Follow
=>> AHU system should be designed as per requirement in new schedule ‘M’ or such other guidelines.
=>> Installation of window A/C without any air filtration and pressure design is not satisfactory.
=>> AHU should be fabricated and installed according to design qualification, and its record should be kept available.
=>> AHU system should be located in a proper, and clean place, and the space should be adequate for cleaning and maintenance.
=>> Proper size filters should be fitted in AHU to supply the air quality of the desired class. Separate AHU for different areas.
=>> Temperature humidity controls should be PLC-based and fully atomized. An alarm system in out-of-specification condition shall be installed.
=>> The material for the construction of AHU should be easily cleanable and not generate any type of contamination.
=>> The design of AHU should be easily cleanable.
=>> Return air ducts should have adequate filters, especially in dusty areas, such as tablets, powder, capsules, etc.
=>> Before the system is utilized for the production area, it should be validated, and validation, (DQ, IQ, OQ, PQ) with SOP should be documented.
=>> Training should be given to personnel for good practices for the Air handling unit, and records should be maintained.
=>> SOP should be correctly written, followed, and displayed near to AHU.
=>> Periodical cleaning, preventive maintenance, and validation should be done, and records should be maintained.
=>> AHU systems for parenteral and other formulations should be designed by considering the proper pressure to differentiate, airflow patterns from cleaner to dirtier, Air changes, heat load, and occupancy.
=>> Fabrication quality of AHU and duct, pipelines should be good with no leakage, and Properly installed wherever required.
=>> Systematic drawing, with the type of duct, diffuser, grills, dust size, elbow, and branching should be available.
=>> AHU system should give desired air quality.
=>> Manometers should be installed to indicate the room inside pressure.
=>> AHU filters in critical, non-sterile areas should be installed at the terminals, for any class filters should be fitted at the terminals.
=>> Air velocity records should be kept.
=>> Filters should be installed properly with proper gaskets to avoid leakages.
=>> Dust from production through exhaust should not be let into the atmosphere.
=>> Filter cleaning and preventive maintenance record should be maintained.
=>> Diffusers, grills, and risers should be cleaned frequently in the powdery operation area,
=>> AHU should be ‘ON’ whenever production is going on.
=>> Start-up, a time to achieve the desired air quality class, should be established and recorded.
=>> AHU should be installed in the shed and not in an open space.
=>> Fire and safety instruments should be fitted to the AHU system.
=>> Temperature, Humidity, pressure, and air velocity measuring instruments shall be made available.
=>> Out-of-specification should be recorded (if Applicable).
=>> Pressure drop across the filter should be maintained and recorded for filter integrity.
=>> Air supply should be adequate in all airlocks.
=>> Working ranges should be marked in green on manometers also mark the green and red zone on the monometer.
=>> AHU’s surrounding area should be clean.
=>> AHU and Area shall be disinfected when there is a longer gap between production activity.
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