DYCOMETAL offers a periodic preventive maintenance service of the environmental chambers, which includes also the general maintenance, also the electrical system, heating system, cooling, etc.
Personalized attention! Do not hesitate to ask for advice from our Departamento Comercial.
DYCOMETAL EQUIPOS DE CONTROL DE LA CALIDAD, S.L., has from March 2011, the CERTIFICATE OF INSTALLATION COMPANY, MAINTENANCE OR REPAIR OF FIXED REFRIGERATION DEVICES, AIR CONDITIONING AND HEAT PUMPS CONTAINING ANY FLUORATED GAS LOAD.
The Royal Decree No 795/2010, of 16th of June, which regulates the marketing and handling of fluorinated gases and equipment based on them, as well as the certification of the professionals who use them, pursuant to Regulation (EC) No 842/2006 of the European Parliament and of the Council of 17th of May, on certain fluorinated greenhouse gases, and Regulation (EC) No. 303/2008, of 2nd of April, on the certification of companies and personnel concerning fixed refrigeration, air conditioning and heat pump equipment containing certain gases greenhouse effec.
Many of the installations with refrigeration systems use fluorinated gases as a refrigerant.
The regulation establishes that companies, personnel with a personal certificate proving their competence to handle (install, maintain, repair, …) equipment with refrigeration systems that use any load of these refrigerants, must also have a specific certificate of company, enabling it for this activity. This certificate is valid for all member states of the European Union.
DYCOMETAL is registered in the register of Refrigeration Installations Conservative Installations (REIF) nº 080158862.
Regulation (EU) 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) 842/2006 obliges users (from 1 January 2015) of climate equipment with fluorinated gases to periodically check for greenhouse gas refrigerant leaks. This verification can only be carried out by companies that have the Certificate of Installation, Maintenance or Repair Company of Fixed Refrigeration, Air Conditioning and Heat Pumps that contain any load of Fluorinated Gas. The user is obliged to keep logs (Control of the refrigerant charge and Record leakage controls) for possible environmental inspections for at least 5 years.
DYCOMETAL puts at your disposal an Accredited Calibration Laboratory ENAC, nº141/LC 10.101, according with Accredited Scope (the scope could be consulted in the website of ENAC www.enac.es).
Request a Calibration Offer, of isothermal means without compromise.
Validation process according the ICH and FDA guidelines for Test Chambers
DYCOMETAL carries out Validation Processes in Pharmaceutical Companies, since 1999. The Qualification involves the delivery of the following documentation:
- Qualification Plan, where the guidelines to be taken into account to carry out the Qualification will be presented.
- Design Specifications, known as DQ document, where the Chamber will be described, as well as its operating and control systems, and its securities. This document will be made based on the specifications described by the user and the final project carried out by DYCOMETAL.
- Qualification of the Facility, known as an IQ document, where all the necessary tests will be carried out to verify that everything described in the DQ is installed correctly. The training of future users will take place.
- Operational Qualification, known as OQ document, where the necessary tests will be carried out to verify that all the systems, components and securities installed, work correctly. The functioning tests of the Chamber and the stability tests will be carried out, in a vacuum, in the work instructions.
- Process Qualification, known as PQ document, where the operating and maintenance NTPs will be presented. Stability tests will be carried out, under load, in the work instructions, and abnormal performance tests.
- At the end of the PQ, the final Qualification report will be drawn up, which will include the results of all the tests and results obtained during the Qualification as well as the Non-Conformities along with the implemented solutions.
Monitoring Software Validation, according with the ICH and FDA guidelines
- Configuration of the Monitoring System, software and associated hardware.
- Deliver CSV compliance demonstration documents, as well as ERES requirements according to GxP regulations (see [A11] and [21CFR11], and recommendations described in [PI011]).
- IQ , Qualification of the installation with cross reference to the Standard Functional Specifications and description of the tests carried out by DYCOMETAL.
- OQ, Operational qualification performed “in-situ” at the customer’s factory.
DYCOMETAL offers to the Customer the possibility to receive the training “in-situ” in its own Factory. The training contemplates the use of the controllers, maintenance and the software teaching from our specialist technicians.
The On-Line service is a practical tool that DYCOMETAL makes available to the customers. All technical doubt can be solved without the need for travel, like the management of the Regulation/Programming, the Software or the Device.