Steri-Tek
Steri-Tek is a US-based, privately-held contract sterilization and R&D services company that operates high-volume E-beam and X-ray irradiation facilities for medical device, pharmaceutical, biotech, and tissue product manufacturers. It runs two LINAC-equipped sites (Fremont, CA and Lewisville, TX) with proprietary DualBeam configurations.
- Company typePrivate
- Founded2016
- HeadquartersFremont, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Steri-Tek does
Steri-Tek (SteriTek, Inc.) is a US-based, privately-held contract sterilization and R&D services company that operates high-volume E-beam and X-ray irradiation facilities on a per-order basis to medical device manufacturers, pharmaceutical companies, biotechnology firms, tissue banks, and R&D organizations. The company was founded in 2016 by Larry Nichols, the former CEO of predecessor Nutek Corp, and operates two sites: a headquarters in Fremont, California (Silicon Valley) and a newer facility in Lewisville, Texas (Dallas metro) that opened in April 2023. Steri-Tek holds ISO 13485, ISO 27001, SOC 3, FDA, MedAccred Sterilization, CBER Tissue, and DEA Schedule II-V registrations, and is licensed for drug and device manufacturing in California and registered with the Japanese Ministry of Health.
The technical backbone of the business is a fleet of high-power linear accelerators (LINACs) arranged in a proprietary DualBeam configuration, in which two horizontally opposed LINACs simultaneously irradiate product carried in custom totes, eliminating the need to flip customer boxes and delivering true LINAC redundancy. The Fremont facility houses two 10 MeV 20 kW LINACs, while the Lewisville facility houses two 80kW-capable LINACs with X-ray capability and pre-allocated expansion space for additional accelerators. The company differentiates on three axes relevant to a sterilization buyer: (i) dose flexibility from below 1 kGy to beyond 100 kGy with split-dose and cryogenic processing (-60C to -80C) for sensitive materials; (ii) throughput, advertised as the fastest standard turnaround in the industry at 2-6 business days with 24-hour and Same Day RUSH options; and (iii) turnkey ISO 11137 VDmax validation packages that bundle irradiation with protocol generation, microbiology coordination, and regulatory reporting. Specialty services include a Sensitive Materials Optimization System for drugs, biologics, allograft/xenograft tissue, combination devices, and regenerative medicine products.
Steri-Tek monetizes primarily through per-order contract sterilization fees billed on Net 30 terms (major credit cards accepted, no credit check), supplemented by professional-services revenue from R&D Innovation Center access, sterilization validation, consulting, and dose-mapping studies. The go-to-market combines event-driven demand generation at major industry conferences (PDA Week, MD&M, CPHI, Bio International, AdvaMed) with direct enterprise sales led by a Director of Sales, supported by a self-service NetSuite Customer Portal for routine orders. Partnerships with Triple Ring Technologies (sterilization simulation), Pacific BioLabs, Eagle Medical, Medizap, and WCDA extend the offering into testing and regulatory support. No funding rounds, parent company, or external institutional ownership are disclosed, and the company appears to be founder-led.
Steri-Tek firmographics
Firmographics- Name
- Steri-Tek
- Legal name
- SteriTek, Inc.
- Website
- https://steri-tek.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Steri-Tek is a US-based, privately-held contract sterilization and R&D services company that operates high-volume E-beam and X-ray irradiation facilities for medical device, pharmaceutical, biotech, and tissue product manufacturers. It runs two LINAC-equipped sites (Fremont, CA and Lewisville, TX) with proprietary DualBeam configurations.
- Ownership category
- akta.pro rank
Steri-Tek industry classification
Industry- Product category
- Contract Sterilization Services
- NAICS
- Irradiation Apparatus Manufacturing (334517)
- SIC
- X-Ray Apparatus & Tubes & Related Irradiation Apparatus (3844)
- akta.pro primary industry
- Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers) (HLAHANAB)
- akta.pro secondary industry
- Radiation Processing & Sterilization Services (Medical device sterilization, food irradiation, materials modification) (EUAKAIAG)
Keywords
Where Steri-Tek is headquartered
LocationHeadquarters
- HQ city
- Fremont
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Steri-Tek business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Infrastructure, Operations, Personnel, Technology or R&D, Marketing or Sales, Supply Chain
Revenue model
- Contract Sterilization Services: Steri-Tek provides high-volume E-beam and X-ray contract sterilization services to medical device, biotech, pharmaceutical, tissue product, and other industries on a per-service basis. Services are priced per order with payment terms of Net 30 or major credit cards accepted. No credit check or scheduling issues prior to processing required.
- R&D and Consulting Services: Expert consultative services including R&D innovation center access, sterilization optimization, compliance support, design assistance, testing, validation, and production support for customers developing and manufacturing complex products.
- Managed Validation Services: Turnkey sterilization validation packages providing complete protocol management, microbiological laboratory services coordination, and final comprehensive regulatory reports appropriate for product regulatory review.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Standard E-beam/X-ray sterilization - 2-6 business day turnaround |
| Unit Pricing | Pay-as-you-go | 24-Hour Expedite Service |
| Unit Pricing | Pay-as-you-go | Same Day RUSH Service |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
Steri-Tek product offering
Product offeringCore offering
Steri-Tek is a high-volume E-beam and X-ray contract sterilization provider and R&D innovation center. It delivers on-demand terminal sterilization, microbiology testing, cross-linking, and expert consultative services to medical device, biotech, pharmaceutical, and tissue product manufacturers using proprietary DualBeam linear accelerator technology across two U.S. facilities.
Product overview
SteriTek is a high-volume E-beam/X-ray contract sterilizer and R&D innovation center providing on-demand sterilization, microbiology, cross-linking, and expert consultative services to medical device, biotech, pharmaceutical, tissue product, and other industries. The core offerings center on two primary sterilization technologies: E-beam Sterilization and X-ray Sterilization, both powered by the proprietary DualBeam™ process that utilizes dual horizontally-opposed LINACs for high-volume production. These core services are supplemented by specialized offerings including Sensitive Materials Processing (for drugs/biologics, tissue products, and combination devices), Turnkey Sterilization Validation packages (ISO 11137 VDmax, Method 1, Methods 2a and 2b), temperature-controlled processing capabilities (including cryogenic -60°C to -80°C), and controlled substances handling (DEA registered for Schedule II-V). The company operates two facilities (Fremont, CA and Dallas/Lewisville, TX) as an R&D innovation center supporting both startups and global companies.
Differentiator
Problem solved
Functional benefit
Products and services
- E-beam Sterilization
Quantifiable outcome
- 2-6 business day standard turnaround vs. industry average of up to one week
- +2 more outcomes
Companies that use Steri-Tek
Customer profileSegments5 records
Ideal customer profiles4 records
Steri-Tek technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature5 records
Steri-Tek partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and minor.
- Triple Ring TechnologiescoreStrategic partnership to provide packaging configuration sterilization simulations to customers, helping them determine optimal packaging for sterilization and select the best sterilization method for their products and packaging configurations. Joint efforts bring sterilization simulation capabilities to Steri-Tek customers to accelerate time to market.
- Pacific BioLabsminorListed as a partner providing testing services, R&D, and regulatory support to Steri-Tek customers.
- Eagle MedicalminorListed as a partner providing testing services, R&D, and regulatory support to Steri-Tek customers.
- MedizapminorListed as a partner providing testing services, R&D, and regulatory support to Steri-Tek customers.
- WCDAminorListed as a partner providing testing services, R&D, and regulatory support to Steri-Tek customers.
Scale indicators4 records
Recent moves6 records
Expansion highlights6 records
Steri-Tek competitors and assessment
Company assessmentDirect peers
- Sterigenics (Sotera Health): The largest global contract sterilization provider, offering gamma, EO, and E-beam across a global facility footprint. Directly competes with Steri-Tek for medical device, pharma, and biotech sterilization contracts, with significantly broader modality and geographic coverage.
- Ionisos: European-headquartered contract sterilization provider operating E-beam, gamma, and X-ray facilities for medical devices, pharma, and cosmetics. Directly comparable business model and technology stack, with overlapping customer types but primarily European geographic footprint.
- BGS Beta-Gamma-Service: German provider of contract sterilization and radiation processing using electron beam, gamma, and X-ray technologies for medical devices, pharmaceuticals, and industrial products. Closely comparable in service portfolio and customer mix to Steri-Tek.
Broad incumbents
- STERIS: Diversified sterilization and infection prevention leader with gamma, EO, and X-ray contract sterilization alongside equipment manufacturing. Overlaps with Steri-Tek in contract sterilization services but operates at much larger scale and across the full sterilization value chain.
Others
- Triple Ring Technologies: R&D and engineering firm that partners with Steri-Tek to provide packaging configuration sterilization simulations. Adjacent rather than competing — enables Steri-Tek's customers to optimize packaging for sterilization but does not itself offer irradiation services.
- Eagle Medical: Sterilization testing and validation partner to Steri-Tek customers. Supports regulatory and microbiological testing adjacent to Steri-Tek's irradiation services rather than directly competing for sterilization contracts.
Emerging players
- Pacific BioLabs: Northern California contract testing and R&D lab listed as a Steri-Tek partner for microbiology, testing, and regulatory services. Comparable in serving medtech/biotech R&D and validation needs but focused on laboratory services rather than irradiation.
Regional players
- Symec Engineers (India): Indian contract sterilization provider focused on E-beam and gamma irradiation for medical devices and pharmaceuticals. Comparable service offering to Steri-Tek but serves primarily the South Asian market rather than the US.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Steri-Tek social profiles
Digital presenceSteri-Tek compliance and trust
Trust signalCompliance10 records
Steri-Tek financial estimates
Financial estimateRevenue estimate
Valuation estimate
Steri-Tek leadership team
Management profileNumber of profiles
Profiles6 records
Steri-Tek funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Steri-Tek M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Steri-Tek
What does Steri-Tek do?
Steri-Tek is a high-volume E-beam and X-ray contract sterilization provider and R&D innovation center. It delivers on-demand terminal sterilization, microbiology testing, cross-linking, and expert consultative services to medical device, biotech, pharmaceutical, and tissue product manufacturers using proprietary DualBeam linear accelerator technology across two U.S. facilities.
Is Steri-Tek a public or private company?
Steri-Tek is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Steri-Tek founded?
Steri-Tek was founded in 2016. It employs 51 to 100 people.
Where is Steri-Tek based?
Steri-Tek is headquartered in Fremont, United States, in the North America region.
How does Steri-Tek make money?
Three revenue lines are on record. Contract Sterilization Services are the primary driver. The others are R&D and Consulting Services and managed Validation Services.
Who are Steri-Tek's main competitors?
Direct peers on record are Sterigenics (Sotera Health), Ionisos and BGS Beta-Gamma-Service. STERIS is listed as a broad incumbent. Others are Triple Ring Technologies and Eagle Medical. Pacific BioLabs is listed as an emerging player. Symec Engineers (India) is listed as a regional player.
Does Steri-Tek have an API?
No public API is recorded for Steri-Tek.
What industry is Steri-Tek in?
Steri-Tek's product category is Contract Sterilization Services. Its primary akta.pro industry code is HLAHANAB, Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers), with a secondary code of EUAKAIAG, Radiation Processing & Sterilization Services (Medical device sterilization, food irradiation, materials modification). Its NAICS code is 334517 and its SIC code is 3844.