A European perspective on training and certification standards for professionals
Peter Fernie
Managing Director
Fernie Technical
Services
Oranmore, Ireland
As usual, the Romans were able to sum it all up in a short and pithy aphorism: “Quis custodiet ipsos custodes?” The phrase, attributed to the poet Juvenal, is literally translated as, “Who will guard the guards themselves?”
but is frequently expressed as, “Who will watch the watchmen?”
The phrase readily springs to mind as we look at the question of
cleanroom validation and certification.
We spend large sums designing and building cleanrooms
for specific purposes. Before the handover to the end user, and
continually during its lifetime, it is necessary to test according
to a clearly defined set of ISO parameters to ensure that the
cleanroom is working correctly and to the agreed specification.
For example, we need to at least test the amount and quality of
air supplied, the air movement between and within the cleanroom, and the particle and microbiological counts. All of the
testing parameters are laid down in a number of ISO and EU
guidelines, supplemented by requirements from various other
regulatory bodies such as the UK Department of Health, the
FDA, the Irish Medicines Board, and many, many others.
It is self-evident that the theory of testing a clean-
room is well regulated; however, it is in the prac-
tice that has, in the past, left a lot to be desired.
Around the turn of
this century in
Scotland,
some horrific cleanroom validation incidents were revealed.
Validation or installation engineers had, in some cases,
destroyed the integrity of a cleanroom by inappropriate practices, such as puncturing a HEPA filter with a screwdriver and subsequently forgetting or omitting to record the incident. Further
investigation of engineers’ skills and qualifications indicated that
many received only cursory training and few had even a basic
understanding of how a cleanroom worked. There was no standard of certification of skills within the U.K. or Europe.
A training initiative
In 2002 the Scottish Cleanroom Society set up an independent non-profit body, the Cleanroom Testing and Certification
Board (CTCB). Principally directed by Bill Whyte, the CTCB
brought together a team of industry experts to devise and
initiate a training program, based upon ISO 14644, with both
written and practical examinations at the end of the course.
The first Cleanroom Testing and Validation course was run in
Scotland in 2002.
The Irish Cleanroom Society (ICS), which had been closely involved from the early days and which represented a large
and growing density of cleanroom users in Ireland, joined the
initiative and ran their first course in November 2003. Even at
this early stage, there was interest from mainland Europe and
the first Irish course included observers from Scandinavia.
A practical program of certification
Two levels of certification are available. Professional certification is for a person whose profession is cleanroom testing
and who routinely carries out all aspects of cleanroom testing;
Associate certification is for people who are familiar with
aspects of cleanroom testing and wish to gain a fuller knowledge of the subject.
Professional candidates are only accepted for examination
if they have been routinely testing cleanrooms for a minimum
of two years. It is expected that the candidates have good
written and spoken English language, and preferably a tertiary
qualification.
On registration, the candidate receives a set of self-study
course notes, a Q&A handbook, and an example of a written
examination paper. Prior to attending the course, the can-
didates are also sent information on how the practical
examination is run and what is expected from
them during the examination. The candi-
dates must study the course notes, and
then attend a one-day practical course, a
half-day lecture course, and pass a written
International Certification of
