Archive for the ‘Warehouses’ Category

Temperature Mapping Hacks

Posted on: September 14th, 2015 by Dickson No Comments

Pharmaceutical Warehouse Audit Survival Guide (Featured Image)

Temperature mapping your facility, warehouse, or refrigerator is a daunting task. We know, we’ve done it a lot. With each new project, comes a laundry list of new challenges, from where to hang data loggers, to how magnetic strips may affect the accuracy of your data loggers, to how to operate a semi-broken forklift. We’ve seen a lot of curveballs, and haven’t always knocked them out of the park.

After taking our big cuts and occasionally missing, we have gained unparalleled experience in the temperature and humidity mapping industry. And we’d like to share some of that knowledge with you.

”Hackers,” ”hacking,” and ”lifehacks,” stopped being taboo about 5 years ago. The term has gone from meaning something tech-based, nefarious, and virus-infected to something good: easy tips and tricks to help you get stuff done, and make your life easier. The world has seen the creation of message boards, websites and books dedicated to teaching us how to work smarter, faster, and easier.

As avid readers of those message boards, websites, and books, we thought we would write down a few hacks that our customers may find useful, specific to one of our favorite temperature-based applications: environmental mapping.

So, continue reading for some easy ways to solve problems and not make mistakes during your next temperature mapping project.

Before Mapping: Use a three tiered labeling system for your loggers.

Label your data loggers like this: 1A, 1B, 1C, 2A, 2B, 2C, etc. This task is easy enough with a standard label-maker, and you will be very happy that you labeled your data loggers this way. Each data logger should get a label, which you can associate with its serial number for future reference. But why do it a three tiered labeling system? Unless you are doing a mapping project for a vertically-challenged room, your mapping project will include three vertical planes. The three tiered system, keeps all your data loggers at a particular plane on the same y-axis: a huge help when visualizing temperature swings, and generating your final report.

Before Mapping: Learn how to work a forklift, or a ladder.

This is a big one. You don’t think it matters until you have everything in place to map your facility, begin placing loggers, and have to delay the study because you can’t reach the necessary heights to monitor your facility completely. Most facilities will have someone who knows how to operate a forklift. So, make sure she/he is available to place data loggers in your facility, or learn how to operate a forklift yourself.

Also, make sure your insurance information is straightened out and good to go.

While Mapping: Magnets, magnets, magnets.

Magnets are great for the shelving in your facility, and for attaching to processing equipment that can’t have adhesives strapped on to it. We use magnets on every data logger. Attaching loggers to walls, equipment, pallets, and more is one of the biggest challenges facing any mapping study. You want the loggers out of harm’s way, but you also want them to be measuring the temperatures your products are in every day. With magnets, sometimes we need them, sometimes we don’t. But we are always happy having them as an option.

But . . . make sure your data loggers won’t be affected in weird ways by magnets. Sometimes you can get some strange readings.

While Mapping: Command Strips on Walls.

The SAVIOR. Command Strips are the most important piece of equipment outside of your actual data loggers. We just got done building magnets up, but a healthy supply of command strips is even more important. Command strips are perfect for both the 24 hour mapping study and the week long mapping study, because they come off walls so easily.

While Mapping: Bright colored rope and tape for any hanging loggers.

Safety Green or Bright Orange is what we recommend. If you are temperature mapping a large facility, you will need to hang some ropes from the ceiling to monitor high points and middle points in the middle of a room/area.

To do that, you will need rope. We recommend that not be a rope that is good at going incognito. You want facility staff to notice that your data loggers are hanging from the ceiling, and to thus avoid knocking them down.

After Mapping: Back It Up.

Ah, your temperature mapping study is done! Time to download the data and do some hardcore analysis, right? Hold your horses, and don’t jump for data analysis joy just yet. Before you do anything with the downloaded data from your data loggers, BACK IT UP. If you used wireless data loggers, that transmit readings via WiFi or Ethernet to the cloud (like DicksonOne!) you are probably okay, as your data is saved redundantly in the cloud.

But if you are manually downloading your data, you need to copy it off your computer to another server/computer, and to the cloud as quickly as possible. We backup our data at least three times. Don’t be the person who is at fault for having to do the whole study over again.

 


 

 

How To Complete Method Validation Documentation

Posted on: June 5th, 2015 by Dickson No Comments

Warehouse Temperature Validation First Page Document

What Belongs On The First Page?

Whether you have brought on an organization to map your facility, or you are performing the mapping study yourself, you will need to know what the document containing mapping or validation results looks like. While it may seem cliché, the first page of your mapping or validation document is probably the most important.

Now, when we say ”mapping or validation document” we are speaking specifically to the results that your company or a mapping contractor will generate after the mapping is done. If you are preforming a mapping validation yourself, the outline and overall form of this document should have already been created before you placed your first sensor in your facility. If you are hiring a contractor to map your facility, or validate some piece of your cold chain equipment, you should ask to see a sample copy of what they will provide you after the mapping study is complete.

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The first page of your mapping or validation results is also known as the “Approval Page.” This first page contains essential information that your auditor will look for when she or he is reviewing your temperature mapping or validation study.

The first thing that this page should have written on it, probably in bold, is the name of the project or study. Usually somewhere at the top, the name should tell you exactly what was done. For example, ”Temperature Mapping Study for the Dickson Company.”
The second piece of information that needs to appear on your approval page, is the contact information of the group who performed the study. If you performed the study, then that’s your company’s name, address, and telephone number. If it was performed by an outside group, you should have not only their company name, address, and telephone number on this page, but the contact information of their project lead as well.

The third piece of crucial text that must appear on your temperature mapping or validation approval page is the make, model, and serial number of the unit being validated or mapped. If an entire warehouse is being mapped (as opposed to a single refrigerator or cold room) then the address of the facility should appear on the approval page as well. Your auditor will want to know that this mapping study was performed on a specific piece of equipment or a specific facility.

Next up, is date(s). Not the date that the document was created, or the date that you received the document from an outside contractor, but the date(s) associated with the mapping or validation study. If the mapping or validation took more than one day to complete (it probably will) then the beginning and end dates of the study should be listed. This piece of information is also referred to as the date executed.

Finally, and most importantly, are signatures. Your approval page should obviously have some signatures on it. The most important signatures are by the people completing the study, and the project lead(s) on your end. In many validation documents, the organization completing the validation study (again, that could very well be you) and your project lead will have initialed signatures and dates on every single page. For the approval page, initials don’t cut it. Printed and signed names with associated dates from the project lead and person performing the validation or mapping study is essential to the proof and legitimacy of the document.

 


 

 

Data Analysis and Validation in Temperature Mapping

Posted on: May 27th, 2015 by Dickson No Comments

Data Analysis Temperature Mapping Validation

What Do You Do With All That Data?

After the mapping study is complete, when you’ve collected all of your labeled EDLM’s from your temperature mapping locations, and have them in a container with pages of their associated data sheets at your desk, it’s time to start the next step of the temperature mapping process: analyzing your data. Below are the steps you should take after you have all your mapping EDLM’s out of your facility (or you have all of their data, delivered wirelessly at your desk).

1. Download

You need to download your data! If you used a wireless data monitoring system, this could be as easy as going into your cloud-account and clicking download, or visiting your data file folder and dragging the information to your desktop. If the data loggers you used in your mapping study connect to your computer via USB, plug them in and start downloading!

2. Save

Immediately upon downloading your temperature mapping data, back it up. We can’t stress this enough. Save it to a Dropbox folder, save it to shared company drives, save it to Google Drive, whatever. Just make sure that your temperature data is not just stored on your local hard drive. It should be saved to multiple locations, for disaster prevention.

3. Find Failures

The next step is to find those sensors that failed to record data. If you are mapping a large facility, at least a few sensors will fail: it’s just the nature of temperature mapping. Whether they fail the entire temperature mapping study, or just a portion of it is for you to find out. If you find a failed sensor, there is an accepted process for accounting for that failed location. You should take the averages of the 3 closest sensors to the failed sensor location, and average out their data for the time range that the sensor failed for. As long as you weren’t being too sparse with your sensor placement, the averages of those data loggers will suffice. Just be sure to document it!

4. Calculate

We wish we could say outright that this step was completely automated for you (if you are using a contractor to map your facility, it will be) but it’s not. You should know what averages and calculations you will need to make from the EDLM’s temperature and humidity data before you start the study. Now is the time to calculate it. Some EDLM software can calculate values like Mean Kinetic Temperature for you, and we highly advise using such software (like the new DicksonWare) to calculate your averages and means.

5. Find Deviations

Next up is the scavenger hunt. Ideally, your storage area has a single, perfectly uniform temperature. But, that won’t be the case. This next step may be the most important. What you or your contractor will first look for, is temperatures that are out of the acceptable range. This can be done via a graph-overlay. Ideally, you want to take the data from each of the EDLM’s and place their graphed data over top of each other. You should either create physical or mental reference lines within your EDLM software of the highest and lowest temperatures that your products can be stored in. If at any time during the study an EDLM recorded temperature data outside of that acceptable range, you know you have a problem spot.

That may seem simple enough, but finding deviations is a little more nuanced than that. You should also look for trends of sensor groups towards extremes. If you notice that sensors placed in the southeast corner of your facility read temperatures that were 2-3F colder at night then sensors in the rest of your facility, you know that you have a potential problem spot in that corner.

6. Investigate

Once you’ve found deviations in your facility’s layout, it’s time to investigate. This step should be done in haste, especially if a product is located where the deviation occurred. First, you should remove product from the deviation locations until the EDLM temperature reading can be corroborated with another sensor. Next, you should corroborate the EDLM reading with a continuous monitoring device. Checking that device frequently in the time after the mapping is crucial to the investigation process, as you will want to not only corroborate the temperature excursion, but the timestamp for that temperature excursion. Finding the cause and then fixing the problem spot is the final step of your investigation.


 

 

Pharma Transport: Three Things You Need to Know

Posted on: May 12th, 2015 by Dickson No Comments

Transporting Pharmaceuticals Three Things To Know

1. YOUR TRANSPORT ROUTE IS BEING SCRUTINIZED

The World Health Organization (WHO) recently published guidelines for the storage and transport of time and temperature sensitive pharmaceutical products, and on the transport side, this was something that caught our eye. Qualifying the route your plane, truck, or ship takes is more than just saying,

“This is the most direct route.”

The WHO includes the following qualification parameters: weather data, laboratory tests, equipment tests, and field tests. Maybe most importantly, is the equipment qualification for the transport. If traveling through an especially extreme environment, auditors and regulatory bodies will want to know that your truck, and its cooling system were validated and qualified to hold up in such an environment.

2. THERE IS A TEMPERATURE TASK FORCE

The International Air Transport Association (IATA) is the global trade association for air transportation of goods, and represents over 200 countries. That organization is concerned with the quality of medical and pharmaceutical goods up in the air. So much so, they went ahead and created a task force to deal with temperature sensitive products.

That work group, the Time and Temperature Task Force (TTTF) will now begin creating guidelines for the pharmaceutical industry, and act as a liaison between the IATA and pharmaceutical manufacturers and distributors.

3. 10-MINUTE SAMPLE INTERVALS FOR TRUCKS

The WHO wants you taking and logging the temperature of your road vehicles at a specific interval, or at least no less than six times per hour per sensor position. That’s important, because many, many data loggers have a standard logging time of every 15 minutes. If you have data loggers in your truck, and are transporting pharmaceutical drugs, you need to have many of them, and they need to be taking the temperature of the inside of your truck at least every 10 minutes.


 

4 Important Acronyms In Temperature Mapping and Validation

Posted on: April 16th, 2015 by Dickson No Comments

Warehouse Mapping Drawing Temperature Define

Some abbreviations and acronyms are like words in our vocabulary: we don’t even think twice when we see them. In the digital world, acronyms like LOL, and NP, are part of our colloquial language. Even in the business world, acronyms like PO are nearly universal to companies, and make up the fabric of our daily work language.

When you dive inside individual industries, language can get a bit more confusing. Phrases and terms you may have never heard before are thrown around in the normal vernacular for specific industries. In the temperature monitoring industry for example, the acronym RTD may mean absolutely nothing to you. However, for us it stands for a specific type of temperature probe, a Resistance Thermometer Detector, which is a highly accurate temperature probe.

While temperature mapping is not an industry, but rather a process within multiple industries, it also has a unique language. In fact, the sheer number of industries that perform temperature mapping studies make the acronyms that are thrown around in it all the more important. When the overall goal is to keep an item cold, a food producer in Oregon may use the same language as a pharmaceutical technician in China.

This breadth leads to confusion. If temperature mapping jargon makes your eyes glaze over, or sends you running to Google, that’s bad news for your products.

To help you out, we’ve named some of the most commonly used acronyms used in temperature mapping and validation, and described them below. Some of these terms you may have heard before, as they are not specific to temperature mapping but rather the cold chain or even more generally manufacturing as a whole. So when that’s the case, we’ve decided to describe the acronym with respect to its use in temperature mapping, while not stepping on our Dickson Dictionary’s toes too much.

DL/EDL/EDLM: Data Logger, Electronic Data Logger, Electronic Data Logger Monitor

You will most likely see these acronyms written on a page over spoken to you in your facility. When you read ”DL,” ”EDL,” or ”EDLM,” the document is speaking to data loggers. These devices have quite a few names, and in your industry they may be referred to as sensors, monitors, recorders, or thermometers. They are the devices that are distributed in your facility and around your facility collecting environmental data.

GMP: Good Manufacturing Practice(s)

Good Manufacturing Practices are part of the fabric of the cold chain, manufacturing, and distribution sectors for food, pharma, and medical device worlds. There are several pillars of GMPs, including hygiene, controlled environments, and proper documentation. Temperature mapping inhabits the controlled environments and documentation pillars. A mapping study provides manufacturers and distributors of consumable products (monitored by the FDA and like governmental bodies) documentation that their environment is suitable for the product that they are storing in it, and therefore, that they are abiding by Good Manufacturing Practices.

LOP: Location of Product

In facility layouts and facility descriptions, LOP will pop up frequently. If you plan to temperature map a large facility, LOP is one of the most important acronyms you should know. It’s pretty self-explanatory upon first sight. Location of Product does mean where your product is located. For mapping professionals however, it’s a bit more nuanced than just circles on a blueprint. Product location changes, and changes frequently. Product is placed in different parts of a facility at different times of day, facility layouts change throughout the year, and product locations can change depending on the amount of inventory you have in your facility. LOP is a rabbit hole, and temperature mapping experts go down that rabbit hole to document all the locations your various products inhabit.

NIST: National Institute of Standards and Technology

The National Institute of Standards and Technology will make its appearance on your Data Logger Certificates of Calibration. When performing a mapping study, you should only use data loggers that have been calibrated to a NIST standard. NIST is your friend: they help make sure that the EDLM’s that you are using are accurate.