Breakthrough Batch Manufacturing Solutions

Speakers

Kent Melville

Director of Sales Engineering

Inductive Automation

Tom Hechtman

CTO

Sepasoft

Jeff Fitch

Product Development Manager

Sepasoft

Batch manufacturing has not seen major innovation for decades – until now. Creating batch solutions that include process graphics, communications to business systems, traceability, e-signatures, and WIP inventory historically required purchasing and interfacing together several separate software packages, resulting in inconsistent production quality, difficulty making recipe/batch changes, and struggles to comply with regulatory requirements. Finding the right tools to conquer these challenges is key to unleashing your production’s full potential.

In this webinar, join industry experts from Inductive Automation and Sepasoft as they discuss how to solve these challenges and show real-world examples of modern low-code batch-processing solutions. You’ll also get an inside look at the exciting new updates in Sepasoft’s Batch Procedure Module that make it easier than ever to achieve your production goals with Ignition.

• Separate the recipe author from the engineer with low-code recipes
• Meet requirements for 21 CFR Part 11 with new e-signature and Electronic Batch Record (EBR) functionality
• Easily change/add recipes with HMI screens and batching on a unified platform
• Achieve traceability and Work In Process (WIP) inventory (with zero coding)

Webinar Transcript

00:00
Kent Melville: Hello, welcome to today's webinar, “Breakthrough Batch Manufacturing Solutions.” I'm Kent Melville, the Director of Sales Engineering at Inductive Automation, and I'll be your moderator for this webinar. Joining me today is Tom Hechtman, the President and CEO of Sepasoft, along with Jeff Fitch, the Product Development Manager at Sepasoft. Tom, Jeff, welcome. Can you both share a little bit about Sepasoft and what you do there? Tom, we'll start with you.

00:25
Tom Hechtman: Yeah. Well, as Kent mentioned, I'm President and CEO. Started Sepasoft in 2010 and basically built MES solutions. We're solely focused on MES, so manufacturing execution systems that sit on top of Ignition. So, glad to be here today and show you some of our new products.

00:47
Jeff Fitch: And I'm Jeff Fitch. I'm the Product Development Manager here at Sepasoft. And my responsibilities lie in the area of software development, testing, and technical documentation, and I'm really excited to be here too. Thank you everybody for your time.

01:04
Kent: Alright, well it's great having both of you here. Let's jump into the agenda. So, first off, I'll quickly tell you about our software platform Ignition, and then I'll pass things off to Tom and Jeff for the main portion of the webinar. And they'll start by addressing major challenges in modern batch processing along with innovative solutions to overcome those challenges. Then they'll be able to show you some real-world examples of low-code batch processing solutions. And after that, as always, we'll wrap it up with some audience Q&A. If you have any questions during the presentation, you can just type them into the questions area of the GoToWebinar control panel and we'll answer as many questions as we can. If we can't get to your question in time, we encourage you to reach out to one of our account representatives and they'll be happy to answer that for you.

01:49
Kent: I'll also add that a recording of this webinar and the webinar slides will be available within the next couple of days, if you wanna rewatch this or share it with someone else. Alright, so a little quick blurb about Ignition here, for those of you who may not be familiar with it. Ignition is a universal industrial application platform for HMI, SCADA, MES, and IIoT. And it's used by 57% of the Fortune 100. Why are so many people using it? Well, they like its unlimited licensing model, its cross-platform compatibility. It's built using IT-standard technologies and leverages a scalable server-client architecture. It's web-based, web-managed, with a web-deployed designer and clients. And really it gives you a rapid development and deployment tool. Another thing is that rather than buying kind of a all-in-one solution, it's modular, you can buy, you can pick and choose which modules you want to add to your system and to unlock new functionality. And so, because of that, works for a lot of people with a lot of different use cases. And that's Ignition. Today though, the focus isn't just about Ignition, but it's about what Sepasoft can do on top of that Ignition platform. And so, to talk about that today, I'll pass it off to Jeff.

03:07
Jeff: Thank you, Kent. For those of you who haven't met us, either at ICC or in any other way, Sepasoft is a system that connects aspects of the entire manufacturing process and that spans all the way from ERP systems at the business end, all the way down through the Ignition platform and down to the manufacturing equipment itself. So, we talk to systems like ERP or PLM systems, send data up to business intelligence systems, which we'll talk a little bit about, in the... Here in the next few slides. But also, we help turn data into information and that information allows the manufacturing process to be more efficient, reduce the waste of the process, and just improve overall productivity in many different ways. And we'll talk about that. So, we sit on top of the Ignition platform, as Kent said, and it's very important to understand that that gives you a lot of advantages, single configuration, whether you're using the designer or you have configurability, and we'll talk a little bit about that in our low-code no-code capabilities. It's all an HTML5 user interface. So, everything is uniform, everything can be integrated together.

04:52
Jeff: We sit on top of any of the communications protocols that Ignition uses. OPC and MQTT are very popular ones. We leverage the report segment and we build on top of the security modules that Ignition has, and we'll talk about that when we talk about e-signatures. So, our place in the manufacturing ecosystem is between all of the business systems we talked about ERP and PLM, but also business intelligence at the top. And this means that we have a connection using what we call Business Connector. And it's very similar in its functionality to what you'll see in batch recipes. So, we take that information or push the information back up to the enterprise and we use it to help run the equipment on the floor to translate what comes out of all of these business systems into usable information for manufacturing. So, batch in particular, and I wanna make sure that everyone understands that this is batch and procedure. So, we'll talk about procedural manufacturing a little bit as well.

06:10
Jeff: There's a workflow manager, so that allows us, we call those recipes, that actually enables us to separate the recipe authors or the product experts from the engineers. So, the engineers create these phases, and the authors use them to build the recipes. It's low code. We'll walk through the user interface. Those of you who are familiar with SFC charts will feel very at home with this. It allows you to visually build your production procedures, whether you are a batch processing company or whether your manufacturing process is procedural in nature, both manual and automated. Tom, if you could walk us through some of the batch processing?

07:02
Tom: Yeah, I'd be glad to. So, well, Jeff is making me the presenter here. We're not gonna cover everything in batch and procedure today, that basically there's just too much to cover. So, we're gonna hit the highlights of some of our key features that we have in the module that we added recently here. So, Jeff was talking about separating the engineer from the recipe author. So if I was engineer right now, I could come in here and create what's known as phases in ISA88 speak. But just think of them as building blocks. So, here I have add ingredient one, I'm gonna go in and edit that and we can expose that out and I'll show that, it basically is gonna expose it into tags in the Ignition system. And we have a whole bunch of parameters with that. So, those parameters are associated with when we're adding ingredient one. So, we have a lot of like... Here's the command that's... If you're familiar with ISA88 there's a standard that if you're dealing with PLCs, you send a command down, start, it sends back a state “I'm running,” “I've completed,” we send down a command, says reset, you have that communication.

08:27
Tom: So we see all that in here, and we see a lot of other things, just the date/time that we ended, the duration, all of that. But really what I wanna show today is that we have a new data type here that allows us to take material in or material out. And actually in addition, we could specify supplemental equipment. So if you had a punching press and you have dyes you're using or that kind of thing, that's supplemental equipment. So, if I look at this material in here, I have like, okay, what's the actual quantity that we used? And you're able to set that to go to an Ignition, what type of Ignition tag you want. I mean it could just be a memory tag, it could be a reference which we're doing. We're referencing another tag in the system or the OPC communications. So reference tag might be if you're using MQTT or some other method that you're getting a value into a tag. So, definitely the case of what we're demoing today. So, you have a lot of settings here. I'm not gonna go into all of these. If you'd like to get a demo of the batch system and all that type of information, please contact us and we will definitely be glad to give you a demo. So, I have that material in here. You can have alternate groups. A lot of times you have materials and while this one's not available, what's an alternate? The priority of those.

09:58
Tom: We can create lots on the fly. Not all times you have receiving the material, you don't want to go through that step. You wanna make it simple. So as soon as you consume it, we'll create a lot and it will show up in the Trace Graph. So, whether you want to bypass your quantity, just a lot of information where to get that, what equipment to get that material, if you have a silo, anything like that, you can specify that here. The lot number, you can auto-select the lot number, you can specify a lot number. It might be a barcode scanner, may have been determined by ERP system, lot status. So, if you have quality checks and you have bad material and you need to rework it, you can set a status on that so it doesn't end up in your main production. Unit of measurement...

10:50
Tom: Whether you want to pre-allocate. Pre-allocate is really nothing more than just when we start this batch, we want to pre-allocate the material so no other batch or process in the plant can consume those materials. So, we don't wanna get partway through a batch and then find out we can't get the material 'cause somebody else used it and we have a partial batch. So basically that's the type of information that we have in here with our material. Now a lot of them can be blank, like you see a lot of them we can fill in. So, to do that I would just add another type of... If I had add ingredient two in or out, I'm gonna do an out, basically I'm just selecting that type down here and then the sub-parameters will show up for that and you can have as many in or out as you want.

11:45
Tom: So once you do that, I'm gonna go over to the Ignition designer here. Over in the tags, two different things happen. One, a UDT gets created automatically. So, I had some of these set as reference and they show up as a different tag type, but I can come in here and map these to my devices. So, for every unit that I have, a mixer in this case, every one of those I have, the tags can map automatically. Again, that's getting into a lot of detail and we just don't have time today to do that. The other thing that happens is the unit, in this case, it's a mixer. These start exposing out here and the real values are available here and we can view them here and they can be mapped to either OPC, MQTT, or reference tag. So with that building block and we'll look at how to use that building block. But these tags then are available. So, now I can do graphics, I'm not sure there's a batch system around that has the graphics integrated in. So, you can build your graphical screens or user screens integrated in with batch all on the same system.

13:10
Tom: You don't have to transfer tag values back and forth or some other means of getting data back and forth and all that extra effort. It's all right here. So, if I come over to the properties here, I selected that pump, I can come up here in the state of that pump, I can select and bind that to a tag here. And then I can put the mapping, when it equals two, the tag value, it means it's running, we're gonna show the pump animated and then otherwise we're gonna show it stopped. You could add other ones for fault and whatever else there. So I just wanted to briefly show how tightly it integrates in with Ignition platform, all using the same designer. Alright, now I'm gonna go over into back over here and we'll take a look at the recipe editor. So, that's the building block and typically that's done by the engineer, but when you get over here, now we're shifting roles. Now I can be a... We call it recipe author, operations person, brewmaster, whatever the case might be.

14:27
Tom: And so here's our basic, like Jeff mentioned, SFC, technically it's PFC for batch. Very, very similar. I'm not gonna get into the differences today, but we can see I have a pre-weigh step here. So that's gonna be a manual step where, one, we're showing a document to the users and I could come in here and edit this document right in here, but that's gonna be a user interface we display to the user and tell them how to tare a scale and weigh for manual step. We're also reading a value from the scale, then we're gonna go down after that completes, we have this transition. So that's gonna run until this transition becomes true. On the transitions, you can have expressions and you can have AND and OR, and order of operation and all that kind of stuff. You can refer to tags, you can run a script in here. All kinds of things to control that transition. Simply here we're saying when we're complete with that, allow it to go down into the mixer. So then when we take the look at the mixer, we pre-allocate. So we're gonna lock in those materials we want to consume. We're gonna add some yellow, we're gonna add some blue. We're gonna come down and manually we pre-weighed our sugar. We're going to tell the operator to now add that to the batch.

15:51
Tom: And then when we're done, we're gonna start agitating and heating at the same time. And then we're going to pump out and we'll be complete. So, that's the flow of the recipe we're going to look at. And we can come in here, I'll add yellow, we saw that over in the phase, that building block. So here we see the same information and we can further put some settings in here. We can link these two other parameters and all kinds of things there. So really what happens here is, I have those building blocks for this. I can simply just drag those. If I wanted to add ingredient three, I can drag that over here, link it up, and come in here and change some settings. And the recipe author is just dragging these building blocks or phases, setting some parameters of what they want. Now we're gonna actually run this demo. So we're gonna take a look at the execution screen here. Now these execution orders, a lot of times they come from ERP, but they can come from manual here as well. And I'm gonna put in a lot number, base lot number here.

17:09
Tom: We'll call it “A,” so it shows up at the top of the list here. Okay, so these are just some of the batch parameters here. We have a complete bill of material. That bill of material, like I said, could come from ERP, when this is added. It could be automatically to the list or manually here. You can set all those settings. So, very common that recipes are controlled on another system and are coming down into this, are added to this system. So I added that to the list here. I have a screen I built up over here already, so I'm gonna go over there. We have the pre-weigh and the mix. I'm gonna go to the mix. That's where we saw our graphic and such. I'm gonna go ahead and select it and start it. Okay. And this is just a view that tells us where we are in the recipe.

18:12
Tom: So we can see we're up on the unit procedure for pre-weighing sugar, what steps we're on, all of that. So, we can navigate and see where we're at. I'm gonna go over to the pre-weigh screen and there we see our instructions for doing the scale. So step one, I need to tare. So we have our scale here and we're gonna pre-weigh here. And then after we pre-weigh, we have our three storage tanks here with different ingredients. And then we have a mix tank. And probably hard to see, but we have pumps behind the tanks. They pump over, we have flow meters. We have an agitator that's gonna mix it. We also have just an LED bar that lights up red when we're heating. So, it's telling me right now to tare.

19:03
Tom: So I'm gonna go ahead and tare, then I need to... I can see there that I have a target of five grams, see how close I get here. A little heavy. Not that it matters too much for us right now. Okay, I'll go with that. And then I'll hit the print button. Now you can have an automatic scale but this is just a one that is manual, so very common that things are done manually. Okay, so I go ahead and accept that. Now we can see we're done with our pre-weigh, we're down on our mix, and true to demos, our communications with the scale is not working, we’re gonna go over to the batch monitor here, go into here, because it did not pre-weigh... I'm gonna bypass that step. So now we can see, our yellow is pulling out of the storage tank, it's going and adding it to our mix tank, and we're doing one ingredient at a time, but if your recipes are to add multiple, it's just how you drag your blocks, so now we're adding some blue to that, and it's turning more and more green over there, now we have our green product, classic green.

20:29
Tom: Okay, so right now, I'm gonna go back... And we see we have a message showing up here... On here... We can have a component and just show them the message list. We chose to do it with an icon here. So, when I click on that, it's telling me to add the sugar. So, here we go. Manual step. So, we're mixing automatic and manual here. So, I'm going to acknowledge that I added it. And then automatic picks up again. It's agitating and it's heating, we see the red light back. We also see the graphic on the screen is reflecting that. Agitator's animated. So again, this is all in the same system. We don't have a separate HMI/SCADA system and separate batch system. We also are consuming materials, we're seeing that, as well. And it will do the pump bell. We can see the pump animated there, just simply by binding to a tag. So, while it's doing that, I'm gonna go over to the Trace Graph. Here's our A lot that I had told it to type in and use. And that's a pre-weigh.

22:09
Tom: Okay, so the Trace Graph would be like this. So we have our yellow ingredient, our blue ingredient, and then our pre-weigh going into the mixer and going over to final. And we can see that we have all the details here of everywhere we used that lot. We see a lot of information that is available there. So, pretty powerful details, no code, in order to get this. This was all done just by setting those parameters and dragging those blocks on the screen. If we go over and look at inventory, and we go to our finished goods tank, we would see our A lot up here. We produced 550 milliliters of that, we haven't consumed any. If I go over to our yellow ingredient, we see the different lots there, and even in pre-weigh, and what was consumed and what was produced. So, with that, I'll pass it back to Jeff here.

23:21
Jeff: Thank you, Tom. So, as Tom mentioned, there's no code required to do any of this integration that he was showing. All of the components that were on the screen were pre-built by Sepasoft. The integrations to the Ignition system already pre-exist. And the pre-application of materials is very straightforward. You can pre-allocate those or not, depending on your process or your requirements, and it's intended to keep you from starting a batch without having all of the materials available to you.

24:02
Tom: The cool part about that too, Jeff, is that if those low-code approach doesn't hit all of your requirements, you're still on Ignition. You can still go, and you have a powerful scripting engine, database, communications, and you can finish out that last whatever percentage.

24:24
Jeff: Yeah, that's a really good point, Tom. All of the scripting engine is still there. All of this, of what you see in the user interface, has a back end to it... In the scripting functions, and the methods on the objects, all use the same back end as the user interface. So, it's completely flexible. So, the batch lots that Tom demonstrated, the material in and the material out types of components, are... Can be lots or serialized items. You saw the visual Trace Graph, a terrific way of identifying all of the places that a particular lot is used or created from. And then of course, the genealogy and the reporting, so all of that functionality is built into the system as well. So Tom, if you could tell us a little bit about e-signatures and the standards behind that.

25:25
Tom: Yeah, so the FDA has put these regulations in place, called 21 CFR Part 11. And basically, what they are... And it's funny, because I talked to various people, and I think it's good to just kind of cover the concept here, to just make sure everybody has it. So, you think of the old days, you had paper. And you had your data on the paper, and then the person attested to that by actually putting a wet signature on that paper. Well, now we're into, we don't wanna do everything on paper, we wanna do it electronically. Well, there's challenges that come up. Somebody could change it electronically. It could be lost. It could be, how do you know who actually attested that the information is correct? So, the regulations apply to just that. We're gonna collect information electronically. We want to ensure that data... The integrity of it is good and trustworthy, it's reliable, and who attested to that information that it was accurate and all that.

26:39
Tom: So two parts to it, one, you have the electronic signature, that is just basically if Jeff Fitch is in front of the computer, that we need to know Jeff is really there, that he didn't share his password and other people are using his password. So part of the regulation is procedures to prevent, rules basically saying, "Jeff, don't share your password." The other part of it is the system saying, "Hey, I need to know Jeff's here, he didn't forget to log out, and somebody else came along." So it re-pops up and it asks him to authenticate again. You might even run into where you need multiple signatures.

27:26
Tom: And then the electronic records aspect of that, that you have an accurate historic record of all the data for your process that you are doing that you can maintain and go back to. And if there was alternations made to it, that you have a history of that, you have an audit log of that. So that's in essence what 21 CFR Part 11 is. Then we take a look at how our software helps with that. Ignition has added into their core platform, an identity provider, it's used to verify the identity of individuals, they use it as a log-in system, but you can also use it to challenge to make sure that who is supposed to be in front of the terminal is in front of that terminal.

28:20
Tom: We have extended beyond that and we have some extra capabilities that are commonly needed for 21 CFR Part 11. Record generation will show that, they're commonly called electronic batch records, so it's just the... All the data used during that process. Audit trails, that if it changed, when did it change? Who changed it? All that. Permitted sequencing and steps. I think we kinda showed you that with batch already, authority checks, talked about that. We also have document control in there, so we saw a document there to do the pre-weigh, and then we can also sign those electronic records that we have with the person that's there, and then multi-person integrity.

29:16
Tom: So I talked a little bit about this, the main thing is that we have some tools in here that allow you to set up templates of required signatures. So if you need a supervisor and an operator, you can put that expression in, or I need a supervisor and two operators, I could do that or ORs or what have you. So it will keep track of who signed, who's left to sign, notification of those. It could be on a different system, maybe the supervisor's going in with an iPad, or maybe you want that supervisor to be at the production terminal, and specifically, you're able to specify that they have to be there. And that's all recorded in electronic batch records.

30:06
Tom: So we'll take a look at, if we're in our recipe here, I showed this before, and I wanna add this step to get the electronic signature, I'm gonna come in here and just remove that, I'm gonna drag the electronic signature over here to connect that and put a transition below it, and then I'm gonna connect that transition over there and clean that up a little bit. So in this electronic signature, I have to tell it who I want to sign, so this is where we refer to the templates, now we have some built-in templates that if you want to prevent somebody from stopping a batch or to start a batch, you can go in there and add the people or the roles of people that you want to authenticate before they do that, I have one I created yesterday, which is this validate operator.

31:16
Tom: So I'm gonna say, use that template, and I can put in a description here, so... Okay. And that's really all that's needed on that, and... Let's see that UP10, I can name that, whatever. But the default is UP10. I'm gonna say UP10 is complete. So we're gonna find out who the operator is before we do the pre-weigh. We're gonna save that off, we're gonna add another batch. Alright. And I'm gonna go back to this demo screen, select that new lot, I'm gonna go ahead and start it here, and right away we see a little signature icon, again, you can have a component that's always showing, but this lets me know that I have one authorization that's needed here. So I can go ahead and click it, and I see that that description I put in validate pre-weigh operation, and it just requires one operator, who's gonna verify that I am here doing that pre-weigh.

33:01
Tom: We could have multiple, and you would see... Like if they required also a supervisor, you'd see that all of them are listed. And you have the ability to reject, saying, "Nope, I don't want to allow that." But I'm gonna go ahead and approve, and... Tool tips pop up. It's popping up right in the designer here. Or not the designer, but the user interface, to log in. This is optional. Depending on the identity provider used, this might not be available, it might show up in another tab. You can have your bio input as well. You might have a fingerprint, all that kind of stuff. So, for here, I just have my name and password. And I don't want to save that. So now it continued on. We're actually past that, if we look in the recipe monitor.

34:05
Tom: We're past that e-signature step, and we're back down into the pre-weigh now. Okay. So if I go over to the electronic batch record viewer, even though I'm still running that I can do this, and I can go to the steps, and I have my pre-weigh step there. I can close this one here. All the details are here. So here's the electronic signature. This is when it began, this is when it ended. This is where it happened. This is, it was approved at this date and time, and it required the role of an operator, 77 seconds. All that data is here. An incredible wealth of data. So not only for this electronic signature, but for the entire batch as well. So if I went back to the one I did previously, and look at the mix, we see an ingredient one, we see the lot number that it pulled from.

35:27
Tom: Just a ton of information. So every time a parameter value changes, it essentially gets recorded off, along with the time stamp. Even if it changed multiple times... Like command changed multiple times here; here's the start, and then it went to none. You see a complete history, the quantity... I probably didn't need to record off every quantity change but I did. So this is the electronic batch record. Back to you, Jeff.

36:00
Jeff: Thank you, Tom.

36:02
Tom: Oh, and I should have mentioned too. So that electronic batch record, it's available. You can get it in JSON. You can even pull it out Python objects. You can use it up in the reporting; there's a data source in the reporting to do that. We have a component that makes it easy for an operator to get in there. That component you can filter down to what parameters, if you just want the user parameters, if you wanna exclude parameters, include parameters to show in that, you can do that. If you wanna change the details area and what data is shown in those, you can change those. Very configurable. So it's very intuitive for the operator. And I think I mentioned all the different areas. So it's not uncommon to pull some of that out. The bill of material, what materials are used and the quantities and all that. You can pull that out in EBOM, send that up to your ERP system as a verification of, this is what we actually used.

37:08
Jeff: Great. Thank you for that. So we talked a little bit earlier about integration with business systems. And you'll notice here that the interface for what we call Business Connector, is very similar to the recipe editor. It is also a low-code no-code type of tool and allows you to use this visual configuration capability to connect to other systems. Typically, what we see is an ERP system that is sending either work orders or recipes down to the manufacturing floor, and we have everything from very specific connection capabilities like BPEL, or connections to SAP, or we have more general modules for REST APIs and SOAP APIs for interfacing with all different types of systems. I've talked about this as point mapping and bringing data into the MES systems, and this can go to any module, it's not specific to batch, but I want you to know that this also sends data out. So if you have business intelligence systems or reporting tools, or if you just have information that you need to update your ERP system with, the data can... It can be bidirectional. So, Tom's gonna walk us through a couple of very specific examples, real-world examples, of how all of these systems have worked together, and maybe some recent implementations of it.

38:52
Tom: Yeah, so it's always a question we get, "Where are you using it? Where have you had success? Relatively new product for us, the batch module has been out for a while. These features I showed you today are just out now. So Stone Brewing has been running for, maybe upwards of a year now, and phenomenal success. So they had a previous system, and the engineers had to go in and make changes every time they wanted to make a formulation change, or even just display another message to the operator, the engineer had to go in and do it. It also had kind of a mixed language, so that made it a little bit more challenging. I think it was German. So they installed our system on... This is on the brewhouse. The brewing staff, with very little training, started copying recipes, started putting in extra messages that get displayed at certain steps, and just true to the point that we're talking about, and this is verification of what we're talking about, separate the engineer from the recipe author. I think one thing that just was incredible too, is they had no waste. They started up the system, and they didn't have any bad batches to have to deal with, and they're continuing to expand and use batch in other areas.

40:26
Tom: The other one is, we can't name the name because of an NDA, but they manufacture equipment, and they have a lot of parallel operations where you start working on a base system, and then you start in sub-assemblies, and then those are all gonna come together on a main assembly line and numerous options on this. So I want a USB outlet, I want an air conditioner, I want a heater. Just more options than cars have, and all of that is maintained in ERP. It comes down to our system. Our system controls the sequencing of all that, and the user interface along with Ignition to display, "Here's the options, here's the instructions,” and that it did check off. We have a complete ERV of every detail. And if there's any... They don't wanna hold up the main assembly line because of one problem, so they can flag it as an exception, and those exceptions are maintained and taken care of, and there's re-work, so all the re-work shows up in the electronic batch record as well, and then information goes back up to ERP. So not even liquid processing, not something you would think as a ISA88, but very specific to that. So that's why we say batch and procedure management. That's the procedure management aspect of it.

42:04
Jeff: Great. Thank you for that, Tom. So to bring this all back together: key elements, very simple, very fast to implement, keeps everyone in their wheelhouse, areas of expertise, whether it's an engineer on the floor, I'm working with the control systems, they set up the phases, or the recipe authors who use those building blocks, as Tom showed you earlier, uses building blocks to create and modify recipes. Those recipes can also come down from an ERP, or a PLM system, or any business management system that's holding the information such as work orders.

42:50
Jeff: Code is not necessary, although you can highly customize this using the scripting functionality. It can be all graphical, and what you saw today was everything. All of the components were created by Sepasoft and were dropped on a screen in a very simple fashion. So native integration with both document management, we saw that on the way in dispense, and then track and trace. And track and trace is tracing material in and material out through lots and serial members. Very important to have e-signature compliance. The majority, or many of the batch manufacturers follow 21 CFR Part 11. Electronic batch records are key in managing the history, and maintaining complete records of the process of what happened during manufacturing, and all of this sits on top of the Ignition platform. So integration with your SCADA system is very straightforward. Kent, thank you very much for having us. Back to you.

44:04
Kent: Well, Jeff, Tom, thank you so much. That was great. Really informative. For those of you who have never tried Ignition, we encourage you to go download it and play with it. You can download the most recent version, 8.1.25 right off our website. A couple of new cool things in that, including a new driver, IEC 61850. That's definitely worth checking out. As always, Ignition only takes three minutes to download. You can use it in trial mode as long as you want, absolutely free. And you can also hop over to sepasoft.com and download the Batch and Procedure Module, it works in that same trial, and you can play with all these same features you've seen today. We have a lot of learning resources online as well, not just the download, but the next slide shows inductiveuniversity.com. And Inductive University is free online training. There's hundreds of free training videos that can walk you through Ignition step by step at your own pace, and we've also got a comprehensive online user manual that you can refer to, and Sepasoft also has training websites that can be found on their page as well.

45:05
Kent: We're accepting project submissions for the 2023 Ignition Community Conference Discover Gallery. The conference takes place September 26–28 this year. Discover Gallery is a part of that conference, and it showcases the most exceptional Ignition projects from around the world. The submission deadline is April 28th, so make sure you submit your project soon. You can access your submission form on the Discover Gallery page of the conference's website, which is icc.inductiveautomation.com. And if you have any questions about the Discover Gallery, you can email us at icc@inductiveautomation.com.

45:44
Kent: And then for those of you outside of North America, we want you to know that we have a network of international Ignition distributors who provide business development opportunities and sales and technical support in your language and time zone. To learn about the distributor in your region, you can visit the websites that's shown on the screen here, or you can contact our International Distribution Manager, Yegor Karnaukhov. Alright. And then all the ways you can call us, you can see our account representatives here at our headquarters in California. To be in touch with them, you can call 1-800-266-7798. But with all that being said, we've had some questions coming in. As a reminder, if you do have questions, you can go to the questions panel in the GoToWebinar control panel, and yeah, we'd like to jump into some of those questions.

46:36
Kent: So Tom, there are a lot of questions about some of the logistics of your demo. Kind of to start off, there's one here from Patrick that says, "When you say the UDTs are created automatically, does that happen when you first add the Sepasoft module to Ignition, the Batch and Procedure Module? Or at what step do these UDTs get created?

46:57
Tom: That's a good question. So you do need the Sepasoft module, batch module, and then when you configure a phase, and there's a setting on that phase you can expose, and when you set it to true, it will create the UDT at that time. And then you can then go in and do your mappings in that UDT. And then when you say to a unit, so ISA88, you have process out, then you have units underneath it, so a unit can be a mixer, it can be another, and it can be anything like that, reactor. So when you set that phase basically, I'm simplifying it, say, "Hey, I wanna be able to run that phase on that unit." It then will create an instance of those UDTs under that unit, and make it available. So those are created automatically at that time.

47:56
Kent: Kind of along similar lines, is the batch logic executing in the gateway, or do you have to create phase logic in the PLC?

48:04
Tom: Yeah, it's your choice. So I think that's one thing that is unique about us, from what I understand. I don't know all batch systems out there, I know some of them. So take a timer for example, very common that you have to implement a timer down in the PLC, and then you can use the timer up in your batch recipe, but not everybody wants to do that. Some people still wanna do that and they still can, but if you just wanna have a timer and run it in the batch engine, you can. So we have numerous phases, that e-signature phase was one, we have the document phase, which is another. These all run in the batch engine only, we just have several others there where we can pre-allocate material that's not... Doesn't involve the PLC. We can allocate some shared equipment, if you have a heater that's used across multiple mixers, let's say that pre-allocation, or that allocation of that unit and de-allocation of it all happens in the batch engine.

49:15
Tom: So there's a variety of these phases, and you'll see more and more over time, so you'll see an SPC phase where you can drop it in there and either collect sample data automatically, or have a pop-up that shows where the operator takes their sample, and you'll see others as well over time that don't involve the PLC. So you could have an implementation that doesn't even involve a PLC at all, and you could have one that everything is in the PLC and everything in between those two.

49:53
Kent: Yeah, thank you, Tom. Jeff, a question for you, is there a certificate training available for these things?

50:00
Jeff: So there is a certificate training available, so you can get certified in batch and many other modules such as OEE and Track and Trace, so all of that is available including the batch certification.

50:15
Kent: Perfect. And Tom or Jeff, you can decide who wants to take this one, but Victor asked, "I didn't see the operation level in the recipe, is that optional?”

50:27
Tom: Oh. Yeah, it is. So it is there. So in your unit procedure, you can have an operation. We don't require that you use it, so it's up to you whether you wanna use it at that level or not, and we do have where you could set the operation up as a template, and then just drag that template out. We also have that for a unit procedure as a template, you can just drag it onto the designer, it will... Whatever logic's in it, it will use.

51:00
Kent: Perfect, another question here from Ronald. “Does the software support deferred parameters both for setpoints and actual values?”

51:07
Tom: Yes. Yeah, it does. So I had it in there, I didn't go dive down into it deeply, but at the procedure level, I had some parameters which were exactly that. They were set points, and then I... Over in my phase, you actually can refer to those parameters, and you can actually, taking it a step further, have a calculation, so it could be a single line of Python script in there, so you can do scaling, you can concatenate, some strings, do all kinds of things in there.

51:48
Kent: Perfect. Another question, “Can someone go into the actual database and be able to change, or adjust records?”

52:00
Tom: So just like Ignition, the user selects their database that they want to use, and they're also responsible for the security on that database. So within our software, you don't go in and modify that. Now, can you go over in the database tool or do custom queries and things like that? Yes, you can, and it's up to you as a customer to set up that security to prevent that.

52:31
Kent: Perfect, and for those who are looking for guidance on that, certainly on the Inductive Automation website you could do a search for “security hardening guide” and there are some useful tips there, but yeah, as was stated, certainly you can go and do that on the database side. Pick the database of your choice.

52:48
Tom: I think also Inductive Automation has a 21 CFR Part 11 guidance. Sepasoft has also created one, and it will be out in a couple of weeks here, that says, "What's customer responsibility, what's handled on our software, what are the best practices for going about that?"

53:10
Kent: Yeah, absolutely. If you haven't seen the new 21 CFR Part 11 document, I highly recommend you go check it out. We had one that we've shared for a long time that it was just a few pages, the new one has about 50 pages of good content walking you through, "What's your responsibility? What's our responsibility?" All that kind of stuff, very informative, so you can find that on our website under the resources section as well, or you can just do a search for it. Tom and Jeff I don't know if you've seen the questions in the questions panel, did you have any last questions you wanted to make sure that we covered today?

53:46
Tom: Yeah, there's one. So one question here is whether it ties in with Rockwell's PhaseManager in the PLC. So just to explain to people what that is, is in the Rockwell Control Objects Processors, they have an additional feature that you can install, which they call PhaseManager, and it basically does the equipment phases down in the PLC, and you can issue start commands, stop commands, all that, and you get the state back and you have separate sub-routines that run for each of those different states, and all that. So Stone Brewing used that, and so we definitely interface with that. It does require in the PLI sub-routine to do the mapping back and forth, so we send down a numeric value for the command, Rockwell, it's an instruction, it's not a data value to issue that command, so that you're just saying, "Yep, command from Sepasoft equals one. Okay, run the start command." So it's very straightforward mapping in the PLC. If you're not using the Rockwell PhaseManager, then you're just looking for those command values and feeding back to the state values, as in our demo unit. Exactly what we did here.

55:09
Kent: Perfect. Well, thank you so much, Tom, thank you so much, Jeff. We didn't get to all the questions today, lots of good questions here. If we didn't get to your question, please reach out to us, we would be happy to get a meeting scheduled so we can talk to you about all this in much more detail, but always fun to see a demo, Tom, I was... Cool to see your new equipment there and mixing the colors and everything, so, yeah, I think it was great. But yeah, thanks everybody for attending today. We do have additional webinars that will be coming, so please check back next month, also, you can get latest updates on social media and through our weekly newsfeed email, but that's all for today, so... Thanks everybody, have a great day.

55:50
Jeff: Thank you everyone.

55:51
Tom: Thank you everyone.