foreign hello everyone nice of you to be joining us please let me know in the chat if you can hear me yeah now the camera is also working and nice good so we'll give people another minute to log in before we start our session today please use the chat freely introduce yourself to let's say where you're from and we are really excited to start this session in a few minutes we'll start in a few moments 30 seconds one minute so people who want to join us in junior right now can do it in time okay so we are one minute into this session so let me again welcome you and start a decision already during that I know that more people are joining us but we will start because we have so much to cover so I welcome you to today's webinar by cool history my name is Yan and I will be your moderator for this session and during the k q a we'll have also a guest speaker Adam the one of the founders of Ukraine joining us as well so today's talk is titled intro to do it temperature mapping how to determine sensor location amount and I do think that you will learn a lot today from this session and this webinar will teach you what temperature mapping is and why it's important Additionally you will learn how to determine the number of sensors for the mapping to be aware that this event is recorded in the link to the recording will be sent to you within several days and please use the chat box to your right freely to discuss the topic with your peers as the webinar progresses and if you have a question make sure that you click the question mark button and if it's relevant also mention the relevant slide and please send a message also in the chat to the moderators and to me also directly if you have any issues during the session and if you have any technical issues first please refresh your window or try another device it usually helps so this webinar will be around 90 minutes and we will also have a q a session at the end where Adam from you pre will be the moderator and if you stand till the end of the session you will receive a free certificate of attendance sponsored by our event partner you pray so the certificate will be sent to you probably next week and uh please give it up to seven days to be sent to you before sending us questions and inquiry it could easily aim to provide from professionals with Worldwide free accessible education and Industry insights and we managed to do it with the help of our incredible Partners so for this webinar or sponsor and partner is yupri and I want to thank them for supporting this event so if you have never heard of ubreak before here is a brief overview of what they do so you protect your hand through all part of temperature complaints including continuous monitoring mapping and qualification so your pre-solution comply with the conveyto fdngp requirements sensors is ISO 17025 accredited calibrated in the air it is easy to use and make you ready for an audit with one click so imagine sleeping well at night before an audit that's a really a good because we all know how stressed we are and so I know it also is an auditor how people get stressed when they get Auditors into the warehouse and you go through the calibrations so Europe also assists companies all over the globe and so they have very intuitive software and short delivery times that make super Solutions very reliable and you're free they know that time is all that matters on mapping was used to be done when a mfp has to be done yesterday already so now I'm eager to introduce to you the speaker today's webinar Nathan Roman so Nathan is the director of validation in Genesis and he is responsible for qualification and validation consulting services at the company over the last 22 years Nathan has placed thousands of temperature sensors in hundreds of control temperature Chambers and he helps people in the health Life Sciences Industries to ensure compliance with current regulations while carrying out commissioning qualification and validation projects so and his passion is to help those that must perform temperature making such as learning how to make temperature maps and how to qualify the equipment correctly and he does it by providing simple proven practical tools so I'm really confident that you can learn much from Nathan today so happy learning and Nathan please take it from here fantastic thank you yawn um allow me a second to get my screen all right so I want to confirm can can everybody here hear me okay and as you're confirming that um can you see my screen I have today's agenda set up all right cool good all right hey everybody Welcome to today's session uh this meeting today is known as our intro to temperature mapping meeting uh we'll be together like Jan said for about 90 minutes um I like to start by giving you an overview of today's session I found that following a five-step agenda provides the most efficient way for us to communicate so with that step one is going to be uh about me a little bit about me so that you know I'm not practicing on you it's just a quick history step two is about you so I can understand where you've been where you are and where you're going step three would I will go over the keys to effective temperature mapping we'll go over some key elements that give you everything you need for a successful temperature mapping experience step four a quick guide to mapping protocols so you can see how I put protocols together and you can literally take and start using today step five is determining sensor locations we'll take a look at how to determine the number of sensors for a CTU and then of course at the end we'll have some q a so a little about me I'm a driven I'm driven by a passion to help others and bring value to to their lives working alone or part of a team I I feel I thrive in a creative and adaptable environment that enables me to understand and execute my tasks so my expertise lies in helping individuals and organizations Implement temperature mapping studies and Equipment qualifications in order to meet those regulatory requirements uh as John mentioned uh over 22 years of experience in commissioning qualification and validation Services I'm I'm dedicated to providing accurate and informative guidance to those uh in need my journey in this pharmaceutical validation field may not be typical but I'm very grateful for the opportunity to make the difference in in this field of ours from the age of 18 I've worked as a computer-aided draftsman in the aggregate industry I I prepared detailed plans drawings and 3D renderings for the manufacturer and erection of Steel columns beams trusses handrails things like that used in the construction of uh Quarry Rock plant structures uh my job at the time was very rewarding and I was just looking I was just kind of getting started into my profession as an AutoCAD draftsman but my uncle who happened to be a consultant in the pharmaceutical industry and had been for many years prior called me up and asked if I knew how to read P IDs he had an opportunity to pull some additional help in um on a local project and he needed someone to to walk down some P IDs so of course I knew how to read them because I prepared detailed plans and drawings on AutoCAD every day all day since I knew generally what he was looking for I went to give him a hand on this weekend project out in Lancaster Pennsylvania and that was my first exposure to this pharmaceutical world um walking around the facility um holding uh p i d in one hand and a highlighter in the other just marking up the prints um that that was back in the year 2000 so P ID markups was still done that traditional way performing duct work and process piping walk downs was my first exposure to the pharmaceutical industry and from that point on he brought me and my two cousins his sons into the industry I left the AutoCAD world and entered the validation world um over two decades of experienced working hand in hand with customers and and folks like like yourselves on these days I do what I do by providing simple and practical tools for um compliant mapping and qualification and today I'd like to talk about some key elements that give you everything you need for a successful temperature mapping experience but first so I can understand uh where you've been and where you are at right now and where you're you know going please take some time to check out the uh poll questions um about you it it helps me to gauge any needs in the industry topics that should be addressed and ultimately it helps me to to help you so those polls are are being added to the poll section of this webinar right now foreign I'll just give a minute of time to allow folks to to check them out to respond and then I'll uh I'll continue on so I will allow myself to moderate a bit the part of the pulse of the first Pole where we're asking people to rate their knowledgeable temperature mappings also far 40 fall in the from one to five so forty percent are located in the three area um ten percent one twenty percent cool twenty percent four so forty percent are in the three area I will close the poll and I will continue with the next one so feel free to continue inputting the poster will launch we have quite a lot of interesting polls and they will be available for you throughout the session yeah on that first question five is is uh would be the expert on that first pull all right so I'll I'll continue to get moving here um so imagine that you're a scientist working in an r d laboratory and your team has just developed a new drug candidate or compound that the potential to it has the potential to revolutionize treatment for a particular disease well this drug compound has undergone rigorous testing and has shown promising results and you and your team are eager to move forward with the next phase of development however there's one critical aspect that you cannot afford to overlook storage and handling of the drug compound you know that the stability of the drug can be greatly affected by temperature and that even a slight fluctuation in temperature can cause degradation and potentially compromise the effectiveness of that drug this is where the importance of maintaining and monitoring temperature comes in by ensuring that the freezer in which drug compound is stored is properly calibrated and functioning at the optimal temperatures you can ensure that your drug compound is preserved in the best possible conditions this is just one of the examples of the many ways in which maintaining and monitoring temperatures is critical in our farm industry um whether you're working with drug compounds vaccines or other temperature sensitive materials the proper storage and handling of these materials is essentially it's essential to their integrity and Effectiveness maintaining and monitoring temperatures is a crucial aspect and one that should not be overlooked and so by taking the necessary uh precautions in implementing proper temperature control practices we can ensure that those valuable materials we're working with are preserved and protected incubators refrigerators freezers and other controlled temperature units are the single most qualified piece of equipment in the pharmaceutical Biotech Industry this is typically an entry-level activity often executed by inexperienced individuals that who are new to the industry or experience individuals new to the process and as a result significant resources are spent correcting failures that could have proactively been addressed if proper training was given to those individuals executing the work so this course is a training experience where we'll learn how to effectively and efficiently thermal map various types of temperature controlled units using data loggers upon completion of the course you will come to know what is temperature mapping why we temperature map types of CTU equipment how to generate an ioq types of temperature mapping equipment and of course the sensor location and number of sensors the first key to successful temperature mapping which I always emphasize is to clearly Define what temperature mapping entails temperature mapping is the process of collecting and analyzing temperature data from different locations within a facility or storage space or temperature controlled environment to ensure that it is operating within predetermined limits and to identify any deviations from those limits now don't get me wrong temperature mapping and qualification are not the same qualification is a regulatory requirement and temperature mapping is is often performed as a part of the qualification process for Pharma biotech and Med device facilities and equipment and it's typically required by Regulatory Agencies such as the FDA however temperature mapping solely focuses on the uniformity of temperature distribution and the qualification protocol uh extends beyond that and for those of you that aim to comply with regulatory requirements there's a continued emphasis on um the continued emphasis by Regulators on the need to perform temperature mapping on controlled temperature units as a seasoned veteran in the validation industry with well over 20 years of experience now I've gained a wealth of knowledge through training from industry Consultants previous managers training classes and absolutely Life Experiences so through these various Avenues I've I've come to understand the importance of temperature mapping for meeting the requirements of EU and U.S regulatory authorities and Industry guidelines temperature mapping is a crucial process for ensuring proper environmental conditions for time and and temperature sensitive materials such as vaccines products or other samples the end user study director uh responsible person or equipment owner is responsible for number one ensuring proper environmental conditions for their processes and operations and number two proving temperature and humidity control and providing proper maintenance of their equipment I understand that different countries have their own regulatory agencies that oversee the Pharma industry and these agencies often have specific guidelines and regulations regarding temp mapping um however in general the purpose of temperature mapping is to ensure that a temperature controlled storage space is capable of maintaining appropriate storage conditions for your Pharma products this typically involves taking a representative sample of the storage area within a storage space and measuring the temperature at those various locations within the area the results of temperature mapping are are then analyzed to determine if the controlled storage space is capable of maintaining appropriate conditions for the products being stored or transported ultimately this process serves to protect the product and the patient in addition to conducting temperature mapping it's important for pharmaceutical companies to have proper temperature control systems in place to ensure that their products are are stored and transported under appropriate conditions this may include the use of temperature controlled storage and temperature Transportation equipment so as well as monitoring and recording systems to ensure that their products are not exposed to temperature excursions or temperature deviations um all right so this slide here this is our first engagement poll I just want to kind of gauge the uh the audience on their requirements or guidelines that they're familiar with so Jan will post a a couple polls over on the poll side and go ahead and and vote go ahead and cast your um your selections but I'm going to go ahead and continue um with the presentation as you guys are checking out those those polls foreign so what do the guidelines and regulations say about temp mapping temp mapping is a crucial process for ensuring proper storage and transportation for pharmaceutical products in various regulatory bodies such as FDA the USP the CDC the EU or european Commission the mhra and the World Health Organization have specific guidelines and regulations in place for this process uh according to the fda's guidance for the industry temperature mapping of storage and transportation conditions for drug products temp mapping should be conducted to ensure that a facility or equipment is capable of maintaining appropriate storage conditions for their drug products the guidance recommends conducting temperature mapping in a representative space of where the storage and transportation areas are within a facility and that the temperature mapping should be representative of the types of drug products stored and transported in the facility it also recommends conducting temperature mapping at the time of facility or equipment qualification and re-qualification and documenting and reviewing those results to ensure that the facility or equipment can maintain appropriate storage conditions for their drug products in addition to FDA guidance the USP provides guidance and considerations on temp mapping and storage locations the CDC recommends implementing clearly written detailed and up-to-date storage and handling standard operating procedures and appointing a coordinator or a responsible person to oversee the proper handling and Storage and the EU or the European commission speaks of the need for product storage segregation and ensuring adequate control of the temperature controlled environments taking into account seasonal variations even the mhra recommends conducting temperature mapping once in the summer and and once in the winter the World Health Organization has also has a lot to say about temperature control George areas intent mapping um so they have so we aim to comply with these different regulations um and requirements and so understanding the process and importance of temperature mapping is is very essential why we tempt map as previously mentioned temperature mapping is crucial for product production transportation and storage of those time and temperature sensitive products in in Industries not just in pharmaceutical Industries but for food and beverage and Med device production all of these industries are regulated by the government and must provide data on the environmental temperature temperatures during production transportation and storage to ensure compliance companies must also verify that their equipment is operating correctly and that their products are safe there are several reasons why temp mapping is important for our Pharma industry one to ensure product stability and effectiveness to to validate temperature control systems and equipment three to identify infrastructure and design issues for to meet regulatory requirements so one uh to ensure product stability and Effectiveness temperature excursions can potentially impact the stability and effectiveness of the product and so by conducting temp mapping you can identify areas within a facility or equipment that may be at risk of experiencing temperature excursions and you can take steps to mitigate those risks two was to validate temperature control systems and Equipment temperature mapping can help to validate the effectiveness of temperature control systems and Equipment such as refrigerators freezers and temp controlled storage and transportation containers such as shipping containers or you know doers and by conducting temp mapping you can ensure that these systems and Equipment are functioning properly and are capable of maintaining the required storage and transportation conditions for these products being stored number three was to identify infrastructure and design issues so for example if a temperature mapping reveals that certain areas of the facility are consistently warmer or cooler than the desired storage temperature than um that reading can indicate that there are issues with the facility's heating venting and air conditioning HVAC systems or with the installation of the facility number four was to meet regulatory requirements um and as previously mentioned many regulatory bodies have specific guidelines and regulations regarding temp mapping but by conducting temperature mapping you can assure that your facility is in compliance with those regulations and that brings me to the question on the screen that I'd like to address with the definition that I'm I'm quite fond of what is the purpose of temperature mapping the purpose of temperature mapping is to ensure and prove that a temperature controlled space is suitable for its intended purpose so ensure means to make sure certain or safe and prove means to establish the existence truth or validity as by way of evidence so I really like this this definition of the purpose of temperature mapping um the purpose of temperature mapping is to ensure improve that a temperature controlled space is suitable for its intended purpose Okay so we've touched on what temperature mapping is a high level view of what the regulations and guidelines say we've addressed why we temp map and the purpose of temp mapping now I'd like to share a little bit about the types of equipment uh or ctus that we perform temperature mapping qualifications on so here's a list of some common temperature controlled units that we use to store our products so we have cryogenic storage freezers ultra low freezers lab freezers refrigerators incubators um ovens walk-in cold rooms stability Chambers warehouses um but it's it's with all that it's hard to say which unit on the list is the most used in the industry but um it can vary depending on how we um you know need to use the equipment it's application or even depends on the facility that um are using the equipment however the ultra low freezers in refrigerators are commonly used in the pharmaceutical and Biotech Industry and by performing temp mapping for these units ensures that every Point within the defined storage area confidently meets specific acceptance criteria the temperature mapping is performed over a period of time to ensure that as the systems actuate the temperature is always within limits and without deviation foreign in the pharmaceutical industry you may be responsible for generating an installation qualification an operational qualification and a performance qualification for new equipment or processes right so these qualifications are typically required to ensure that the equipment and processes are installed operated and they perform correctly and that uh that and that they meet um that they continue to meet the required specifications and performance criteria here's a general step-by-step process for generating an ioq first determine the scope of the qualification this includes identifying equipment or processes to be qualified as well as any Associated systems and utilities that will be included with the qualification second develop a qualification Plan before you can start a temperature mapping study or qualify your equipment you must be sure to create a detailed test plan or develop a qualification plan that plan must be based on the equipment or the process description and its intended use the detailed plan that we're talking about is also known as the protocol this plan should outline the specific activities and tests that will be conducted as part of the qualification as well as the acceptance criteria that must be met in order for the qualification to be considered successful a properly developed qualification protocol will help ensure that equipments meet all the documentation requirements and performs as expected this includes ensuring that the temperature mapping study is carried out correctly okay so this webinar today here focuses on only three stages of qualification that are required before release of temperature controlled area or space for routine use conduct uh the installation qualification conducting the operational qualification conducting the performance qualification and then of course documenting the results of the qualification review and approval of the qualification so in terms of conducting the I oq that means to demonstrate that the process or equipment meets all specifications that it's installed correctly and all required components and documents needed for continued operation are installed and in place this may include inspections tests and documentation review the oq demonstrates that all facets of the process or equipment perform as specified when operated in accordance with standard operating procedures and manufacturer recommendations and that it confirms that the equipment is capable of meeting its intended use this may include functional testing performance testing and operational testing and the PQ will demonstrate that the process or equipment consistently performs as intended under routine operations and may include testing the equipment or process over a range of operating conditions and verifying that it meets the required performance criteria all right so it's important to note that the quality of the qualification depends largely on the quality of your test plan so what does a basic qualification protocol contain here's a list of what a basic control temperature chamber qualification or temperature mapping protocol should contain generally a protocol contains a documented approach to conduct the qualification process along with a procedure a scope an equipment description responsibilities your test method or your qualification method IQ oq and PQ test Scripts the acceptance criteria of those test scripts and then of course your final report and uh your approval process since some of these concepts are not entirely always clear the ispe good practice guide for controlled temperature Chambers provides guidance on commissioning and qualification temperature mapping periodic reviews and they also provide examples and Sample templates in their in their guide um but for some some quick guides I I'm providing in the the file section of the webinar Yan will include a a file that I created that is is yours for just a quick guide to generating ioq protocols come on prior to performing a qualification or requalification on any temperature controlled unit you'll want to ensure that you have all documentation required to meet the manufacturer's specifications and site requirements for your protocol this document may include things like installation instructions operating manuals and any relevant regulatory guidelines when all insulation operational and performance testing has been completed and all exceptional conditions if any have been documented and resolved and all your acceptance criteria have been met the completed iqoq protocol will then be circulated for post-execution approval and once that IQ has been approved by all appropriate departments the temperature mapping qualification of the CTU is considered completed the completed qualification and mapping study certifies that the equipment is performing as per required standards during testing and may be suitable for for then operation however it doesn't mean that it will ensure the same performance will continue thereafter quick question have any of you ever encountered a situation where you were unable to begin qualification protocol due to your equipment not being fully installed or ready meaning have you gone out to the field to execute your protocol and the unit isn't set up right if yes then I have a quick tip for you I recommend conducting it an equipment walk down prior to starting any documentation to ensure that all necessary supplies and materials are present and accounted for this will not only help meet the owner's requirements but it will also provide an opportunity to identify potential issues or areas for improvement before they become a problem or before you start the qualification in this next section of our webinar we'll be discussing the different types of temperature mapping equipment available and understanding the different types of equipment available you can choose the right one for your specific application and ensure that the best performance of your temperature controlled Chambers you will perform the temperature mapping Studies by using calibrated temperature sensors or data loggers the World Health Organization says that a mapping study contains a significant uh a sufficient number of they call them electronic data logging monitors Ed LMS in in the who guidelines and that's to ensure that the temperature distribution in the space is to be mapped and adequately characterized so with this slide yawns going to put up a couple quick Data Logger polls on just some quick questions around what type of equipment do you use for temp mapping um and how many types of data loggers do you currently use in your facility for temp mapping just a couple quick polls to uh to understand where you guys are at and what you're using I'll go ahead and and keep moving so those polls will be there so take your time get to them when you can so there are a variety of temperature mapping equipment options available for for use in our industry data loggers come in all different shapes and sizes right so data loggers have can come with internal sensors um USB data loggers that those devices connect to a computer via USB we have wireless data loggers cloud-based data loggers and these devices can store data in the cloud allowing you access from anywhere with an internet connection portable data loggers designed to be small and lightweight making them easy to carry around and be able to use and put in different locations data loggers cost vary from around ten dollars to several thousand dollars um the quality differences between these loggers are substantial I'm I'm no expert in um the data loggers sales and and service but um I know that the quality and accuracy of the loggers increase with the cost of some loggers um and some of them are are not suitable for all mapping applications so you you always want to watch out for the different mapping applications that you have um for example any extreme temperatures of um Island 2 cryo vessels or that of an autoclave or oven requiring a specific Data Logger or even the use of thermocouple application some other important considerations for data loggers are the accuracy of the logger does it contain an internal external sensor what are the material of of construction of the Data Logger can your application handle or can the Data Logger handle that application your logging frequency memory calibration data loggers should um should always be calibrated annually either by an ISO 17025 calibration lab um and it should be traceable to your National standards and another consideration is the software ensure that your software is 21cfr part 11 compliant so what is the expected result of temp mapping these data loggers are placed in specific predefined locations inside uh our Chambers or our freezers refrigerators and they expect results of temperature mapping study is to identify areas within that space or equipment that may be at risk of experiencing temperature excursions um and it's also to determine if the space or equipment can maintain appropriate storage conditions for for our products temperature mapping typically involves collecting temperature data from a representative sample area or of space or equipment and those data loggers must be undisturbed for a period of time typically it's 24 hours for a off-the-shelf unit once the testing is complete and you've collected data for the full-time allotted the data loggers are collected and the data is downloaded the results of the temperature mapping study should be documented and reviewed to ensure that the facility or equipment is meeting the required storage or Transportation conditions and it's also to identify any areas that may be a need to be addressed in order to maintain those conditions this activity shows you what is happening inside of your space such as hot spots or cold spots and your results will be documented in the data can be compiled into one main report or separate reports for individual analysis of time and temperature you'll use that data to determine whether or not your storage unit meets the specifications or requirements you set for the intended product or samples the reagents that you want to store or in other words is your equipment fit for its intended use overall the expected result of temperature mapping is a is to ensure that a space or equipment is capable of maintaining the appropriate storage conditions for your products and to identify and address any issues that may impact those conditions okay so important question here why did the engineer install so many temperature sensors because he wanted to make sure he had a temperature map that was accurate to the degree sorry guys um I am a dad and um many times over so to me that's funny it's a joke um I I think it's funny you can you can just classify it as a dad joke um but you know just thought I'd throw that in there I thought it was cute but we can we can move on thank you some of you are laughing I see some of some of you are probably dads Okay so we've touched on what temperature mapping is why we tempt map uh different types of CTU considerations we've talked about a quick IQ oqpq guide to knowing what's in a protocol we've touched on different types of temperature mapping equipment so now that brings us to this Slide the number one most asked temperature mapping question right how do you determine the number of sensors for mapping well regulatory guidance does not give definitive answers to that question how many sensors however there is industry guidance that's found to be acceptable by the regulatory bodies and as an industry-leading temperature mapping specialist I can tell you that the placement of thermocouples or data loggers is an important consideration when conducting a temperature mapping study the number of data loggers to be placed in a controlled temperature chamber is determined by a combination of factors including the size of the chamber which we'll cover in a minute the volume of product being tested the number of temperature zones inside that chamber or controlled space and the level of precision required for the study needing to ensure that the temperature throughout the process is within its acceptable range so as you know thermocouples and data loggers are used to measure and record temperature at various locations with in the space and those locations where those devices are placed can impact the accuracy and reliability of the temperature data collected so how can the location of data loggers impact the accuracy of your data well the location of data loggers is critical and can significantly impact the temperature data collected for some of the following reasons uh airflow patterns product location temperature gradients and interference airflow patterns from the standpoint of the location of data loggers within a CTU can affect the airflow patterns within the unit which in turn can impact the temperature distribution inefficiency also happens when airflow is neglected placing data loggers in strategic locations can help to ensure that the temperature data collected accurately reflects the temperature conditions inside the unit product location for example placing temperature loggers close to where the product being stored can provide a more accurate representation of the temperature conditions experienced by those products uh temperature gradients so ctus are not always evenly uh temperature controlled and the temperature gradients may exist within the unit the location of data loggers can impact that measurement of these gradients and therefore the accuracy of of your temperature data interference so the location of data loggers can also impact the accuracy of the temperature data collected if if it's placed in location that may be subject to interference from other sources such as sunlight electronic devices or other heat sources so the placement of data loggers within a CTU is important to ensure that your temperature mapping data collected is accurate reliable and representative of the actual temperature conditions with within the unit let's quickly touch on the placement of thermocouples or data loggers when it comes to number of sensors and positions for temp mapping and qualification of our ctus I recommend you to refer to the ispe good practice guide on controlled temperature Chambers during a qualification when you're placing thermocouples or data loggers it's important to follow these guidelines outlined in your temperature mapping protocol but if you're a person generating that protocol then you'll want to know how do you determine the number of sensors for mapping but first please remember when placing thermocouples or data loggers it's important to confirm that these devices are properly calibrated before use to ensure that your regions are accurate for example do you have a calibration cert in hand before you execute it's important to ensure that these sensors are properly calibrated before use to ensure that your temperature readings are accurate all right so back to the question at hand how do you determine the number of sensors for mapping well industry guidance recommends that when determining mapping locations the potential storage location should also be considered along with some other General considerations for the placement of thermocouples or data loggers representative locations the sensor should be placed at locations as previously mentioned that are representative of the storage and transportation areas of the equipment taking into account factors such as the layout and design of the equipment the types of products being stored and the temperature requirements of those products another is accessibility the sensors should be placed in locations that are easy easily accessible for for mapping while also minimizing the risk of interference or damage and when placing thermocouples or data loggers it's important to follow the guidelines outlined in accepted industry guidelines for the typical commercial off-the-shelf controlled temperature chamber like a freezer a refrigerator incubator or environmental chamber that we consistently perform mapping studies on it is recommended to use a minimum of 10 temperature sensors in Chambers with internal volumes of up to two cubic meters or 70 cubic feet and to put that into perspective for you the typical unit size that we map on a regular basis range from three cubic feet to 30 cubic feet in the picture displayed are typical double door refrigerators single door freezers or even a single door incubator there those are the typical type equipment that that we will be performing mapping on that um that I follow my team follows um the guidelines on how many temperature loggers to place in there industry guidance suggests the sensors be placed in each of the eight corners of the chamber and with one in the geometric center of the space so so that's nine sensors plus an extra one to be placed adjacent to the control or display monitoring probe so that makes a minimum of at least 10. this approach will allow you to capture data from a variety of locations with within your your equipment or your temperature controlled space including areas that may be less or more effective by external forces such as the sun exposure or drafts again it's important to ensure that your sensors are properly calibrated and that multiple reads are taken at each location in order to improve the accuracy of the data you're looking for so just to quickly recap on on this you'll need to place sensors in a uniform pattern in all three dimensions of your space top to bottom you know left to right front to back all sensors other than the one in the center should be placed away from nearest walls at a distance that will Define the actual volume of the the space used for storage don't forget to add the additional sensor that should be placed near the display control or monitoring probes in the unit so for larger units you can see on the sensor placement example guide that I have listed you can place you know five sensors on the middle Shelf or even lay out an alternative pattern on the middle shelf for example five sensors on shelf one uh shelf two you can place the sensors in the back left corner in the right front corner shelf three can place one in the middle um shelf four you'd have front left and right back and five you could have five more on the bottom so in summary it's it's important to adhere to Industry guidelines when installing sensors in a chamber or other enclosed space like a cold room but this means placing at least 10 sensors in strategic locations including the corners in the center of the space as well as near any display or control monitoring probes by following these guidelines that are provided you can ensure that you'll capture the the accurate temperature data from all areas of your space including those that are susceptible to the extent external factors like like sun or drafts remember to properly calibrate again the sensors to to make multiple readings um I I talk about calibrating the sensors a lot because for those of us validation Specialists or Engineers that um go out to the to the field and and qualify these units um if you don't have properly calibrated sensors um or um your calibration dates have been missed and you're using a Data Logger or a device that is outside of calibration and you don't pick up on that you don't look at that first and you go out and you actually start qualifying units um you know that that brings into a lot of issues deviations observations uh calls into a question a lot of the qualifications that you've done so that's why harp on remembering to checked that you have calibrated sensors here's a step-by-step guide for how to determine sensor locations and the amount of data loggers for temperature mapping studies one uh Define the scope and objectives of the temperature mapping study to identify the critical temperature zones and locations within the equipment or storage space three determine the number and placement of sensors and data loggers four install sensors and data loggers five test and calibrate the sensors and data loggers and six collect and analyze temperature data so with number one um this should include the intended use of the equipment or storage space the regulatory requirements that apply and the specific temperature limits that must be maintained number two identifying critical temperature zones um these are the areas where temperatures most critical to the Quality safety and efficacy of the product where deviations from predetermined limits could have the greatest impact number three determine the number and placement of sensors the number and placement of sensors and data loggers should be sufficient to provide comprehensive coverage of the critical temperature zones and locations and to ensure that the temperature data collected at uh is at an appropriate frequency and resolution number four install the sensors and data loggers they should be installed in a manner that is consistent with manufacturers instructions and in accordance with good engineering practices number five was test and calibrate sensors um so sensors and data loggers should be testing calibrated to ensure that they are functioning correctly and that the data collected is accurate and reliable and number six collect and analyze temperature data temperature data should be collected and analyzed over a sufficient period of time to ensure that the facility equipment or systems are operating consistently and within predetermined limits any deviation from those limits should be investigated and and addressed okay so I wanted to give you guys um some some simple tips for ensuring good temperature mapping experiences um I've also included these over in the form download section of the webinar um I believe that it's a part of the same form that was provided to you earlier so if you wanted to check that out you could go and download that um number one was to know and understand your equipment requirements two verify CTU calibration prior to execution a third tip is to document the placement of each thermocouple or Data Logger on the sensor replacement data sheet that's in your protocol and sketch out any additional details and you should do that at the time of placement sometimes people will go out into the field and and and put data loggers all throughout your unit and then think they'll go back to the table and fill out the you know where they put the data loggers um that'll bite you do it at the time of placement tip four was um before starting the temperature mapping study ensure that all sample intervals are correctly programmed for studies greater than or equal to two uh to 24 hours five or ten minute intervals are standard and for studies less than two hours 30 second intervals are recommended number five was is to allow your thermocouples or data loggers and the controlled temperature chamber to reach temperature equilibrium once your unit is stabilized at the desired temperature and the sensors have acclimated I would allow your sensors to collect to collect 10 to 30 minutes of more data to allow for your appropriate data set to be collected sometimes people will will start their sensors put them in the unit and start collecting right away and after they close that door sometimes that unit takes time to get back to temperature range or get down to temperature range so that's the purpose of that tip um don't forget the typical mapping durations so ctus that we've been talking about this morning are 24 hours typically 24 hours cold rooms are typically 72 hours or three days and warehouses are seven days or 168 hours um for their duration number seven was label each thermocouple or Data Logger for identification purposes this can be done physically with a label maker or in the applicable software data logging software that you're using you can usually label your your sensors there number eight was to keep thermocouples distance from any walls or boundaries number nine the thermocouple or sensor tips should be suspended um so sometimes you're going to need to use thermocouples and you're going to need to have them suspended in the in the air or you'll use a Data Logger which will have thermal thermistors which will have sensors on the end so they should be suspended not lying down on a surface or up against a surface or pinched between surface just in the air tip 10 was the thermocouple should be measuring in Open Air versus being placed in a buffer so I know that that is a controversial topic um many different places do it many different ways and some say the sensors should be placed in a buffer that has similar properties to um that of the RTD or the EMS probes and most of them are in a glycol buffer another example would be them they would be in a bottle of glass beads or glycerin or in a dampening block but the idea is to measure open air but I know some folks um you know it's a topic of for debate but uh just thought I'd throw that in so with that um we've discussed how temperature mapping is a critical tool um we've discussed how it ensures the stability and quality of temperature sensitive products and samples in a variety of Industries right um by implementing consistent and routine mapping practices utilizing state-of-the-art data loggers and software and following industry standards and regulations you can ensure that compliance and protect your uh yours or your customers products and reputation and as we've discussed today temperature mapping can be a complex process that requires expertise and and experience to perform correctly but my hope is that you have a little better understanding of the importance of temperature mapping and the benefits that it can bring so with that I'd like to thank you for your attending our webinar um intro to temperature mapping uh if you have any further questions or would like to schedule a a meeting or consultation for temp mapping feel free to give me uh a call email me contact me I'd be happy to work with you to develop a temperature mapping and qualification plans that would meet um the unique needs of your business so again thank you for attending and I hope to that we see you in the future webinars perfect Nathan thank you very much for this amazing presentation about the intro to temperature mapping and how to decide where to put the sensors and how many to use and it's incredible how much we can cover in in small webinar but we are planning with you as well more things we have a podcast with you which will launched lunch soon and we are planning a more webinars with you and with you pre so there is a limit on how much we can cover in one small session but that's why we want to have more with you so I will launch a poll right now which asks you what additional topics are you interested in and you can also let us know in the chat if those topics are not in the poll so just let us know what really interests you and just type it in so we have right now 20 minutes for a q a discussion so I've seen that the upright team did an amazing job answering a lot of questions during the session but I think we can still address many of them or maybe collect some of the most interesting questions so everybody can hear and enjoy the answer and for this I would love to invite Adam Hartman the founder at yupri to take the moderation of the Q a and the discussion and yeah so thank you again for everybody who has come and stay with us for this interesting q a discussion so Adam the station viewers as well thank you very much Jan and and to you Nathan it's uh once again been a pleasure uh seeing your presentation wow you know you it's just so clear to me yeah the the expertise and uh and the abilities that you have in this field it's been really wonderful to uh to take us through uh this presentation thank you very much Nathan yeah thank you it's hard to compact everything into you know into a small bit of time but you know you do the best you can I think you did a great job at least because you really covered so many aspects of this you know because it's both like super regulated and there's so many parts that is you know that's the reason why you do it and then there is a part which is like it's so heavily uh you know a practical thing there's so many things that can go wrong out there which you really can't foresee all the time and and I assume that's a big part of your your work also oh yeah absolutely absolutely I mean I say it a bunch of different ways a bunch of different times that you know knowing the things that um it impacts and knowing the way that it it can help is the reason why we do what we do so absolutely and that's also you know when when we look at all the questions that that's come in during the chat here there are a lot of it that is kind of subjected to uh you know not just uh the the the hardcore why and and how you should do it but also you know what happens out there that can go wrong doing a a mapping which is also something we see in in Europe a lot of time and uh we asked this poll at one time which was um which of these problems has occurred to you during a thermal mapping or a temperature mapping and funny enough you know all of the above was one of the the answers and 27 answers that all of the above and a a list of things that could go wrong so I assume it's kind of you know it's it's it's normal that a lot of things does go wrong out there yeah no it's definitely normal and and I knew that that that that that answer uh all the above was probably gonna probably gonna win that poll was because um everyone has different experiences everyone um sees and hears and and feels different things so you go out into one one industry and they'll see a ton of issues with you know I don't know um placing thermocouples or you know and you have another another fella who I guess it's just because every we're all different right so we're all going to you know um produce not that we're trying to produce other problems um on our own so we're gonna see a ton of different problems um and the one thing I can think of is you know um pension and at least in the old days is pinching the thermocouples in the door or having you know a wire break or or or one of the data loggers malfunctions during the study and now we don't have enough data for our our 24-hour study so yeah um the the issues are are widespread but we do what we can to keep moving forward I I think you must have because you know these things happen it's also one of the questions that that come along quite often is like related to the fact that what if these things happens what about then the uh the test that you have just run a loaded test taking let's say in a warehouse seven days or a similar like what about that test you know how do you go on with that do you simply just do it all over again or I assume you've been in this position quite a quite some time oh yeah quite quite often and so I guess it's it's again it's handled differently at at all different places but one of the ways you can address um potential issues are writing that into your plan right into that into your qualification you know so if let's say you're you're mapping in in one of your data loggers um fails and now you don't have the the correct number of data loggers to to gather the data um it it shouldn't just be a deviation and now you have to redo the test there should be something worded into that that that qualification plan that allows for some kind of you know a 10 of the data loggers are allowed to fail and you know there should be it should be worked in the plan so that you know you have you know not not a way out but you have um something to support the reason for continuing doing and and sometimes um sometimes you do just need to redo the study and that's nothing wrong with that but I know it takes time and and resources but sometimes um you just need to do that sure yeah that obviously is subjected to uh well your definition um I got a question that is kind of related because during your presentation you um you talked about the the pre-calibration and the you know we're working with the certificates and it's it's a big part of the work because you know you have X amount of data loggers in the CTU it's around 10 to 15 and you have the surroundings also and in a warehouse it's a lot more so you have a lot of calibration certificates also to to handle but what about the post-calibration of the equipment do you do it you know between the test or is it just in the end of all your tests um okay so post calibration or verification of of of your sensors or your data loggers um it really depends um because using you know uh like your data loggers right or um other other sensors that are you know based on a thermistor or an RTD type of a sensor they don't require regular um post-calibration or regular verifications because um because it's it's it's different it's it's manufactured differently than it's not a thermocouple right so thermocouples you need to do every time every time you use that sensor um you need to do a post verification or calibration um because of the way it's um you know it's manufactured it's it's a thermocouple versus a an RTD or a thermistor so if I was going to map units using units like yours or uh similar I would go with the recommendation that they don't need to be re um verified post calibrated at the end of every unit or every test because um because of the calibration around that that sensor that RTD um but if I was to be using thermocouples and on in the warehouse or in a cold room or in a freezer um yes after every um qualification I would do a post verification on those thermocouples however if there was if it was written into the qualification plan if it was written into the protocol um that we're starting to group several of these units together we'll do three qualifications and then a post verification of your your thermocouples or data loggers and then you you know you move forward like that um because you want to limit yourself because what if you do have a um an out of Tolerance on a thermocouple or something and you just qualified 50 units you call into question all your your mapping so you kind of want to probably just group them out a little bit um three four units at a time and then do a verification yeah absolutely that uh that that seems very like a case we often see and and by the way a super good selling point uh over here again I'm representing you free obviously as the as the founder of Copenhagen company uh doing equipment software and uh and all this compliance work and so we heavily rely on people like you Nathan to to go out there and and do the great job of of being the assistant on the ground right because there's so many things that just happens out there during a uh a uh a test or or an entire qualification another thing a question we got was that you know when you have this huge Warehouse I know we've not touched too much about like uh warehouses and then the mapping of those because that's just you know uh ex it's just a bigger issue than than the the smaller ctus basically um but a question we got like how do you actually do a loaded test of a warehouse um which is fun to ask so um that's a good question um so new warehouses new spaces that are um that are that are built um they're going to be empty so you're going to you're going to map those empty um but then as far as a loaded Warehouse um you know you're typically you'll typically a warehouse will be loaded with um you know the products or the storage um components that are in there and you'll map the you'll map that space loaded um but as far as um having to load it or with some you know typically in a fridge or freezer we will load with a representative load of um of a freezer or refrigerator so that could be you know the boxes or the bags or freezer components but in a warehouse right so where do you get big pallets of something to represent the load you're not going to right so um I guess in in my situation it would be the way you write that protocol out um you would you know it's going to be an empty Warehouse study um you know and it when you are going to provide a loaded study then you'll document that it's a loaded study um but for a large 4 000 you know to a hundred thousand square foot Warehouse you're not gonna just be able to create a you know a representative load to do a loaded study um and it makes perfect sense to me also but but could you if you are in doubt and if it is in your qualification blend like would you um would you then do a part of it loaded just to you know validate that you you've done the the test overall uh the entire warehouse but now you're doing like a it's just a minimized experiment uh in in a part of it yeah and and I think that you you could but um but you just need to put right right that into your document um you know talk about your your qualification plan and um you know what size load are you going to be working with and what does that load consist of sure is that then the same with the another question we got like um if you let's say that that in in the beginning of your presentation you talked about this ensure and purpose and that's that's all what this is about you know and then you realize I've been been mapping your storage area that are that there are just certain areas of this location CTU or Warehouse which really doesn't comply with uh with your with your plan do you then need to you know obviously you can start all over and fix it up but could you also you know just take that out of production say that that's not part of the storage area we are going to use and then clearly you know indicate that this is not part of the the area that we're using and thereby the the mapping the qualification that we've just done is actually complying uh with our protocol yeah um exactly so I've done that before um many many situations many times um for some strange reason if an area um doesn't meet the the criteria um or it just it can't or it won't um you can do that it's you know a procedural thing it's not just you know we kind of taped off that that that shell for that space in the unit or in the space but procedurally we'll document in the um in the protocol for one but also in the SOP for that for that unit um so that users lab users or or whomever know because they've been trained on all the Sops they they know that that area is not to be used for storage got it and and what about the um you know another thing you mentioned is that you know uh equipment that drift you know you can't always be sure after you've done a mapping that you can now just trust this equipment forever and ever and that's probably also why you do the recalibrate uh re um validations once in a while but have you have you any example of you know equipment that you just you know you could you could feel that you know this one is just gonna drift or could you could you give some sort of indicators what what that could be is it the surroundings or is it just you know you can't really foresee anything like that no you can foresee it so that's a that's a really good question because just several weeks ago um our team had experienced that so when we do a temperature mapping on on a new unit or a a legacy unit um you can see where the temperature um range is on your graph um you can see that maybe you're running low you're running cold or you're running hot depending on what type of unit you're working with but you can you can gauge that and you can see and lots of times if if we are running cold on a refrigerator for example and we're all down by the three the two and three degrees mark um on the graph we know okay this thing is running cold it's got a set point of five it's running um it's running you know two or three degrees as the average um and so and we know the unit you know is is 10 years old 15 years old what have you um you know that um something needs to be done the you need to call the manufacturer into to to make some adjustments here you need to maybe it needs a recalibration um you know different things that it may it may they need sometimes um it just needs to be replaced right because it because it is old but using that um temperature mapping is your indicator to see you know that drift on that unit time after time you'll see that that that temperature is getting you know closer and closer to the uh the outside ranges so um you definitely want to use that as your indicator and and and and that's exactly what we did by um seeing that the the operating range was so low or the actual range was so low compared to where the set point was and so we had you know you got to call in some folks to get some things fixed and adjusted we remap and if that um the inside control range is still not doing what is expected um then you need to to potentially replace that unit yeah that's really good uh good answer to it um and isn't it really you know the the sole reason why you almost do temperature mappings is to to Really you know catch that uh bad situation you know bad storage situation where you can just see this is you know this is just not gonna work guys you need to replace it yeah I mean that's one of the one of the reasons why um you are to do it you know so so you can catch those things that's great and thank you again everyone out there because you've uh you've really really been been putting out a lot of cool questions that we could moderate this q a session from so I'm super sad if I can't make it all within this time I can't I can't really see them because again if I look at him I start getting distracted and then I miss what you say and I'm looking yeah that's how it is and then you know normally we would have been on the stage Nathan but in reality we're just a an ocean from each other right now so uh just a small pond yeah I would have given you a bottle of wine and said like thanks a lot it's been great um and it may be one of the last ones I just want to put a hit to you is um now we've done the mapping it's over we succeeded what about placing the you the monitoring equipment the one two three how many and how do you decide that yeah um so I guess that could be a different session different webinar but um but as far as where you place the modern sensor um it I believe that it depends on what you're mapping um refrigerators freezers incubators different than a cold room or different than a warehouse right so um typically you're not going to have two and three different monitoring sensors inside of a of a refrigerator like those examples I showed up on the screen you have one right um and you know in a warehouse or a cold room or a walk-in you'll have your different sensors based upon you know where based upon your data that you ran based upon a risk assessment that takes into account what you're storing you know the the requirements of temperature sensitivity of your of your of your samples and product so you'll you'll run that risk assessment and you'll be able to determine how many based on that and where the best spots should be put based on your your temperature mapping data thanks that was a great answer Nathan and now I think we are at the at the end of this webinar that might be a cliffhanger for our next one that could be about the monitoring equipment afterwards and then again I really want to thank you out there um maybe check out your pres site for temperature mapping equipment I think we can help you with both software and ISO 17 or 25 calibrations that are something that Nathan really touched upon today uh plus some interesting equipment um Jan are you out there to help us get through this end yes I'm here so thank you very much for this amazing session I think I'm a stagger I'll turn off my video but you can hear me right yeah we can hear you yeah perfect I'll just stay behind so thank you very much for this amazing session so I will open a thread in LinkedIn to discuss it further so if your question was not answered please go to my LinkedIn profile and check the post about this webinar so if we didn't manage to ask this question ask it in this thread in LinkedIn and Nathan could answer it there as well maybe even the upris team will do it on top of the chat you see my LinkedIn profile which you can follow me there in the post and you can see also the link for the next episode let's say the next webinar on the topic of a thermal validation things that can go wrong during the thermal validation how to avoid so please go also to this link and register and join us for this next session and I really hope that we see you again and more of such a session with Nathan and you pray so again thank you everybody for coming through to Nathan thank you Adam for doing this with us thank you very much and have a great day in the evening to the people worldwide thank you Jan and I think you out there you can expect an email with the webinar recording right Jen and a certificate afterwards also exactly right so please please expect the certificate and the the slides within several days hopefully so um it can take it depends on we have a lot to send so it depends also on our teams and Europe so maybe within a week or so you should probably get it okay and so this the um we will start sending certificates uh maybe Friday maybe Monday and then the recording we will polish it make it uh smoother and then we will share it with you perfect thank you thank you Nathan it's been a pleasure to uh to host this with you it's I'm really looking forward to the next one and uh yeah cheers to you yeah see you next time goodbye yeah thank you guys bye