History
- Operations started renting a space in a hospital located at street 5 de Febrero, Col. Algarín in Mexico City carrying out clinical analysis for this and other hospitals and associations of HIV patients.
Routine tests and special analysis such as subpopulations of T, CD4, and CD8 lymphocytes, MIF, ELISA (p24, anti-HIV antibodies, etc.), Western Blot among others; it must be mentioned that all these tests were carried out manually.
Permit to operate as Clinical Laboratory was obtained as Sanitary License No. 200 604 2262.
- An arrangement with the Mexican Association for Biochemistry allowed to promote LEI presence through posters and triptych flyers in Querétaro, Acapulco, Veracruz and Morelia mainly with the tests for HIV.
- Approval was requested from the Health Ministry to act as Auxiliary Laboratory for Analytical Control of the Chemical-Pharmaceutical Industry, mainly in immunological tests for human blood derivative products.
- Two working sets were acquired (13 and 14) in the microindustry module, Col. Ampliación Casas Alemán, our current office and operating address.
Automation was started in the clinical area for tests of CD4, CD8, T and B lymphocytes, Macrophage Migration Inhibitory Factor (MIF), blood biometry, blood chemistry and other tests such as ELISA, TORCH, and immunoglobulins.
Sets 13 and 14 were furnished for the Pharmaceutical Division as Auxiliary Laboratory for Analytical Control for Sanitary Regulation, with tests such as HPL Chromatography, PAGE, Factor VIII potency. Laminar flow hoods were acquired for cell culture and viral propagation tests.
- License was obtained as Sanitary Responsible No. 39336.
License to operate as Auxiliary Laboratory for Analytical Control of the Chemical-Pharmaceutical Industry was obtained: No. 100 701 8329.
Set 14 was refurbished with the mice and guinea pigs facilities. Participation in EXPOFARMA began.
- Sets 9 and 10 of the microindustry module were acquired.
- Sampling installations moved from street 5 de Febrero to street Asturias No.1.
The Quality System was implemented, norms ISO-9001-2000 and ISO-17025-2000.
- The Food Division was created to provide the microbiological analysis for the national and transnational industries applying official methods for the counting of indicator groups (for example: aerobic mesophilic, total coliforms, etc.) and pathogenic microorganisms.
- Remodeling of sets 9 and 10 was finished for the Pharmaceutical Division and the Research and Development Division was founded in those same facilities.
An area for the preparation of culture media, reagents, solutions and diverse materials was established in the Food Division.
An increase of the analyses lines was requested for the Auxiliary Laboratory for Analytical Control of the Sanitary Regulation, Sanitary License 09 007 13 0001.
- The Cosmetics Division and the Systems area were founded. The latter was meant for the administration of the information technology. A reliable informatics system was developed for the documentation of tests carried out at LEI.
Set 13 was remodeled for Food and culture media preparation as well as the Cosmetics area which integrates into de Food and Cosmetics Division.
- Two additional sets were acquired (4 and 8) in the microindustry module.
Approval from the Ministry of Health was obtained through COFEPRIS as a Third for Arbitration Laboratory No. TA-09-04 for the Food and Cosmetics Division.
- Sets 2 and 3 were acquired in the microindustry module.
An area of Promotion and Sales was established in order to promote the personalized attention as well as to keep a follow up of customers’ requirements.
- Approval from the Ministry of Health was obtained through COFEPRIS as a Third for Arbitration Laboratory No. TA-13-06 for the Pharmaceutical Division.
LEI obtained the renewal of the authorization as Third for Arbitration Laboratory for the Food and Cosmetics Division No. TA-21-06.
- Office facilities and a cafeteria were built in sets 2, 3 and 4.
A rabbitry was built.
More space was alloted to the Pharmaceutical Division and the Research and Development Division in set 8.
The area of Personnel was formally established in order to administrate hiring, remaining and technical and integral development of employees which allows the assurance to customers that the quality of the analyses of their products is performed by excellent professionals.
The area of Innovation was founded in order to establish a suitable contact between customers and the various areas involved in the performance of analysis and implementation of new methods as well as to establish the time for reporting results.
The area of Validation was established in order to validate the methods required by internal and external customers
The Metrology area was established as an independent area in order to serve, qualify and verify the analytical equipment, measuring instruments, and systems in order to obtain consistent, reliable and exact results.
- Analytical and Administrative spaces were built, remodeled, and relocated (set 8) in order to make LEI operations more efficient.
An increase of the analysis lines was requested for the Laboratory for Analytical Control of the Sanitary Regulation, Sanitary License 09 007 13 0001.
- Remodeling and expansion was finished for the analytical spaces of the Pharmaceutical and Research and Development area, administrative area, secretarial area for Pharmacy, offices for the Scientific Advisor of Analytical Operations, Direction of Analytical Operations and Quality, Manager of Pharmacy and Research and Development and the General Director.
Remodeling will follow for set 10, it comprises mainly the area of general reception of samples, lockers, rest rooms, glassware and instrumentation washing for Pharmacy and Research and Development, storeroom and area for Molecular Biology. |
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