Certificate in Cleanroom Manufacturing Practices

Cork Institute of Technology (CR_ECLMP_6)
Key Programme Details
Award

Special Purpose Award Certificate (10 credits)

NFQ Level

6 About NFQ

Delivery Method

Classroom - Evening

Mode

Part Time

ECTS Credits

10

Department

Department of Process, Energy and Transport Engineering

Skills Area

Engineering, manufacturing and construction

General Information
Contact

Mary Quirke, Lecturer in CIT / Ciara Lavelle CAMMS Project coordinator

Email

BioPharmaSpringboard@cit.ie

Phone

021-4335342/ 021-4326264

Address

CAMMS
Cork Institute of Technology,
Bishopstown,
Cork

Role

Lecturer/ CAMMS Project coordinator

Important Dates
Application Deadline

14/09/2018

Start Date

17/09/2018

End Date

31/08/2019

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, Medical Devices and Food industries. 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

Identify sources of contamination within the manufacturing environments.
Identify control strategies to mitigate the risks of contamination
Understand the principles of cleaning validation
Classify a cleanroom to ISO, EMP and FDA standards
Identify the principles of cleanroom design, behaviour and procedures
Understand cleanroom validation and cleanroom environmental monitoring
Practical skills involved in contamination control and cleanroom monitoring management

Entry Requirements

Candidates under the age of 23 must have obtained at least 5 passes at Ordinary Level (minimum 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. Eligible candidates may be interviewed.

Please attach and upload any documents such as transcripts, CV, other details relevant to the application.

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, Medical Devices and Food industries. 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 includes: Understanding of the importance of contamination control; Sources, detection and identification of contamination within the manufacturing environment; Contamination control strategies used and Cleaning Validation; Effective sterilisation methods and the emergence of Single-Use-Technology; Facility design; Practical skills using microbiological, sterilisation and detection methods. Completion of GMP check sheets.

On successful completion of the module, Cleanroom Management, you will gain an understanding of the following:
Identify and measure sources of cleanroom contamination; Selection process and use of cleaning agents; Classification of cleanrooms according to ISO14644; Cleanroom design and construction; Cleanroom garbing and behaviour; Cleanroom, control and monitoring and validation; Practical skills in environmental monitoring, interpretation of psychometric charts and gowning practices.

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. In this Special Purpose Award, the 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.

Timetable Info

Contamination Control, Monday evenings 6-9 pm

Delivery Location

Cork Institute of Technology, Bishopstown Campus

Delivery Notes

Campus/Classroom

Admissions Contact Details
Instructor

Ciara Lavelle

Address

CAMMS
Cork Institute of Technology,
Bishopstown,
Cork

Phone

021 4326264

Email

ciara.lavelle@cit.ie

Application Procedures

Please ensure you provide the following documents with your application:
• Qualification certificates showing academic eligibility
• Up to date Curriculum Vitae
• Documentation showing Springboard+ eligibility.
These may be scanned and uploaded as a single document or alternatively uploaded as a zip file. Your application cannot be approved without these documents.

Media
Cleanroom Manufacturing Practices

CIT Website

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