Cleanroom training
By Tony Breeze
Pharmaceutical Consultant, Hartford Hygiene
Table of Contents
Introduction
Why train?
Who to recruit?
Who to train?
What to cover
How to train
How to assess training
Summary
Introduction
Cleanrooms are restricted areas and admission should be by authorized personnel only. But who authorizes the personnel? And on what grounds? Length of service? Ability? Expertise? Personal attributes? Training? The decision will often be made on seniority and/or expertise and may be very subjective. What rational grounds can we use for making the decision to authorize? Regulators take a keen interest in all aspects of cleanroom operations, particularly in the pharmaceutical industry, and it is important to be able to justify the decisions we make. Although it is psychologically difficult we must be prepared to look at previous decisions and to review them if necessary. One of the acceptable ways of deciding on a person's suitability for work in a cleanroom is to consider the training they have received and the outcome of that training. This article sets out the criteria to be considered in the selection of a training program that will best suit your needs.
Why train?
Building and equipping a cleanroom is a major project that requires months or years of careful planning, considering the business needs, specification, location, size, and so on, and with due regard to regulatory requirements. This article is naturally biased towards the pharmaceutical industry, but whichever industrial sector is involved, be it pharmaceutical, electronic, or optical, the installation will involve heavy capital expenditure in terms of plant and specially designed or modified equipment. Yet often the equipping (or training) of the personnel who will be entrusted with working in the cleanroom is an afterthought. Often, the need is only appreciated when something goes wrong or regulatory authorities are critical of the lack of provision. The need for a recognizable program of training is often poorly understood by managers who maybe have been lulled into a false sense of security by the cleanroom installation company which has given a perfunctory amount of training for some of the operators. Unfortunately, training is often the 'Cinderella' of an organization—kept in the background and not properly appreciated.
However, forward-looking manufacturers who want to increase their efficiency and maximise profitability recognize that training operators and technicians is necessary to ensure competent operation of manufacturing processes. Training is also recognized as being necessary to comply with the requirements of Good Manufacturing Practice (GMP) and of quality systems such as ISO 9000. The long awaited standards for cleanrooms (ISO 14644-4) will contain a requirement that cleanroom training is documented in an operator's training record.
Working in and operating a cleanroom require specific additional training apart from the expertise that an operator will acquire in other areas of work. For example, a worker may well be very proficient at operating a filling machine but is (s)he capable of performing the same job as efficiently in the very specialized environment of a cleanroom? Just as importantly, without compromising other activities going on simultaneously? It is often not appreciated that to operate competently in a cleanroom requires a second level of training, in cleanroom skills.
Who to recruit?
The recruitment of cleanroom operators is a specialized area. There is a whole range of personal characteristics that must be taken into account. The operators, who need to operate for long periods, must first of all be selected for their suitability for working under rigorous constraints. Those who require constant music or conversation will not easily adjust to their absence and need to be screened out if possible. Likewise, individuals with persistent skin or hair problems, while they may be brilliant operators, are going to be a constant source of contamination problems. Unfortunately, there are some people who fidget a lot, who constantly touch their hair or face, they too must be excluded from the cleanroom environment. We also need to be looking for operators who are meticulous in their work and economical in their movements, because over-vigorous activity has a very marked deleterious effect upon the clean environment.
Who to train?
Anyone and everyone who works in a cleanroom needs to be trained to a greater or lesser degree. This is because the entry of engineers, service or quality assurance technicians and janitorial staff can seriously compromise the quality of the air and the level of cleanliness. There must be a basic level of awareness training so that all who enter a cleanroom are conscious of the effect they will have on that environment. So anyone who might possibly need to enter a cleanroom for whatever purpose and for however short a time should undergo some level of training and don't forget first aiders—there isn't time to give instructions on cleanroom etiquette when they are responding to an emergency situation. The flurry of activity will affect the clean environment but we are talking about damage limitation here.
The operators will require the highest level of training but it's easy to forget their managers who need to understand what can and cannot be done in a clean room and how long it takes to work correctly in there. It is unreasonable for a manager or production planner to think that they are going to get as much work done in the cleanroom as they would be entitled to expect outside. It takes time to wash properly, to gown up suitably and to enter the cleanroom correctly. A correct understanding will lead to fewer requests for work practices that are inappropriate.
What to cover
In order for personnel to comprehend the need for training there must be a thorough understanding of how cleanrooms are different from other environments and how that difference can be eroded by inappropriate equipment and the wearing of unsuitable apparel. The origin and nature of particles, their removal from the environment by the use of High Efficiency Particulate Air (HEPA) filters, and the avoidance of particle shedding all need to be an integral part of the operators' and their managers' thinking.
The classification of cleanrooms is a minefield of different and changing standards. But existing cleanrooms will have been built to a particular standard depending upon the specification. The operator needs to know to which particular standard his cleanroom is being operated, including the difference between 'as built', 'at rest' and 'operational'. (S)he should be aware of the general categories of cleanrooms and the way in which they are differentiated on the basis of the number and size of airborne particles and used for different purposes depending upon the degree of cleanliness required. There are important differences in the requirements of the pharmaceutical, optical and electronic industries. The absence of infectious organisms such as bacteria is of paramount importance in the pharmaceutical industry to prevent drug spoilage and/or infection of the patient. The exclusion of solid particles (including bacteria) and fibers and the avoidance of the build up of static electrical charges is important in the fabrication of electronic components.
The way in which we deal with the behavior of operators in a cleanroom is perhaps the most contentious part of a training program. Yet if we've recruited the right sort of operator we will avoid many of the problems. Whoever is chosen they must still have drilled into them the necessity of working in a manner which causes as little particle generation as possible; they must be made aware of the need for personal hygiene; the need to report any infectious disease; in short, the appropriate behavior for cleanroom operators.
Correct gowning procedures are also of paramount importance. One of the problems with particulate contamination is that it is largely invisible to the naked eye. Any contamination introduced into the cleanroom on the outer surface of clothing will go unnoticed and so any breakdown in correct gowning procedures will not be immediately apparent. Thus it is vital that operators are well versed and well practiced in correct gowning procedures. It can be very helpful if a system of mutual help is in place. That is, the operators observe each other and, in a non-threatening way point out faults that may occur.
Operators will have a better understanding of their working environment if they are aware of the engineering and building design constraints of a cleanroom. The frequency of changes of conditioned air, the design and finish of cleanroom fittings, the type and location of air inlet and outlet vents are just some of the factors that it is beneficial for the operator to be aware of.
The question of cleaning procedures is an excellent example of the need to tailor the training to the requirements of a particular company. There are many different opinions about the sequence and the methods of cleaning. Sometimes the trainer is able to provide advice as well as training and ensuring consistency throughout the work force. This requires great tact and diplomacy. It is also an opportunity to reinforce what has gone before: behavior, apparel, construction, and housekeeping. It is quite amazing the amount and type of surplus materials that have been stored in a cleanroom. Not only is this bad cleanroom practice but is likely also to be a contravention of Good Manufacturing Practice (GMP). The cleaning process is a good chance to take stock of what is in the cleanroom and to clear it out.
The validation of the cleanroom is carried out by a contractor and is not something that the operators need to be familiar with but it is helpful for them to know what tests will be applied and what the contractor will be looking for. There may be tasks that will be delegated to the operators and they will perform those better if they know why they are necessary.
One particular problem area, especially in the pharmaceutical sector, is the assessment of bacterial counts. There is no satisfactory correlation between particle and bacterial counts especially if settle plates are used. The message that needs to be got across is that regular testing builds up a picture of the 'normal' level of counts and any deviation needs to be investigated.
How to train
There are many different training techniques, all of which have their advantages and disadvantages. Traditionally, training has been provided by experienced personnel, ("training on the job"/ "sitting with Nellie"). This can be excellent and the trainee will benefit from the experience of the 'trainer'. There are also several disadvantages. It is time consuming for the trainer who may or may not have been trained properly themselves and many bad habits are passed on in the form of "wrinkles"—so-called time saving tips which actually are often detrimental to productivity.
The use of video-based training has become very popular in recent times and there are many advantages. It is convenient to have the tapes available for new trainees and for refresher training for existing operators. But convenience comes at a cost, the tapes are relatively expensive to buy, they need to be replaced if, for example the regulations change, and they are rarely tailored to the needs of a particular group of workers or even to an individual company.
Interactive CD-ROMs are also popular training methods. People like them because they are a familiar medium—at least to those addicted to computer games. Currently there are no disks available for cleanroom training but this situation is sure to change.
One training method that has stood the test of time and is undergoing a resurgence of interest is face-to-face tuition by an instructor with a small group (10–12) of trainees. This is a relatively expensive way of providing training but there is an argument that the advantages outweigh the disadvantages. The training can be tailored precisely to meet the needs of small groups of individuals and the business needs of their employer. The latest available information can be readily imparted and training sessions are supremely interactive, with the trainer being able to respond to pertinent questions from the trainees. The trainer sometimes learns things as well!
How to assess training
There is an argument that a training course is only as good as the method used to assess the effectiveness of the training. After all, if the training cannot be assessed then you have no idea if the training message has been absorbed. You can of course observe the trainee subsequently to see if their performance is as expected. The use of "Happy sheets" will only tell you at best that the trainees were not bored with the trainer, most of the time you will get to know that the facilities were not too bad—lighting acceptable, room not too stuffy, lunch OK. It is necessary to keep the trainees comfortable and happy but feedback on the appropriateness and acceptability of the training is much more important. One technique is to use a form of continuous assessment during the training course. If the course is divided into topics or sections, it is convenient to use a questionnaire to assess the trainees' understanding of the training material and to stimulate questions. It is quite noticeable as the training course progresses that trainees will become much more active in raising points for discussion and asking questions. The usual time for this is in the assessment period at the end of each section. The training session becomes truly interactive and one can often sense a real feeling of interest and involvement.
The satisfactory completion of the assessment exercises is an integral part of the program and is the basis on which a "Certificate of Achievement" can be awarded. At present there is no formal qualification in cleanroom training. In the UK there is a couple of units in an NVQ administered by the Association of the British Pharmaceutical Industry in the field of pharmaceutical packaging but that doesn't really address the needs of all cleanroom operators, particularly those in other sectors such as electronics and optics.
Summary
This article has briefly presented the reasons for training, from regulatory to commercial; how to do it, video or CD based or interactive face-to-face; what to include, from personal hygiene to validation; and how to assess the success of it, continuous assessment is one suggested method. The objective is to raise the profile of cleanroom training that often languishes as an afterthought to something that is perceived as having real value for a company. There will be issues which have not been covered but maybe the status of training has been lifted from Cinderella at least to Snow White whose name certainly conveys the right image.
For more information: Tony Breeze, Hartford Hygiene Consultancy, 4 Kingsley Close, Hartford, Cheshire, CW8 1SD UK. Tel: +44-1606-87-15-83. Email: tony@breeze.supanet.com.
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