MicroBios Lab
Analysis and services
for Pharmaceutical & Cosmetics Industry

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

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

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.

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.

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.

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