What Iskra PIO does

Iskra PIO d.o.o. is a Slovenian private limited company founded in 1991 and headquartered in Šentjernej, designing and manufacturing cleanroom systems, isolators, laminar airflow chambers, airlocks, material handling equipment, and proprietary decontamination systems (PIO Flash, DECON line) for pharmaceutical, biotechnological, hospital, nuclear medicine, and industrial customers. The company's technology stack centers on SIEMENS PLC controllers with iFIX SCADA monitoring, HEPA H14 filtration, H2O2 bio-decontamination, and full GMP/GAMP 5/21 CFR Part 11/Annex 1 compliance, covering more than 25 years of accumulated isolator expertise and including specialized lead-shielded hot cells for nuclear medicine radiopharmacy applications. Customer logos span 30+ enterprises including Novartis, Novo Nordisk, Bristol Myers Squibb, Lonza, Krka, Lek/Sandoz, Bosch, Henkel, Heineken, and NEK (Krško Nuclear Plant).

The company generates revenue through direct enterprise sales of custom-engineered capital equipment (one-time project-based contracts including design, manufacturing, installation, and commissioning), validation services (particle counting, filter integrity, SMEPAC, airflow/pressure testing, temperature mapping), and engineering services (CNC metal processing, laser cutting, surface treatment). Pricing is quote-based and non-public. GTM is a direct enterprise field-sales motion complemented by trade show presence (BioPharma & LabXperience, CPHI, PowTech) and a multilingual corporate website with inquiry forms. The company is currently executing two major EU co-funded projects: an EUR 8.07M RecovREE R&D initiative (2026-2029) entering rare earth recycling and Nd-Fe-B magnet production for electromobility, and an EUR 8M+ Next Generation EU capacity expansion for isolator manufacturing. Recent recognitions include the GZDBK Gold Innovation Award 2026 (jointly with L-TEK for advanced aseptic glove testing) and the GZS National Award for Outstanding Economic and Entrepreneurial Achievement presented to director and founder Andraž Rumpret.

Name

Iskra PIO

Legal name

Iskra PIO d.o.o.

Website

https://iskra-pio.si

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

101–250 employees

Short description

Slovenian manufacturer of cleanroom systems, isolators, and decontamination equipment for pharmaceutical, biotech, hospital, and nuclear medicine customers. Direct enterprise sales of custom-engineered GMP-compliant capital equipment, validation, and engineering services across Europe.

Ownership category

akta.pro rank

Headquarters

HQ city

Sentjernej

HQ country

Slovenia

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Industrial Cleanroom and Isolator Equipment Sales: Iskra PIO designs, manufactures, and sells cleanroom systems, isolators (for cytostatics, sterile applications, nuclear medicine), LAF chambers, laminar flow units, material airlocks, and decontamination equipment. Products are sold as custom-engineered capital equipment to pharmaceutical, biotech, and hospital clients. Revenue is generated from equipment delivery, installation, and commissioning.
2. Validation and Testing Services: Iskra PIO offers a comprehensive range of validation services including particle counting, filter integrity testing, pressure difference measurements, airflow velocity, smoke testing, SMEPAC testing, tightness testing, inertization testing, and temperature/humidity mapping. These services are provided alongside equipment sales and as standalone engagements.
3. Engineering and Manufacturing Services: Engineering services including design and project management for cleanroom and isolator installations. Manufacturing services include CNC metal processing, laser cutting, and surface treatment — offered as part of project delivery and as standalone job-shop services.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Iskra PIO designs, manufactures, and commissions controlled-environment equipment — cleanrooms, isolators (cytostatic, sterile, flexible, nuclear medicine), LAF chambers/systems, airlocks, weighing/dosing systems, material handling systems, ultrasonic devices, and PIO Flash/DECON decontamination generators — for pharmaceutical, biotechnology, healthcare/nuclear medicine, and research customers. The company also delivers validation services (filter integrity, particle counting, SMEPAC, tightness, airflow, temperature/humidity mapping) and engineering services (CNC metal processing, laser cutting, surface treatment) to support equipment lifecycle needs.

Product overview

Iskra PIO is an industrial equipment manufacturer specializing in controlled environment solutions for the pharmaceutical, biotechnology, healthcare, and nuclear medicine industries. The product portfolio centers around clean room technology and containment systems, with core offerings including Clean Rooms (Čisti prostori), Isolators (Izolatorji) for various applications (cytostatics, sterile work, flexible configurations, and nuclear medicine hot cells), LAF (Laminar Airflow) Chambers and Systems, Personnel and Material Airlocks, Weighing and Dosing systems, Material Handling Systems (MHS), and Ultrazvočne naprave (Ultrasonic devices). The company also provides a DECON decontamination product line featuring mobile generators and the proprietary PIO Flash® system. Supporting the hardware portfolio is a comprehensive Validation Services division offering testing for clean rooms, isolators, and safety cabinets, plus Engineering Services including CNC metal processing, laser cutting, and surface treatment. Products are designed for pharmaceutical manufacturing, hospitals, and research institutions with focus on operator protection, product protection, and environmental safety.

Differentiator

Problem solved

Functional benefit

Brands

• SmartCon GMP: SmartCon GMP clean room product line
• DECON
• PIO Flash
• SonoMag
• SmartCon GMP Čisti prostori

Products and services

• Clean Rooms (Čisti prostori) Cleanroom systems designed to provide controlled environmental conditions for pharmaceutical, biotechnology, and healthcare applications, maintaining specified air cleanliness levels for GMP manufacturing.
• Isolators (Izolatorji) A comprehensive line of isolators covering cytostatic, safe-work, sterile, flexible, and nuclear medicine configurations, providing operator, product, and environmental protection through hermetic sealing, HEPA filtration, and controlled pressure differentials.
• Sterile Isolators (Izolatorji za sterilo) Sterile-application isolators providing clean conditions and product/process protection when working with sterile substances, featuring H2O2 bio-decontamination, laminar airflow, automatic glove integrity testing, and GMP Annex 1 / 21 CFR Part 11 compliance.
• Nuclear Medicine Isolators / Hot Cells (Izolatorji za nuklearno medicino) Lead-shielded hot cells providing operator protection and clean working conditions for safe handling of radioactive substances in nuclear medicine, featuring 50 mm lead lining, HEPA filtration, negative-pressure control, and SIEMENS-based monitoring.
• Flexible Isolators (Fleksibilni izolatorji) PU-foil-based flexible isolator alternative to conventional fixed isolators, offering lower investment costs, shorter delivery times, and no cleaning-validation requirement; FDA- and ATEX-compliant and suitable for high-potency active substance handling, weighing, sampling, and sterile work.
• LAF Chambers (LAF komore) Laminar airflow chambers including mini vertical, vertical laminar, microbiological safety, and horizontal configurations providing clean air flow for product protection across pharmaceutical and laboratory applications.
• Personnel Airlocks (Osebne zapore) Personnel airlocks including air showers and water-mist showers used to decontaminate personnel entering controlled environments prior to cleanroom access.
• Material Airlocks (Materialne zapore) Material transfer systems including passive and active pass boxes, H2O2 pass boxes, extraction cabins, and vertical guillotine doors for transferring materials between controlled environments.
• LAF Systems (LAF sistemi) Complete laminar airflow systems including mobile LAF units, LAF/UDF units, RABS systems, sampling booths, and weighing stations for aseptic production environments.
• Weighing and Dosing Systems (Tehtanje in doziranje) Weighing and dosing solutions including isolator-integrated balances, weighing systems, and dosing systems designed for precise handling of pharmaceutical materials within controlled environments.
• Material Handling Systems (MHS - Upravljanje materialov) Material handling equipment including lifting devices, container/drum mixers, docking stations, grinding-sieving systems, and process containers for pharmaceutical production environments.
• Ultrasonic Devices (Ultrazvočne naprave) Ultrasonic cleaning and dissolution equipment including desktop cleaners (GT, DGT), SonoMag active-substance dissolution devices, freestanding ultrasonic baths, automated ultrasonic systems, ultrasonic generators, and submersible transducers for pharmaceutical and industrial applications.
• DECON Decontamination Product Line Mobile decontamination generators and catalysts (DECON Mini, DECON Classic, DECON Professional, DECON Clean) using hydrogen peroxide vapor for bio-decontamination of cleanrooms, isolators, and controlled environments.
• Drying Chambers (Sušilne komore) Drying chambers for pellets and cleaned equipment used within pharmaceutical manufacturing processes, integrated into overall cleanroom and controlled-environment workflows.
• Validation Services (Validacija) Comprehensive validation services for cleanrooms, safety cabinets, and isolators, including filter integrity testing, particle counting, pressure difference measurements, airflow velocity, SMEPAC testing, tightness testing, inertization testing, visual smoke testing, and temperature/humidity mapping.
• Engineering and Manufacturing Services (Inženiring in Storitve) Engineering services for cleanroom and isolator installations (design, project management) plus in-house manufacturing services including CNC metal processing, laser cutting, and surface treatment for custom project and job-shop requirements.

Quantifiable outcome

• Over 25 years of experience in isolator technology with validated and tested subsystems ensuring required protection levels.
• +3 more outcomes

Named customers30 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Two partnerships are on record, tiered core and minor.

• L-TEKcoreStrategic or Co-development Partner · 19 June 2026Iskra PIO and L-TEK jointly developed the Gold Award-winning innovation 'Advanced Aseptic Glove Testing with GMP Annex 1 Traceability'. This partnership combined engineering expertise and innovative approach to create a solution for reliable integrity verification of gloves in aseptic isolator systems with full GMP Annex 1 compliance and complete traceability. The collaboration demonstrates the value of inter-company partnerships in achieving advanced industrial standards in pharmaceutical manufacturing.
• Sartorius Croatia – Libra Elektronik d.o.o.minorGTM or Marketing PartnerSartorius Croatia – Libra Elektronik d.o.o. organized the BioPharma & LabXperience 2026 event, at which Iskra PIO participated as an exhibitor. Iskra PIO expressed gratitude to the organizer for enabling quality knowledge exchange and professional networking within the biopharmaceutical community.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Getinge: Swedish global medtech and pharma equipment incumbent offering sterile transfer, isolators, and DPTE systems; competes with Iskra PIO on pharma containment projects but as part of a much broader hospital and life science portfolio.
• Steris: US-based global leader in sterilization, infection prevention, and pharma processing equipment; competes with Iskra PIO in pharma containment and decontamination through its Life Sciences segment.

Direct peers

• SKAN AG: Swiss specialist in aseptic and containment isolators, cleanroom technology, and decontamination for pharmaceutical and biotech manufacturers — directly comparable to Iskra PIO's core isolator and DECON decontamination product lines.
• Bioquell (Ecolab): UK-based specialist in hydrogen peroxide bio-decontamination systems for cleanrooms and isolators — directly comparable to Iskra PIO's PIO Flash and DECON product family.
• Telstar (Azbil Group): Spanish manufacturer of pharmaceutical equipment including isolators, lyophilizers, and cleanroom solutions — directly comparable in scope and customer base to Iskra PIO.
• Germfree Laboratories: US manufacturer of modular cleanrooms, isolators, and biocontainment equipment for pharma and life sciences — comparable product architecture and target customers to Iskra PIO.
• JCE Biotechnology: French manufacturer of sterile and containment isolators for the pharmaceutical industry, including hospital pharmacy and radiopharmacy applications — closely comparable niche offering.
• Fedegari Group: Italian manufacturer of sterilizers, isolators, and integrated containment systems for the pharmaceutical industry — overlapping with Iskra PIO's GMP/GAMP-compliant isolator portfolio.
• Comecer (ATS Group): Italian manufacturer of pharmaceutical isolators and nuclear medicine hot cells; the nuclear medicine shielded isolator line overlaps directly with Iskra PIO's hot cell offering.
• Tema Sinergie: Italian specialist in sterile and containment isolators for pharma and hospital pharmacies — closely comparable to Iskra PIO's cytostatic, sterile, and flexible isolator ranges.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/p/Iskra-PIO-100027199856213
• Xx.com/iskrapio

Compliance7 records

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 Iskra PIO