ELPRO Advances Software to Calculate Stability Budget
ELPRO has announced a new release of the elproVIEWER software enabling pharmaceutical shippers to perform detailed analysis of temperature data in the supply chain including calculating stability budget and life-cycle stability analysis.
As GDP regulations around the world get stricter requiring documented evidence of control throughout the medicinal supply chain, pharmaceutical manufacturers are in need of tools to efficiently calculate total time out of refrigeration temperatures so they can make product usage decisions quickly. Until now, these calculations have been done manually, i.e. export all measuring values of the concerned data loggers and combine them in MS-Excel, define calculation formula (how long was temperature outside of specified limits) and build their own report. Shippers will usually log e.g. +2 °C..+8 °C strict and handle excursions in retrospect or work with consolidated shipments (+2 °C..+8 °C and +15 °C..+25 °C goods in same container) and have to do an assessment in retrospect. Using elproVIEWER in conjunction with LIBERO PDF Loggers allows for these calculations to be done during the distribution chain to make immediate decisions on how to handle the product. For example, if the total allowable excursion time is nearly used before the load gets to the wholesaler, the forwarder or shipper can decide to increase temperature control measures.
Technical Report 53 of the Parenteral Drug Association (PDA) recommends calculating a stability budget for each product as a best practice approach by "using scientific data and rationale necessary to determine an appropriate stability budget for a drug product over the entire lifecycle of a product". This becomes very important when a product is questionable to be released at destination. For example Takanori Aasberg Miyashita, System Manager Temperature Control, at Novo Nordisk explains that "Right now we manually calculate total time out of refrigeration against allowable excursion time. The challenge is adding up all deviations across the different supply chain ‘levels’ (manually)".
In the 2014.7.1.0 release of elproVIEWER Professional, the "join" functionality has been enhanced and offers now two reports, the Joint Report and the Joint Assessment Report. It allows combining temperature data of up to 16 PDF reports, e.g. to calculate the life-cycle stability of a batch or to determine the annual MKT. elproVIEWER automatically calculates the statistics over the life cycle or the entire year and outputs the result in a Joint Report. For customers using our web database liberoMANAGER it is now also possible to archive these reports in liberoMANAGER.
Beat Rudolf, CEO, ELPRO describes the recent advances in elproVIEWER, "Customers want to easily manage product stability across the supply chain, without the manual work. Hence it is possible for QA to check the availability of remaining stability budget of former transport ‘legs’ and assign unspent stability budget to remaining transport ‘legs’ using elproVIEWER. From a QA perspective, avoiding using spreadsheets eliminates the possibility of data manipulation because the data is embedded in the PDF and cannot be altered in the software".
Important applications of the updated elproVIEWER software include:
• Combining up to 16 different LIBERO PDF reports that allows user to define start/end of each temperature curve, apply multiple alarm zones, and issue an assessment report that considers all monitoring periods and the whole stability budget or all allowable time/temperature information
• Assigning unspent stability budget of former transport sections to a transport that did not meet the set alarm conditions
• Performing life-cycle stability analysis
• Calculating annual MKT (Mean Kinetic Temperature) using a the Joint Report function
ELPRO will be teaching a workshop on the practical application of data analysis software at the IQPC Boston Cold Chain Global Forum on 30th September. The workshop is entitled "Make your Temperature Data Work for You…to Improve Logistics Processes and Meet GDP Quality Management Requirements". It will be attended by logistics and QA professionals to discuss using temperature data to develop risk-based profiles conduct quality assessments and optimize supply chain performance.
ELPRO continues to develop data analysis software and its SaaS (Software as a Service) platform further to meet customers' requirements and include industry leading concepts on collection, analysis, release and documentation of monitored objects and performance of equipment used.
ELPRO, founded in 1986, is a leading Swiss manufacturer of innovative monitoring solutions and data loggers for documenting environmental conditions in production facilities, warehouses and the cold chain. ELPRO partners with clients to develop solutions that integrate ELPROs high-quality measurement components into their business processes. ELPRO is consistently dedicated to quality, which resonates throughout all facets of our operation – service, technology and customer support. As the inventor of the LIBERO PDF Logger, ELPRO supports pharmaceutical and healthcare companies around the world in simplifying their cold chain while having less manual work thus reaching quicker release times. ELPRO’s US subsidiary has been established in Marietta, OH since 2003 with a full turnkey support and technical staff.