What we offer

  • Physicochemical Analysis

    In our physicochemical analysis area we offer analysis for a wide range of assays and tests, under international norms and standards, among others, we have ENAC accreditation (546/LE1162) and GMP certificate NCF/2214/001/CAT.

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    MicroBios Análisis químicos
  • Microbiological Analysis

    From our Microbiological analysis area, we offer different analytical solutions that we apply to a wide range of samples: raw materials, pharmaceutical products, cosmetic products, food supplements, etc.

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    MicroBios Lab Analyses Microbiological
  • Pharmaceutical and Healthcare (Medical Devices)

    It is the most demanding sector in terms of quality, we help you find the solution to achieve your objectives, in design and control. We know the pressure imposed by the industry in the rapid launch of new products in the market. Our goal is to offer a fast, personalized and quality service.

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    MicroBios laboratorio de farma
  • Cosmetics and Hygiene Products

    For more than 30 years, we have been analyzing your cosmetic products to ensure their compliance with the different standards (ISO, USP, EUP,…) or your own. We work together intensively in order to shorten time and costs in the development of new products or in the improvement and optimization of existing ones.

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    MicroBios laboratorio de Cosmética
  • General Chemistry and Biocides

    For any project, we advise you to ensure that your products meet the quality requirements and are in line with the applicable standards. Modern industry increasingly demands strict compliance with environmental regulations.

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    MicroBios laboratorio químico
  • Dietetics and Food Supplements

    Your medical devices require the highest quality. We strive to help you achieve it.

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    MicroBios Nutracéuticos
  • Consulting and Training

    Our flexibility and know-how allow us to provide tailor-made solutions that meet the specific needs of each project.

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    MicroBios formacion y consultoria DSC 6570

Sterility Assays

The manu­fac­ture of sterile prod­ucts is subject to special require­ments to mini­mize the risks of micro­bial, partic­u­late and pyrogen cont­a­m­i­na­tion. It depends, in large part, on the skill, training and atti­tude of the personnel involved. Quality Assur­ance is of partic­ular impor­tance and this manu­fac­turing must strictly follow care­fully estab­lished and vali­dated prepa­ra­tion methods and procedures.

At Micro­Bios Labo­ra­tory we have a Clean Room approved by the Spanish Agency of Medi­cines and Medical Devices, for the perfor­mance of sterility tests. It is divided into two areas: a prepa­ra­tion area with C clas­si­fi­ca­tion and a second area with B clas­si­fi­ca­tion for the analysis and studies. This second area is also equipped with a laminar flow cabinet. The useful surface area of the facility is completed by the two existing SAS or passage cham­bers designed to ensure safety during the transfer of prod­ucts between the different areas, as well as with the outside.

Sterility tests are already being carried out in the new clean room, both by direct seeding and by STERITEST® filtra­tion, according to, among others, the following standards:

  • ISO 11737 – 2:2010: Ster­il­iza­tion of medical devices. Micro­bi­o­log­ical methods. Part 2: Sterility tests performed for the defi­n­i­tion, vali­da­tion and main­te­nance of a ster­il­iza­tion process.
  • Ph. Eur. 2.6.1
  • USP <71>
  • Aseptic Process Simu­la­tion (APS), formerly Media Fill Test
In addi­tion, we plan to start up several studies of different types that require clas­si­fied rooms with high tech­nical equipment.

The approx­i­mate number of tests carried out annu­ally is 5000, in a multi­tude of different formats, among them:

  • water for injections
  • ophthalmic solu­tions
  • sutures
  • parenteral solu­tions
  • lyophilisates
  • sterile containers
  • pros­theses
  • disin­fec­tants
  • tissues
  • medical devices

Set-up and validation of chromatographic methods

Our team offers its expe­ri­ence and the neces­sary agility to carry out this devel­op­ment phase, saving time for our customers and providing solu­tions through fine-tuning, vali­da­tion and/​or analyt­ical transfer of methods for the deter­mi­na­tion of active ingre­di­ents and impurities/​degradation prod­ucts, both gas chro­matog­raphy (GC-FID) and high perfor­mance liquid chro­matog­raphy (HPLC-UV).

Taking as a refer­ence the existing guide­lines for their design and execution:

  • ICH Q2 (R1) Vali­da­tion of analyt­ical proce­dures: Text and Methodology
    ISO 12787:2011 Cosmetics – Analyt­ical methods – Criteria for vali­da­tion of analyt­ical results by chro­mato­graphic techniques.

Suitability of microbiological control methods

Micro­Bios performs Suit­ability tests of micro­bi­o­log­ical control methods (Suit­ability tests) neces­sary to verify the adequacy of analyt­ical methods in routine control. Applic­able to all crit­ical phases in the product life cycle:

  • Raw Mate­rials
  • Manu­fac­turing
  • Cleaning vali­da­tion
  • Condi­tioning material

By means of Neutralization/​dilution and membrane filtra­tion methods and in compli­ance with the require­ments of the applic­able regu­la­tions, among others:

  • Ph. Eur. 2.6.12 Examen micro­bi­ológico de productos no estériles: Pruebas de Enumeración Microbiana
  • Ph. Eur. 2.6.13 Examen micro­bi­ológico de productos no estériles: Pruebas de microor­gan­ismos especificados
  • ISO 21148:2017 Cosméticos. Micro­bi­ología. Instruc­ciones generales para el examen microbiológico.

Preservative efficacy studies under GLP

At Micro­Bios we offer our expe­ri­ence in the execu­tion of the neces­sary studies to test the effi­cacy of preser­v­a­tives, also commonly called Chal­lenge test, in phar­ma­ceu­tical and cosmetic formu­la­tions according to the usual regu­la­tory standards:

  • Ph. Eur. 5.1.3 Effi­cacy of antimi­cro­bial preservation
  • USP ˂51˃ Antimi­cro­bial Effec­tive­ness Test
  • UNE-EN ISO 11930:2012 Cosmetics. Micro­bi­ology. Test of the antimi­cro­bial protec­tion of a cosmetic product.

For which we have Good Labo­ra­tory Prac­tices (GLP) certi­fi­ca­tion and there­fore we are a research center regis­tered under the number BPL031CAT and the Good Labo­ra­tory Prac­tices Compli­ance Veri­fi­ca­tion Program.

We conduct approx­i­mately 500 studies per year in a wide variety of formats, such as:

  • Parenteral prepa­ra­tions, eye prepa­ra­tions, intrauterine prepa­ra­tions and intra­mam­mary preparations
  • Ear prepa­ra­tions, nasal prepa­ra­tions, prepa­ra­tions for skin appli­ca­tion and prepa­ra­tions for inhalation
  • Oral prepa­ra­tions, uromu­cosal prepa­ra­tions and rectal preparations.
Our team offers flex­i­bility in study design, for example, by incor­po­rating endoge­nous strains and vari­a­tions in counts and/​or recontamination.

Empha­sizing proac­tivity in the commu­ni­ca­tion and eval­u­a­tion of results and the elab­o­ra­tion of study conclusions.

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