Tinytags Help Verify Storage Conditions of Pharmaceutical Materials
Tinytag temperature and relative humidity data loggers monitor storage conditions of materials used in pharmaceutical manufacture.
Tinytags are used by a manufacturer of Precipitated Calcium Carbonate, used in the pharmaceutical industry, to monitor warehouse temp/RH as part of an ongoing product stability programme.
Speciality Minerals manufactures Precipitated Calcium Carbonate which is used in the construction, automotive, food and pharmaceutical industries. As the products are used in pharmaceutical applications, the Company is required to have an ongoing stability programme to determine the storage conditions and shelf life of the products. This gives customers confidence that products are safe for human medicines/consumption and will not spoil over the quoted timescale.
The company has four Tinytag Ultra 2 temp/RH loggers, two in constant use, and two in reserve. One of the data loggers is used to monitor in the warehouse, and the other is used to monitor conditions in the stability sample storage area. By monitoring these two different areas, Quality, Safety and Environmental (QSE) Manager John Cooper is able to prove that the stability samples and the products in the warehouse have been stored at very similar temperatures and R/H , to help validate recommended storage conditions and product shelf life claims.
Tinytags were initially recommended to John by a visiting instrument technician who had seen the loggers used successfully at other companies in very harsh conditions. On his recommendation John purchased the Tinytag Ultra units, and has found them to be robust, reliable and very easy to set up and download.
John comments, "When I am being audited by pharmaceutical customers I am able to prove to them (by showing them the downloaded graphs from the Tinytag Explorer software) that the temperature of our stability sample area is the same as our warehouse. This gives the customer confidence and makes my life easier!"
He adds, "In the pharmaceutical industry customer and legislative requirements are always changing and our customers now require calibrated data loggers. Gemini Data Loggers was able to supply calibration certificates which satisfy our customers, and I plan to have Gemini service the loggers and renew the calibration annually."