ECTS Credits

10

Department

Department, Process Energy &Transport Eng.

Skills Area

Advanced Manufacturing

General Information
Contact

Elaine McCarthy

Email

elaine.mccarthy@cit.ie

Phone

021 4335150

Address

Department, Process Energy &Transport Eng.
CIT
Bishopstown
Cork

Role

Department Secretary

Important Dates
Application Deadline

09/09/2017

Start Date

09/2017

About this Course

This Special Purpose Award in the Cleanroom Manufacturing Practices is a level 6 accredited programme (10 credits). This is an industrial relevant course specifically designed for existing employees to upskill and build on their professional experience as well as for potential new recruits in the Biopharmaceutical, Pharmaceutical and Medical Technologies. This course aims to develop skills, knowledge and confidence to enable the learner to understand the principles, practices and skills essential to the manufacturing activities within the cleanroom environment.

Objectives

Key topics addressed include identifying and measuring sources of cleanroom contamination, materials compatibility in controlling contamination, selection and use of cleaning agents, the classification of cleanrooms according to ISO14644-1, cleanroom design and construction, cleanroom garbing and behaviour, cleanroom monitoring and validation.

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 when assessing applications.

Long Description

This Special Purpose Award in the Cleanroom Manufacturing Practices is a level 6 accredited programme (10 credits). This is an industrial relevant course specifically designed for existing employees to upskill and build on their professional experience as well as for potential new recruits in the Biopharmaceutical,Pharmaceutical and Medical Technologies. This course aims to develop skills, knowledge and confidence to enable the learner to understand the principles, practices and skills essential to the manufacturing activities within the cleanroom environment.

The course comprises of two modules: Contamination Control and Cleanroom Management. Key topics addressed in the Contamination Control module include: understanding the importance of contamination control; sources of contamination within the manufacturing environment; contamination control strategies used; cleaning validation; detection and identification of contaminants; effective sterilisation methods; facility design. On successful completion of the module, Cleanroom Management, the learner will gain an understanding of the following: cleanroom classification and standards (e.g. ISO14644); cleanroom design and construction; cleanroom garbing and behaviour; control, monitoring and validation of cleanrooms.
This one-year capacity-building programme is focused on equipping the learner with fundamental knowledge and skills in order to work within a highly regulated environment. This is an ideal programme to suit the training needs and the Learning and Educational Development (LED) of employees within the medical technology, pharmaceutical and biopharmaceutical sector. It is also a ‘good fit’ for individuals who wish to upskill into these manufacturing sectors. There is a strong laboratory focus associated with the programme that will develop the students' ability to analyse and critically evaluate scientific data in order to communicate experimental results in accordance with current technical report methodology used in industry. Practical skills includes those related to microbiological, sterilisation and detection methods, environmental monitoring, interpretation of psychrometric charts and gowning practices as well as completion of industrial documentation. Students can also avail of the career professional development (CPD) services in Cork Institute of Technology (CIT) to support individuals in their quest for sustainable employment.
Students on completing the programme will be able to work within the high-tech sterile manufacturing environment and occupy roles which support GMP, QA, Validation, Manufacturing Operations, Technology Transfer and Bioprocessing.
On completion of this programme, there are a number of options for further education:
1. Graduates can progress to the Higher Certificate in Science in GMP and Technology (level 6). This offers an attractive alternative to individuals who are apprehensive about taking their first tentative steps back into education and also, who have other lifestyle demands.
In particular, this is an ideal programme for homemakers. Students can undertake this short programme (two modules per year) and obtain an accredited qualification worth 10 credits which would allow them to gain credits towards the Higher Certificate in GMP and Technology.
2. Those who can demonstrate significant levels of workplace learning may be eligible to apply for direct entry to the BSc in GMP and Technology, a level 7 degree which is delivered in CIT in part time mode. More information is available on http://www.cit.ie/course/CRSGMPE7Y1.

Why Choose This Course

A nationally accredited education programme designed to meet the education and training needs of people in the areas of Production, Quality Assurance and Validation in the Biopharmaceutical, Pharmaceutical, Medical Devices, and Food industries.

Career Opportunities

Course is designed for existing employees or potential new recruits in the Bio-pharmaceutical, Pharmaceutical, and Medical Devices, and Food industries who would like an accredited qualification and includes:
Certificate in Cleanroom Manufacturing Practices: Contamination Control and Cleanroom Management.

Timetable Info

Semester 1: Contamination Control is timetabled for Wednesday evenings, 6 to 9pm.
Semester 2: Cleanroom Management, timetable to be confirmed.

Delivery Location

Campus/Classroom, Bishopstown campus, CIT

Delivery Notes

Campus/Classroom

Admissions Contact Details
Instructor

Admissions Office

Address

The Admissions Office, CIT, Bishopstown, Cork

Phone

(021) 433 5040

Email

springboard@cit.ie

RPL Information

http://www.cit.ie/rpl

Application Procedures

Apply online through www.springboardcourses.ie