Rotronic HygroLog HL-1D Data Logger used in retail pharmacies
Products & Services | Rotronic AG
Rotronic’s HygroLog HL-1D data logger is an inexpensive and compact cigarette box-sized device that provides dependable and accurate measurements of temperature and relative humidity.
Designed for laboratory or storage facility use, the HL-1D is finding increasingly important applications among retail pharmacies to protect their shelf stocks of drugs and medicines.
Design and Features
The HygroLog HL-1D will measure relative humidity to tolerances of ±3.0 %RH and temperature to ±0.3° Celsius.
The rugged and compact design provides high ingress protection (IP67) as well as a clear LCD display with visual alerts. These include battery indicator that tell uses when it’s time to replace the easily swapped CR2 battery, which has an approximate service life of three years under normal operating conditions.
The HL-1D offers storage capacity of up to 64,000 data points in onboard memory while the bundled HW4 software enables programmable start and stop times, switchable minimum, maximum and average data readings. The software also enables the unit to meet FDA 21 CFR Part 11 , GxP and GAMP 5 requirements.
Retail Pharmacy Applications
Data loggers such as HygroLog HL-1D are finding increasingly important application among retail pharmacies, in monitoring storage of stock. HL-1D was specifically designed for such applications.
Although high street pharmacies appear to store drugs and medicines on normal shelves, their pharmaceutical stocks must obey strictly controlled and monitored conditions to ensure they reach end-users in perfect condition.
Medicines are sensitive products. Moisture or excessively high or low storage temperatures, can impair their quality. Incorrectly stored medicines lose their efficacy, leading to significant health risks. Correct storage is therefore vital, offering as it does the guarantee that medicines remain safe and efficacious and retain their high quality right up to their expiry date.
Meeting Pharmacy GDP/GMP requirements
It is compulsory to document the storage conditions of all medicines with GDP (Good Distribution Practice) Standard 9.2, inspected by responsible authorities, legally regulating the storage of medicines on site.
For example, insulins and other liquid antibiotics must be stored in medical refrigerators at temperatures between 2°C and 8°C. The vast majority of other medicines need to be stored at temperatures between 15°C and 25°C.
Rotronic specifically designed the HL-1D data logger to suit medicinal and pharmacy environments, exhaustively testing it under real-life conditions in the Rotpunkt Rosengarten pharmacy in Bassersdorf, Switzerland.
Rotpunkt Rosengarten’s managing director, Ivan Mihajlovic, says HL-1D’s features make the pharmacy’s operations much easier.
“The quick evaluation of the data and the clear visualization of the measurement values in a PDF report meet all QMS requirements and allow us to document the data long-term,” said Mihajlovic.
Rotronic HF5 Series Laboratory Humidity Tools
|Dimensions||90 x 60 x 23 mm|
|Range of application||-20…70 °C / 0…100 %RH|
|Accuracy at 23 ±5 °C||±3.0 %RH / ±0.3 °C|
|Power supply||1x CR2 battery|
|Battery life||3 years (at a logging interval of 1 h)|
|Humidity sensor||ROTRONIC HYGROMER® IN-1|
|Measurement interval||30 s…24 h|
|Display type||LCD, 2 lines, resolution 1 decimal|
|Display refresh rate||5 sec. (Standard):(when logging same refresh rate as log interval)|
|LED indicator||2 LEDs: Right LED flashes green during data logging: Left LED flashes red when alarm limits breached or low battery|
|HW4 compatible||V3.4.1 and higher|
|Storage capacity||64,000 data point memory|
|Communication interfaces||Mini USB|
|IP protection rating||IP67|
|FDA/GAMP compatibility||FDA 21 CFR Part 11 and GAMP compatible|