Tiofarma, together with its sister companies, leading specials and contract manufacturers in the Netherlands, is implementing Ci-DMS Weigh and Dispense software from CI Precision as part of renewal and extensions of its plant in Oud-Beijerland, near Rotterdam. The company is the Netherlands' largest manufacturer of ‘specials’ for hospitals and pharmacies and also manufactures pharmaceutical products under contract. Production capabilities cover a complete range of solid, semi-solid and liquid formats.
With commissioning expected in mid 2015, the Ci-DMS system will be installed and fully integrated with a suite of new business IT systems and will provide improved control and recording of the dispensing of raw materials, intermediates and packaging materials for each production batch.
Jan Altena, Project Manager Systems at Tiofarma, explains that Ci-DMS will supersede an existing installation, providing greater functionality, optimum cGMP compliance and offering connectivity with plantwide information management systems. 'We want to ensure a high quality dispensary as the foundation of our production facilities. Safety and product quality are key considerations for us. We handle a great variety of raw materials, some of them highly potent, so exposure of our operators must be reduced to the absolute minimum,' he explains.
'The Ci-DMS system will achieve this by guiding and streamlining processes, such that operators will spend their time in the weighing booth as reliable, secure and effective as possible.'
The system will deliver significant efficiencies while also providing greater visibility of stock availability and usage. Ci-DMS will provide operators with step by step instructions for each weighing, including health and safety instructions per material. In addition, barcodes will be used to identify raw materials in all process steps: from incoming goods to production. Ci-DMS creates a single electronic record of all actions. 'Ci-DMS has onboard web services that allow open standard integration with other software to make retrieval of a wide range of data very straightforward,' adds Altena.
The search for a new system began early in 2014 and ultimately came down to a choice between CI Precision’s offering and one other. Hans Waals, Tiofarma’s Managing Director, says that although the alternative system has a significantly larger market share and a higher profile than CI Precision, the decision was based on a general consensus that Ci-DMS was the more flexible solution. 'It is clear that Ci-DMS will adapt to and work well with our established processes, where we see a closer fit to our organisation considering future growth and development when compared with the alternative,' he says.
The new system will provide the platform for future use of CI Precision’s Nexa electronic batch record modules to replace paper based protocols and batch records for the complete manufacturing and packing process. It supports Tiofarma in next steps to convert to paperless operations.
Working in partnership with Tiofarma’s quality team, CI Precision will complete the installation using proven validation templates to ensure that the system is fully validated to GAMP 5 standards and complies with cGMP.
That spirit of partnership is highlighted by Waals. 'This is a major project for us, impacting what we consider a crucial step in manufacturing: weighing. The software is, of course, key but it was also vital that we select a partner who will support us through the transition. In CI Precision we have found just such a partner and we look forward to a long and successful collaboration.'