MCI expands its technical capabilities with a new international accreditation
At MCI, we continue to strengthen our commitment to quality and technical excellence in order to meet the highest standards required by the medical device and pharmaceutical industries. As part of this continuous improvement strategy, MCI has obtained accreditation as an accredited calibration laboratory, granted by the International Accreditation Service (IAS) under the ISO/IEC 17025:2017 standard, with accreditation number CL-316.
This accreditation represents a key milestone in strengthening the metrological control of critical equipment used in regulated environments and controlled areas, especially for calibrations that are not available at the regional level.
Accredited calibration laboratory for volumetric flow in SAS Air Sampler
The IAS CL-316 accreditation officially recognizes MCI’s technical competence to perform volumetric air flow calibrations on SAS Air Sampler equipment, which is essential for environmental microbiological monitoring in cleanrooms, classified areas, and critical equipment.
Scope of accreditation:
- Calibrated quantity: Volumetric air flow (SAS Air Sampler)
- Range: 100 L/min to 200 L/min
- Calibration method: Airflow calculation through velocity measurement in a wind tunnel
The entire process is carried out under an accredited quality management system, ensuring metrological traceability, reliability of results, and compliance with international regulatory requirements.
Strategic value for the pharmaceutical and medical device industry
Having access to an accredited calibration laboratory provides direct benefits to organizations operating in highly regulated sectors:
- Cost reduction by having a locally available, internationally accredited service
- Greater reliability of microbiological sampling equipment
- Compliance with regulatory audits and quality standards
- Reduced risks associated with inaccurate measurements
- Strengthening environmental validation and microbiological control programs
Proper calibration of SAS Air Samplers is essential to ensure accurate results in the monitoring of viable airborne particles, especially in processes subject to frequent inspections.
Integration with MCI’s accredited services
This new accreditation adds to MCI’s capabilities as an ISO/IEC 17025:2017–accredited testing laboratory, which include:
- Environmental microbiological analysis
- Bioburden determination
- Bacterial endotoxin testing
- Water analysis
- Microbiological identification
- Biological indicator sterility testing
- Ethylene oxide residue analysis by gas chromatography
In this way, MCI consolidates a comprehensive service offering, covering everything from sampling and analysis to the calibration of critical equipment under a single accredited quality system.
Your strategic partner in quality and regulatory compliance
With the IAS CL-316 accreditation, MCI reaffirms its position as an accredited calibration laboratory, demonstrating technical competence and alignment with the international requirements of regulated industries.
Our technical team is ready to support your organization in regulatory compliance, continuous improvement, and the protection of the microbiological quality of your manufacturing processes.
Contact us for more information about our SAS Air Sampler calibration services and accredited solutions for the pharmaceutical and medical device industries.
