Optima H4 process nested vials, syringes and cartridges
German pharmaceutical packaging company Optima Pharma will explore key trends and issues in its recently launched series of expert interviews known as O! talks. New equipment types and features tailored to meet changing customer needs will be discussed on the exhibition stand.
Topics will include the latest trends in pharmaceutical freeze drying, such as: What development goals are the specialists at Klee currently pursuing? Where is isolator technology headed – what will the next five years look like?
Another focus of the talks is on filling and closing technology: How can filling and closing processes be optimised for small batches, a broad range of formats and isolator technology?
The interviews will also address how flow visualisation can be effectively used in customer projects. What opportunities and potential does this technology offer?
Optima will exhibit a system that generates only a single vial of product loss in the entire batch process, including startup, weighing, production and end-of-batch. The system demonstrates that even small batches with the highest SAL (sterility assurance level) can be cost-effectively processed.
The machine on display includes a rotary washing machine, a sterilisation tunnel and a filling and closing unit. In the 4 + 2 peristaltic dosing system, the dosing pump is situated outside the isolator-protected area – one of the reasons why the machine can be completely changed over to a new product within 15 minutes.
A practically maintenance-free isolator from Metall+Plastic provides H2O2 and catalytic ventilation for considerably shorter cycle times. The maximum output is 5,500 vials/h, with a format range from 10–500ml.
Combining the ultimate in system flexibility with time and cost advantages, the Optima H4 processes nested vials, syringes and cartridges. It can accommodate filling systems based on rotary dosing pumps, peristaltic filling and time-pressure filling. If necessary, a robot can open the tubs and remove the Tyvek paper, and this function has already been installed in the filling machine section, which saves space. Semi-automatic systems can also be integrated.
The combination of a Kugler Linoline and multiple Inova components shows how bottles, vials, conical closures, screwcaps and pipettes can be flexibly and aseptically processed
Flexibility is also the byword when it comes to containment: whether oRABS, cRABS or isolator, all systems can be cost-effectively fitted to the standardised machine base. A ten-position system is provided for filling. The transport system in the Optima H4 ensures gentle container handling. It achieves a standard output of up to 24,000 objects/h but can be retrofitted to reach the level of 36,000 objects/h. The machine can also be later upgraded with IPC (in-process control) and vacuum filling/stopper insertion without changing anything on the machine base.
The combination of a Kugler Linoline and multiple Inova components shows how bottles, vials, conical closures, screwcaps and pipettes can be flexibly and aseptically processed. A rotary washing machine and sterilisation tunnel prepare the containers for the filling process. A single-position peristaltic pump then fills the containers, followed by 100% filling weight checking. To minimise product loss, dosing can take place on scales both at the beginning of the batch and at the end. Stoppers, caps and parts that come into contact with the product can be introduced through SteriSet boxes. The format range runs from 0.5–50ml, with a maximum output of 3,000 containers/h. Designed for wall mounting, the system can be completely operated from a single side and comes equipped with a SCADA system.
Finally, a new glove tester from Metall+Plastic checks glove integrity directly on the machine. Up to six gloves can be tested simultaneously in just 15 minutes and the results documented. The unit requires nothing more than an electrical outlet; two compressors are already integrated. RFID technology allows the gloves to be unmistakably identified. Test protocols are saved in protected storage and transmitted via a secure WLAN radio module. Following testing, all test covers and tubes can be conveniently returned to their storage hangers.
Hall 3 Stand A73