Every business in every sector needs to work efficiently and manage budgets carefully. But in industries where ISO 14644 is front of mind, striking a balance between meeting the highest hygienic standards whilst controlling costs is one of the greatest challenges
The hygiene requirements of any cleanroom are, rightly, stringent. Air particle management has to be the top priority for any business or organisation and every element of a cleanroom workspace has to be closely considered in order to maintain a risk-free environment.
In a cleanroom, every small detail counts and even the most innocuous items or processes can become the greatest time stealers and, consequently, the biggest money wasters. Michelle Locke, product and marketing manager at Teknomek, explains more.
Root cause analysis of swab testing almost always reveals furniture to pose the most significant risk for microbial contamination
Microbial management lies at the heart of Good Manufacturing Practice (GMP), and hygienic best practice dictates that, typically, up to a third of a scientist's day can be spent cleaning and swab testing. Clearly, this isn’t the most cost-effective use of their time, but managing risk will always take precedence over productivity.
While it’s unlikely any microbial contamination will spike within a closely controlled environment, any upwards trend - regardless of how far below alert levels it is - will require additional monitoring and investigation. This translates to lost time and resources.
Keeping cleanrooms consistently below alert level is always a priority. Whilst there is no substitute for a robust cleaning regime, the combination of a scrupulous hygienic standard operating procedure (SOP) with well-considered procurement choices can at least reduce the risk.
While there is no one-size-fits-all cleanroom solution, there are certain hygiene and cleaning considerations that translate to any scenario and avoid unnecessary time wastage and, ultimately, cost implications.
Cleanroom design and layout for SOP
Cleanroom furniture such as workbenches, cupboards and desks are at the heart of every cleanroom. But, when it comes to planning a space with good manufacturing and hygienic best practice at its core, furniture specification is not often given the close attention it requires.
Root cause analysis of swab testing almost always reveals furniture to pose the most significant risk for microbial contamination, so it is essential to invest in specialist furniture and equipment which has been designed and manufactured to meet the needs of your sector and with risk management in mind.
If you have any doubts, take the time to do the necessary research and ask the right questions to ensure you make the right procurement choices first time. Poor design decisions can actually create an environment in which microbial life can flourish. Therefore, a key action should be to look closely at how hygiene is factored into each and every piece of furniture.
It’s a great irony that despite being installed to maintain hygienic standards, one of the most significant risk factors in cleanrooms are sinks
The secret to selecting the right hygienic furniture is to work backwards from the practicalities of the cleaning regime. It pays to think like an auditor here. In particular, assess each item for ‘dirt traps’ - ledges, gaps, folds, and even raised welds - that could collect dirt and harbour bacteria or even mould.
Consult with your in-house experts – your cleaning team – to identify challenging areas that could become a risk.
If there’s even a hint an item could collect dirt, and thus become a time stealer, it should be rejected. It also makes sense to audit existing furniture and if anything takes longer to clean than is strictly necessary, it’s probably going to be cheaper to replace it in the longer term.
Look out too for anywhere liquids could accumulate. It’s a great irony that despite being installed to maintain hygienic standards, one of the most significant risk factors in cleanrooms are sinks. Microbial life flourishes in standing water so look out for any flat surface(s) and check for clear drainage points. Also note that filtering water for all taps can help to reduce the risk of biofilm.
Going beyond the design factors, think carefully about how each item would fit into the practicalities of the cleaning process. So, carefully consider its placement within the space. Simply shifting furniture around for better access, removing anything that’s superfluous, or used irregularly, can also make clean down much easier and more thorough.
Manoeuvrability can play a hugely important role. After all, an auditor isn’t just going to look at a piece of furniture in isolation. They will also need to be sure the floors beneath and surrounding it are also free of contaminants, as well as the walls behind it. Therefore, if an item does not offer easy access, ensure it is lightweight - or failing that on castors - so it is easy to move. The devil is always in the detail, so if you do opt for castors check they are easy to clean as this needs to happen regularly. Time is money, and any equipment which takes a few extra minutes to clean will equate to significant expense over time.
Optimising air flow
Ventilation systems are, of course, a fundamental part of cleanroom management. Air change rates (ACR) have historically been used as the main measure of performance when it comes to cleanrooms: the quality and efficiency of ventilation systems was measured by the number of complete air changes which took place each hour.
However, in isolation, ACR is no longer a reliable indicator of cleanroom performance. Over-reliance on heating, ventilation and air-conditioning (HVAC) systems results in running very energy-intensive spaces representing anything up to 80% of a cleanroom’s energy consumption.
With the climate crisis, at last, moving higher up the political agenda, HVAC specialists are finding ways to reduce the number of air changes required in a cleanroom, whilst still ensuring effective and compliant particle management.
A core part of this is to consider where air vents are placed in a cleanroom. It may be obvious to state, but ventilation systems, once installed, are often prohibitively expensive to change so getting it right from the start is vital. Thorough consideration of the type and placement of furniture and equipment can have a significant, positive impact on efficient air flow, helping to reduce energy consumption and, critically, reducing risk of contamination.
Where are the risk points for the vents in your cleanroom? Where could blockages be created or still air points occur? Seek specialist advice on where best to place your equipment and furniture in relation to vents and airflow to avoid a build-up of risk and take steps to ensure that when HVAC is applied, it is as energy efficient as it can possibly be.
And what about your people? The single biggest risk to hygiene in cleanrooms and laboratories is humans and the 10 grams of skin we each shed every day. But humans present another risk in terms of their impact on airflow. A person working in the wrong place for an extended period can cause air flow blockages and affect the hygiene of a cleanroom.
The more people move around in a cleanroom, the more the particle count increases. So consider the comfort of your staff. If they are using a well-designed, ergonomic workstation with a comfortable chair, they are less likely to move around.
So, when configuring your sterile workspace, consider how both your furniture and your people may impact the airflow and the aseptic environment.
Thinking about sterilisation
Another consideration when it comes to selecting furniture is whether or not it will be suitable for your chosen sterilisation option. This should be a defining consideration because making the wrong choices will certainly prolong cleaning procedures and can actively increase contamination risk.
Stainless steel has become a standard fixture in cleanrooms because it is chemically inert, physically tough and easy to clean. However, its working lifespan will nonetheless be dependent on aligning the grade to the sterilisation regime.
Where are the risk points for the vents in your cleanroom?
Because harsh sterilisation methods have become standard in pharmaceutical and micro-biological manufacturing environments, cleanroom furniture needs to be designed and manufactured to mitigate the possibility of rouging or tiger stripes while reducing contamination risk and supporting improved clean down productivity.
Harsh cleaning chemicals such as chlorine and hydrogen peroxide can reduce the lifespan of furniture built from 304-grade stainless steel whereas 316-grade stainless steel, due to the inclusion of molybdenum, is more robust against pitting and crevice corrosion by chemicals.
In addition, opting for an ultra-smooth finish can have a positive impact on both your cleaning regime and the longevity of your furniture. Chemicals can pool on coarser surfaces if not thoroughly removed with IPA wipes and, over time, the trace amounts of these chemicals will corrode, stain and contaminate the passive layer of the stainless steel. Stainless steel, or specialist furniture such as Sealwise WCB or Trespa, with a lower surface roughness has fewer microscopic grooves where harsh chemical cleaning fluids can lurk and corrode the furniture.
Having selected your grade of stainless steel, it’s also worth reviewing your mix of clean-down products. You may discover you can improve the efficacy of your clean-down by mixing different types of cleaner – they don’t have to be super strong on every application. Taking a less toxic approach will be kinder to furniture and can also save you money while potentially improving your hygiene performance and risk management.
We all know the phrase ‘look after the pennies and the pounds will take care of themselves’. Every minute spent on unnecessary cleaning caused by poor cleanroom design has an impact on the bottom line of your business.