Fedegari manufactures sterilizers, washing systems, and isolators for the pharmaceutical and biotech industry – from process design to validation.
Fedegari Group
Albuzzano (PV), Italy · Sellersville, PA, USANew on Amplifa
Solution Partner for Sterilization and Decontamination
Fedegari is an Italian manufacturer of sterilization and decontamination systems for the pharmaceutical and biotech industry. The company produces saturated steam, superheated water, and steam-air mixture sterilizers, dry heat sterilizers, GMP washing systems, laboratory sterilizers, glassware washers, bio-decontamination units, as well as pharmaceutical isolators and sterility testing isolators – including central plant components manufactured in-house. As a solution provider, Fedegari supports customers throughout the entire lifecycle: from process design and optimization to engineering and automation, manufacturing, installation, and commissioning (IQ/OQ/PQ), up to GMP-compliant validation, as well as after-sales support and spare parts supply. In addition to the headquarters in Italy, the company operates a Tech Center in Sellersville, Pennsylvania (USA), which is used, among other things, for PDA practical training on the validation of moist sterilization processes. Customers include Mark Cuban Cost Plus Drug Company, WuXi Biologics, and Aboca; around 90 % of production is exported.
- Site
- Albuzzano (PV), Italy
- Processes
- Moist sterilization (F0 process), Dry heat sterilization and depyrogenation (FOD), Sterilization with saturated steam (FOF), Sterilization with superheated water (FOW), Sterilization with steam-air mixture (FOA), Washing/Cleaning (GMP washing processes, steam washers, laboratory glassware washers), Bio-decontamination (Hydrogen peroxide vaporization), Sterility testing (Sterility Test Isolator)
- Materials
- Saturated Steam Sterilization, Steam-Air Mixture Sterilization, Superheated Water Sterilization, Dry Heat Sterilization and Depyrogenation, GMP Steam Washing Processes, Laboratory Glassware Washing, Bio-Decontamination with Hydrogen Peroxide Vapor, Commissioning and Validation
- Certificates
- B-Corp (in certification process), GMP-compliant Validation (IQ/OQ/PQ), B-Corp (Certification Process), ISO 9001
- Founded
- 1953
- Industries
- Pharmaceutical and Biotech Industry, Life Sciences
- 01
Process design and optimization
- 02
Engineering and automation of systems, machines and processes
- 03
In-house manufacturing of systems, machines and basic components
- 04
Commissioning (Installation, Startup, IQ/OQ/PQ)
- 05
GMP-compliant validation
- 06
After-sales support and spare parts supply
Processes and Technology
Saturated Steam Sterilization
Flexible standard solution for moist heat sterilization processes with F0-based control.
Steam-Air Mixture Sterilization
Positive pressure sterilization for air-sensitive, packaged products.
Superheated Water Sterilization
Positive pressure sterilizer for products in containers and sealed packages.
Dry Heat Sterilization and Depyrogenation
For dry sterilization and depyrogenation, e.g., of glassware.
GMP Steam Washing Processes
Effective washing strategies using steam as a heat carrier, without detergents.
Laboratory Glassware Washing
Economical cleaning of laboratory glassware.
Bio-Decontamination with Hydrogen Peroxide Vapor
Decontamination of rooms, isolators, and equipment.
Commissioning and Validation
Installation, operational, and performance qualification according to GMP standards.
Sites
Albuzzano (PV)
ITHeadquarters: Manufacturing, Engineering, Validation
- Materials
- Stainless Steel Equipment Components
- In-house manufacturing of systems, machines and related fundamental components
Sellersville, PA (Tech Center)
USTech Center for Training, e.g., PDA Hands-on Training for Moist Sterilization Process Validation
Equipment and Systems
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Moist sterilization (F0 process)Heat Treatment | – | – | – | – | – |
| Dry heat sterilization and depyrogenation (FOD)Heat Treatment | – | – | – | – | – |
| Sterilization with saturated steam (FOF)Heat Treatment | – | – | – | – | – |
| Sterilization with superheated water (FOW)Heat Treatment | – | – | – | – | – |
| Sterilization with steam-air mixture (FOA)Heat Treatment | – | – | – | – | – |
| Washing/Cleaning (GMP washing processes, steam washers, laboratory glassware washers)Surface | – | – | – | – | – |
| Bio-decontamination (Hydrogen peroxide vaporization)Surface | – | – | – | – | – |
| Sterility testing (Sterility Test Isolator)Testing | – | – | – | – | – |
| Process design and validation (IQ/OQ/PQ, GMP-compliant validation)Engineering | – | – | – | – | – |
| Engineering and Automation of systems, machines and processesEngineering | – | – | – | – | – |
| Manufacturing of systems and machines incl. basic components in-houseAssembly | – | – | – | – | – |
| Commissioning (Installation, startup)Assembly | – | – | – | – | – |
12 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Saturated Steam Sterilizer | Fedegari FOF | – | – | – | – |
| Eco-Steam Washer | Fedegari FWS | – | – | – | – |
| Sterility Test Isolator | Fedegari FCTS | – | – | – | – |
| Vertical Laboratory Sterilizer | Fedegari FVA/A1 | – | – | – | – |
| Bio-Decontamination Unit | Fedegari FCDV | – | – | – | – |
| Superheated Water Sterilizer | Fedegari FOW | – | – | – | – |
| Wash-Sterilizer | Fedegari FOWS | – | – | – | – |
| Laboratory Glassware Washer | Fedegari FGW | – | – | – | – |
| Steam-Air Mixture Sterilizer | Fedegari FOA | – | – | – | – |
| Dry Heat Sterilizer | Fedegari FOD | – | – | – | – |
| Pharmaceutical Isolator | Fedegari FCIS | – | – | – | – |
| Stand-alone Laboratory Sterilizer | Fedegari FOB5 | – | – | – | – |
Additional services
Reference customers
Quality and Validation
Fedegari verifies machines and processes according to GMP standards, including IQ/OQ/PQ activities as part of commissioning. The company is in the process of obtaining B-Corp certification.
| Evidence | Albuzzano (PV) | Sellersville, PA (Tech Center) |
|---|---|---|
| GMP-compliant Validation (IQ/OQ/PQ) | ||
| B-Corp (Certification Process) | ||
| ISO 9001 |
History
- 1953
Founding of Fedegari
- 2026
Fedegari becomes ISPE Gold Corporate Partner 2026–2027