Temperature monitoring system installed in pharmaceutical laboratory
Ferring is a biopharmaceutical company active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics.
Following an external audit and due to the strict nature of quality processes Ferring were required to install a temperature monitoring system to audit and facilitate the correct temperature within their six laboratory shakers. These shaker devices mimic the human body and therefore need to be monitored at 37 degrees Celsius.
In addition, the solution was required to be compliant with 21 CFR II which regulates electronic records and signatures within the food and drug sector. Ferring came to JWF due to our track record in providing measurement solutions. Their requirement was a complete turnkey solution including the design, supply of product, installation, set up and commissioning.
JWF provided the following solution including all wiring, installation and commissioning:
- A new enclosure with an RVG 200 colour chart recorder was mounted next to the shakers showing the temperature reading in a chart and indicative format.
- 6 RTD’s were mounted in the shakers and terminated within the enclosure, this gave precise readings back to the chart recorder where the operator can visually check the temperature to ensure correct operation and temperature being displayed was within limits.
- Operator training with Datamanager software provided to give in depth analysis of all the data and chart files generated to historical and traceable standards.
Ferring are delighted with the service from JWF and solution to this issue which meet both the 21 CFR II regulations and audit recommendations.