What is a cleanroom

Connor Murray  0:04  

COVID-19 has shone a light on Indoor air quality, which has probably been ignored over many, many years. So there's a whole focus now on quality of air.

Dusty Rhodes  0:18  

Hello there and welcome to Let's talk a clean air our regular look at how clean air can affect the quality process for you and the workplace. On this episode, we're going to understand more about clean rooms and controlled environments. We hear a lot about them. And today we'll hear exactly what they are, how they work and how they help us. My name is Dusty Rhodes joining me to explain more about this is control room expert, Connor Murray, who is the principal consultant at three dimension and the current chair of the TC 5 healthcare Standards Committee, among others, we are also joined by Alan Sweeney, who has decades of experience in the area with camfiland is their current clean process a segment manager in Europe.Connor. If I go to you first, can you just explain to me what exactly is a clean room or a controlled environment?

Connor Murray  1:04  

I suppose without going into the standard definition, a clean room is I suppose what it says in the name, it's a controlled environment. So first of all, it's a room that is controlled in some manner, which means it's got a three dimensional space. And you're trying to control the environment inside that space. That means things like standardizes would be things like temperature, maybe humidity, lighting levels, noise, the environment under which people work in or the process, but the particular emphasis on the cleanroom side is the indoor air quality, which we're familiar with in our home environment, or in an office environment. But in a cleanroom, we're looking at the number of particles. And we're really concerned about what we call the unseen enemy or invisible particles, which are very, very small. So it's a controlled environment of a space where you're controlling the environment and a number of the parameters in the environment. Why are we doing it? Because there's a risk of a failure of the productOr ultimately patients there's always a goal in creating a cleanroom. I hope that helps.

Dusty Rhodes  2:04  

No, it does, actually. Because when I think cleanroom I think of visible dirt. And you what you're saying is it's not just visible dirt, it's the invisible stuff that you can see to make sure that that's clean as well. Exactly. All right, what kind of industries use them,

Connor Murray  2:19  

the industry is vary, very, very broadly. So if you talk about where the original cleanrooms came from, they were driven by a necessity because they couldn't make products. So for instance, optics, gyroscopes, they found that they were unreliable and failed. in a hospital environment, it was around infection control, so patients got ill, or died because the contamination coming from the people side of in terms of surgeons. So if you if you take it all the way to the modern day, and things like everyone uses a mobile phone, and they contain billions of transistors or electronic devices within those are what we call the line geometries, or the separation between functions are so small, they're microscopic, that any level of contamination can cause a fault in that, and there are billions of connections. So it doesn't take more than a few connections to cause the problem, the fault to make the product fail. So that's the modern version of that. But equally, so COVID-19 is a perfect example. It's a virus of around point one of the microns. So it's, it's something of the order of a 100th of the size of what we can see. It flew freely float around in the air. And we're talking about the environments where the vaccines are made have to be ultra clean. So the product we're injecting into our arms is sterile, and we don't get sick from a contamination in during the manufacturing and the vaccine does its job.

Dusty Rhodes  3:46  

So let me ask you, then what makes a controlled environment clean? I mean, how do you stop these contaminants from coming in?

Connor Murray  3:52  

Well, there's there's really two, the two formal ways are very simple one is you make sure the air that comes into the control environment cleanroom is filtered. And I'll come back to that in a moment. And the other one is you're not bringing in the contamination either through materials through people coming in, or under wheels or people and then you try and stop the generation. But going back to the first point, the fundamental part of the cleanroom is the filtered air. And that's where camfilcome in as the world leader in terms of air filtration, and we call use the word hEPA filter as an high efficiency particle air filter and over that will be more Alan's area. I'm sure you can talk a lot about that. But certainly, I've been using camfil for decades. They certainly would be the industry standard.

Dusty Rhodes  4:35  

And in what kind of facilities Do you use them?

Connor Murray  4:38  

It could be a compounding unit , it could be an intensive care unit. It could be a manufacturing facility with Micro-electronics, like our TVs have LED panels, big flat screens. They all the contamination control was done by HEPA filtration in those manufacturing. It goes all the way down to plastics, medical devices, pacemakers that were using stents as part heart valves, replacement knee operations, hip operations, the compounds that go into those the drug was that we, we consume, even if they are oral are we, we would, we need to make sure that the contamination is removed from the manufacturing space all the way into food. So we look at food, and the lifecycle of the preservative that goes into food is a contaminant on its own. Whereas if you can manufacture the food or clean environment, the shelf life is increased. And you get the quality of food that you want to eat, not the preservative. So it's kept to maintain.

Dusty Rhodes  5:32  

Let me bring in Alan from a camfilalan, when we're talking about these kind of rooms, I mean, they're fairly high end rooms, what kind of costs are you looking at to set them up?

Alan Sweeney  5:41  

The cost is different depending on the operation and the number of air changes, but it's really the heating, ventilation and air conditioning equipment that moves the air. Unfortunately, when moving, the air costs will be incurred. Because once you put a filter in an air stream, or in a liquid stream, you create an impediment. That impediment is called a pressure or pressure drop and the equipment has to overcome that pressure drop. So your fan is from the day it starts ruining burning energy. So it's important to get involved with connor and with other experts in the field to ensure that you're using the correct amount of air filter correctly, but at the lowest pressure possible, and that will alleviate high operation costs and high costs. So yes, it's expensive. On the other side of the coin is that if something goes wrong, and you get a contaminated batch of product, drugs, semiconductors, or even implants, the repercussions are very severe. So it's a balancing. It's an expensive operation. But there are a lot of means with eco design to save on operating costs.

Dusty Rhodes  6:43  

If anybody is using a cleanroom, or any kind of controlled environment is obviously a mission critical part of their operation, whatever it is, when it gets to reliability, then for these clean rooms and control environments, what kind of reliability percentages are you looking at

Alan Sweeney  6:58  

clean rooms, reliability is directly affected by the performance of the filters, the air changes, periodic checks are done. Maybe every six months, some every month, at least once a year, the operation is shut down, tested, validated, cleaned, etc, etc. So reliability once it's kept under a well maintained criteria is phenomenally high. If I'm honest, in my opinion, yes, we have failures on occasion, there are shutdowns on occasional like any industry. But it's typically due to something that's caused by manual error, or a lack of a good maintenance regime , in my opinion. So when you're

Dusty Rhodes  7:31  

looking at the effectiveness of one of these rooms, you're the kind of results that you would hope to expect is like 99.9% effective or something like that, do we get open to that kind of a range,

Alan Sweeney  7:41  

we can depending on the class of cleanroom. And also depending on as Connor said, it's not just the filtered air going into the room, but what's being generated in the room are the machines and the operators well dressed and protected to stop any particle migration into the room is there a lot of movement is it controlled movement in the room. So the operation of personnel and production equipment is critical in maintaining the class of the room as filtration is critically important. But operations and the use of the room has a huge effect on us.

Dusty Rhodes  8:12  

There's so many different things that go into these I often look at airplanes and the 1000s. And 1000s of systems go into that to make them work. clean rooms, I'm sure are similar in many ways. Connor, can I ask you about clean rooms? Because there's different scales and different uses? How are they classified and validated.

Connor Murray  8:31  

So there are there is a series of standards, which we call ISO 14644. And there's various dashes for the different elements of the clean rooms. And unfortunately, or fortunately, we're up to dash 19 currently, so that's a lot of different types of standards for different types of clean rooms. Because in the overall scheme of things, we're looking at a cleanroom. And we're looking at various contaminants, the primary one being particles that can cause a product failure or risk to a patient both in air or settling on surfaces. So you've almost got a matrix between air and surfaces. And the contaminants can either be particles, microorganisms, chemicals. And we've also introduced in the last 10 years nano particles which behave almost like a gas, and also macro particles, because micro organs travel generally on skin flex. So we have a number of those ones, which is the reason we've got so many different types of standards, but the fundamental standard is dash one on the classification of the cleanroom, which you must classify by airborne particles start, but just add I suppose in a way to your question to Alan unreliability, there's two key things in a cleanroom. One is you need to establish control. And part of the filtration is part of establishing control. And the other one is you need to demonstrate control. So in a way the reliability is almost almost 100% Because either you've a failure or it works. So you're very, very high levels. And the expensive part of the cleanroom is in plan preventative maintenance. So you do another a number of these checks. So we have a number of the standards like the 14 644. Dash two is on monitoring of cleanrooms, primarily on particles, so you can't just build a clean room and then expect fees run, you need to intervene. And we normally recommend either automatic controls to measure the quality of the cleanroom. Or you do it on a periodic basis, and the higher the greater cleanroom. And Alan alluded to this earlier on the highest grade, we would typically call ISO 3 or ISO 5, which would be equivalent to what you require for a sterile environment, for manufacturing very high quality intravenous drugs, where you're injecting them directly into the body. And the body doesn't have any further filters than that. So when we eat something, we have various acids and otherwise in our stomach, if we breathe them in, we're very filtered in our system before it gets the bloodstream. What's interesting is the primary engineering control is where the product, or the patient is most at risk. And that's where you put the most amount of money. And that's where your highest level of standard is, we also use the principle of an onion, where you've layers of controls before you get to the primary engineering control. And I use a lot of word, a Swiss cheese approach, that you may have holes in the Swiss cheese. But if you've enough layers on the Swiss cheese that doesn't get through. And that's a perfect example, if we bring it back to ground zero at the moment, on COVID-19. We're talking about social distancing, we're talking wearing face coverings, we're talking washing your hands frequently, not touching other things staying outdoors, they're all the Swiss cheese approach, they don't guarantee you won't get it, but they they mitigate against the obvious getting or super spending events associated with. So that's where the context of these commands and standards, it also brings you into harmonization. So if you have an ISO five cleanroom in, in China, or in the US, or Ireland or Germany, or Thailand or Australia, then you have an expectation of what you'd expect to see in that ISO five environment. And fundamentally, you expect to see a lot of HEPA filters. So it's a way internationally of understanding a common expectation of the design and also the maintenance and demonstrating control and an ongoing basis.

Dusty Rhodes  12:26  

Okay, let me go back to Alan, how are these rooms then measured? And how are they validated, who says, I've done this test, therefore, it's ISO five, as Connor was describing,

Alan Sweeney  12:37  

as Connor said, it could be automatic equipment in the rooms performing continuous particle counting, or alternatively, either by annually annually or semi yet, every two years, an independent on the word independent is important validation company will come in, test the various containment barriers, test the airlocks, and make sure that the room is performing as it's expected to perform. And for me, it's critically important that this, either the equipment they use is very well validated, or it's an independent test company, you don't want a Joe Bloggs, who's built it for you testing it for you, etc, unless the equipment is independently validated. And it's a it's a quality operation. So it really either automatic parking counting or periodic shutdown and testing as record.

Connor Murray  13:21  

Sorry, if I could just add to what Elena said there. What What is critically important, as he as he said that it that part of the expense of the cleanroom is what we call the OPEX, the operational costs to ensure it's demonstrated in control. So there's a number of, of cleanroom societies of which I'm chairman of the Irish cleanroom society, which they work to provide education and supporting vendors like camfil in the industry. So we will have certified programs for testing companies on testing individuals who test cleanrooms. So they're tested against the standard their tests against cleanroom is the ISO 14 644 dash three, which has measurement methods. So you've got a measurement method, including calibration, how to do various tests, and then the people who are doing the testing have to be experienced, and certified and accredited. So the whole industry is all around getting to the stage where you're trying to ensure you protect the patient the product, so it's not far off a nuclear type approach, which is even more expensive than cleanrooms are. But it is, at the end of the day, there's either a product failure, which if my mobile phone fails, it's not a major problem because I can't text or social media. But if I'm target on top of a mountain, I've just broken my leg and I need to call in an ambulance, then it does become mission critical. But if I'm if I'm in an ICU, and I'm recovering from COVID-19, and I have breathing problems, and I've got a drug to help me breathe better and stay alive than the quality of that product, to protect me as a patient is very, very important. So cleaners can be very personal. It could be your sister, your mother your around your daughter. Or in my case, my grandchildren. So they're really, really important. And that's, that brings us around that you must establish control and then demonstrate control. And that's testing and measurement by competent people with a common objective of protecting the product for reliability, or a patient,

Alan Sweeney  15:17  

competent and qualified important to anybody can buy a scalpel, it doesn't make you a surgeon.

Dusty Rhodes  15:22  

You mentioned Connor, that you were the chairman of the IRS clean rooms society. From an overview point of view, what do you think are the key challenges faced by these environments?

Connor Murray  15:33  

Well, the key challenge is you're trying to not bring in particles or contamination into a space. So to some extent, the HEPA filter is fundamental to that. But it's also the simplest way of doing it, because it's the filter, that's that prevents fear any particles coming into the room, the real practical issue was people. And I mean that in a nice way, because people generate probably 80% of the contamination. And you might have an automatic filling line. But then if you have a problem, and you have an intervention by somebody, that's when you have a risk of contamination being transferred onto the product. So the challenges today are really around people. The second challenge really is around managing the cleanroom operation to be as efficient and as effective as possible. So clean rooms are getting bigger, at higher and lower classes. And they're getting getting smaller, the higher end classes. So we're into containment, we're into isolators. And also education. So we've also got to how do we bring in robotics. So there's a big drive towards AI, bringing in robotics, or trying to allow people to stay out of clean rooms. And and more and more, you're having things like cameras or  that you can imagine part of reliability is that I'm sitting having a glass of wine in La Rochelle with my family. And a problem occurs in a cleanroom. And I tell the guy to put a GoPro on his helmet, and are on his bunny suit and go into the cleanroom. Show me around. Let me look at some data here, hold on, pull my laptop out, look at the data stream, oh, go up to the plant room, Valve number 42 on the screen has failed. So it's either a failure in the HVAC support systems as in heating, ventilation and air conditioning and filtration. Or it may be an operational issue or maybe looking at the microbiological data that's coming out of the environment. And the wonders today of AI and modern technology is it allows us to get to there very quickly. And that's why there's a coincidence of technologies including things like 5g, which allows me even to be on a catamaran in the middle of outside La Rochelle, getting a quick phone call, and the guy sends me a screenshot of a possible issue, which should I do first and I can say hey, you need to do this first and then this and then wait like up, I can have my glass of wine. Now show me the recording on GoPro. Now go in a bit like the scalpel, the intelligence is around where to use the scalpel and how to use it. That's where the cleaner challenge coming in is bringing older clean rooms up to speed and applying the right level of technology and not being over the top. So you can clean rooms which are too big, too much air that need to be appropriate. And it's around measuring the quality of air and how it is doing and relative to product quality, reliability and ultimately, patient safety.

Dusty Rhodes  18:29  

There's a lot of technology involved. And also, you know, I'm just thinking you've got the aircon elements, you've got the heat element, you've got the ventilation element. Alan, with all of this equipment that we're using to keep rooms clean is energy cost a concern?

Alan Sweeney  18:45  

Yes, energy cost is a huge concern in the industry, and has been for many years. And we're lucky in that. On the supply airr units the air handling units that would protect the hepa filters as Connor said the hepa will be the last line of defense that typically in the ceiling. The air is then supplied by air handling units open the plant room. The filters in those air handling units are typically certified under Eurovent standard. And we've got a Eurovent4/ 21 standard, which will actually grade the filter according to its energy consumption. So you can choose the correct filter BIT bit similar to buying a washing machine or a computer having a label ABCDE or you can choose a filter with the lowest energy consumption to ensure that at least whilst your equipment is running, you're using as lower pressure on as little energy as possible. So yes, it's a concern and again as Connor said, older clean rooms that may have been designed with the things like very higher changes to achieve good, considered good. Cleanliness classes inside by changing lots of air. We looking at those designs with Connor and other experts help and looking at how little air can be moved to maintain that class will again caught on energy consumption. You've got to do it within the standards and adhering to the standards, but energy savings can be made.

Connor Murray  20:05  

So if I can just add to what Alan said dusty, the, the ISO 14 644- 16 is specifically around guidance around energy efficiency and cleanrooms, both as part of design and as part of operations and reviews. I did say we dash 19 at the present time. So that's one of the many dishes that gives guidance to industry on how to apply standards and harmonization on a worldwide basis.

Dusty Rhodes  20:35  

We've been talking very much at the high end of life with clean rooms and and highly controlled environments, from what you guys know, would you have any kind of general principles that people should be thinking about with protecting general buildings, especially in the light of COVID.

Alan Sweeney  20:52  

We're seeing a lot of legislation around Europe and certain countries were looking for they're looking at carte blanche implementing HEPA filters into buildings, it is a good idea, it can introduce extra pressure drop, there are requirements to have maybe framework changes, etc. HEPA filterdoes not use the same framework as a regular particle filter for an air handling unit. So there is an increasing reliance on hackers to protect people in indoor environments. In some cases, it's a great idea. In other cases, it might require a complete rework or rebalancing of a complete system. So it's not as easy as it might say, it's not a no, it's not as simple as it might appear on front first instance, using things like mobile air cleaners, again, bringing HEPAs inside the buildings and maybe polishing the air is another option that's been quite successful in a lot of industries and a lot of applications. But definitely the use of HEPAs, and trying to make not a clean room. But a cleaner environment is becoming much more necessary with our current crisis. And it is definitely possible. But again, just carte blanche trying to drop it happen into an existing system will not work in all cases, because of the repercussions on pressure and designed. So just be careful, and experience voice as possible.

Connor Murray  22:11  

So from my from my perspective, it's interesting, the COVID-19 has shown that he likes on indoor air quality, which has probably been, to a large extent, ignored over many, many years. And the interesting part of indoor air quality is that some of the contaminants are not necessarily particles. So we are clear of the obvious ones. If somebody has asthma, and you've got pollen, you wind up having a outside in the air and then brought into the house. But you've also things like chemicals. And there's there's a big trend now true move plasticizers that are PVC, chemicals using chemical agents in sprays. So there's a whole focus now on quality of air, inside a room as well as inside the house, and is becoming much more personal nevermind an industrial application. But when we talk about HEPA filters, we talked about them being used more than being used, the higher the grade cleanroom. But cleanrpp,d are also getting bigger and broader and wider applications. Examples would be things like plastics, and uncommon medical plastics, where you've lived large areas, surface areas, it's coming into other areas. In terms you mentioned, data centers, now there are less involved in data centers now than they would have been originally. And that's mainly because of the of the type of the way the chips are protected in a way. But there's an increasing number of, of cleanerooms be used, and particularly in terms of food applications, right. And you've also think called nutraceuticals, which is coming around beauty products that are put on the skin. So there's a kind of you look at space applications, there's many, many areas that we're looking at where the they have applications, including things like credit cards from visible contamination, because of static control. So so the cleanroom environment is dominated by particles, but there's other contaminants in it. It's a very big industry sector, it's very important in this country, because we're probably looking at the huge generation of GDP between microelectronics, ICT and pharmaceuticals, and were viewed as a safe pair of hands. And that's part of the cost of cleanroom is dominant, establishing control and demonstrating control. So energy efficiency is way we need to manage the cost of that from an operational viewpoint with the indoor air quality is an COVID has raised awareness of the importance of air quality in the home and outside the home and in the industry and cleanrooms

Dusty Rhodes  24:39  

Well, there's a huge amount in it, obviously, but I think both of you have given us a really, really good overview. So I'll leave it there. And thank you both for that. That kind of Marty from three dimension and Alan Sweeney from counsel. Thank you. If you'd like to find out more about this, just follow the links in the show notes which you will find in the description of this podcast on your smartphone or what every device you're listening to us on right now, our podcast was produced by Camfil , a world leader in the development and production of air filters and clean air solutions. To stay up to date on how clean air can affect the quality process for you and the workplace. do click a follow on your podcast app right now so that you get our next show automatic under them from a self destructs thank you as always for listening and take care