Hemant Meshram

Criteria to be considered for Data Loggers selection

By Mr. Hemant Meshram Pharmaceutical products such as Vaccine, Biologics, Drugs and other products require cold chain supply and one of the common temperature range is 2 to 8 deg. cel. To maintain the cold chain is tough job but it is even tougher to ensure cold chain has been maintained and for the same, one […]

Choosing Temperature Monitoring Data Logger – a New Insight

Pharmaceutical products such as Vaccine, Biologics, Drugs and other products require cold chain supply and one of the common temperature range is 2 to 8 deg. cel. To maintain the cold chain is tough job but it is even tougher to ensure cold chain has been maintained and for the same, one is dependent on electronic temperature monitoring data loggers.

Data Loggers have become an indispensable tool for Pharma companies to monitor cold chain and facilitating supply chain’s professional job – A True Companion. There are many data loggers available in market with new one coming each day and in today’s world very easily accessible. But as always, searching the True Companion is a toughest task.

To find that Perfect tool or True companion, we follow many methods some of them as below:

  1. Asking our friend / colleague in the industry
  2. Searching Internet
  3. Cold call
  4. Put up enquiry

You may select any one or combination of the above. Now, Law of nature plays the role – each tool has Pros & Cons. We all know Pros but I just want to take your attention to some Cons

Asking a Friend / Colleague –

  1. A product suggested is the one that is being used thus one is devoid of other good & new options in market
  2. Basic requirements would be similar but each individual / company has different needs

Searching Internet

  1. Huge data available – Confusing – searching a needle in huge stack
  2. Companies do SEO / Promotion – so only top list is seen

Cold Call

  1. Unknown company / person
  2. Selling company – Devil’s advocate

Putting up Enquiry

  1. Quite a few times, enquiry reaches to right company and it reaches to one who pays for it
  2. Numerous sites

Whatever method you choose one thing for sure is you will have to do – “Analyse various options available in market by yourself”. Thus in order to make your data logger selection job easy, I hereby put some of the key points that will help you to choose good data logger.

All the criteria or points to be considered for Data Loggers selection can be classified as under:

  1. Regulatory Compliance
  2. Efficiency
  3. Durability
  4. Usability
  5. Usage Cost

To further make job easy, each criterion has been classified on basis of Importance. Wait a Minute; it is not importance of a parameter / feature over others rather it indicates – “Importance of each parameter over wide range of Data Logger”.

Here is one important point to note – Nearly all the data loggers in market has to comply with this otherwise it won’t sell. But in the whole process company makes our job easy while selecting Data loggers we don’t need to concentrate on this one, please note – only while selection of data logger from options available. Thus, all the parameters on which nearly all the data loggers comply or have similar feature would be considered as low importance.

Also, as a marketing trick company projects this feature and roll other crucial points under it. High importance will be one that is only available in selected few or that is crucial – while selection of data logger from the range.

Now, we will discuss each criterion in detail:

A) Data Loggers Regulatory Compliance

Selection Importance – High

Parameters Depends Product Availability in Market Reason
Need for calibration Products, Country, Company Loggers are calibrated for the life of the battery in the logger Calibration for defined period compels one to Re-Calibrate, even if Battery is Live and cost of usage is higher
Temperature monitor response time Products, Country, Company 30 second to 240 seconds Lesser the value more efficient data logger
Mean Kinetic Temperature Products, Country, Company Available as required US Pharmacopeia and others requires this

Selection Importance – Low

Parameters Depends Product Availability in Market Reason
Compliance Products, Country, Company 21 CFR Part 11 Nearly all data loggers comply
Approvals Products, Country, Company WHO, UNICEF Nearly all data loggers comply
Test, Performance & Suitability (Chilled & Frozen foods) Products, Country, Company EN 12830 Certification Nearly all data loggers comply
Company Certification Products, Country, Company ISO Certified Nearly all data loggers comply
EC directives Products, Country, Company CE mark Nearly all data loggers comply
Products validation Products, Country, Company 3-Point NIST Calibration certification Nearly all data loggers comply
Data Sampling interval Products, Country, Company 5 sec to 180 hours 5 mins to 30 mins  is used by most in industry

Of the above, you will notice that Data Sampling Interval is given low importance as most of Data loggers are designed to have data sampling interval as required by industry starting from 5 mins to 30 mins, which is generally maintained by Industry.

B) Data Loggers Efficiency

Selection Importance – High

Parameters Depends Product Availability in Market Reason
Max excursion count Products, Country, Company 48 Bigger value more efficient data logger

Selection Importance – Low

Parameters Depends Product Availability in Market Reason
Temperature Measurement Range Type of products  -30°C to +80°C (customised available) Nearly all data loggers have same range
Measurement Accuracy Type of products and regulatory compliance  ± 0.5 °C over the temperature range available Nearly all data loggers have same value
Temperature Resolution Type of products and regulatory compliance 0.1 °C Nearly all data loggers have same value
  1. C) Data Loggers Durability

Selection Importance – High

Parameters Depends Product Availability in Market Reason
Battery Life Personnel using & Place up to 3 years Some loggers calibrated for Life of battery, more battery more cost efficient
Shelf Life Personnel using & Place up to 5 years More shelf life more cost efficient

Of the above, Battery Life and Shelf Life varies a lot, generally data logger is available with 1 year Battery Life that compels you to use only for a year or so. Now the fact is you will loose 1 month of Battery Life – coz of order processing and final delivery of product at your doorstep. The above is true for Shelf life as well.

Selection Importance – Low

Parameters Depends Product Availability in Market Reason
Water Resistant Products, Country, Company NEMA 6 / IP rating 68 Nearly all data loggers comply
Type of battery Products, Country, Company Lithium Nearly all data loggers same type
  1. D) Data Loggers Usability

Selection Importance – High

Parameters Depends Product Availability in Market Reason
Memory Capacity Monitoring Time 2000 to 16,000,000 More memory more data
Data Access options Personnel using & Place USB or wireless Ease of usage, more productive personnel
USB Probe Personnel using & Place In built Ease of usage, more productive personnel
Alarm Settings Personnel using & Place Up to 8 programmable alarms More alarms more diverse data
No. of times configuration Personnel using & Place N no. of times Limitless better than with limit (usage count is unaffected)
Logging Time (Range of Monitoring Time Products, Country, Company Max 1095 days Higher value longer shipment and more data
Downloadable data Personnel using & Place Countless time Limitless better than with limit (saves in case of data loss)
Data Transfer Rate Personnel using & Place About 1 to 10 min Lesser value more efficient
RFID / NFC / Bluetooth Personnel using & Place Available as required Futuristic (USB will be outdated soon)

Selection Importance – Low

Parameters Depends Product Availability in Market Reason
Software capabilities Personnel using & Place Free Downloadable software and configuration as per users need Nearly all offer this feature
Configuration Personnel using & Place Default or custom configuration available Nearly all offer this feature
Product Support Personnel using & Place Available as required Nearly all offer this feature
Range of Solutions Personnel using & Place USB, NFC, Probe, Dry Ice – as per needed Nearly all offer this feature
External probe Personnel using & Place Available as required Nearly all offer this feature
Flexible installation Personnel using & Place Plug n Play Nearly all offer this feature
Blink on excursion Personnel using & Place Customer to choose Nearly all offer this feature
Event Personnel using & Place Single or Cumulative (continuous time above or below temperature) Nearly all offer this feature
Start Mode Personnel using & Place Auto or  Manual – Button Press Nearly all offer this feature
Stop Mode Personnel using & Place Auto or  Manual – Button Press Nearly all offer this feature
Start & Stop Buttons Personnel using & Place Auto or  Manual – Button Press Nearly all offer this feature
Start-up Delay Personnel using & Place 0 sec to 168 hours Marketing trick, as loggers have option to start with button press (Most sought)
Soaking Countdown time Products, Country, Company Min 1 min to Max 255 min Even if Higher value not used in actual practice
Programmable Temp. Alarms Personnel using & Place Prog. Single and Cumulative time-out-of-range events Nearly all offer this feature
Display Current Temp. Readings Personnel using & Place LCD Nearly all offer this feature (Irrelevant – personnel is analyse data not have watch over it)
Excursion indication Personnel using & Place LED factory-programmable option – Red/Green flashing lights Nearly all offer this feature
Trigger Type Personnel using & Place min 1 min, Max – no limit Even if Higher value not used in actual practice
Set Label Personnel using & Place Available as required Nearly all offer this feature
Tag Life Personnel using & Place Available as required Nearly all offer this feature
Expiration date Personnel using & Place Available as required Nearly all offer this feature
Multi Use Personnel using & Place 25 to N no. of times Definite limit to use data logger per year. (A data logger is used 250 times or less for a year)
Temperature Bins Personnel using & Place Available as required Some require this feature
Reporting  File Format Personnel using & Place PDF and excel Nearly all offer this feature
Report Personnel using & Place Summary, Graph, Table Nearly all offer this feature
Graph Personnel using & Place Histogram, Curve, Pie Nearly all offer this feature
Automated Email Alert Personnel using & Place Customizable automated email alert for out of range tags Nearly all offer this feature
Plug n Play Personnel using & Place Available as required Nearly all offer this feature
No. of Times used Personnel using & Place Available as required Nearly all offer this feature
Weight (approximately) Personnel using & Place 10 gms to 100 gms Nearly all data loggers have same value (Irrelevant during practical use)
Warranty Personnel using & Place 12 to 24 months Nearly all data loggers have same value (Irrelevant during practical use)
Logger Size Personnel using & Place Available as required Nearly all data loggers have same value (Irrelevant during practical use)
Security Personnel using & Place Password protection for Data logger and reports Nearly all offer this feature

Of the above that are considered important, I will discuss into details:

  1. Memory Capacity – This will determine, how many data points you can have, in short – more memory more data and longer the shipment can be tracked
  2. Data Access options – This will determine, ease of usage. More easy to access data more will yield more productive personnel
  3. USB Probe – This will determine, ease of usage. In built USB, is always a better option, imagine – searching USB data cable when you don’t have time to …
  4. Alarm Settings – One can have different alarms at different temperature.
  5. No. of times configuration – Some data loggers have cap on Configuration going to 3000 – 5000 times but it’s always better to have innumerable.
  6. Logging Time (Range of Monitoring Time) – More the number longer the shipment can be tracked
  7. Downloadable data – Some data logger have cap, once data downloaded the recorder stops or other but what is the point that you generate report and you can access it once and above it, what if that one time generated report is lost / deleted.
  8. Data Transfer Rate – Lesser time more efficient processor and more productive personnel
  9.  RFID / NFC / Bluetooth – Downloading data just by wireless scanner, Mobile, Tablet is near future. This is what other data loggers are working on.

The only thing that should be noted is: Number of times data loggers Data loggers can be used is classified as of low importance even though some may consider it highly important. The reason being, the shortest time of dispatching a shipment and receiving it back would take at least 12 hours and on an average data logger is used once per 24 hours and on average data logger is being used for 20 times a month thus totalling to 240 times per year.

Thus, even if 1000’s of usage remains, it will be of no use till Battery Life is more than 1 year.

E) Data Loggers Usage

Selection Importance – High

Parameters Depends Product Availability in Market Reason
Suggested Pricing Products, Country, Company 3000 to 15000 Company’s budget

The above is important of all, coz it will determine the cost effectives. But a point to note – even 1000 Rs. Data logger will be more cost ineffective, as it is not the quantity but the quality.

Selection Importance – Low (Unfortunately None)

Parameters Depends Product Availability in Market Reason
Monitor Recording options Data Logger Return ability in good condition Single Use or Multi-Use Nearly all offer this feature

To summarise – for Data logger selection following parameters needs more of your attention as generally all or some were neglected quite often:

  1. Need for calibration
  2. Temperature monitor response time
  3. Mean Kinetic Temperature
  4. Max excursion count
  5. Battery Life
  6. Shelf Life
  7. Memory Capacity
  8. Data Access options
  9. USB Probe availability
  10. Alarm Settings
  11. No. of times configuration
  12. Logging Time (Range of Monitoring Time)
  13. Downloadable data
  14. Data Transfer Rate
  15. RFID / NFC / Bluetooth

And now, you know, what to neglect and how to select data logger.

All the best for your Data Logger Selection!!!

Note – Data considered till the date of article written and though minor changes will be occur but major changes will take time in years.

Author – Hamant Meshram

Cold Chain Monitoring – A Challenge

Cold Chain Monitoring – A Challenge
OH YES !!!
This is the inner voice that will come as soon as you read the above heading. Though, we all agree on this but are we doing enough to have addressed it.

Many of us says yes coz many are maintaining cold chain since quite a few years, 5,10, 15, 20….so on. In this period, all of us have situation where we failed – in terms of not maintaining proper cold chain.

Many of times, it was observed that everything was well – the equipment’s were working ok, data showed correct values, personnel were doing their job efficiently, etc…etc… and then also, when the end user received the package the product goes bad or some items from that batch to a particular user goes bad.

Reason Obvious – That end user might have not stored or handled it properly. Second reason, could be the guy or CFA did not handled it properly.

Now, how do I control the third person or party and when I delivered him, everything was OK from my side and if the problem occurred then it is not due to me and that person has to be blamed. Yeah, you are correct and nobody will hold you for that.

But in this whole scene, are you missing an important point – Whose company, brand and / or product is at stake, I heard –Me. Sad but true that you will are being held responsible for no act of yours.

Consider, another situation where a layman – who is illiterate, buys your product as prescribed by doctor. Later on, administering to himself or child, founds that product did not work or sometimes more serious – product had adverse reaction (not to mention five lettered word, it can cause —–).

If any of the above occurs, then it would the only one who would be blamed – the company, personnel & person managing cold chain and above all, everyone involved is at risk.

Now, get out of whole this scene. Just think, are you the only one facing this challenge, the answer is NO thus it means everyone in the world is facing it. So, if everyone in world has this challenge, there must be some solution to it and your job is to only find that – Available solution.

The solution is to have small devices that will be close enough to the product and will give some indication to the user or carrier, of whether the product has been maintained in cold chain.

Yeah now, your brain is starting to link this to similar kind of solution that you have seen or heard of or is being used – VVM labels.

The fact that VVM labels are for specific vaccines and can’t be extrapolated to everything but there would be some products that would do the job – Time & Temperature monitoring labels.

The only issue with this product, it has been used worldwide but not in India and people don’t feel necessary to use it.

Yes, the common answers –
• I haven’t faced this problem;
• My cold chain is good enough and the writer is talking of someone else;
• Ok, not now but I need to have this product in future;
• If govt. is not recommending then why this guy ….again etc…etc…

I am leaving it up to you, be proactive before the problem arrives or be reactive, choice is yours…

Author – Hemant Meshram

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