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:
- Asking our friend / colleague in the industry
- Searching Internet
- Cold call
- 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 –
- A product suggested is the one that is being used thus one is devoid of other good & new options in market
- Basic requirements would be similar but each individual / company has different needs
Searching Internet
- Huge data available – Confusing – searching a needle in huge stack
- Companies do SEO / Promotion – so only top list is seen
Cold Call
- Unknown company / person
- Selling company – Devil’s advocate
Putting up Enquiry
- Quite a few times, enquiry reaches to right company and it reaches to one who pays for it
- 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:
- Regulatory Compliance
- Efficiency
- Durability
- Usability
- 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 |
- 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 |
- 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:
- 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
- Data Access options – This will determine, ease of usage. More easy to access data more will yield more productive personnel
- 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 …
- Alarm Settings – One can have different alarms at different temperature.
- No. of times configuration – Some data loggers have cap on Configuration going to 3000 – 5000 times but it’s always better to have innumerable.
- Logging Time (Range of Monitoring Time) – More the number longer the shipment can be tracked
- 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.
- Data Transfer Rate – Lesser time more efficient processor and more productive personnel
- 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:
- Need for calibration
- Temperature monitor response time
- Mean Kinetic Temperature
- Max excursion count
- Battery Life
- Shelf Life
- Memory Capacity
- Data Access options
- USB Probe availability
- Alarm Settings
- No. of times configuration
- Logging Time (Range of Monitoring Time)
- Downloadable data
- Data Transfer Rate
- 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