Steristar

What Steristar does

Steristar is the export brand of Necati Kaya Tıbbi Cihazlar San. Tic. Ltd. Şti., a privately held Turkish medical device manufacturer headquartered in Akyurt, Ankara. The company produces sterilization monitoring and control consumables used by Central Sterile Services Departments (CSSD), hospitals, and clinics to verify the effectiveness of steam, ethylene oxide, hydrogen peroxide plasma, formaldehyde, and gamma sterilization processes. Its product portfolio spans Bowie & Dick Test Packs, Type 4/5/6 chemical indicators and integrators, Helix Test PCDs, cleaning efficacy tests (protein residue, ultrasonic washer, washer-disinfector tests), sterilization packaging materials (Tyvek reels, SMS wrap), and accessories such as autoclave tapes, container filters, labels, and security seals. Core technology rests on proprietary chemical indicator formulations and a patented Ultrasonic Foil Test design, all compliant with international standards including ISO 11140-1, ISO 11140-4, ISO 15883-5, EN 15883, ISO 9001:2015, and EN ISO 13485:2016.

The business operates a direct-to-customer sales model, shipping Steristar-branded products to healthcare facilities in more than 65 countries, with 95% of production processes performed in-house at the Ankara Ivedik OSB facility and quality controls executed in an on-site test laboratory. Revenue mechanics are one-time consumable sales with quote-based pricing negotiated through the website, phone, or email — no public pricing or subscription tiers are disclosed. The company also runs an import department acting as sole authorized Turkey representative for selected foreign medical device brands, providing ancillary distribution revenue. Ownership is family-controlled under founder and President Necati Kaya, a chemical engineer with over 40 years in the medical device industry; no external institutional investors, funding rounds, or M&A activity are referenced in the source materials.

Name

Steristar

Legal name

Necati Kaya Tıbbi Cihazlar San. Tic. Ltd. Şti.

Website

https://steristar.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

Steristar manufactures and exports sterilization monitoring and CSSD consumables — Bowie & Dick test packs, chemical indicators, cleaning efficacy tests, and sterilization packaging — to hospitals and sterile services departments in more than 65 countries from its Ankara, Turkey facility.

Ownership category

akta.pro rank

Product category

Medical Device Manufacturing

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391), Plastics Packaging Materials and Unlaminated Film and Sheet Manufacturing (32611)

SIC

Surgical & Medical Instruments & Apparatus (3841), Unsupported Plastics Film & Sheet (3081)

akta.pro primary industry

Sterilization Consumables & Packaging (Wraps, Pouches, Indicators, Trays/Containers) (HLAHANAC)

akta.pro secondary industries

Sterile & Aseptic Medical Packaging (Pouches, Wraps, Sterile Barriers) (IMALAIAB), Medical Device Packaging (Trays, Clamshells, Kits) (IMALAIAD)

Keywords

• CSSD consumables
• Sterilization monitoring
• Chemical indicators
• Sterilization packaging
• Infection control supplies

Headquarters

HQ city

Akyurt

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. CSSD Consumables Sales: Sale of sterilization monitoring products including Bowie & Dick Test Packs, chemical integrators, indicators, and sterilization packaging materials. Products are sold in various pack sizes and quantities to healthcare facilities worldwide.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Steristar manufactures and sells CSSD (Central Sterile Supply Department) consumables used by hospitals, clinics, and sterile services departments to verify and document sterilization and cleaning processes. The product portfolio covers chemical indicators (Type 2/4/5/6), Bowie & Dick tests, Helix PCDs, washer-disinfector and ultrasonic cleaning tests, sterilization packaging materials (Tyvek reels, SMS wrap), and traceable accessories such as autoclave tapes, container labels, security seals, and documentation labels.

Product overview

Steristar is a leading manufacturer of CSSD (Central Sterile Supply Department) Consumables. The product portfolio consists primarily of sterilization monitoring and control products including Bowie & Dick Test Packs, chemical indicators (Type 4, 5, and 6 integrators and emulating indicators), sterilization process challenge devices (Helix Test PCD), and cleaning efficiency tests (Protein Residue Test Kit, Ultrasonic Washer Test, Washer Disinfector Efficiency tests). Supporting products include packing materials (Tyvek Sterilization Reels, SMS Wrap), accessories (Autoclave Tapes, Container Labels, Plastic Security Seals, Tape Dispensers, Permanent Pens, Documentation Labels with Labeler), and specialized test apparatus (Seal Test for Rotary Sealers, Cannulacheck Test Apparatus). The products cover multiple sterilization methods: steam, ethylene oxide (E.O), hydrogen peroxide plasma, formaldehyde, and gamma radiation. All products are designed for healthcare facilities to ensure sterilization effectiveness and patient safety.

Differentiator

Problem solved

Functional benefit

Products and services

• Bowie & Dick Test Packs Test packs designed for vacuum-assisted sterilizers that evaluate vacuum system efficiency, remove air from the sterilizer chamber, and detect leaks, using a water-based non-toxic chemical indicator compatible with ISO 11140-4 (Type 2 + 4). Intended for daily sterility testing in CSSDs.
• Protein Residue Test Kit Rapid detection kit for protein residues remaining on medical instruments after cleaning, providing fast visual color change results for cleaning efficacy validation. Compatible with ISO 15883-5.
• Tape Dispenser Heavy-body dispenser with a cutting edge for clean tearing of sterilization tapes, plus additional non-slip feet to prevent slipping during pack preparation.
• Permanent Pens for Traceability Wipe-resistant and sterilization-resistant permanent pens with 1mm line thickness, available in multiple colors, used to mark pre-sterilization packages and sterile loads.
• Tyvek Sterilization Reels Long-life tear- and puncture-resistant sterilization packaging reels that are anti-allergenic, anti-bacterial, and waterproof, suitable for ethylene oxide, gamma, and hydrogen peroxide plasma sterilization, with controlled steam sterilization compatibility.
• Autoclave Tapes Autoclave closure tapes whose chemical indicator lines turn dark under proper steam sterilization conditions, providing immediate visual identification of processed items. Water-based and non-toxic, compliant with ISO 11140-1.
• Plastic Security Seals Single-use plastic seals inserted into sterilization container lock cross holes to safeguard against unauthorized opening, available with or without chemical indicator in red or blue colors.
• Ultrasonic Washer Test Clear vial filled with reactive green-colored solution and glass beads that monitors the cavitation capacity of ultrasonic washers, changing color from green to yellow when the washer functions correctly, and includes labels for result archiving.
• Ultrasonic Foil Test Patented foil-based test material that dismembers when cavitation energy is emitted correctly by an ultrasonic washer, providing visual confirmation of washer performance. Compatible with ISO 15883-5, with areas for recording results.
• Protectors for Surgical Instruments Transparent film pockets that protect small, sharp, and fragile surgical instruments during sterilization, reducing damage risk to packaging material, suitable for steam sterilization.
• Helix Test PCD and Apparatus Daily Process Challenge Device for pre-vacuum hospital sterilizers and Class B benchtop steam sterilizers that tests steam penetration and inert gases. Available with indicators for Steam (pink to dark), EO (blue to green), and H2O2 (purple to blue), with self-adhesive feature for permanent record-keeping.

Quantifiable outcome

• Products validated for compliance with ISO 11140-4 (Type 2 + 4), ISO 15883-5, and other international sterilization standards

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• STERIS: Major sterilization and infection prevention provider offering CSSD consumables (V-PRO, Verify) alongside capital equipment. Overlaps with Steristar's chemical indicators and sterilizer validation products.
• 3M: Global healthcare products conglomerate with a leading sterilization monitoring franchise (Comply, Attest). Competes directly with Steristar in chemical indicators, integrators, and sterilization tapes across all hospital segments.
• Getinge: Global medical technology group with a strong infection control and CSSD consumables portfolio, including sterilization monitoring products and packaging materials. Direct overlap with Steristar's indicator and consumables range.
• Hu-Friedy: Dental and medical instrument reprocessing company offering cleaning monitors, sterilization packaging, and CSSD workflow products. Adjacent peer with overlapping infection control consumables offering.
• Advanced Sterilization Products (ASP, Johnson & Johnson): Subsidiary of J&J specializing in low-temperature sterilization (Sterrad H2O2 plasma systems) and associated monitoring consumables. Overlaps with Steristar's H2O2 plasma test products and broader sterilization monitoring.

Direct peers

• GKE GmbH: Germany-based specialist in sterilization monitoring indicators, integrators, and process challenge devices (PCDs). Closest specialist peer to Steristar—competes head-to-head in Bowie & Dick tests, Type 4/5/6 indicators, and Helix tests.
• Propper Manufacturing: US-based sterilization monitoring consumables manufacturer with a long history in autoclave indicators, integrator strips, and Bowie & Dick tests. Directly competes with Steristar in chemical indicator consumables.
• Terragene: Argentine manufacturer of sterilization monitoring products including chemical indicators, biological indicators, and BIs for steam/EO/H2O2 processes. Directly comparable as a regionally-rooted specialist exporter of CSSD consumables.
• Crosstex: Cantel Medical subsidiary manufacturing sterilization packaging (Steri-Pouches, sterilization wraps) and infection prevention products. Directly comparable packaging and consumables overlap with Steristar's Tyvek reels and SMS wrap.
• PBI (Packaging Basics Inc.): US manufacturer of sterilization packaging (CSR wrap, Sterilization pouches, Tyvek pouches) and process indicator products. Comparable to Steristar's sterilization packaging materials and packaging-integrated indicators.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/user/KAYAUDK
• Facebookfacebook.com/steristar
• LinkedInlinkedin.com/company/steristar
• Instagraminstagram.com/nkmedica

Compliance5 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 Steristar