By definition, the
The problem lies in the lack of practical advice. The standards provide “requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.” (ISO website)
If this challenge resonates with you, let me assure you: you’re not alone. With our own team of cleanroom operators and engineers that practise in-house and on client sites, we understand the gap between guidelines and cleanroom-specific protocol.
We cannot advise you on the specifics of your own risk assessment and protocol development. Instead, we want to share some practical examples of how to flesh out GMP and ISO in training staff to maintain the highest standards.
Hiring your dream team
The first step to establishing a team that operates to the highest of standards is to appoint the right individuals. Though training and monitoring your staff is a continuous process, using selective hiring criteria can prevent an ongoing battle against high-risk behaviours. Two main areas that should be considered during the recruitment process are accreditation and personal character.
Anyone hired to work in a cleanroom should be qualified. Not necessarily academically, but through experience or having the appropriate personality traits and habits that are suitable for cleanroom operation. Thinking you can cheaply hire an untrained person, gown them and put them to work in a cleanroom is likely to prove a false economy, with a potentially litigious kicker.
With today’s stringent regulations and highly competitive commercial climate, it’s not only how qualified your
Peter Fernie, writing on cleanroom training courses in Controlled Environments Magazine, advises that there are two levels of certification that are appropriate for different roles:
“Professional certification is for a person whose profession is cleanroom testing and who routinely carries out all aspects of
In addition, professional candidates are required to have a minimum of two years’ experience in routinely testing
Associate certifications, such as the ICEB’s cleanroom and contamination course, treats subjects according to the relevant ISO standards. Courses are accredited within guidelines set by the association, and successful candidates are awarded a certificate with the association’s logo. The association itself establishes a quality assurance system to ensure a high standard of courses.
Keep the distinction between these levels of certification in mind, and you’ll have a much deeper understanding of your candidates’ experience and training when you look through CVs.
The most important hiring criteria: personal character and health
We live in an age of sensitivity that embraces personal choices and eschews discrimination. But, when it comes to the rigorous
Tony Breeze, Pharmaceutical Consultant at Hartford Hygiene recommends looking for “operators who are meticulous in their work and economical in their
Personal traits to take note of and ask candidates about during the interview process include:
- Chronic skin, hair or respiratory conditions
- Fidgeting and restlessness. Those who constantly touch their hair or face, or pace the room will pose
unnecessaryrisk to the cleanroomenvironment.
- The need to work to background music or conversation
Training your dream
cleanroom team in good practice
Working at getting the most suitable team on board is half the battle won. Next up is laying the foundation for the best possible
General principles for
- No rushing and scuttling about! Due to the greater rate at which human-related particles shed as movements increase in speed and frequency, the pace of work done in the
cleanroomis required to be much slower than outside. Staff must be made aware of the importance of practising slow, deliberate movement and walking. The gowning procedure mustn’t be rushed either, as it takes timeto wash properly and gownup suitablyto enter the cleanroom.
- If it’s not cleanroom kit, clear it with your manager! While jewellery and makeup are adornments
non- gratain all cleanrooms, the particular cleanroommanager is at liberty to implement additional guidelines according to their own discretion. Staff must be encouraged to speak to their manager whenever in doubt about the appropriateness of their facial hair or other garment and dress.
- Smoking and drinking are prohibited in the
cleanroom, no exceptions.
Personal hygiene and health
Approaching a staff member about inadequate personal hygiene is a task that most of us would avoid if at all possible. The best way around these awkward conversations is to have them pre-emptively, with all your staff, on day one. Better still, put it in writing as part of a staff handbook or posters in the gowning area to remind
Staff must be made aware of the fact that
- No nose picking or fiddling with their skin. While this seems an obvious etiquette, operators must not assume that everyone is on the same page, or even aware of their own bad habits in this area.
- Fingernails must be short and clean. False nails are not only unhygienic but impractical in a setup where gloves are used.
- Staff must not wear makeup, this significantly increases the number of particles shedding from the skin.
- It would be better for male operators to be clean shaven, if not they must cover their faces if they have not shaved for over 24 hours, even in lower grade
- Staff should not only wash their hands before
gowning,but also apply hand sanitiserto their gloves frequently during operation.
- Staff must report respiratory and skin infections to their manager before entering the cleanroom, as it could make them unfit to enter high-grade areas.
- Chronic skin and respiratory conditions must be brought to the manager’s attention as soon as symptoms appear.
Training staff in cleanroom-particular risks
Once personal etiquette and
- The degree of cleanliness that’s required.
- Routine cleaning and sanitation practices that will be required.
- The need to exclude certain solid particles and fibres.
- The quality and grade of gowning required for
a space’sparticulars, including the correct gown and the extent of the gowning process.
Engineering and building design
When it comes to the engineering and design of the space, Breeze points out that staff’s general understanding of their working environment will benefit from being informed of:
- The frequency of changes of conditioned air.
- The design and finish of
- The type and location of the air inlet and outlet vents, and how to prevent blocking air return.
- The most common and highest risk contaminants that the
cleanroomdeals with on a regular, occasional and case-by-case basis.
- The level of staff’s exposure to these particles.
- The actions they must take to avoid personal injury and product contamination.
- The appropriate gowning and gloving procedures.
- Routine cleaning and sanitation protocols.
To confirm staff’s level of adherence to these protocols, operators must implement regular testing through contact plates and finger
While it’s unnecessary to train every staff member in the use of decontamination equipment, operators should train one or two of their most competent people per shift. Decontamination units and air
Operators would be wise to undertake the validation of the decontamination cycle themselves to ensure the accurate calculation of the room’s volume, air flow and the appropriate volume of sterilant to be used. Once the process has been validated and
Bridging the gap between regulatory guidelines and
I hope that the points I’ve covered in this article will be of some use in helping you lift regulatory guidelines off the page and turn them into workable