What Primolab Srl does

Primolab S.r.l. is an Italian microbiological and physical analysis laboratory headquartered in Spresiano (Treviso), operating under ACCREDIA accreditation (certificate 01573) in compliance with UNI CEI EN ISO/IEC 17025:2018 and an ISO 9001:2015-aligned quality management system. The company serves three B2B verticals — medical devices, pharmaceutical, and hospital/healthcare — providing seven core test families: microbiological air and surface monitoring in classified cleanrooms (GMP Annex 1), biological indicators monitoring, residual protein contamination detection, bioburden analysis (ISO 11737-1), sterility analysis (ISO 11737-2, European Pharmacopoeia § 2.6.1), bacterial endotoxin testing via kinetic turbidimetric and chromogenic LAL methods (Ph. Eur. § 2.6.14), and sterile barrier system verification (ISO 11607). Testing is conducted in two physically separated laboratories equipped with annually validated instrumentation, vertical steam autoclaves, thermostatic baths, Class A laminar flow hoods, and continuous temperature data loggers.

The firm's commercial model is direct B2B professional services: clients access the laboratory through website contact channels and downloadable analysis request forms, with dedicated email routes for general inquiries ([email protected]), customer service ([email protected]), administration ([email protected]), and complaints ([email protected]). Each engagement includes test execution, report issuance, optional report drafting, and consultation including on sampling methodology. The laboratory operates standard Italian business hours (08:30–17:30, Monday–Friday). Geographic scope is Italy-only; pricing is not publicly disclosed; no funding rounds, parent company, acquisitions, or leadership changes are recorded in the available data. The company is privately held as an S.r.l. with 1-10 employees and no disclosed ownership structure.

Name

Primolab Srl

Legal name

Primolab S.r.l.

Website

https://primolabsrl.it

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Primolab Srl is an ACCREDIA-accredited (certificate 01573) Italian microbiological and physical testing laboratory in Spresiano, serving medical device, pharmaceutical, and hospital clients with sterility, bioburden, endotoxin, and cleanroom monitoring services.

Ownership category

akta.pro rank

Product category

Laboratory Testing Services

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Microbiology & Infectious Disease Testing Laboratories (HLAFAMAD)

akta.pro secondary industry

Impurity / Reference Standard Synthesis & Characterization (HLAGAHAG)

Keywords

• Microbiological testing services
• Physical laboratory analysis
• Medical device testing
• Pharmaceutical testing services
• Cleanroom monitoring

Headquarters

HQ city

Spresiano

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Others

Revenue model

1. Laboratory Testing Services: Primolab provides microbiological and physical analysis services to clients in medical devices, pharmaceutical, and hospital sectors. Services include test execution with report issuance, report writing, and consultation including on sampling. The laboratory operates from 08:30 to 17:30 Monday to Friday.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Primolab Srl is an Italian analytical laboratory that provides microbiological and physical laboratory testing services — including sterility, bioburden, endotoxin (LAL), biological indicator, residual protein contamination and sterile barrier system verification testing — as well as microbiological air and surface monitoring for medical device manufacturers/reprocessors, pharmaceutical companies, and hospitals. The laboratory complements testing with technical-scientific consultation and the issuance of recognized international test reports.

Product overview

Primolab Srl is a microbiological and physical analysis laboratory offering a comprehensive suite of testing services for the medical devices, pharmaceutical, and hospital sectors. The company operates two separate laboratories (Laboratorio A and Laboratorio B) equipped with validated instrumentation including incubators, refrigerators with temperature data loggers, vertical steam autoclave, thermostatic bath, and class A laminar flow hoods per GMP ANNEX 1 standards. The service portfolio includes seven core testing services: Microbiological Air and Surface Monitoring, Biological Indicators Monitoring, Residual Protein Contamination Detection, Bioburden Analysis, Sterility Analysis, Bacterial Endotoxin Testing (LAL Test), and Sterile Barrier System Verification. All tests include analysis execution with report issuance, potential report drafting, and consultation services including sampling advice. The laboratory operates in compliance with UNI CEI EN ISO/IEC 17025:2018 and is accredited by ACCREDIA (Certificate 01573).

Differentiator

Problem solved

Functional benefit

Products and services

• Microbiological Air and Surface Monitoring (Monitoraggio Microbiologico dell'Aria e di Superfici) Environmental monitoring service for controlled environments (cleanrooms, operating theatres, isolators, RABS) that measures microbial contamination of air and surfaces to verify GMP Annex 1 compliance, used by medical device, pharmaceutical and hospital clients.
• Biological Indicator Monitoring (Monitoraggio Indicatori Biologici) Testing service that uses biological indicators (Geobacillus stearothermophilus, Bacillus atrophaeus, etc.) to validate and routinely monitor the effectiveness of sterilization cycles for medical device reprocessors and hospital sterile supply departments.
• Residual Protein Contamination Detection (Rilevazione Contaminazione Proteica Residua) Analysis using the ninhydrin-based method to detect and quantify residual protein contamination on surgical instruments and reusable medical devices, used by CSSDs and sterile service departments to verify cleaning efficacy per ISO 15883 and ANSI/AAMI ST79.
• Bioburden Analysis (Analisi Bioburden) Quantitative enumeration of the total microbial population on medical devices, pharmaceutical products, or raw materials prior to sterilization, performed under ACCREDIA-accredited ISO/IEC 17025:2018 methods to support sterilization dose validation and routine batch release.
• Sterility Testing (Analisi Sterilità) Sterility test performed under Class A laminar flow conditions per GMP Annex 1 to confirm that terminally sterilized or aseptically processed medical devices, pharmaceutical products, and tissues meet the sterility criteria of the European Pharmacopoeia and ISO 11737-2.
• Bacterial Endotoxin Testing / LAL Test (Analisi Endotossine Batteriche)

Quantifiable outcome

• Protein contamination sensitivity of 9 µg per device

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

One partnership is on record.

• ACCREDIAcoreOthersACCREDIA is the Italian national accreditation body. Primolab is accredited by ACCREDIA (certificate number 01573) per UNI CEI EN ISO/IEC 17025:2018 for microbiological and physical testing. ACCREDIA attests to the technical competence, independence, and impartiality of the laboratory, and guarantees international recognition of Primolab's test reports.

Scale indicators2 records

Recent moves1 record

Expansion highlights3 records

Broad incumbents

• Intertek: Major testing and certification group with pharmaceutical and medical-device laboratory services including sterility, bioburden, and packaging validation — directly comparable to Primolab's core portfolio.
• SGS: World's largest testing, inspection and certification company with substantial life-sciences and medical-device testing operations in Italy. Competes with Primolab on pharmaceutical QC and sterility testing, though as part of a much broader service portfolio.
• ALS Limited: International testing services group with life-sciences and pharmaceutical microbiology offerings including environmental monitoring, sterility, and endotoxin testing relevant to Primolab's services.
• Bureau Veritas: Global TIC group with healthcare and life-sciences laboratory services including microbiological and physical testing. Offers overlapping sterility and environmental monitoring capabilities across multiple geographies.
• TÜV SÜD: Testing, inspection and certification body with dedicated medical-device and healthcare laboratory services, including sterilization validation and packaging testing that mirror Primolab's portfolio.
• Charles River Laboratories: Global CRO offering endotoxin (LAL) testing, sterility testing, and biologics safety services to pharma and medical-device clients. Direct overlap with Primolab's microbiological QC service lines.
• Eurofins Scientific: Global leader in bioanalytical and microbiological testing for pharmaceutical, medical-device, and clinical sectors. Directly overlaps Primolab's sterility, endotoxin, and environmental monitoring services but at vastly greater scale and geographic reach.

Regional players

• CERB (Centro di Ricerche Biologiche): Italian CRO providing biological and microbiological testing services to pharma and medical-device clients. Closely comparable Italian regional peer in the same laboratory testing niche.
• Lab Analysis Srl: Italian analytical laboratory providing chemical, microbiological, and physical testing for pharma and medical-device customers — overlapping Italian regional competitor in the same QC testing market.
• Chelab Srl: Italian analytical testing laboratory (now part of Mérieux NutriSciences) offering microbiological and chemical testing for food, pharma, and consumer products. Comparable regional laboratory testing competitor with similar B2B service model.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/primolab-srl

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

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 Primolab Srl