Gerresheimer develops pharma filling line for cleanroom environment
Packaging and filling line built to a tight schedule
In addition to the optimisation for plastics processing, industrialisation and production, Gerresheimer Werkzeug- und Automatisierungstechnik planned and built a pharmaceutical filling system for cleanroom operation to ISO class 7 EN ISO 146441-1/. Gerresheimer Regensburg loaded the first clinical samples, which were required for clinical studies and approval.
The line was developed to a tight schedule in close cooperation between Gerresheimer Regensburg, Gerresheimer Werkzeug Automatisierungstechnik (the moulding and automation department of Gerresheimer Medical Plastic Systems) and the pharmaceutical company. The filling line concept took into account the flow of goods, the existing transport equipment and the airlock technology used in the pharmaceutical company’s cleanrooms. The pharmaceutical filling line was also coupled with the downstream packaging line.
Manfred Baumann, coo/cto of Gerresheimer Regensburg, considered the coordination of both lines as one of the major challenges of the project.
He explained: ‘The ISO Class 7 filling line and ISO Class 8 packaging line are separated by airlocks. Moreover, the cycle times of both lines and even the breaks of the staff operating on both sides of the airlock are different. Together with the university of applied sciences, HAW Weiden, Gerresheimer developed a transport concept to solve this issue. Computer simulation engineering helped us, which ensures a smooth continuous production process.’
The pharmaceutical filling line complies with EN ISO 146441 Class 7 and meets the standards of Good Manufacturing Practice (GMP) and Good Automation Practice (GAMP). Extensive FMEA assessments were carried out. A special control system is responsible for data management and transmission. The customer will carry out commercial filling.