• How long does it take for a complete changeover from TUB to TRAY including a change of Ready-To-Use components?
This is the most demanding changeover in machine configuration. From RTU syringes pre-arranged in TUB & NEST to RTU vials pre-arranged in TRAY, it usually takes no more than 4 hours. Simpler changeovers, when maintaining the same primary package and just changing the internal RTU container, changeover time ranges from 1 to 2 hours.
Is the size changeover controlled by the HMI?
Yes, all the electronically configurable data are stored within each “size recipe”. The mechanical size parts to be replaced are driven by the HMI support.
When changeover is only related to the size of the syringe, vial or cartridge (e.g. from a 1 ml syringe to a 5 ml syringe), how long does it take?
No more than one hour, normally.
• How are contamination risks minimised during the steribag cutting procedure? More specifically, how is the tub/tray transferred to the following (peeling) module?
We have a patented, in-house solution for the fully automatic opening of the steribag. The cut is made keeping the bag flaps in a closed and fixed position. After cutting, the package is instantly transferred by an internal transfer port to the isolated processing area. To preserve the sterility of the tub, the bag flaps are opened by the suction cups only when they are docked at the gate connecting to the isolated area. The whole tub-opening unit is completely robotised and no operator intervention is required. All operations are protected by unidirectional airflow.
Is this solution applicable in the case of a double steribag (outer + inner bag solution)?
Yes. However, it is imperative that the steribag suppliers ensure an identical geometry and packaging configuration of the bag, thus allowing a completely automatic handling operation.
Can INJECTA handle different steribag materials such as PPT, PPE and so on?
Generally speaking we can handle different materials, yet we believe it fit and wise to arrange internal tests with sample materials provided by the suppliers/customers.
• How does INJECTA fulfil the updated, improved requirements present in the new Annex 1?
The new Annex 1 guidelines, concerning the sterilisation of the parts in contact with the product, drove our development of an advanced linear plugger/stopper orienting system, avoiding the use of the traditional vibrating bowl. This linear plugger/stopper feeding system is made of small-sized components ideal for RTP transfer by canister with minimal operator intervention. This is in compliance with Annex 1 requirements in terms of the sterilisation process.
In view of the growing demand of the pharmaceutical market to reduce human intervention in sterile handling operations, can this application be defined as a “real gloveless” solution?
We prefer to define our application as a “towards gloveless” solution. At IMA Life we believe that until the authorizing bodies and the pharmaceutical companies commonly agree on the effectiveness of a continuous viable particle monitoring system, to avoid the need of placing microbiological monitoring plates at critical points inside the machine, it is incorrect to use the definition «GLOVELESS MACHINE». Unfortunately, these innovative real-time viable monitoring solutions are still at a development stage.
Does a similar solution already exist for a disposable filling circuit?
Currently we are working closely with all SUS (Single Use Systems) suppliers to complete the filling circuit with pre-assembled nozzles on the supports with quick blocks.
• How is batch quality preserved?
We guarantee a cost-saving solution with a 100% IPC of all processed products with single rejection of individual non-conformities. Furthermore, we fulfil “zero reject” demands at the start and end of each production batch.
Which types of non-conformities can be detected?
We detect individual, non-conforming products caused by wrong dosage and/or plunger/stopper presence or misplacing. On demand, we can also reject the complete tub/tray.
Single rejection can be performed both in the case of a nested solution or in de-nesting.
What degree of accuracy of the plunger/stopper position can be detected?
In the case of de-nesting operations, we can detect a ±0.5 mm accuracy of plunger/stopper placing. We use dedicated cameras suitable for undergoing sanitization cycles with VHP.