Posted on 22 April 2018
ITW Julie Cautres for Abiolabs ENG / NC
Can you profile Abiolabs for me? What are the activities?
Abiolabs is located in Ebène Business Park, Mauritius, in premises specially designed to meet the very specific needs of its customers and its field of activity: analysis.
The 115m 2 laboratory is divided into two distinct and independent parts:
- 75m2 of clean rooms meeting ISO5/ISO7/ISO8 standards dedicated to microbiological and particulate tests.
- 40m2 dedicated to physico-chemical tests.
Abiolabs provides a complete range of tests and analyses meeting the highest standards recognized worldwide.
Our objective is to meet the specific needs of companies specializing in medical devices, but also in other health sectors, such as cosmetics, hospitals and clinics…
As such, we offer tests such as bioburden (enumeration of microorganisms on a product), endotoxin analysis, sterility tests or the enumeration of particles from a product or liquid.
Our expertise in controlled environments covers, among others, clean rooms, operating rooms and laminar flow hoods. We offer comprehensive qualification services (Installation, Operation and Performance) that include air flow analysis and air change calculations, filter integrity verification, microbiological air and surface analysis, temperature, humidity and differential pressures.
We use internationally recognized standard methods, mainly ISO, USP and ASTM.
Under what circumstances was this laboratory set up?
Natec Medical, an international company based in Mauritius, one of the world leaders in medical devices, has specialized in catheter manufacturing for 20 years.
The project was born from NATEC Medical’s desire to be able to carry out microbiological and environmental tests independently. To successfully carry out this project, the Group has equipped itself with a world-class laboratory that meets its internal needs as well as those of its customers and partners, thus demonstrating its ability to create a favorable industrial ecosystem environment based on autonomy,flexibility, responsiveness and competitiveness.
This is how Natec created Abiolabs in 2015, its own laboratory, which allows it to gain even more independence and autonomy in relation to its needs.
How much investment was required to set it up?
Vincent Lagarde has invested more than Rs 12 million in the setting up of the laboratory in infrastructures and equipment…
How does Abiolabs complement Natec?
Natec, an international company based in Mauritius which exports, has a value chain modelled on the standards of the trade which are the international rules.
Our needs required horizontal as well as vertical integration: from crimping to cutting, from machines to product design, extrusion, sterilization and of course, analysis… It is a true value chain federated around small structures. By allowing us to carry out our analyses “in house”, we save precious time and substantial savings for our customers and we control the whole chain.
Does Abiolabs only perform tests for Natec?
No, of course, Natec is our main client, but we offer our services to everyone.
We work with other medical device companies but also clinics and companies producing cosmetic and hygiene products.
At present, we work on the local market but we wish in the near future to offer our services to companies in the Indian Ocean region.
In concrete terms, what does this accreditation mean for Natec?
It is the reward of rigorous work aimed at mastering an internationally recognized level of quality that has earned Abiolabs this certificate of competence. Wishing to assert its professionalism and have it recognized, Abiolabs has set up a specialized method and quality service which has earned it ISO 17025:2005 accreditation.
ISO 17025:2005 establishes the general requirements for competence to perform tests and/or calibrations, including sampling. ISO 17025:2005 is THE standard used by laboratories that develop their management systems for quality, administrative and technical activities. ISO 17025:2005 expects the laboratory to commit to working in accordance with good professional practices and regulations.
ISO 17025:2005 defines the high requirements for management systems and technical competence, ensuring the consistency and accuracy of our test and calibration results. Abiolabs’ accreditation demonstrates its commitment as well as operational and quality management efficiency.
In this respect, solid quality controls are defined with regard to the choice of methods used, the control of data and the results obtained. ISO 17025: 2005 guarantees reliability and expertise by requiring the evaluation of personnel, methods, equipment and even analytical reports to ensure the validity of test results.
ISO 17025:2005 accreditation by SANAS (South African accreditation body, member of ILAC: International Laboratory Accreditation Cooperation) and Mauritas now recognizes Abiolabs competence in the fields of Chemical, Microbiological and Controlled Environment Analysis.
The choice to work with SANAS (ILAC member) gives our accreditation an international scope. In doing so, Abiolabs becomes the 2nd laboratory to obtain this prestigious accreditation with an international scope in Mauritius.
What are Abiolabs’ projects?
With an experienced team in this very specific field, Abiolabs intends to continue developing its expertise.
Our objective is to provide a "turnkey" service to our customers by offering them the tests they need but also a consulting service to help them if they need it. Financial and human resources have been allocated for the implementation and implementation of this project.