info@tci-ingenieria.es
(+34) 91 664 46 37
Idioma Español English language

Company

TCI has a professional and highly qualified team,  with experience in this market since 1997, with either the technical knowledge for developing, manufacturing and starting up of clean rooms and production equipments, either   nationals and international regulations knowledge , as for instance GMP, FDA and ISO.

TCI has an engineering department that gives support to the manufacturing, managing at site, start up and maintenance. Once the project is achieved (installations and start up) TCI offers the client one experienced team to carry out the qualification.

The available technical staff covers engineers, design expertise, draftsmen, site managers, and also start up technicians, maintenance, after sales technical support and qualification, not only for the installations, but also for the equipments we manufacture.

Certificates and standard norms

TCI S.L.L. is an engineering company, plus an installator and maintenance company authorized by the  Consejería de Industria, energía y minas de la Comunidad de Madrid, and we are specialized in the study, design and construction of high value installations. We are entitled to the following authorizations:

  •     Frigorific company, level II (13-B-D53-NIVEL II)
  •     Installator RITE (13-B-D20-ITE)
  •     Maintenance company  (13-B-E20-ITE)
  •     Installator of equipments under high pressure, rank EIP-2 (13-B-D62-categoría II)
  •     Repair company of equipments under high pressure ERP-2 (13-B-E62-categoría II)
  •     Engineering and consult company (13-B-A00-consultora, 13-B-B00-ingeniería)

Furthermore, TCI is a qualified company in accordance with the Reglamento de la Ley de Contratos del Estado Grupo J Instalaciones Mecánicas, and is entitled to the ISO 9011:2088.

The environment norm in which TCI works is the following:

  •     Good manufacturing practices (European GMP)
  •     Code of federal regulations / Food and Drug Administration:
        - 21 CFR part 210 – Current good manufacturing practice in manufacturing processing, packing or holding of drugs;
           general.
        - 21 CFR part 211 – Current good manufacturing practice for finished pharmaceuticals.
  •     Clean air classification as per the European GMP, annex 1 and the ISO 14644.
  •     ICH Q1 AR, Stability tests for new products and medicines.
  •     PIC/S (Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme).
  •     Monographs on American Pharmaceutical (USP 35) and/or European Pharmaceutical 7th edition.
  •     20/2006  Spanish Law of July 26th on “Warranties and Rational Use of Medicines and Health Products”
  •     FDA   21 CFR part 11.
  •     Fullfiment of recommendations of ISPE specially “baseline for water systems”.
  •     ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities.
  •     Good engineering practice for documentation and control (ISPE).
  •      Filters efficiency as per stardard norms (CEN, British Standard BS 2646, ISO, ANSI, ASHRAE).
  •     Materials: fullfilment of the international standards (ASTM, ASME, CEN, ISO) as well as norms in force. Certificates must comply with standards of norms EN 10204 (certificate 3.1B) and/or ASTM E1831.
  •      Instruments: The calibration will be carried out with trackable patterns and certified by a national or international recognized institution. (ENAC or similar).
  •     Construction: fullfilment of NBE norms (Normas Básicas de Edificación), CTE (Código Técnico de la Edificación) and RITE.
  •     Electrical design in accordance with the REBT 2002 norm.

Contact us


Calle Trueno, 58
Pol.Ind. San José de Valderas
28918 | Madrid ( España )

Tel: +34 91 664 46 37

info@tci-ingenieria.es

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