The INOVA SV is suitable for a wide variety of applications, from testing to producing small and medium-sized batches. Since numerous product changes are typical in the biopharmaceutical industry, the system can be equipped with comprehensive upstream and downstream equipment and barrier functions to ensure safe processing of various types and classes of pharmaceuticals.
The system allows the processing of nested, ready-to-use syringes, nested vials, and carpules in one unit. The operator can set up the machine alone, and can make a quick change within 30 min. The contact points of the system to the containers are reduced to an absolute minimum to allow gentler processing. In addition, there is no glass-to-glass contact of any kind during the processing.
A number of filling-system variations are possible, all of which can be set up very quickly and easily. Rotary piston pumps, peristaltic pumps, mass flow metering, and time-pressure systems offer advantages and disadvantages relative to the various types of pharmaceuticals.
Further options include: the possibility to fill under a vacuum, or to pre- and post gasify the filled products with an inert gas if appropriate modules are used; in-process control (IPC) is possible, by which the filling weights are recorded up to 100% and statistically evaluated; the enabling of an especially high-level of filling accuracy; buffer systems to temporarily store the product.
Nested syringes or vials are usually pre-sterilized 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. Fully-automatic, semi-automatic, or manual functions for bag opening (cutting open), for handing over to the transport system into the next higher room class, to pull off the sealed Tyvek foil from the nest, and to remove the intermediate layer (e.g., TR robot or Tyvek Removal Box) are available as options which can be added to the machines.
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 help ensure pharmaceutical quality. Labelers label the products and document the processing. Tack & trace systems can likewise be implemented.
The INOVA SV can be equipped with both isolators and laminar flow units that can be operated from the control panel. Higher clean room classes, operator protection, and protection of the pharmaceuticals against contamination are added as required, including systems for processing toxic substances. The compact and narrow footprint of the INOVA SV makes effective use of barrier systems.
The system can be scaled and modified at any time to suit changing market conditions or new requirements of the pharmaceuticals to be processed, allowing the initial investment to be very flexible.
