Cleanroom Training

Cleanroom Training: Lead by Example

This article was originally published on Cleanroom Technology in December 2002. Click here to see the article.

Some years ago I took part in a site visit to a company manufacturing a high volume of small medical devices in a cleanroom environment.

I saw operators on the production line visually inspecting the finished article. Despite what would appear to be a laborious task, they conducted each inspection in a very meticulous and conscientious fashion. On asking one operator what her role in the process was, she replied: “I save lives.”

This initially seemed a little far fetched but on reflection, it was most certainly the case. What I was most impressed with was the pride and importance of that job to the individual when it was quite clearly a small part of a much larger process.

It was an illustration that the training given for the role had not only taught the staff member how to do their job but also how critical their input was in the delivery and safety of the end product.

The training was obviously of a high standard and achieved excellence through group understanding, as well as an awareness of the individual’s responsibility to the product and end user.

As an industry we need to recognise that, although task led, training yields its own rewards and allocating a budget to staff development is as imperative as maintaining the environment and plant in which they operate.

I took this early insight into the value of training with me when setting up Clean Air Technologies and establishing our operating standards. Our quality and training of staff continues to be one of the key areas that steers our development and sets us apart from some of our competitors.

The company implements a rigorous and comprehensive training programme for all our cleanroom engineers from trainee through to senior level. The training is structured and provides each engineer with a sound knowledge of the following:

  • Contamination control issues
  • Testing procedures
  • Identification of cleanroom components
  • Why products are manufactured in this controlled environment
  • Problem solving encouraging thinking outside the scope of their allocated tasks

The six basic training modules devised deal with:

  1. Method of use for test equipment
  2. Cleanroom standards
  3. Clean Air Technologies’ reports and administration
  4. Air balancing and commissioning
  5. Project management
  6. Draughting and design

We still use these modules today, although they are constantly evolving as changes are applied to the contamination control industry.

The modules themselves take a trainee engineer six to nine months for completion and can only be signed off by a Senior Engineer who witnesses the actual task or test to be performed. The work of the engineer is always coupled to ensure continuous supervision until all of the modules are successfully completed. A final evaluation of the engineer’s skill set is then conducted at Director level.

Engineer forums are frequently held as a platform to facilitate sharing of information on individual skill sets and exchange on-site working experiences.

There are sound reasons and benefits behind the working practices that are adopted. While generic cleanroom validation tasks can be taught in a short space of time in a classroom, this does not equate to the experience gained by engineers actually implementing the processes and procedures on the various different cleanroom systems and equipment available on each specific site.

The emphasis on training and the sharing of information allows our Engineers to test, interpret, recommend and rectify problems and prevent them from occurring again.

Cleanroom operators recognise the importance of contamination control and invariably manufacture within purpose-built, controlled environments. To engineer such an environment is costly; however, to monitor the performance parameters is not.

Sources of particles in the cleanroom
Fig.1 Sources of particles in the cleanroom

A properly designed and constructed cleanroom will not generate particulate but remove it. It is a well-documented fact that the operators inside the environment cause most contamination problems (see Fig. 1). The cleanroom is checked regularly by means of analysing its performance, but can the same be said regarding that of the operatives?

By recognising the need for cleanroom training, our company decided to evolve training courses on the principles of cleanroom contamination control.

A dual approach was identified to look at two distinct areas including cleanroom engineering and cleanroom disciplines. As specialists in engineering plant and cleanliness monitoring we joined forces with AIS Cleanroom Products Ltd, which is a company offering expertise in operator gowning, consumable selection and cleanroom disciplines.

The course has been successfully run for a number of our existing customers. These clients recognised the benefits gained by having on-site training by independent cleanroom experts, emphasising contamination issues and the need for cleanroom discipline in an informal manner.

While training cannot compensate for the failure of poorly designed products, it does minimise the risks and provides solutions for sound working practices. Delegate feedback has shown the courses to be professional enjoyable and educational.

Hourly particle count changes
Fig.2 Hourly particle count changes

Feedback has also shown that the cleanroom manager gains the cooperation of staff through a greater appreciation of the specialist environment
in which they work, and their acknowledgement of their ability to contaminate the product and the associated knock-on effects (see Fig. 2).

As cleanroom operators we should all strive for 100% efficiency yield or zero contamination or plant failure. Indeed, if an aircraft that was only rated as 99% safe, would you be happy to travel as one of its passengers? Everybody wants 100% safety – the same should be said for goods produced in a cleanroom. At the very least, product failure by operator contamination accounts for lost profitability, reputation and the inherent risk of safety issues.

Cleanroom MOT

Cleanroom M.O.T.

This article was originally published on cleanroom-technology.co.uk in September 2002. View the article.

Having just experienced the problem of a company vehicle failing its annual M.O.T., our attention focused on aspects of cost, inconvenience and the inevitable issues of safety. We had the car regularly serviced so why did it fail? The garage admitted to only checking the items they were contracted to do and not to looking at the car as a whole. The schedule of service tasks had subsequently not taken into account the rigours endured from UK roads and the resulting wear and tear on the rear suspension of heavy test equipment in the boot.

I was drawn to an analogy of running a car and my business of servicing cleanrooms.

Typically, cleanroom operators implement validation tasks, such as particle counts, HEPA filter installations leak tests on a regular basis to assess and ensure airborne particle counts meets certain designated standards. These routine service tasks relate solely to the air quality in a controlled environment.

However, can it be said that equal consideration is given to the condition and operation of the mechanical and electrical components that work together to ensure the cleanroom performs to its operational specification?

This is where a measured, monitored and methodical approach is critical to the sure and effective operation of a cleanroom. Moreover, as with a car M.O.T., do you know what to expect despite best efforts endeavoured?

Our company ensures the highest of operational procedures in all aspects of air movement plant equipment. These procedures include meticulous levels of maintenance and ongoing performance testing. We liaise with the client to provide detailed analysis – such as that of a cleanroom M.O.T. checklist. Implementation by our current clients has proven to minimise cleanroom downtime, increase plant longevity and alert the cleanroom operator in advance to plant deterioration and to budget for future replacement.

Additionally, operators are provided with a datum for future benchmarking of cleanroom performance when assessing the implications of system modifications and any concurrent operational changes. Below is a list of recommendations gained through experience and the conversion of
sound business theories and principles into working practice.

Cleanroom Components

Air handling unit:

“A drive belt broke in the air handling unit resulting in the loss of air pressure in my cleanroom and four hours downtime while I sourced a replacement belt at a cost of £12 for the belt and thousand of pounds in lost production.”

  • Change pre-filters, ensure, fitted correctly with air by pass. – spare filters to be kept in stock
  • Change fan drive belts, align pulleys and tension correctly, leave spare belt in air handling unit
  • Clean and biocide heating and cooling coils
  • Clean and biocide condense tray and trap, ensuring condense runs freely and no stagnant areas.
  • Measure and record the fan motor running amps to ensure phases in balance and motor winding not failing.
  • Change humidifier bottle and clean strainers
  • Have all heating and cooling plant services checked by approved HVAC operator

Air movement system:

“We lost pressure gradually in our room, the belts and the filters seemed fine, it was not until I was in the car park to leave, did I notice the autumn leaves blocking the air intake grille. Next day, I removed the leaves and the pressures returned”

  • Clean fresh air intake of any debris
  • Measure and record the proportion of fresh air to recirculated air and compare to original design
  • Measure and record airflow volumes at all test points and compare to original data
  • Measure and record the pressure differentials across each individual component for a comparison to manufacturers data
  • Inspect ductwork for leakage and damage
  • Inspect lagging of ductwork and re-fix where necessary
  • Lubricate all dampers then rotate through full movement, re-securing in original position

Energy usage (CO² emissions)

”By modifying our air conditioning control system by fitting a time switch to control temperature only during periods of occupancy, we paid for the modification in three months in reduced energy consumption with the added benefit of reduced wear and tear. “

  • Measure and record switch on/off time for temperature and humidity control. Then compare against operating hours
  • Record night set back temperatures
  • Measure and record inverter settings on each fan motor
  • Have environmental controls serviced by HVAC approved contractor
  • Note and record overload setting on all breakers
  • Check condition of fuses and associated electrical wiring
  • Check operation of actuators and valves through the temperature and humidity control range
  • Record filter type, dimensions, and pressures. Is it technologically up to date?
  • Newer, advanced filters provide more energy efficiency
  • Investigate fitting of filters

Fabric and structural checks

“We had an HSE inspection and the inspector checked that our emergency lights and door interlock were tested regularly and results recorded”

  • Inspect all structural supports for condition and security
  • Check ceiling panels for damage during maintenance
  • Inspect all wall panels, doors, and record any damage
  • Inspect condition and operation of doors, interlocks, hinges and door closures. Results to be recorded
  • Inspect condition and operation of all emergency exits and crash bars
  • Inspect condition of floor, all weldings and joints. Defects to be noted
  • Inspect condition of all seals and mastic jointings. Record defects
  • Check operation of all lights and emergency lights

Cleanroom performance

”We found that through investment in training of our cleanroom personnel we received an tangible benefit, as we found our daily particle
counts improved immediately”

  • Particle counts to be taken with:
    Cleanroom in non-operational state
    Cleanroom with no personnel present, but equipment in operation
    Cleanroom in full operational mode
  • This will facilitate future benchmarking for operational improvements
  • Hepa installation leak test
  • Measure and record air change rates in each area
  • Measure and record light levels at the working plane. To be compared to specification for visual activity
  • Measure and record noise levels in both the unmanned and operational states
  • Measure and record pressure differentials between each room
  • Measure and record the cleanroom area cleanup rate; recovery time will be a function of airflow distribution pattern and volume of the filtered air. It is also an excellent indicator of efficiency of the air supply system.

Conclusion

“Prevention is better than failure”

Modern day cleanroom managers need to strictly control their budget, and make informed decisions. These can only be made with all the facts.

Accurate monitoring and recording of all strategic component’s performance will allow effective cleanroom management utilising the data as the cleanroom key performance indicators.

A non-informed manager will only know they have a cleanroom performance problem on component failure, with the ensuing downtime and costs while the fault is identified and then rectified or when there is a increase in product failure, with the related decrease in profitability warranty costs and loss of reputation.

The above checks are beneficial to all operators ensuring less downtime, the planning of future upgrades or repairs to the area or air-handling units.

They also allow you the operator to know and understand your cleanroom. Also ensuring that when Clean Air Technologies Ltd and other specialists come to call you will know and understand both what is happening and why it is beneficial to you. To finish the analogy: Your cleanroom may be regularly serviced but would it pass its Clean Air Technologies M.O.T.??

8 factors that will influence the cost of your new cleanroom 1

8 factors that will influence the cost of your new cleanroom

We are often asked by clients to provide a rough square metre rate for the design and construction of a new Cleanroom, and all too often we have to use that horrible phrase ‘that depends’. Unfortunately, when it comes to providing an estimated cost for a new Cleanroom facility it really does depend and below are 8 important factors that need to be considered:

Classification– What classification of Cleanroom do you need? This is the starting point and will begin to drive the design of the HVAC systems, the type of filtration and the specification of finishes that will be required.

8 factors that will influence the cost of your new cleanroom 2

Temperature and Humidity Tolerance – Having to control temperature and humidity within the Cleanroom to tight tolerances will have a significant impact on the cost of the plant, equipment and controls required to run your Cleanroom. 

Challenge your specifications. Are your temperature and humidity requirements being driven by your process, your people or your materials? Is tight control really required in all areas or just in one section; is it required at all?

Number of Occupants– People can be the biggest source of contamination within a Cleanroom, so filtration and air change rates will have to be designed accordingly. People also generate a lot of heat, especially when wearing Cleanroom clothing, so temperature and humidity control is required to ensure a pleasant and comfortable working environment.

8 factors that will influence the cost of your new cleanroom 3

Work Activity – What activities will be carried out in the Cleanroom? Will it be done by machines or people? Both machines and people can generate particles and a lot of heat. These factors need to be understood to enable HVAC systems to be sized and also the facility layout to be designed correctly.

Size and Complexity– It is possible for a small, high classification and complex Cleanroom to be more expensive to design and build than a larger and more straight forward facility.

If your Cleanroom requires tight humidity control, medical gases or compressed air, an Environmental Monitoring System or possibly chemical extraction, then all of these will have an impact on the construction costs.

8 factors that will influence the cost of your new cleanroom 4

Location, Location, Location – It is not difficult to understand why a Cleanroom built on the 5th floor of a refurbished office block in the centre of London is going to be more expensive to build than the same specification facility constructed in a newly built, open plan warehouse in Kent – logistics and installation complexity. However, another factor to consider is the proximity of the HVAC plant to your Cleanroom. Where will your AHU, chillers and controls have to be located relative to your Cleanroom facility? 

Availability of Services – Are the services you need to run your Cleanroom already available at site? This will again have an impact on construction cost. Are there hot and chilled water services in an existing plant room or does a packaged chiller need to be procured? Are existing compressed air system, or medical gas lines, available to be tapped into or are completely new systems, compressors and associated equipment required?

8 factors that will influence the cost of your new cleanroom 5

Facility Life Expectancy – Ultimately this comes down to Construction Cost vs Running Cost.  Is the cleanroom to be used for 5,10 or 20yrs? With a longer life requirement for the facility, materials used and solutions provided will differ.

A simple example would be that of in-line duct heater batteries – The procurement and installation cost of an electric heater battery will be significantly less than that of an hot water coil, which will need piping, control valves and complex commissioning. However, if there is an existing hot water system on site than the running cost of the hot water coil will be significantly less than that of the electric battery over the life of the facility.

Ultimately we would always recommend that the first step is to develop a suitable User Requirement Specification which will help identify the requirements for your facility. Considering the impact 8 factors will be a good starting point for your Cleanroom construction.