Production site in Pavia
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Welcome to Savio Industrial Pavia: your reliable and flexible CDMO partner
Our state-of-the-art 61,500 m2 production facility specialises in the primary and secondary formulation and packaging of oral solids and oral liquids pharmaceuticals.
Maximum production capacity: over 1000 tons of loose bulk; 200 million blisters; 20 million bottles.
Advanced production modules: our high-capacity, highly automated production modules feature modern designs implemented in recent years through collaboration with excellent suppliers.
New product scale up: we manage the scale-up process for introducing new products through partnerships with specialized experts ensuring seamless integration into our facilities
Automated packaging lines: Fully automated packaging lines for support primary packaging in aluminum, PVC and PVDC and glass bottles.These lines are equipped to comply with serialization and anti-counterfeiting standards for packaging
Integrated systems and warehouse: our operations are supported by integrated planning, procurement and material management systems. We maintain fully automated, temperature and humidity-controlled high-density warehouses with approximately 11,000 pallet locations.
Regulatory approvals and global reach: The plant is authorized to supply multiple European and international markets and holds certifications from Italian and other authorities, such as the US and Turkish ones.
Logistics and distribution:
We provide efficient logistics solutions capable of preparing and shipping mixed loads of insulated and controlled pallets to the EU markets and other non-European regions.
Commitment to quality and compliance: Our facility upholds stringent standards in terms of Compliance, Quality and Product Supply, supported by
highly skilled workforce dedicated to innovation, problem-solving, and consistent excellence.
Production unit – overview
Covering approximately 700 m², this unit was originally constructed in the early 1980s and underwent a complete renovation between 2004 and 2005. It is fully equipped to support key stages of manufacturing with the following equipment:
- 1 raw material Broaching area for loading pre-weighed ingredients;
- 1 Diosna 400 litre granulator;
- 1 Aeromatic T6 fluid bed dryer
- 1 1000-litre ribbon mixer;
- 1 vacuum transfer system for ground granulate;
- 1 Fette 3090 double-station tablet press;
- Dedicated washing area with separate storage rooms for clean and used components
- Dedicated personnel changing rooms
Completed in 2002, this unit is dedicated to the the production of non-sterile oral solid forms, and occupies three levels with a total surface area of approximately 12,000 m². Each level is designated to support distinct stages of the production process: At level 3 raw materials dispensing area; at level 2 wet granulation and dry mixing areas, while level 1 It is dedicated to the processes of compressing and coating tablets.
Dispensing
At level 3, raw materials delivered from the warehouse – including Active Ingredients and excipients – are dispensed into dedicated Containers (IBC) using a fully automated pneumatic transfer system.
Five stations are equipped to automatically dispense high-volume ingredients via load cells.
Two laminar flow hoods (Extract Technology) are also equipped for the manual dispensing of pre-weighed medium- and low-volume ingredients.
The entire system featured validated human-machine interfaces (HMI) and scanning systems, which not only guide operators through each operational sequence, but also provide a dual-verification function.
The dispensing area in question is also equipped with dedicated spaces designed to accommodate potential future expansion of the systems.
Once the raw materials have been loaded into the IBCs, according to the approved recipes stored in the dispensing system, the resulting batches or sub-batches can be transferred to the next processing areas using two laser-guided vehicles (AGVs).
Wet granulation
3 High Shear wet granulation modules are currently installed.
The oldest module features a 600lt Diosna granulator, connected to two T8 Niro Aeromatic fluid bed dryers.
The entire module is fully automated and operated via a Human Machine Interface (HMI).
The granulator has a variable working capacity ranging from 150 to 220 kg;
To optimize the process cycles, the two dryers can be used in parallel.
The system is equipped with Cleaning in Place (CIP),
and is suitable for processing solvent-based granulating solutions.
The two more recently installed modules (commissioned in 2022 and 2024) were supplied by IMA and offer batch capacity of 600lt and 1200lt, respectively.
Dry Mixing (Direct Compression)
Dry mixing operations can be performed directly in IBCs, using a column mixer, which is also employed for lubricating IBCs originating from the wet granulation module.
Alternatively, a dedicated module equipped with a 2,250 litre ribbon mixer is available, capable of mixing batch sizes from 450 to 1,000 kg.
The module is fully automated and operated via a HMI, and it gravity-feeds a Fette3090 double-exit tablet press.
Each of the three floors of the production facility is equipped with a dedicated washdown areas, with stainless steel sinks, and clearly separate zones for storing dirty and clean equipment.
Across all production areas, the separation between clean and dirty zones is further reinforced by a pressure cascade system specifically designed to maintain controlled airflow and avoid cross-contamination.
Compression
The compression area is equipped with Fette automatic tablet presses, including 3090 double station and 2090 single station model.
All machines for tablet presses are housed in dedicated enclosures with pharmaceutical-grade partitions that separate the machine room from the operator room. This setup to minimizes the direct contact between personnel and product, while a significantly reducing dust level and ambient noise in the working environment.
Each tablet press is equipped with:
· check master – an automated system for performing and recording in process- checks,
· dust collectors
· metal detectors.
These features ensure optimal production efficiency, safety, and compliance with pharmaceutical quality standards.
Coating
The coating area is equipped with two Manesty Premiere perforated basket pans, each managed through a dedicated HMI system.
Both coaters can handle variable batch sizes, efficiently processing loads ranging between 200 and 600kg of tablets.
Oral Liquid Production and Packaging Unit
The Oral Liquid Production and Packaging Unit covers an area of approximately 500m² and has been designed to ensure a clear separation of flows between personnel, production, packaging materials and finished product.
The unit includes a dispensing area, equipped with a suitable hood for the containment of potent compounds (raw materials classified as OEB 4 and 5) where the pre-solubilization of the active ingredient in the dilution liquid can be performed efficiently.
The department is equipped with two separate dispensing areas, equipped with a preparation tank, a storage tank, transfer pumps, filtration units. Both preparation rooms are connected to the primary and secondary packaging line, allowing flexible production.
The primary packaging consists of the following machines:
· blowing machine
· capsule loading machine
· bottling machine.
The secondary packaging includes: lung n.1, bottle labelling machine, lung n°2, cartoner, case labelling machine, final case packing
The entire line is fully equipped to comply with current serialization and anti-counterfeiting regulations, ensuring product traceability.
The power plants with centralized utilities serving production are able to supply the plant with energy, hot water, steam, chilled water and compressed air through the following systems:
- Three steam boilers with production capacities of 2, 4 and 6 tons per hour
- Four oil-fee air compressors, including two 90 KW units and two 132 kW units
- Four interconnected electrical cabins equipped with transformers rated at 800, 1600, and 2500 kVA
- An integrated fluid distribution network
- three refrigeration units; two of 2.5 MW CARRIERS and one 1.7 MW high-efficiency YORK
- One 1 Mwe Cogeneration plant
- One wastewater treatment and purification plant
Energy efficiency
An energy efficiency management program has been in place at the plant since 2004. Energy consumption is continuously monitored through a comprehensive metering system (Energy Sentinel). Approximately 1000m2 of the roof covering has been equipped with a photovoltaic system, which supplies around 7% of the plant’s total energy needs. Since 2018, a 1MWe cogeneration plant – providing combined generation of Electricity and Thermal Energy – has been fully operational and serves the entire facility.
Purified water Production Plant
The purified water production system managed by a Rockwell / Auteco supervision platform, supplies Purified Water in compliance with EP/USP standards. The system operates through a continuously sanitized hot loop at 80°C serving production unit 2 and a second loop at ambient temperature for the rest of the facility, sanitized on a weekly basis.
Warehouses and Packaging
Components delivery to the packaging lines is managed through an automated Material Handling System (MHCS), fully integrated with the high-density storage warehouses (HBS). Components are transported by laser-guided automated vehicles (AGVs) and delivered to dedicated pallet stations located near the packaging lines.
Two high-density warehouses (HBS) offer a total storage capacity of 10,300 pallet positions, distributed as follows:
• WH 1 – 7,400 pallet slots
• WH 2 – 2,900 pallet slots
Both warehouses are fully segregated and are fed operated though automated lifts and conveyors. Personnel access are is not permitted to these areas.
They are controlled for both temperature and relative humidity and critical parameters are continuously monitored.
The packaging area spans approximately 3,700 m² and houses 11 Marchesini packaging lines, all fully integrated with the Material Management System (MHCS).
Each line ensures physical segregation between primary and secondary packaging areas, with dedicated personnel and material flows, and appropriate differential pressure gradients maintained between the various zones.
All lines are equipped to meet the requirements of Directive 2011/62/EU – “Falsified Medicine Directive”, through the implementation of data matrix printing and verification systems and anti-tampering devices, in accordance with the European Commission deadlines.
Compliance, Quality, Safety and Environmental responsibility
Company management is committed to providing adequate the necessary resources and ongoing oversight to ensure that all pharmaceutical dosage forms meet the highest quality standards and fully comply with applicable regulatory requirements and customer expectations.
Equally importance is placed on achieving excellence in Occupational Health and Safety for both internal staff and external collaborators, as well in Environmental Protection.The company actively promotes a culture of continuous improvement, ensuring its commitment to sustainability is shared to all stakeholders.
Quality
In line with ICH Q8, Q9 and Q10 guidelines, Quality and Compliance are considered a competitive advantage and are based on two key pillars:
A state of Permanent Readiness for Inspections, whereby all employees are actively engaged and feel personally involved and responsible for the Quality Systems under their jurisdiction:
Quality Assurance ensures the implementation and maintenance of robust Quality Systems that govern manufacturing, packaging, control, storage, and distribution in full compliance with cGMP and all applicable regulatory requirements.
Company Management is responsible for allocating adequate resources and providing oversight to meet customer expectations for high level of product quality.
All personnel contribute to a working environment where quality, regulatory compliance, safety and environmental protection are treated as core priorities in every operation.
Lean Quality approach. Compliance is designed to be both effective and efficient, through the integration of Lean Manufacturing principles (such as 5S, Right First Time, Visual Factory, Continuous Improvemente) and Quality Risk Management (ICH Q9).
Quality Control Laboratory. The Quality Control department consists of a chemical laboratory, a microbiological laboratory and a laboratory for testing packaging materials.
The CQ analyses and authorises the use of all raw materials and packaging components, performs environmental tests, analyses finished products for release authorisation. All finished products from non-European countries are subjected to Import Tests, in accordance with current legislation.
Laboratory Equipment & Equipment. The laboratories are equipped with advanced technologies, which includes air samplers, autoclaves, dissolution baths, freezers, gas chromatographs, HPLC, laminar flow hoods, microscopes with video camera and printer, ovens, particle size analyzers, refrigerators, spectrophotometers (IR, NIR, UV/Visible), Total Organic Carbon analyzer and Printed Element Verification System.
The laboratory is equipped with a LIMS and an Empower system for chromatographic data management.
