We are BlueAirLab, We Test Measure Validate Provide Solutions

HVAC services ensure air quality excellence, following procedures set forth in ISO 14644 for controlled environments and GMP requirements:

• Airflow Balancing: Ensures air is evenly distributed throughout the system and that airflow rates are within specified limits to maintain system efficiency and occupant comfort.

• Airflow/Air Velocity Measurement: Ensures proper air exchange rates, which are crucial for maintaining the cleanliness of the controlled environment.

• Installed Filter System Leakage Testing: Verifies that filters are functioning properly and that there are no leaks, ensuring air quality and contamination control.

• Room Differential Pressure Measurement: Ensures that pressure differences between rooms or spaces are maintained correctly.

• Airflow Visualization Test (Smoke Study): Airflow visualization studies provide the analysis, evaluation, and documentation of air movement in cleanrooms and clean zones. Effective contamination control requires comprehensive airflow visualization studies under all operating conditions, including simulated operations. Airflow visualization is the science of making airflow patterns visible for analysis and is an important tool in contamination control.

• Temperature and Humidity Testing: Monitors and adjusts environmental conditions to ensure they remain within regulatory requirements, which is critical for pharmaceutical and biomanufacturing settings.

• Classification of Air Cleanliness by Particle Concentration: Measures particle levels in the air to ensure that the cleanroom meets the required ISO classification, preventing contamination of sensitive processes.

• Room Recovery Rate Testing: Measures how quickly the cleanroom returns to its required cleanliness level after a disturbance, ensuring contamination control.

• Containment Leak Testing: This test is performed to determine whether unfiltered air intrudes into the cleanroom or clean zone from outside the enclosure through joints, seams, doorways, and pressurized ceilings.

Cleanroom testing:

• Visual inspection of cleanrooms

• Verification of design documentation and technical drawings

• Verification of materials used and their certificates (Declarations of Conformity)

• Lighting testing

• Verification of interlock functionality

• Verification of door functionality

• Verification of other functionalities (depending on the system)

• Verification of cleanroom airtightness (Blower Door test)

Duct leakage testing for HVAC air distribution systems

Our laboratory is accredited for duct leakage testing for air distribution systems, with the aim of ensuring that your HVAC system meets high standards of energy efficiency and quality. Testing is performed according to relevant European standards EN 1507 and EN 14239, as well as DIN standards, allowing us to precisely identify and quantify air losses in the ducts.

Regular duct leakage testing provides:

• Reduced energy losses and lower operating costs

• Improved indoor air quality control and thermal comfort

• Extended service life of HVAC equipment thanks to proper system operation

• Compliance with legal and industry requirements in the field of energy efficiency

• Support in the maintenance and optimization of ventilation and air-conditioning systems

GREEN BUILDING AND CONTAMINATION PROTECTION

Testing of building leakage, cleanroom leakage, and isolator leakage (airtightness testing)

Our laboratory is accredited to perform Blower Door testing in accordance with current standards. This method enables precise measurement of airtightness, which is crucial for achieving energy efficiency and quality control in building construction.

Advantages of Blower Door testing:

• Reduced energy loss - air leakage points are identified that lead to higher heating and cooling consumption

• Lower energy costs - better building airtightness directly reduces monthly utility bills

• Improved thermal comfort - by eliminating drafts and temperature differences within the space

• Protection of the building structure - prevention of condensation and mold formation inside walls and insulation

• More precise HVAC system design - based on the actual airtightness of the space

• Increased property value - energy-efficient buildings have higher market value

• Compliance with regulations and standards - especially in the case of low-energy and passive houses

• Verification of workmanship quality - the test is often used as an inspection after insulation and finishing works

• Improved indoor air quality - indirectly, through controlled ventilation without uncontrolled sources of pollution

We conduct testing in:

• Cleanrooms and laboratories

• Residential and commercial buildings

• Individual apartments and houses

Compressed air testing

• Our laboratory is accredited for compressed air testing.

The SRPS ISO 8573 series of standards - the basis for assessing the purity of compressed air - prescribes testing methods and classification of contamination levels for:

• SRPS ISO 8573-1 - contaminants and purity classes (particles, humidity, and oil)

• SRPS ISO 8573-2 - oil aerosol content

• SRPS ISO 8573-3 - test methods for the measurement of humidity

• SRPS ISO 8573-4 - particle content

Based on process and application requirements, we test the following parameters:

• Oil (aerosol or aerosol + vapor) - the presence of oil can cause product contamination and equipment failures

• Moisture (absolute humidity and dew point) - excess moisture can cause corrosion and microbial growth

• Mechanical particles (dust, rust, particles from pipes) - particles can damage machines, contaminate products, and cause malfunctions

• On request: microbiological contamination, CO2, CO, and NO2 content, etc.

Our services include:

• Sampling of compressed air at critical points of the system or points of use (PoU)

• Measurement using calibrated equipment

• Classification according to ISO 8573-1 or pharmacopeia

• Deviation analysis

For pharmaceutical applications, testing is recommended according to both principles: the pharmacopeial minimum for regulatory compliance, and ISO 8573 for deeper technical validation of the system.

Compressed air testing according to ISO 8573-1, -2, -3, -4, and ISO 14644-1 (evaluation depending on the room air class into which the compressed air is supplied) is an integral part of GMP compliance because it ensures the purity and safety of all gases that come into contact with pharmaceutical products and equipment in controlled environments. This includes regular testing for particles, humidity, and oil, as well as assessing whether the compressed air meets cleanliness standards established for specific production areas.

Fluid flow measurement on control valves

Our laboratory is accredited to perform fluid flow measurements on control valves.

Advantages of fluid flow measurement:

• Optimization of system operation - precise flow regulation ensures efficiency and reduces energy consumption

• Increased reliability - identification of irregularities in the operation of valves and systems

• Compliance with technical requirements

Applications of these measurements:

• HVAC systems

• Industrial processes

• Pharmaceutical and food industries

• Other technological systems requiring precise flow regulation

THERMAL MAPPING:

Our laboratory is accredited to perform temperature testing.

Thermal mapping and qualification of temperature-controlled equipment and spaces

Temperature mapping for all types of temperature-controlled devices and spaces - cooling chambers, incubators, ovens, sterilizers, refrigerators, freezers, stability chambers, air-conditioned spaces, cold rooms, storage areas, and vehicles.

We perform thermal mapping of temperature and humidity in CTUs (Controlled Temperature Units) in accordance with internationally recognized standards and accredited methods:

• SRPS EN IEC 60068-3-5 - mapping procedure for temperature chambers (including identification of temperature zones and critical points)

• SRPS EN IEC 60068-3-6 - precise measurements within equipment with complex temperature regimes, including air humidity

• SRPS EN IEC 60068-3-7 - evaluation of the stability and uniformity of temperature and relative humidity over time for chambers loaded with products

• DIN 12880 - a standard specifically applicable to temperature-controlled devices such as incubators and drying ovens, both empty and loaded with products

Our services include:

• Planning and preparation of thermal mapping

• Identification and placement of measurement points according to standards

• Use of calibrated measuring instruments (with traceable calibration certificates)

• Detailed data analysis (graphs, statistics, identification of critical points, etc.)

• Preparation of a validation protocol and report with recommendations for further steps (if needed)

Thermal mapping of warehouses and vehicles according to WHO GDP guidelines

Thermal mapping for warehouses and transport vehicles intended for the storage and distribution of temperature-sensitive products is performed in accordance with the international guidelines of the World Health Organization (WHO):

WHO Technical Report Series (TRS) 961, 2011, Annex 9 - Model Guidance for the Storage and Transport of Time- and Temperature-Sensitive Pharmaceutical Products

Supplements 7, 8 and 11 (2015) - additional guidance for temperature monitoring, transport validation, and risk management

Thermal mapping is a key step in establishing and validating the temperature control system throughout the entire distribution chain, especially in:

• Warehouse spaces (cold rooms, air-conditioned warehouses, ambient warehouses)

• Transport vehicles (trucks, vans, containers, specialized vehicles with coolers or heaters)

• Mobile and temporary storage spaces (containers, portable chambers, etc.)

The goal of thermal mapping is to identify:

• Temperature zones with deviations

• The most critical points (the hottest and the coldest)

• The system's ability to maintain a stable and uniform temperature under real operating conditions

In accordance with WHO GDP requirements, the thermal mapping we perform includes all elements defined in the WHO TRS 961 Annex 9 guidelines and supplements:

• Risk assessment - identification of factors that may affect the maintenance of the temperature regime during storage and transport

• Validation of storage spaces - determining measurement locations according to airflow zones, distance from heat sources, height, and position

• Validation of vehicles under real conditions - temperature mapping during route simulation (including loading and unloading of cargo, stops, and extreme weather conditions)

• Documented protocol and report - including all test phases, instruments used, calculations, and recommendations for the placement of sensors for continuous monitoring

Thermal mapping according to WHO GDP standards enables your quality system to:

• Ensure compliance with regulatory requirements (Medicines and Medical Devices Agency, GMP/GDP inspections)

• Increase supply chain security - protect the integrity of pharmaceutical products and vaccines

• Optimize the monitoring system - optimal positioning of permanent temperature probes

• Support the implementation of procedures in the event of deviations from the required temperature and humidity values

Our services include:

• Preparation of protocols and mapping plans

• Placement of calibrated temperature loggers according to WHO guidelines

• Simulation of operating conditions (during transport and storage)

• Detailed analysis and data visualization (graphs, tables, statistics)

• Preparation of a validation report with recommendations for further activities (if needed)