Unleashing the Power of Flexible Isolators: Insights from Onfab’s Director Mike Brown

So on fab offer a range of flexible isolators and they cover all aspects of processing from oral solid dose through tapeICin assist even down into sort of antibody drug conjugation. Those isolators cover all the types of processing within those parameters. So we have million isolators, we have isolators for dispensing, for tablet presses. You you name it. We've pretty much covered all those aspects. We have around six and a half thousand designs for isolators. So you can imagine within that range, we have covered all aspects including all GMP classifications as well. So if they're an isolator needs to have a nitrogen inertia internally or if there is any particular temperature control, then onfap has the ability to apply that via, basically, technology. So with the the the two different types we've broken our isolators into is a retrofit and then our stand alone isolator range. So a retrofit ice is an isolator that we apply to your process equipment and that then therefore upgrades the capabilities of that process equipment. To allow it to handle more high potent compounds. Therefore, open up such a broader catalog of of products that you can sort of manufacture with those pieces of equipment. And and as I said within those six and a half thousand designs, we've covered all processing parameters. Then our second look line is the standalone systems. So a standalone system is an isolator that provides you with a a space in which you can place a process internally. Began giving you the increased level of protection when you're handling these hypovern active pharmaceutical ingredients. And it really helps support that processing parameters and the protection of those operators when they're handling these poking compounds. So Onfab has a range of films that we utilize for our flexible containment isolators. And they are polyurethane, which is our standard film, obviously comes with anti static and various different FDA approvals and food safe approvals as well for our European clients. Then from that, we have polyethylene, which we make a small amount of isolators from more transfer technology than an actual physical isolators. And we also utilize PVC. Now, the the classification and why we choose those films is based around solvent compatibility we need with the isolators. So obviously polyurethane will have a different solvent compatibility to polyethylene and then to PVC. And we pick them and select them which is most appropriate for the technology that we're trying to contain. Moving on from that, we spent a lot of time looking at ergonomics and and the standard person. I'd do that because everybody I don't know what a standard person looks like. But yeah, we talk about the standard person and to the measures the elbow and to where their shoulders lie. Because what we don't want is people working like this. We want them to be in a natural position when they are operating our eyesight. Therefore, you are limiting their fatigue and also not causing any additional levels of injury to our our operators whilst they're utilizing the isolator technology. And then there's other things on the isolators which are really important to help increase that potential operate to protection. So we have our h fourteen separated cam fill filters. So we're like ninety five percent of an on for isolator would run under a negative pressure. And that then is driven by our our automated fan system, put plus our h fourteen separated filters. Those h four those h fourteen separated filters maintain the pressure inside the isolator with the fan unit and then keep a constant change of air internally. So you not only are you getting operator protection but you're getting an increase in GMP in in inside the isolator as well. And we utilize a range of zippers on our isolators and and they are all high containment zippers. And the reason for that is is that it's possibly as one of the weak points of a flexible system is on the transfer where you're bringing things in and out. So you want that to be strong as possible when you're operating the isolator. So we apply our what we call our black zipper, but it's our strong high high containment zipper on our isolator them. And we have a range of gloves. So again like the films, gloves have compatibility. So depending upon what the operator is handling inside isolator, whether it is small, dextrous operations or whether it's full transfer, then we have a range of gloves for it to handle those applications as well. So supporting again that operates in an ergonomical sense. So on path isolators are subjected to the same level of qualification, there's a rigid isolator would do. So along traditionally, it is installation qualification, operational qualification and performance qualification. When we're referring to the containment performance target that the isolated needs to achieve to deliver the amount protection needed for the products that you're about to process, then we're talking about performance qualification. And that is done via a CPT which containment performance testing. It's driven by the ISP. There's guidance from the ISP as to how that is taken how that takes place. However, traditionally, it is a air monitoring. So you check the concentrations within the air of outside of the isolator, and that will determine that that there is no product lead from the isolator itself. It's normally done in micrograms per meter cubed, but now we are being trialed even down to the low nanogram levels of containment performance. And they are subjected by taking a slight, a small pump. The pump simulates the breathing of a of a personnel, and you have a small little sampler on your lapel normally and that that will then check how much of the particular surrogate that you're using in the CPT is is on that filter face and then they test that and it becomes a it gives you a level of of containment performance for the isolators. Now with the installation qualification and operational quality application. If you have the three stages including the performance qualification, then you get a full range of validation for that isolator. Of the installation qualification will ensure that the isolator is is as designed. The operational qualification will also support the IQ that will support on the basis that the operators can actually physically do what's needed to be done inside the isolator. The partnership of On fab and Benchmark opens up the US market to something that quite new. So on fab's expertise in flexible containment systems has been benefited all over Europe for many years. And and with our partnership with Benchmark, it's allowing us to enter into the US marketplace. Now the main one of the main benefits of of having bench Markwork alongside on purpose is the fact that they have a fantastic facility based in Chicago. So they will be able to stock your replenishment isolators in the form of kits. Those kits then can be stored at benchmark for very very quick delivery. Approximately five days as one of the maximum deliveries. So instead of waiting long periods for the isolators to be shipped from from the UK, you can have them stored as an open order with with benchmark products and and be delivered within those five day periods. So it helps you not having to be able to store those systems in your own warehouse or freeing up space in your warehouse. But also the the main thing is is that as we know, processes and and sort of plans change. So that being able to react very quickly with having those isolated stored with Benchmark in Chicago. Means that you you have that sort of safety net of of additional isolators ready for use.