New Machines and Solutions from Optima Pharma

Visitors at ACHEMA 2015 can view a range of technologies from sterile-filling and freeze-drying solutions to isolators and restricted access barrier systems (RABS) at Optima Pharma’s stand.

Maximizing product utilization. Optima Pharma is showcasing 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 sterility assurance level can be cost-effectively processed. The exhibited machine includes a rotary washing machine, a sterilization tunnel, and a filling and closing unit. In the 4 + 2 peristaltic dosing system, the dosing pump is situated outside the isolator-protected area; according to Optima Pharma, this feature enables the machine to be completely changed over to a new product in 15 minutes. A maintenance-free isolator from Metall+Plastic provides H₂O₂ and catalytic ventilation for shorter cycle times. The maximum output is 5500 vials/h, with a format range from 10ml to 500 ml.

Flexibility with OPTIMA H4. OPTIMA H4 processes nested vials, syringes, and cartridges, offering system flexibility with time and cost advantages. It can accommodate filling systems based on rotary dosing pumps, peristaltic filling, and time-pressure filling. High-tech functions have been integrated into the modular type to further enhance the underlying flexibility of the machine. 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.

When it comes to containment, flexibility is important, especially in fitting all the systems whether it’s oRABS, cRABS, or isolator, to the standardized 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 in-process control and vacuum filling/stopper insertion without changing anything on the machine base.

Sterile filling of varied containers. The combined system 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 sterilization tunnel prepare the containers for the filling process. A single-position peristaltic pump then fills the containers, followed by 100% filling weight checking. To minimize 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 via SteriSet boxes. The format range runs from 0.5 to 50 ml, with a maximum output of 3000 containers/h. Designed for wall mounting, the system can be completely operated from a single side and comes equipped with a SCADA system.

New glove tester. Glove ports in isolators are the weakest point in the protective housing.  The new glove tester from Metall+Plastic checks glove integrity directly on the machine. Up to six gloves can be tested simultaneously in 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.

Source: Optima, Hall 3.0, Stand A73