AMIRA

What AMIRA does

AMIRA Srl is an Italian private limited company (Società Unipersonale) headquartered in Triuggio, near Milan, that designs, manufactures, and distributes contamination-control instruments and services for cleanrooms and controlled environments. Its core proprietary offering is the patented Bioreset family of vapor-phase hydrogen peroxide (V-PHP) biodecontamination generators, which spans eight models (Bioreset, Max, Smart V2, Plus V2, Pro, Pro-V, Combo, Turboflow) and is documented to achieve a 6-log microbial reduction on exposed surfaces, with the Turboflow variant compressing cycle time by up to 50%. The product portfolio extends to the Easypass laminar-flow transfer trolley, particle counters (PMT and the TSI BioTrak 9510-BD real-time viable particle counter using laser-induced fluorescence), ABC Transfer rapid transfer systems, FOM Technologies slot-die coating equipment, glove-box systems, cleanroom cleaning systems, apparel, and DOP/smoke test instrumentation. The company holds UNI EN ISO 9001:2015 certification (April 2023) and offers 21 CFR Part 11 compliant software options for regulated markets.

The company sells directly into Italian pharmaceutical and biotech accounts and reaches 35+ countries through an exclusive distributor network that includes SentrySciences (USA), Partitec (Brazil), Dencom (Japan), Aimil (India), MBraun (Germany), and others, supplemented by strategic co-development partnerships with FPS Food and Pharma Systems (isolator integration) and De Lama (DLVHP systems) and a technology integration with Vaisala for cycle parameter validation. Revenue is generated through three streams: equipment sales (Bioreset generators, particle counters, slot-die coaters, glove boxes, and other instruments), professional services (on-site V-PHP biodecontamination, validation, maintenance, calibration, and equipment rental), and exclusive Italian distribution of third-party product lines (ABC Transfer, PMT, FOM, EMTEK, TSI, Particle Metrix, Laurell). Pricing is quote-based against multi-year contracts and is not publicly disclosed. The company operates the Amira ToTech training and laboratory facility (launched September 2019) and has been recognized among the 1,000 Best Performer companies in Monza Brianza for 2022 by LombardiaPost/ItalyPost. Founded around 2003–2004 and led by President Angelo Delmiglio, AMIRA remains a privately held, single-member company with no external investment, no public listing, and no disclosed funding rounds or acquisitions.

Name

AMIRA

Legal name

Amira Srl

Website

https://amirasrl.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

AMIRA Srl is an Italian manufacturer and exclusive distributor of contamination-control instruments — chiefly its patented Bioreset V-PHP biodecontamination generators, particle counters, and rapid transfer systems — serving pharmaceutical, biotech, healthcare, and materials science customers in 35+ countries through direct sales and an exclusive global distributor network.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contamination Control Equipment

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

SIC

Industrial & Commercial Fans & Blowers & Air Purifing Equip (3564)

akta.pro primary industry

Bioprocess Facility, Cleanroom & Utility Systems (HVAC, WFI, CIP/SIP, containment) (HLAAAJAJ)

Keywords

• Cleanroom biodecontamination
• Vapor-phase hydrogen peroxide
• Particle counters
• Microbiological monitoring
• Contamination control equipment

Headquarters

HQ city

Triuggio

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Equipment Sales: Sale of biodecontamination equipment (Bioreset V-PHP generators), particle counters, air samplers, and other contamination control instruments.
2. Professional Services: On-site biodecontamination services, equipment validation, maintenance and calibration, and equipment rental.
3. Distribution: Exclusive Italian distribution agreements for international manufacturers (ABC Transfer, PMT, FOM Technologies, EMTEK, and others).

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels5 records

Core offering

AMIRA (Amira Srl) designs, manufactures and distributes the patented Bioreset line of Vapor-Phase Hydrogen Peroxide (V-PHP) biodecontamination generators for cleanrooms, isolators, RABS and other controlled environments, alongside particle counters, microbiological monitoring instruments, aseptic transfer systems, glove boxes, and slot-die coating equipment. The company also acts as the exclusive Italian distributor for several international manufacturers (PMT, ABC Transfer, FOM Technologies, EMTEK, TSI BioTrak, Particle Metrix, Laurell) and delivers on-site biodecontamination, validation, calibration, and equipment rental services.

Product overview

Amira offers a comprehensive portfolio of contamination control solutions for pharmaceutical, biotech, and healthcare industries. The core product lines include the Bioreset family of V-PHP (vapor-phase hydrogen peroxide) generators available in multiple models (Bioreset, Bioreset Max, Bioreset Smart V2, Bioreset Plus V2, Bioreset Pro, Bioreset Pro-V, Combo, Turboflow) for biodecontamination of cleanrooms, isolators, and RABS; Easypass for rapid interclass material transfer; particle counting solutions (PMT remote, portable, and handheld counters); real-time microbiological monitoring (BIOTRAK); and rapid transfer systems (ABC Transfer). Additional offerings span slot-die coating equipment from FOM Technologies, glove box systems with PVD deposition, spin processing, cleanroom cleaning systems, apparel, DOP/smoke testing equipment, Nanoparticle Tracking Analysis (NTA), and comprehensive services including biodecontamination, validation, calibration, and equipment rental. The company also provides 21 CFR Part 11 compliant software and distributes internationally through a global distributor network.

Differentiator

Problem solved

Functional benefit

Brands

• Bioreset: Patented line of V-PHP (vapor-phase hydrogen peroxide) generators for biodecontamination of cleanrooms, isolators, and RABS. Includes models: Bioreset Max, Bioreset Smart V2, Bioreset Smart, Bioreset Plus V2, Bioreset Pro, Bioreset Pro-V, Combo, Turboflow.
• Amira ToTech

Products and services

• Bioreset V-PHP Biodecontamination Generators Patented line of Vapor-Phase Hydrogen Peroxide (V-PHP) generators for biodecontamination of cleanrooms, isolators, and RABS, achieving 6 Log microbial reduction on exposed surfaces. Multiple models (Max, Smart V2, Plus V2, Pro, Pro-V, Combo, Turboflow) address different cleanroom sizes and application needs.
• Easypass Laminar Flow Trolley Laminar flow trolley with on-board VHP generator and fast-docking interface, enabling rapid interclass material transfer between cleanroom areas.
• PMT Particle Counters Remote, portable, and handheld particle counters (models A230, 8303, 8306) for monitoring particulate matter in cleanrooms and controlled environments, ensuring compliance with ISO 14644-1 and EU GMP Annex 1.
• BIOTRAK Real-Time Viable Particle Counter Model 9510-BD combining ISO particle counting, real-time viable particle detection, and microbiological membrane sampling using Laser Induced Fluorescence (LIF) technology.
• ABC Transfer Rapid Transfer Systems (RTS) Aseptic transfer systems including ABC Transfer Ultra, Alpha Port, Beta Container, and single-use ported bags for sterile material transfer in pharmaceutical manufacturing environments.
• FOM Slot-Die Coating Equipment Roll-based, sheet-based, and roll-to-roll slot-die coating equipment for thin-film deposition in materials science R&D, including battery research, organic electronics, and biomedical applications.
• Glove Box Systems Advanced technologies for processing in absence of oxygen and humidity, including PVD deposition systems and solvent purification systems for controlled atmosphere applications.
• Spin Processor Single-wafer spin coating and spin-processing equipment for semiconductor and research applications.
• Cleanroom Cleaning Systems Solutions for cleaning and sanitization of cleanrooms and other controlled environments.
• Cleanroom Apparel and Accessories Clothing, gloves, and accessories for operators in cleanrooms and laboratories.
• DOP Test / Smoke Test Equipment Equipment for filter integrity tests (DOP/PAO) and air flow visualization (smoke test) in cleanrooms and controlled environments.
• Nanoparticle Tracking Analysis (NTA) Instrumentation for rapid characterization of extracellular vesicles, viruses, and similar small biological particles using Nanoparticle Tracking Analysis.
• V-PHP Biodecontamination and Support Services Professional biodecontamination services using V-PHP technology, equipment validation, installation protocols, preventive maintenance, calibration, and short- or long-term equipment rental.

Quantifiable outcome

• V-PHP biodecontamination achieves 6 Log reduction in microbial load on exposed surfaces
• +2 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• ABC TransfercoreChannel Partner/ Reseller/ DistributorExclusive Italian distributor for ABC Transfer Rapid Transfer Systems (RTS) - aseptic transfer solutions including ABC Transfer Ultra, Alpha Port, Beta Container, and single-use ported bags. Products designed and developed in collaboration with pharmaceutical companies and isolator manufacturers for patient safety, user comfort, and process security.
• PMTcoreChannel Partner/ Reseller/ DistributorItalian distributor for PMT particle measurement technology products including remote particle counters, portable airborne particle counters, and handheld particle counters. PMT has over 35 years experience with approximately 65 employees across 5 countries.
• FOM TechnologiescoreChannel Partner/ Reseller/ DistributorExclusive Italian distributor for FOM Technologies slot-die coating equipment. FOM is a Scandinavian company offering roll-based, sheet-based, and roll-to-roll slot-die coating solutions for thin-film deposition in advanced materials R&D.
• EMTEKcoreChannel Partner/ Reseller/ DistributorItalian distributor for EMTEK air viable monitoring equipment for detection of bacteria and mold in clean room and critical environments serving biotechnology, pharmaceutical, hospital, and food industries.
• TSI (BioTrak)coreTechnology or IntegrationDistributor for TSI BioTrak Real-Time Viable Particle Counter Model 9510-BD. Uses patented Laser Induced Fluorescence (LIF) technology for real-time detection of viable particles.
• Particle MetrixminorChannel Partner/ Reseller/ DistributorItalian distributor for Particle Metrix NTA (Nanoparticle Tracking Analysis) products focusing on extracellular vesicle, virus, and small biological particle characterization.
• Laurell TechnologiesminorChannel Partner/ Reseller/ DistributorItalian distributor for Laurell Technologies single wafer spin processing equipment, serving the semiconductor and research markets since 1985.
• MBraunminorChannel Partner/ Reseller/ DistributorGerman partner serving as Bioreset distributor for Germany. MBraun has over 40 years experience in inert glove box solutions for clean environments including pharmaceutical and nuclear research applications.
• FPS Food and Pharma SystemscoreStrategic or Co-development PartnerItalian company specialized in containment & isolation solutions. Strategic partnership for integrating Amira V-PHP biodecontamination with FPS sterile isolators, enabling high quality standards in both containment systems and decontamination processes.
• De LamacoreStrategic or Co-development PartnerItalian company with 70+ years in sterilization systems. Amira R&D team developed customized H2O2 generators fully integrated into De Lama's DLVHP vacuum hydrogen peroxide decontamination units and DLVHP/ST high-pressure vacuum systems.
• PartiteccoreChannel Partner/ Reseller/ DistributorExclusive Brazilian distributor for Bioreset products. Provided support to Instituto Butantan for V-PHP biodecontamination solutions in vaccine production facilities.
• OpiraminorChannel Partner/ Reseller/ DistributorAustralian distributor for Bioreset products. Founded 2002, providing indoor environmental testing and risk management services to NATA accredited standards with over 3,000 projects completed.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Bioquell (Ecolab): Pioneer of V-PHP biodecontamination for life science cleanrooms and isolators, now part of Ecolab's Life Sciences platform; offers direct overlap with AMIRA's Bioreset generators and validation services in pharmaceutical sterile manufacturing.
• Particle Measuring Systems (PMS): Specialist in cleanroom particle counters, microbial air samplers and real-time contamination monitoring — directly comparable to AMIRA's PMT particle counter and EMTEK microbiology product lines in pharma and semiconductor cleanrooms.
• TOMI Environmental Solutions: Provider of SteraMist binary ionization technology for room and enclosure decontamination in life sciences, healthcare and pharma — a competing hydrogen peroxide-based biodecontamination modality to AMIRA's V-PHP Bioreset platform.
• Lighthouse Worldwide Solutions: Supplier of airborne particle counters, cleanroom monitoring software and microbial samplers for life sciences and semi-conductor cleanrooms — competes head-to-head with AMIRA's PMT and BIOTRAK-based monitoring offerings.
• TSI Incorporated: Manufacturer of the BioTrak Real-Time Viable Particle Counter (which AMIRA distributes in Italy) and a leading supplier of particle counters and air quality instrumentation; competes in the same cleanroom monitoring category that AMIRA serves through its distribution and Easypass lines.
• ClorDiSys Solutions: Provider of chlorine dioxide-based room and equipment biodecontamination for pharmaceutical and life science cleanrooms — alternative biodecontamination modality targeting the same customer base as AMIRA's Bioreset V-PHP generators.

Broad incumbents

• Getinge: Global provider of sterilization, disinfection and contamination control solutions for pharma and life sciences; competes with AMIRA's Bioreset and integrated isolation/biodecontamination offerings through broad infection control portfolios.
• STERIS: Global leader in sterilization and infection prevention with extensive V-PHP biodecontamination systems, sterilization equipment and cleanroom contamination control offerings — competes directly with AMIRA's Bioreset line for sterile pharma manufacturing accounts.
• Halma plc: Group that owns multiple cleanroom, particle monitoring and pharma process control companies (e.g., Particle Measuring Systems); competes with AMIRA in environmental monitoring and contamination control across pharma/biotech.

Regional players

• FOM Technologies: Scandinavian manufacturer of roll-based, sheet-based and roll-to-roll slot-die coating equipment for advanced materials R&D; AMIRA is its exclusive Italian distributor, making it a customer-as-peer in the materials science segment of AMIRA's portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 AMIRA