VENTILATION SYSTEM PASSPORT
According to the “Rules for the safe operation of ventilation systems in chemical plants” approved by Order No. 164 of 5.10.2009 (NPAOP (occupational safety regulations) 0.00-1.27-09) each ventilation system should have a passport (two copies).
Upon installation and adjustment of the ventilation system, it is checked for compliance with design specifications, and the data obtained is recorded in the passport. Besides, all design and actual parameters, equipment characteristics, airflow rate in the rooms, information about completed repairs, revisions, and system inspections are recorded in the passport.
Periodically, once or twice a year, every ventilation system requires a routine inspection to ensure its effectiveness, followed by recording the obtained data in the passport. Additionally, fire retardant devices, ventilation interlock systems with fire alarm systems, fire-fighting systems, and automatic ventilation shut-off controls should be inspected at least once every six months. Automatic non-return valves must be inspected once a year. The results of all the tests mentioned above are recorded in the ventilation system passport.
Unscheduled testing and adjustment of the ventilation system are carried out after modernization, capital repair or if workplace air does not comply with the current sanitary and hygienic standards and rules, or if process changes have been made. Test results are recorded in the respective sections of the ventilation system passport. The efficiency of ventilation systems is established based on test results, measurement of airflow rates, and air exchange rates. These results are recorded in the respective section of the ventilation system passport.
Proper operation of ventilation systems must be carried out to ensure their trouble-free and efficient performance. It involves:
- a sufficient number of personnel to carry out maintenance or involvement of contractors;
- regular monitoring of the air environment in the rooms at established intervals (temperature, relative humidity, air movement, concentration of aerosol particles, contaminants, etc.), including options provided by testing laboratories;
- carrying out activities to determine the efficiency of ventilation system operation and adjustment using measuring instruments, which have valid calibration certificates with known measurement uncertainty;
- ensuring the proper technical condition of ventilation systems and providing timely repair.
VENTILATION SYSTEM OPERATION AND MAINTENANCE LOGBOOK
Besides a passport, a ventilation system operation and maintenance logbook should be available at each manufacturing site. These logbooks contain information about inspections, defects, system failures, malfunction repairs, maintenance, names of responsible persons, etc. Performance and operation inspection results of ventilation systems for rooms type A, B, C, and emergency ventilation systems are recorded in the logbook at least once per shift.
TECHNICAL REPORT AND SANITARY-AND-HYGIENIC EFFICIENCY OF THE VENTILATION SYSTEM
A technical report should be issued if testing and adjustment of ventilation systems for separate workshop rooms, departments and production areas are conducted. The report must be in any form, taking into account any unit of the ventilation system. Besides, testing results and adjustment of the ventilation system to ensure its sanitary and hygienic efficiency must also be issued in the form of a technical report. While performing sanitary and hygienic control of the ventilation system, the following air parameters, such as temperature, relative humidity, air velocity, radiation intensity, the concentration of hazardous substances in the workplace air, should be measured depending on the particular conditions, aspects of the manufacturing process or type of ventilation equipment for manufacturing areas. Assessment of the sanitary and hygienic efficiency of ventilation systems must be carried out if unsatisfactory results of air environment analyses are received, after ventilation system modernization, or changes in the manufacturing process, equipment replacement, or renewal of the building (change of its intended use).
We offer you the development of documents mandatory for pharmaceutical companies:
- ventilation system passport;
- technical report, certificate for ventilation system efficiency inspection;
- ventilation system operation logbook, ventilation system maintenance logbook;
- ventilation system user manuals, occupation safety guidelines relating to performing maintenance of ventilation system equipment and units, maintenance works, cleaning schedules for air ducts and ventilating equipment.
Testing and measurement
Carrying out scheduled activities and unscheduled testing of ventilation systems, monitoring of the air environment, measurement of air flow rates, air velocity, air exchange rates, noise, vibration, temperature, relative humidity, the concentration of aerosol particles, pressure differential, element resistance, fan capacity, total pressure, heating and cooling uniformity, followed by the further recording of the obtained data in the relevant documents.
Calibration of temperature, humidity, and pressure measuring devices, which are parts of ventilation systems and premises.