What Training Should your Cleanroom Manufacturing Staff Undergo?

By definition, the cleanroom environment is no place for a laissez-faire attitude. With a number of regulatory protocols applying to pharmaceutical manufacture, the chance of falling short is a very realistic risk – and it takes diligence and scrupulous protocol to maintain regulatory standards.

Though studying and memorising the relevant International Standards for Organisations (ISO), Good Manufacturing Practice (GMP) and other relevant pharmaceutical manufacturing standards seems a reliable practice to keep you on track, these sources themselves can cause some confusion and uncertainty for operators.

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)

Yet, the cleanroom operator searching these documents for specific details on how to apply these standards to their own environment will search long and hard, and ultimately unsuccessfully.

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. 

Accreditation

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 cleanroom staff are that matters, but what type of accreditation and experience they carry as well.

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 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.” 

In addition, professional candidates are required to have a minimum of two years’ experience in routinely testing cleanrooms, must have a good grasp of both written and spoken English, and preferably a tertiary qualification.

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 cleanroom environment, those in charge of hiring can’t afford to be indiscriminate. Behaviours such as personal hygiene and attention to detail are bound to reflect in a person’s work practises and affect the additional risk they bring to the cleanroom environment.

Tony Breeze, Pharmaceutical Consultant at Hartford Hygiene recommends 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.”

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 unnecessary risk to the cleanroom environment.
• 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 cleanroom practice, right from the start. We’ve all experienced how much more challenging it is to correct bad technique and habits once they’ve become ingrained. It is therefore imperative to ensure everybody benefits from the clear communication and strict enforcement of cleanroom protocol from day one. 

General cleanroom rules

General principles for cleanroom practice to establish from the start include:

• 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 cleanroom is 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 time to wash properly and gown up suitably to enter the cleanroom.
• If it’s not cleanroom kit, clear it with your manager! While jewellery and makeup are adornments non-grata in all cleanrooms, the particular cleanroom manager 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 everyone of best practice every day.

Staff must be made aware of the fact that cleanroom gowning and routine sanitation protocol is designed for best case scenarios, and not to deal with lax personal hygiene. Operators would be wise to drill down into the detail of the level of personal hygiene practices expected of their staff, including:

• 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 cleanrooms.
• Staff should not only wash their hands before gowning, but also apply hand sanitiser to 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 cleanroom best practise have been established, operators must train staff in the risks that are particular to that environment. Factors such as the cleanroom’s classification, its engineering and building design, and the operator’s risk assessment will determine the rate and rigorousness at which practices must be maintained. 

Cleanroom classification

Tony Breeze, Pharmaceutical Consultant at Hartford Hygiene, advises to train cleanroom staff to know the particular standard that the cleanroom is being operated on, including the difference between 'as built', 'at rest' and 'operational'. Based on these categories, staff should be made aware of:

• 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’s particulars, 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 cleanroom fittings.
• The type and location of the air inlet and outlet vents, and how to prevent blocking air return.

Risk assessment

The cleanroom’s risk assessment is probably the most particular area of training.  In this regard, staff must be trained on:

• The most common and highest risk contaminants that the cleanroom deals 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 dabs. The frequency of testing will be determined by the grade of environment and the training and requalification regime that’s being undertaken at that point. 

Decontamination process

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 samplers vary significantly in the effort and expertise needed to set them up and execute the required processes. Even easy to use devices like MinnCare’s Dry Fogging units require quite a bit of work to set up for operation.

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 documented however, replication of the process can be delegated to competent staff members.

Bridging the gap between regulatory guidelines and cleanroom practices

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 cleanroom protocol. Additionally, if you’re in need of advice on best practice in decontamination and environmental monitoring, please get in touch with us to speak to one of our team.