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;
- 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.