The need for cleanroom testing certification

The standard of validation work and testing carried out in cleanrooms has been of concern in the cleanroom industry. Lynn Morrison, Quality Assurance Manager of a Pharmaceutical Hospital Department in the NHS, and Chairman of the Scottish Society for Contamination Control has pointed out that while a few of the testing companies are working to a very high standard, many are sending out engineers who either are not properly trained, or who simply cannot be bothered to do the job correctly. There is clearly a need to train and certify technicians so that they are competent to carry out this important task. The Scottish Society for Contamination Control (S2C2) are meeting this need by offering a new course which will lead to certification. To this end they have set up a Cleanroom Teaching and Certification Board (CTCB) whose aim is to provide education and training of people who are employed either within or outwith a cleanroom. The Chairman is Lynn Morrison, the Vice-Chairman Jim Carmichael, and the Course Co-ordinator, Bill Whyte. The first course has been set up to train and certify cleanroom testers, and will be of the 'distance learning' type. A course manual is sent to the person, along with a set of question and answers that is used by the candidate to ascertain their knowledge about the course manual. When they are confident of their knowledge they should attend a two-day course and exams, the details of which are given below. In order that the certification reflects the best practices of the cleanroom certification industry, an advisory board has been appointed from well-known and informed members of the cleanroom testing community. They will monitor the course and exams, and suggest changes that may be needed to reflect the needs of the cleanroom industry.

Detailed information about the course:

Who is eligible? Candidates who register for the course should be employed either by a cleanroom testing firm, or a cleanroom company who carries out in-house testing. Other candidates will be considered.

What is involved? On registration they will be entered as a candidate and receive the self-study course notes. They will also receive notification of the date of the next examination. On satisfactory completion of the course they receive a CTCB certificate and will be entered onto the 'List of Registered Cleanroom Testers'. The registration will include the person who passes the exam, and not their firm. The certifier will remain on the list for three years, at which time they must be re-examined.

Course notes and syllabus The candidate will receive a course that contains information required for testing cleanrooms. These notes will be accompanied by a series of questions (and sample answers), so that the candidate can assess their knowledge. Tutors will be available to answer questions and clear up any difficulties. The syllabus of the course contains the following main topics, and will be regularly updated by the Advisory Board:

  • The reasons for validating a cleanroom and validation philosophy
  • How a cleanroom air-conditioning plant works
  • Validation standards
  • Air volumes and velocities
  • Differential pressures
  • Infiltration of contamination into the cleanroom.
  • Air movement control within a cleanroom
  • Air filter integrity tests
  • Particle measuring methods according to ISO 14644-1
  • Microbiological measurements
  • Cleanroom conduct.
  • When they are sufficiently knowledgeable, they should attend the revision lecture course and examination.

    Revision lectures and examination The candidate should attend a two-day revision course and examination. These two days will consist of a revision lecture course and tutorial, to be followed by the written and practical exams. The exams will be organised as follows: Theory exam: This will examine the candidate's knowledge of the course notes. The questions will be short and no essays are required. The questions will be similar, or identical, to those issued with the course notes. Practical exam: The candidate will be required to show their ability to carry out the following important tests: 1. Determine the average air velocity of the air coming from a HEPA filter 2. Demonstrate that they can operate a smoke generator and photometer, and use this equipment to find holes in a filter contained in its housing. The candidate will be required to write up reports of the two tests. The exams will be marked in two parts i.e. practical and theoretical, so that it is possible to pass none, one, or both exams. It is necessary to pass both exams to be certified. Anyone failing an exam can re-sit it at the next examination. Candidates can also attend the revision course, but delay the examination till later. The first certification course and examination is scheduled for the 11th and 12th of June in the Glasgow area.