Ronco Scrivia production site
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Welcome to Savio Industrial - Ronco Scrivia Site
Our plant specialises in the formulation, and primary, and secondary packaging of sterile medical devices in pre-filled syringe vials.
The production site covers a total area of 5000 m2, of which approximately 3200 m2 are occupied by two concrete buildings.
The two buildings are connected at a ground level by metal-structured roofs and on the first floor by a concrete connecting tunnel.
The remaining area is occupied by a square in front of the main entrances and two parking areas at the rear of the facility.
Maximum production capacity:
The annual production capacity is conventionally calculated based on 1 working shift, 5 days per week.
750,000 sterile pre-filled syringe vials per year.
Class III medical devices (pre-filled vials and syringes)
2ml and 4ml → 750,000
Functional principle: SODIUM HYALURONATE
Further potential production capacity data is estimated for a possible 2×5 implementation.
The Workshop is supported by a highly skilled workforce in all aspects of terminally sterilized Class IIII medical device manufacturing.
Water system for injection preparations
Water for injections is obtained by distilling purified water using a triple-effect stainless steel distiller capable of producing approximately 120 litres/h. The plant for producing and storing water for injections is equipped with a recirculation system in AISI 316 L stainless steel that keeps the water produced in motion at a temperature of> 70°C. The system is managed and controlled completely automatically.
Filling machine
No. 1 Vial-syringe filling machine.
Autoclave
N° 1 De Lama Autoclave for sterilization of materials and finished productN° 1 Autoclave De Lama per sterilizzazione materiali e prodotto finito
Secondary packaging
No. 1: Vial packaging line
No. 1: Vial-pre-filled syringe packaging line
Quality Assurance
Quality Assurance is responsible for ensuring that adequate Quality Systems are in place in accordance with ISO 13485, cGMP, RDC No. 665 for Brazil, and all relevant regulatory requirements.
Quality control
Quality Control consists of a chemical laboratory and a microbiological laboratory.
The CQ analyses and authorises the use of all raw materials and packaging materials, performs environmental tests, analyses finished products for release authorisation.
The list of instruments includes HPLC, viscometer, osmometer, UV/VIS spectrophotometer, Total Organic Carbon analyzer, Subvisible particle counter, bacterial endotoxin determination instrument, sterility test instrument.
