TENTAMUS LABORATORIO MICRO-BIOS, S.L. (Unipersonal)

Laboratorio MicroBios — operating as TENTAMUS LABORATORIO MICRO-BIOS, S.L. (Unipersonal) and part of the Tentamus Group global network — is a specialist contract testing laboratory based in Spain providing physicochemical and microbiological analytical services to the pharmaceutical, cosmetic, medical device, dietary supplement, and general chemistry sectors. With over 30 years of experience analyzing cosmetic and pharmaceutical products, the laboratory offers a comprehensive portfolio of GMP-, GLP-, and ENAC-accredited services designed to support product development, regulatory submissions, quality control, and process validation at every stage of the product lifecycle.

The laboratory's sterility testing capabilities represent one of its most technically demanding service offerings. MicroBios operates a dedicated clean room (Sala Blanca) approved by the Spanish Agency for Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS). The facility is divided into two classified zones: a Class C preparation area and a Class B analysis area equipped with a laminar flow cabinet, with two airlocks (Sistemas de Acceso Separado, SAS) separating zones to prevent cross-contamination. Sterility tests are conducted by both direct inoculation and membrane filtration via STERITEST® technology in accordance with ISO 11737-2:2010, Ph. Eur. 2.6.1, USP <71>, and Aseptic Process Simulation (APS, formerly Media Fill Test). The laboratory conducts approximately 5,000 sterility test determinations annually across product formats including water for injections, ophthalmic solutions, sutures, parenteral solutions, lyophilizates, sterile containers, prostheses, disinfectants, tissues, and medical devices.

In the field of chromatographic methods, MicroBios offers development, optimization, validation, and analytical transfer of methods for the determination of active pharmaceutical ingredients and impurities or degradation products. The laboratory employs both gas chromatography with flame ionization detection (GC-FID) and high-performance liquid chromatography with UV detection (HPLC-UV). All validation work follows internationally recognized guidance including ICH Q2(R1) Validation of Analytical Procedures and ISO 12787:2011 for cosmetic analytical method validation criteria, supporting pharmaceutical and cosmetic developers requiring regulatory-compliant method packages for submission or internal quality control transfer.

MicroBios also specializes in microbiological method suitability testing (Idoneidad de Métodos de Control Microbiológico / Suitability Tests), verifying that analytical methods are appropriate for routine quality control across all critical product lifecycle stages — from raw material assessment through manufacturing, cleaning validation, and packaging material qualification. Methods applied include neutralization/dilution and membrane filtration, performed in conformance with Ph. Eur. 2.6.12 (Microbial Enumeration Tests), Ph. Eur. 2.6.13 (Tests for Specified Micro-organisms), and ISO 21148:2017 governing general microbiological examination of cosmetics.

Preservative efficacy studies — widely known as Challenge Tests or Antimicrobial Effectiveness Tests — constitute a further core competency. Under certified Good Laboratory Practice (GLP certification BPL031CAT, registered under the Spanish GLP compliance verification program), MicroBios conducts approximately 500 such studies per year across an extensive range of formulation types: parenteral, ophthalmic, intrauterine, intramammary, otic, nasal, cutaneous, inhalation, oral, uromucous, and rectal preparations. Studies are executed in accordance with Ph. Eur. 5.1.3 (Efficacy of Antimicrobial Preservation), USP <51> (Antimicrobial Effectiveness Test), and UNE-EN ISO 11930:2012 governing antimicrobial protection evaluation of cosmetic products. Study design flexibility includes the incorporation of endogenous strains and variations in inoculum counts or re-contamination protocols, with proactive communication throughout evaluation and conclusion reporting.

Beyond microbiological services, MicroBios provides physicochemical analyses across a broad spectrum of tests and assays under international standards. The laboratory holds ENAC accreditation number 546/LE1162 — the Spanish national accreditation body's ISO/IEC 17025 recognition for testing laboratories — along with GMP certification NCF/2214/001/CAT. A consulting and training division (Consultoría y Capacitación) delivers tailored advisory services to help clients navigate regulatory requirements, implement quality systems, and develop or optimize analytical procedures, drawing on the laboratory's multi-decade sector expertise.

Industries served span pharmaceutical and healthcare (including medical devices), cosmetics and personal hygiene products, general chemistry and biocides, and dietary supplements and nutritional complements. MicroBios has analyzed cosmetic products for more than 30 years, delivering compliance assurance against ISO, USP, and European Pharmacopoeia (Ph. Eur.) standards. As part of the Tentamus Group — an international network of accredited testing laboratories — MicroBios benefits from shared technical resources and a broader network for complex or multidisciplinary projects, making it a credible and well-resourced partner for regulated-industry clients requiring rigorous pharmaceutical and cosmetic analytical services.