Optima Pharma’s INOVA SV has been re-engineered into a highly flexible, modular system that covers a wide spectrum of applications, from testing to small and medium-sized batches.
For biopharmaceutical products that require numerous product changes, the INOVA SV modular system can be equipped with comprehensive upstream and downstream equipment and barrier functions to ensure safe processing of various types and classes of pharmaceuticals.
An INOVA SV machine can be set up either as a semi-automatic or fully automatic system. Versions with two, five, or a maximum of 10 filling points can attain an output of up to 18,000 products/hr, depending on the properties of the product, the number of filling points, and the method used to insert the stopper. The dosing range extends from 0.1 ml to 50 ml.
The INOVA SV allows the processing of nested ready-to-use syringes, nested vials, and carpules in one unit. The operator can set up the machine accordingly within the scope of a form change. Customers can make a quick change within 30 min. The contact points of the system to the containers are reduced to a minimum to allow for gentler processing. In addition, there is no glass-to-glass contact of any kind during processing.
Regarding the filling systems, a number of variations are possible, all of which can be set up quickly and easily as part of the format change work. Rotary piston pumps, peristaltic pumps, mass flow metering, and time-pressure systems offer advantages and disadvantages relative to the various types of pharmaceuticals. A suitable choice can be made in each case with due regard to their specific properties.
If equipped with the appropriate modules, it is possible to fill under a vacuum or pre- and post gasify the filled products with an inert gas. In addition, the filling weights are recorded up to 100% and statistically
evaluated using in-process control. This system attains a high level of filling accuracy via automatic trending control of the individual filling points. Buffer systems to temporarily store the product are also available.
Nested syringes or vials are usually presterilized and placed in the machine. Several functions can be integrated into the upstream area of the INOVA SV to assist in the handling of the packaging materials. Available add-ons include fully automatic, semi-automatic, or manual functions for bag opening (cutting open); options for handing over from the transport system into the next higher cleanroom class; and features to pull off the sealed Tyvek® foil from the nest and to remove the intermediate layer (e.g. TR robot or Tyvek Removal Box).
Closing of the packaging component with a stopper or plunger under vacuum can be done in the downstream area. Syringes can be fitted with a plunger rod, backstop finger flanges, and/or a safety device. Optical and sensory inspection systems ensure pharmaceutical quality, and labelers label the products and document the processing. Track-and-trace systems can be implemented.
Barrier systems are a criterion for deciding which classes of pharmaceuticals can be processed within a unit. The INOVA SV can be equipped both with isolators and laminar flow units that can be operated from the control panel. Higher cleanroom classes, operator protection, and protection of the pharmaceuticals against contamination are added as required, including systems for processing toxic substances. The INOVA SV’s compact and narrow footprint makes effective use of barrier systems.
The machine can be adapted at any time to suit changing market conditions or new pharmaceutical requirements.
