Nutricia ensure compliance for UKAS audits and increase efficiency with testo Saveris data monitoring system
In the pharmaceutical industry, products must be able to demonstrate perfect quality. This applies throughout the supply chain, from research laboratories, to the production of medicines, as well as the storage of sensitive substances. Strict regulations and directives apply, for example ISO 9001, GxP, GMP (Good Manufacturing Practice) and of course 21 CFR Part 11.
If pharmaceuticals are produced or stored under the wrong climatic conditions, the stability and therefore the efficacy of the drugs can suffer as a result. Possible consequences include commercial damage and can go as far as extensive compensation claims.
Nutricia is a subsidiary of the multi-national Danone company, focusing on advanced medical nutritional products. The company develop foods for special medical purposes, tailored to help people with specific medical needs. Their extensive product range generates more than a billion euros sales revenue a year, and includes leading brands such as Neocate, milk for babies, children and adults that are allergic to cows’ milk or are immune-compromised.
Previously Nutricia used manually operated thermometers to monitor temperature, stability and humidity in their Production Development Operation. Using this old-fashioned process meant measurements were subject to human error. This was very time consuming for staff and had the potential to cause issues for audits. This led Nutricia to conclude they needed to gain 17025 UKAS accreditation.
After extensive research of the market place, Nutricia selected Testo and 2 other vendors for consideration. The Testo Saveris data monitoring system was selected after being deemed to have superior product qualities, benefits and economical cost in comparison to other monitoring solutions available on the market.
Testo Saveris records temperature and humidity values in sensitive goods, throughout the pharmaceutical cold-chain. This easy to operate system, provides transparency and traceability, as well as savings of time and costs thanks to automated measurement data recording. Measurement data is transferred by wireless and/or Ethernet connection to a Base station. If limit values are exceeded, the system features several alarm options such as SMS/email alarm or alarm relay.
All recorded data is centrally stored in software, allowing comprehensive analysis and evaluation. Testo’s validatable 21 CFR Part 11 software is also available for applications which require this additional level of security. Nutricia installed their testo Saveris system in their Microbiology Lab, as well as their Production Development and Stability departments.
Nutricia’s specific solution consists of 1 testo Saveris base, 24 x testo Saveris T2 loggers for monitoring fridge and incubator temperatures and 6 testo Saveris H4 temperature and humidity probes for monitoring in their stability cabinets. Nutricia also uses 2 testo Saveris T3 loggers for monitoring autoclave temperatures. An advantage of the testo Saveris system is Nutricia are able to integrate all of the above into the same system. Testo Saveris can also be integrated across multiple sites using the same system.
Following the installation, we spoke with Debbie Fogg, Microbiology Cell Leader at Nutricia about their experience with the testo Saveris data monitoring system. Debbie highlighted the main advantages as time-saving, greater efficiency, traceability and less chance of human error. Debbie also commented of how easy the system was to use, in comparison to their previous method of monitoring.
Debbie was also very complimentary of the Testo UK solutions service team who helped get the system up and running, saying they were very helpful, knowledgeable and organised throughout the process. She also described the Testo team as “Friendly and approachable” and “Good to work with”.
When asked to summarise Nutricia’s experience with their testo Saveris solution Debbie said “The testo Saveris system keeps us compliant with UKAS audits and ensures day to day efficiency”.
Key advantages of testo Saveris:
- Complete solution for climate monitoring in a GMP-regulated environment
- Proof of compliance at a glance for auditors
- Traceanility guarentees the efficacy and stability of phramaceuticals
- Save time with automatic recording of readings and periodic documentation
- Removes chance of human error
- Climatic conditions across sites at a glance
More Information on testo Saveris