New Product Tech Transfer in CMO, Automation + CSV

o Modification of production site control system to adapt it to a new API manufacturing.:
– Changes design according to requirements.
– Programming of defined changes
– Programming of new recipes in Rockwell PLC and/or in FTBatch
– Documentation update of every unit involved in the process to include the performed changes.
– Commissioning: field implementation y and testing, together with process engineers.
– GMP Validation: validation test execution verifying and documenting the compliance to the defined requirements.
– Production Qualification and first batch support.

Benefits are provided at all stages of the project:
o Design and planning: defining the changes to the control system and optimising the actions on the different pieces of equipment on the production line in order to adjust times.
o Development: the use of standardised and customised libraries for the client speeds up development and testing times for the control system.
o Off-line testing (dry commissioning): most of the sequence tests are carried out without interfering with the equipment, thus reducing downtime.
o Commissioning and qualification: our extensive on-site team enables the implementation of changes to the new product in very short downtimes.