Steriline

What Steriline does

Steriline S.r.l. is a privately held, family-owned Italian manufacturer of aseptic processing equipment for the pharmaceutical industry, founded in 1989 in Como by Gerardo Fumagalli. The company designs and builds complete filling lines and standalone machines for the aseptic processing of injectable products, including rotary washing machines, depyrogenation tunnels, vial and ampoule filling machines, capping machines, external decontamination machines, laminar airflow cabinets, oRABS/cRABS, standalone isolators, and a portfolio of robotic solutions (RVFM, RVCM, EDM-RHP, RTL, RTDS2, RNFM) introduced from 2014 onward. Its proprietary Intelligent Compounding System (ICS) extends the offering into automated hospital and compounding-center preparation of parenteral medications within ISO class 4.8 / Grade A environments, with vision systems, barcode readers, and RFID tracking for traceability.

The business operates an enterprise B2B model selling custom-engineered equipment and turnkey lines to global pharmaceutical companies, with a secondary segment in hospitals and compounding centers. Revenue is generated primarily through project-based hardware sales supported by a recurring aftermarket services stream covering technical support, spare parts, validation, qualification, modernization, and training. The company holds ISO 9001:2015 certification and complies with cGMP (Europe and America), GAMP, WHO, and 21CFR Part 11, enabling qualification into highly regulated pharmaceutical manufacturing environments. Exports represent over 90% of revenue, with 2,000+ machines installed across 50+ countries, distributed through direct enterprise sales from the Italian headquarters, wholly-owned subsidiaries in the United States (Bradenton, FL) and India (Mumbai), and a network of 20+ local agents and distributors. The current leadership comprises the second generation of the Fumagalli family, with Ilaria Fumagalli as CEO (since 2024), Gerardo Fumagalli as Chairman, and Federico Fumagalli as Chief Commercial Officer, and a consolidation project is underway to unify all production in a single Como hub.

Name

Steriline

Legal name

Steriline S.r.l.

Website

https://steriline.it

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

101–250 employees

Short description

Steriline is a family-owned Italian manufacturer founded in 1989 that designs and builds aseptic processing equipment, robotic filling lines, and containment systems for pharmaceutical companies producing injectable drugs, with 2,000+ machines installed in 50+ countries.

Ownership category

akta.pro rank

Headquarters

HQ city

Como

HQ country

Italy

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Manufacturing Equipment Sales: Sale of aseptic processing equipment including washing machines, depyrogenation tunnels, filling machines, capping machines, robotic systems, isolators, and barrier systems. Equipment ranges from standalone machines to complete production lines. Revenue is one-time with potential for follow-on services.
2. Aftermarket Services: Technical support, training, software services, spare parts, machine modernization, preventive maintenance, validation and qualification services, and on-site personnel training.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Steriline manufactures aseptic processing equipment for pharmaceutical injectable products, including washing machines, depyrogenation tunnels, filling machines, capping machines, external decontamination machines, robotic filling and capping systems, isolators, LAF/oRABS/cRABS barrier systems, and intelligent compounding systems. The company supplies both standalone machines and complete turnkey filling lines to pharmaceutical manufacturers, hospitals, and compounding centers globally, covering all operations from washing through final decontamination.

Product overview

Steriline is a single-source equipment supplier for pharmaceutical primary packaging of injectable drugs, offering four product lines: Standard Range (mechanical machines for washing, depyrogenation, filling, capping, and decontamination), Robotic Range (robotic automation including vial filling RVFM, capping RVCM, decontamination EDM-RHP, tray loading RTL, tub decontamination RTDS2, and nest filling RNFM), Containment and Isolation systems (LAF, oRABS, cRABS, and standalone isolators), and Other Products (Indoor Sanitization System and Intelligent Compounding System ICS). The company provides both standalone machines and complete turnkey filling lines covering all operations from washing through decontamination, with over 2,000 machines installed globally.

Differentiator

Problem solved

Functional benefit

Products and services

• Rotary Washing Machine RA-RC Rotary washing machine for pharmaceutical vials (2R-100H), ampoules (1-10ml), and cartridges (1-3ml) with capacity up to 24,000 pieces/hour. Part of the Standard Range for aseptic processing lines.
• Depyrogenation Tunnel ST Depyrogenation tunnel with compact design, constant performance throughout product lifecycle, and energy savings. Used for sterilizing pharmaceutical vials in aseptic processing lines.
• Filling Machine VFM Vial filling machine for liquid and powder pharmaceutical products in the 2R-100H vial range. Standard mechanical filling solution for aseptic processing.
• Ampoule Filling Machine Filling machine for ampoules used in pharmaceutical aseptic processing applications.
• Capping Machine VCM Vial capping machine for sealing pharmaceutical containers as part of aseptic processing lines.
• External Decontamination Machine EDM External decontamination machine with capacity up to 48,000 pieces/hour for vial processing. Part of the Standard Range.
• Robotic Vial Filling Machine (RVFM) Robotic vial filling machine with capacity up to 6,000 pieces/hour, vial range 2R-100H, with minimum downtime. Features zero-loss technology without format change parts.
• Robotic Vial Capping Machine (RVCM) Robotic vial capping machine for automated pharmaceutical container sealing with zero-loss philosophy.
• External Decontamination Machine EDM-RHP Robotic external decontamination machine with capacity up to 3,000 pieces/hour, vial range 2R-500ml.
• Tray Loader RTL Robotic tray loader with capacity up to 36,000 pieces/hour featuring quick format changeover capability.
• Robotic Tub Decontamination System RTDS2 Robotic decontamination system for tubs with up to 2 tubes per minute, suitable for all tub types and available for trays with no format change required.
• Nest Filling Line RNFM Robotic nest filling line with capacity up to 18,000 pieces/hour for all commonly used nests.
• LAF and oRABS Laminar airflow cabinets and open restricted access barrier systems designed to grant ISO5 environment for sterile product handling. Features LED lights and standard or PTFE filters.
• In-line cRABS and Isolator Closed Restricted Access Barrier Systems combined with isolators for production of sterile products, toxic or non-toxic. Features integrated vaporized H2O2 generator and automatic pressure monitoring.
• Stand-alone Isolator Pharmaceutical isolator designed for sterile products, toxic or non-toxic, granting highest safety level for product and operator. ISO5 environment, OEB5 exposure level, LED lights, PTFE filters, integrated vaporized H2O2 generator, 2% or less leak rate.
• Intelligent Compounding System (ICS) Fully automated robotic solution controlled by software for compounding parenteral medication doses into appropriate final containers within ISO class 4.8, grade A controlled environment. Based on isolator technology with vaporized H2O2 bio-decontamination. Handles hazardous and non-hazardous medications for patient-specific and batch production. Features vision systems, barcode readers, and RFID technology for identification and traceability.
• Indoor Sanitization System Portable anti-SARS-CoV-2 sanitization system for schools, sports centers, workplaces, and medical offices. Uses vaporized hydrogen peroxide with programmable cycles, available with optional catalyst for H2O2 removal.
• Aftermarket Services Technical support, training, software services, spare parts supply, machine modernization, preventive maintenance, validation and qualification services, and on-site personnel training for Steriline-installed equipment.

Quantifiable outcome

• Up to 6,000 vials/hour with robotic RVFM filling machine
• +4 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Three partnerships are on record, tiered core.

• Politecnico di MilanocoreStrategic or Co-development PartnerPartnership established for research and development projects. Contributed to Steriline's technological advancement in aseptic processing equipment and led to the creation of Steriline Robotics in 2014 based on spin-off project involving robotics and artificial vision.
• EbeTech GmbHcoreChannel Partner/ Reseller/ DistributorBusiness partner for Scandinavia, BeNeLux, Germany, Austria, Switzerland, Hungary, Romania, Spain, and Portugal. Provides local sales and support for Steriline products in European markets.
• MelcherscoreChannel Partner/ Reseller/ DistributorMelchers Vietnam and Melchers Industrial Shanghai serve as distribution partners for Southeast Asia and China markets respectively.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Syntegon Technology: Syntegon (formerly Bosch Packaging Technology) is a leading global supplier of processing and packaging technology for the pharmaceutical and food industries. It is a direct competitor in aseptic fill-finish equipment, including isolators, filling machines, and complete lines for injectables.
• IMA Group: IMA is a global leader in the design and manufacture of automatic machines for the processing and packaging of pharmaceuticals, cosmetics, food, and tea. Its pharmaceutical division directly competes with Steriline in aseptic processing, filling, and containment equipment for injectables.
• Bausch+Strobel Maschinenbau: Bausch+Strobel is a German specialist manufacturer of filling and packaging machines for the pharmaceutical industry. It is a direct competitor to Steriline in aseptic filling lines for vials, syringes, and ampoules, with a strong presence in the European pharma market.
• Stevanato Group: Stevanato Group is an Italian-based provider of drug containment, drug delivery, and diagnostic solutions, including pharmaceutical glass containers and integrated fill-finish systems. It directly competes with Steriline in aseptic processing equipment and is particularly strong in vial handling.
• Marchesini Group: Marchesini Group is an Italian manufacturer of packaging machinery for the pharmaceutical and cosmetics industries, offering complete filling and packaging lines. It directly competes with Steriline in turnkey pharmaceutical packaging equipment for sterile injectables.
• Cozzoli Machine Company: Cozzoli is a US-based manufacturer of precision filling, closing, and processing equipment for the pharmaceutical, cosmetic, and food industries. It is a direct competitor in pharmaceutical filling machinery, with particular strength in liquid and powder filling for injectables.
• Optima Packaging Group: Optima is a German manufacturer of packaging machines and turnkey lines for pharmaceuticals, consumer goods, and paper. It directly competes with Steriline in aseptic fill-finish systems, isolators, and complete injectable processing lines.

Broad incumbents

• GEA Group: GEA is a large industrial group with significant operations in pharmaceutical processing equipment, separation, and homogenization. While it operates broadly across multiple industries, its pharma division competes with Steriline in liquid processing and aseptic applications.
• West Pharmaceutical Services: West Pharmaceutical is a global leader in innovative solutions for injectable drug administration, including elastomeric components, seals, and containment systems. While it focuses on primary packaging components, its integrated delivery systems overlap with Steriline's fill-finish equipment offering.
• Schott AG (Pharmaceutical Systems): Schott is a global leader in specialty glass, glass-ceramics, and related materials, with a major pharmaceutical division providing vials, syringes, and containment solutions. While primarily a primary packaging supplier, it competes with Steriline in integrated fill-finish solutions and isolator-based processing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Steriline