Pens and auto-injectors are assembled without mechanical format changeovers. If additional versions are to be processed, only a simple format change command at the HMI will be required.
All critical processes are automated. Pressing and joining operations as well as function checks are fully monitored as with a high-performance system.
The semi-automatic machine also is equipped with Harro Höfliger’s proven Human Machine Interface (HMI). It goes without saying that it fulfills the CFR part 11 requirements for FDA-compliant electronic signature. Customers benefit from the comprehensive service including service portal and remote maintenance.
The machine‘s proven GMP-compliant design makes operation and cleaning easy. For manual loading, up to two operators have direct access to the insertion point at the rotary table.
The illustrated semi-automatic version achieves up to 56 parts per minute. For laboratory requirements and for high output, additional versions are available: With the lab-scale machine, up to ten single or multi format parts per minute can be assembled. Harro Höfliger’s portfolio also offers fully automatic machines with a capacity of up to 560 parts per minute.
The machine concept allows sub-sequent automation at any time. For example, conversion from semi-automatic to fully automatic mode is possible, in case of increasing production demand. The integration of additional technologies such as labelers, and connections to downstream equipment such as cartoning machines is also possible.
Two products – one machine – no mechanical format changeover
With many years of experience in designing, developing, manufacturing, and commercialization of medical devices, BD supports customers in the rapid market segment of new products. BD Physioject™, a disposable auto-injector (right), was developed following extensive studies and considering user experience. It received the Ease of Use SM commendation from the Arthritis Foundation ® for its ease of handling. The auto-injector can be used in combination with BD Neopak™ and BD Hypak™ for Biotech 1ml Long prefillable glass syringes. BD Vystra™ disposable pen is designed for simple and comfortable administration of liquid medical agents with variable dosing regimens. It can be customized according to customer-specific requirements.
Photos: Helmar Lünig