Over the last decade, our injectable plants specialized in the blending, filling and packaging of injectables for pre-filled syringes and vials. Our skilled staff are highly trained in aseptic filling, and are thoroughly prepared to meet all client needs.
We mainly use stainless steel tanks in the blending process.
We have the capacity to cover a full range of batch sizes. We offer a cleaning system that uses a water for injection (WFI) and a sterilization-in-place (SIP) system. Our processes are duly validated, and effectively minimize the risk of cross-contamination. After blending, the product undergoes a process of sterile filtration using a 0.22 µm filter.
Four filling machines for pre-filled syringes (prefilled syringes from 0.5 ml to 20 ml syringes) and one filling machine for vials. All filling machines are sourced from one of the industry’s top pharmaceutical machinery suppliers.
A fifth line highly flexible is being installed in 2020.
Our quality requirements comply with European guidelines and ISO certification.
The injectable plants are specialized in aseptic filling and, if necessary, terminal sterilization.
Terminal sterilization services are available as part of the whole manufacturing process or as an independent service.
In order to meet a variety of client needs, the terminal sterilization autoclave is located in a separated building, along with all of the services necessary to guarantee its proper operation. The building complies with even the most rigorous standards, offering features such as:
- A dedicated water and clean steam systems for the autoclave.
- Regulated and controlled movement of product and personnel.
Automatic, semi-automatic, and manual inspections are available after the aseptic filling in order to eliminate non-conform syringes and vials.
The automatic inspection provides to Rovi a high resolution with high frame rate, lowering the risk of false rejects and being more efficient in manufacturing processes.
Safety devices assembly
Due to safety legislation in many countries, it has become mandatory to use integrated protection systems to minimize the risk of accidental needle stick injuries.
Since January 2009, Rovi offers a service to place different kind of safety devices on pre-filled syringes with our new, fully automatic assembly equipment, which produces up to 21,000 units per hour.
ROVI Pharma Industrial Services offers the capability of placing different kind of safety devices on pre-filled syringes such as BD Ultrasafe™ and BD Preventis™.