Qualification

expertise for guaranteed compliance

The QCMM Laboratory is dedicated to ensuring compliance with established standards for utilities, processes and production equipment used in industries and hospitals. As a reliable partner, our team offers technical expertise, problem-solving assistance, audits, diagnostics and compliance guarantees for all of our services.

Our team is made up of highly qualified specialists in various fields, as well as leading experts for each area of expertise. We also have reliable measuring instruments calibrated in accordance with national and international standards.

By respecting the standards and references in force, the QCMM Laboratory carries out tests with rigor and provides complete reports, written under the guarantee of quality. Our technical centers are run by qualified engineers and technicians who are continually assessed to ensure better responsiveness and adaptation to our customers and their needs.

Our qualification services include design qualification

the qualification of the installation
operational qualification
performance qualification

all designed to guarantee the quality and safety of your utilities, processes and production equipment.

Qualification in controlled environment

Our qualification activity for thermostatic units consists of testing and certifying their performance according to the industrial standards in force. We use high-precision measuring equipment to evaluate the characteristics of each thermostatic unit, such as temperature, pressure and control capacity. This process ensures the quality of the thermostatic units and guarantees their optimal operation under the required conditions. Test results are recorded and can be used to demonstrate compliance with quality standards required by customers and regulatory authorities.

The pharmaceutical industry frequently uses clean rooms to maintain a controlled environment for the production of drugs and medical devices. The qualification of these rooms is essential to guarantee quality and compliance with the standards in force. Relevant standards include ISO 14644 for the classification of air cleanliness in clean rooms, as well as Good Manufacturing Practices (GMP) issued by regulatory bodies such as the FDA in the United States and the EMA in Europe.
The interventions to be carried out for the qualification of clean rooms include air cleanliness tests, leak tests, air flow tests and other relevant tests to ensure compliance with normative requirements. In addition, the hygrometers, pressure gauges and anemometers used in these rooms must be calibrated regularly to ensure their reliability and accuracy.

The installation of compressed air is crucial for maintaining air quality and production processes in many industrial sectors. The qualification of these installations is essential to ensure that the compressed air used meets the necessary quality and safety requirements.
For the qualification of compressed air installations, we comply with the ISO 8573-1 and ISO 12500 standards for compressed air quality criteria. Tests performed include dew point measurement, oil test and compressed air pollutant test. We guarantee that compressed air installations meet strict quality requirements to ensure reliable and safe operation of the equipment that depends on them.

The qualification of cold rooms is governed by ISO 17025 and cGMP (Good Manufacturing Practice) standards. For the qualification of the cold room, the calibration of the temperature indicator and the temperature recorder are carried out to guarantee the reliability of the temperature measurements. Temperature qualification consists of verifying the thermal performance of the cold room in terms of temperature control.

For transport truck qualification, thermal mapping of the truck chamber is performed to assess the thermal performance of the transport chamber. Calibration of the truck's chamber temperature display is also performed to ensure reliable temperature measurements during transport. ISO 17025 and cGMP standards also apply to the qualification of transport trucks.

The qualification of autoclaves is an important process to guarantee the quality of sterilization of sensitive products. Interventions include temperature calibration to verify the accuracy of temperature measurements inside the autoclave, pressure calibration to ensure sterilization quality, steam quality verification to ensure efficiency of steam sterilization, and plotting the cycle curve to assess autoclave performance. Relevant standards include ISO standards and international quality standards for sterilization equipment. The interventions to be carried out for the qualification of clean rooms include air cleanliness tests, leak tests, air flow tests air and other relevant tests to ensure compliance with normative requirements. In addition, the hygrometers, pressure gauges and anemometers used in these rooms must be calibrated regularly to ensure their reliability and accuracy.

Current standards for incubator qualification include ISO 17025 and industry guidelines, such as that of the Association for Biomanufacturing Standards (ASB).

The interventions include the calibration of the incubator display and the qualification in temperature or humidity of the incubator enclosure. The main objective is to ensure the accuracy and reliability of results for scientific and medical applications. Testing is performed using high precision measurement methods and results are compared to required specifications to ensure compliance with standards.

Control of climatic conditions and working comfort is an important aspect of quality in the working environment. Measurements of temperature, humidity, air velocity, lighting, noise, particle count, CO and CO2 are used to assess the conditions of a work space to ensure a healthy and healthy environment. safe for employees. The standards in force for these interventions may vary according to industrial sectors and occupational health and safety regulations.