Course Introduction

This is designated as a basic course and lasts one full day.

The International Cleanroom Pass course is accredited by the ICCCS and is specifically designed for people at all levels who are connected to cleanrooms in any way. It is not restricted to those directly involved in cleanrooms or their operations.

Everyone that works in your facility should have a basic understanding of the operations of a cleanroom. It's essential that personal from all departments understand the importance of a cleanroom. It may be the purchaser in the purchasing department or the technician in the manufacturing department but all should have an understanding of cleanrooms and how their actions can affect product quality.

The course is divided up into modules covering awareness and behavior. 25% of the course content can be site specific and still holds its accreditation.

Modules Covered

1.  Awareness
   • What does Clean mean
   • Why do we need a cleanroom?
   • Contaminants and Contamination
   • Standards and Regulations (local relevance)
   • Contamination Control
   • Good documentation practices
      
2. Behaviour 
   • Hygiene
   • Gowning
   • Cleaning
   • Safety
   • Case study

The international cleanroom pass is also aimed at contractors who visit and carry out work on your site. Remember any personal that carry out work on your site should be fully be aware of how their actions in the cleanroom can affect product quality and therefore patient safety. How many times have contractors failed to follow basic correct GMP procedure when working in your cleanrooms.

The aim of the course is to give attendees an awareness of how cleanrooms play such a significant role in our day to day life. The courses focuses on the importance of people working or visiting a cleanroom and how our behavior affects the product quality, product reliability and patient safety in a Life Science context and consumer safety in terms of food quality.

The International Cleanroom Pass course will provide essential information on:

• The role of cleanrooms and their applications,
• The importance of the cleanroom environment,
• The importance of people and their contribution to contamination,
• Contamination in a cleanroom, personal hygiene, gowning,
• Behavior in the cleanroom and the importance of ongoing cleaning and decontamination.

At the conclusion of the course each attendee who passes the exam shall receive a wallet size International Cleanroom Pass Card". They will also receive a certificate and a international cleanroom pass booklet which outlines the dos and don'ts of a cleanroom.

Course Introduction

The aim of this one-day course is to give delegates the tools and the knowledge they need in order to implement an effective cleaning programme for a GMP cleanroom. This training course will provide essential information on:

• Introduction to the cleanroom environment,
• Introduction to contamination control,
• Behavior in a GMP cleanroom,
• Gowning procedures,
• What to know before entering the GMP cleanroom,
• Multiple surface cleaning and decontamination techniques,
• Understanding SOP's,
• Cleaning skills demonstration and assessments.

Suitable candidates for this course include:

• Any person in the organisation who is directly involved in the cleaning of a GMP cleanroom,
• Personnel responsible for managing the cleanroom,
• Personnel who have responsibility for choosing the cleaning products for use within the Cleanroom,
• Personnel who work on investigation where a contributory factor is related to GMP cleanroom cleaning.

Course assessments

The Cleanroom cleaning (basic) course is accredited by the International Confederation of Contamination Control Societies (ICCCS and conforms to the ICCCS accreditation framework. Each candidate will complete a 45-minute multiple choice question examination as part of the course assessment. The examination will consist of 25 questions and the pass mark is >20 correct answers. All candidates who pass will receive certification from ICEB.

Course Introduction

The aim of this one day course is to give delegates the tools and knowledge they need in order to implement an effective aseptic cleaning programme for a cleanroom. This training course will provide essential information on the following:

• Introduction to the cleanroom environment,
• Introduction to contamination control,
• Behavior in the GMP cleanroom,
• Cleanroom standards and GMP,
• Aseptic processing, multiple surface cleaning and decontamination techniques,
• Understanding SOP's,
• Practical aseptic cleaning techniques, cleaning and decontamination theories
• GMP cleanroom aseptic cleaning skills demonstration and assessments.

This course is suitable for:

• Any person in the organization who is directly involved in the aseptic cleaning of the GMP cleanroom,
• Personnel responsible for managing or supervising the aseptic process and/or aseptic cleaning in the cleanroom,
• Personnel who have responsibility for choosing the cleaning products for use within the cleanroom,
• Personnel who work on investigation where a contributory factor is related to aseptic cleaning.

Course Introduction

The aim of this one-day course is to give candidates an understanding of the cleanroom environment and the importance of the GMP Cleanroom Equipment Cleaning. It is also aimed to teach candidates how to correctly clean GMP Cleaning Equipment using the correct industry accepted procedures and how to interpret equipment cleaning programme and or SOP's.

The course is aimed at technicians, operators, cleaning personal and supervisors who carry out the equipment cleaning in a GMP environment. This course is restricted to equipment cleaning in a GMP environment. Candidates will be shown practical equipment cleaning techniques of a number of equipment types.

On successful completion of this training course, the candidates should be able to:

• Understand contamination control in a cleanroom setting and GMP equipment cleaning
• Be able to identify what an effective SOP should entail,
• Understand cleanroom design & airflow,
• Perform practical cleaning of surfaces within a cleanroom and examine different cleaning systems available,
• Understand good behavior in the cleanroom, good documentation practices, cleanroom standards & GMP as well as cleaning decontamination theories.

Courses Locations

The courses above are run at various locations across Ireland or onsite if requested.

Course Introduction

The testing of a cleanroom requires skills and the following certification courses are provided to ensure this.

Candidates can register for either

1- Professional Certification (For people whose profession is cleanroom testing, and routinely test all aspects of cleanroom testing)

• Candidates will be required to:
   
  • Study the self study course notes that will be sent to you.
  • Attend a lecture course and then pass a written examination on Cleanroom Testing and a written examination on Particle counting.
  • Attend a one day course on practical aspects of filter integrity and air volume and velocity testing
  • Show a high level of competence in (a) filter integrity testing and (b) measuring air velocities and volumes, by passing a practical exam.

or

2- Associate Certification (For people who are either familiar with some aspects of cleanroom testing, and wish to gain knowledge about the subject or have been working less than two years as a cleanroom tester, but wish to use the certification course as a basis of training and working towards professional status.).

• Candidates will be required to:
   
  • Study the issued course notes.
  • Attend a lecture course and then pass a written examination on Cleanroom Testing.
  • Attend a one-day course on practical aspects of filter integrity, and air and velocity measurements.
     
• Students who have obtained the associate qualification may convert to a professional certificate once they have a minimum of two year experience and are able to pass the practical exam.

Further information can be obtained by visiting the CTCB-I website (Cleanroom Testing & Certification Board-International).