28. 5. 2013
In May 2013, a large project for the British biotechnological company SCM Pharma in New Castle was successfully handed over.
The new plant for production of special vaccines required a device for fast, volume de-pyrogenisation and hot air sterilisation of glass ampoules before filling on the production line. The device VENTICELL IL 1500 class 5 fulfilled all and any setting conditions, i.e. sufficient speed of the cycle, temperature stability, complex solution of the loading system, additional measuring of various pressure differentials and mainly control via the state of the art control system SIEMENS PLC from both sides of the device. Naturally, it complies with the GAMP 5 standard.
More, the device must respect cleanness of ISO 5 class clean premises, i.e. inter alia to continuously clean the inner atmosphere through the system of inner HEPA filters. Regardless the request for prompt delivery, we performed some 45 client changes on the device, including adjustment of control SW so as to meet the British regulation for de-pyrogenisation HTM 2010.
The subject of the supply included partial sheathing of walls in the place of installation and complete installation of the device in clean premises of the new plant in New Castle/UK. More, within the scope of the project our company prepared and performed complete validation of IQ, OQ, PQ and DQ based on constructive co-operation with the client. The total volume of 29 chapters of validation documentation includes inter alia the validation of temperature, air flow, integrity of HEPA filters and occurrence of particles in the course of the sterilisation cycle.
This is another successful installation of our new line of industrial hot air driers of the line VENTICELL IL, currently extended in two volume lines of 1500 and 700 litres. The new volume of 700 litres should arrange more flexibility and efficiency for small pharmaceutical plants with more variable production program.
The project team of MMM Group already intensively prepares another project for a client operating in the pharmaceutical industry in Mexico.