Servicing, validations, and calibration laboratory

Servicing, validations, and calibration laboratory
Kruzici iso certifikata
servis validacije
As a leading manufacturer of clean rooms, ventilation, and air conditioning equipment, Klimaoprema offers a complete turnkey service,
which, in addition to the design, production, and construction of clean rooms, includes servicing and regular preventive maintenance, as well as validation and calibration of measuring devices.

At Klimaoprema, we follow a quality system with the following integrated standards:
• Quality management system (ISO 9001);
• Environmental management system (ISO 14001);
• Occupational health and safety management system (ISO 45001);
• Medical devices management system (ISO 13485);
• Energy management system (ISO 50001);
• General requirements for the competence of testing and calibration laboratories (ISO 17025).
The requirements of the corresponding technical standards form part of the integrated management system.

Services we provide

• Commissioning of the HVAC system
• HVAC balancing
• Qualification of clean rooms and devices
• Testing the integrity of the HEPA filter
• Particle counting
• Room recovery test
• Airflow visualization test/Smoke study
• Temperature mapping/monitoring
• Balancing the distribution of technological media (refrigerants, domestic hot and cold water).
• Preparation of validation, qualification, and requalification documentation pertaining to HVAC, technological media, clean rooms, temperature-controlled equipment, and other equipment in the same or similar domain (pass box, LF cabins, and cabinets, BSC Class II cabinets, refrigerated chambers, refrigerators, warehouses, temperature-controlled rooms...).
• Calibration of differential pressure, temperature, and relative humidity meters

Servicing and validation

Regular servicing, maintenance, and validation of the equipment or facility ensure safety during use and a longer device lifespan. A modern approach to running a system requires continuous care regarding maintenance and traceability of documentation throughout the exploitation life cycle. With the new approach, the documentation is just a continuation of the previous one, meaning that after the design, execution, commissioning, system commissioning, system qualification and subsequent validation will follow to confirm that the required parameters were obtained. All this requires organization and knowledge of the results, standards, and methods of measurement tests used in the pharma or health environments.

Full or partial maintenance

  • Total care of the plant, system or device
  • Contractual maintenance
  • Emergency interventions within 0-24 hours from reporting the failure
  • Partial services
  • Preventive inspections and replacement of spare parts
  • Qualifications / Validations / Calibrations at the request of clients

Preparation of validation and qualification documentation

Compilation of the documentation necessary for the implementation of qualification activities in the project execution phase, during reconstruction, during the initial validation of a device or clean room, and during regular revalidation of a device or clean room.

We offer preparation of the following documentation:
• URS – User requirement specification,
• GMP RA – Risk assessment,
• RDS – Room data sheet/Roombook,
• FS – Functional specification,
• TS – Technical specification,
• DQ – Design qualification,
• MC – Mechanical Completion procedure,
• IQ – Installation qualification,
• OQ – Operation qualification,
• PQ – Performance qualification,
• TEMPERATURE MAPPING – Cold or Hot Rooms,
Chambers, Warehouse
• Sensor calibration certificates
• Preparation of documentation using advanced programs that ensure good documentation practice (GDP) – COMOS, DMS, and KNEAT

Professional qualifications of the validation team:

Calibration laboratory

The laboratory operates in accordance with the ISO 9001 standard, and the laboratory's compliance with the requirements of the HRN EN ISO/IEC 17025 standard ensures that the laboratory operates in an impartial manner and ensures the confidentiality of information obtained during the process of calibration tests. The calibration laboratory has top-of-the-line equipment for carrying out calibration both on the premises of the laboratory and at the client's location. The domain of laboratory calibration includes calibration of temperature, differential pressure, and relative humidity meters.

We are currently able to calibrate the following:
• Temperature meters in the range from -35°C to +165°C
• Differential pressure meters from -5000 Pa to +5000 Pa
• Relative humidity meters in the range from 5 to 95% RH.

Professional qualifications of the calibration laboratory:

To perform measurements at the most professional level, the laboratory staff has been educated by the most renowned local and foreign institutions, including LPM (Laboratory for Process Measurements – Faculty of Mechanical Engineering and Naval Architecture), HMD (Croatian Metrology Society), NPL (National Physical Laboratory – national laboratory for measurement standards in the United Kingdom), etc.