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Dust control during AHU design in Pharma Company

Dust control during AHU design in Pharma Company

Dust control in Pharma Company in measure challenge Wherever possible, dust or vapour contamination should be removed at source. Point-of-use extraction, i.e. as close as possible to the point where the dust is generated, should be employed. Spot ventilation or capture hoods may be used as appropriate.

Point-of-use extraction should be either in the form of a fixed high velocity extraction point or an articulated arm with movable hood or a fixed extraction hood.

Dust extraction ducting should be designed with sufficient transfer velocity to ensure that dust is carried away, and does not settle in the ducting. Periodic checks should be performed to ensure that there is no build up of the dust in the ducting.

The required transfer velocity should be determined: it is dependent on the density of the dust (the denser the dust, the higher the transfer velocity should be, e.g. 15–20 m/s).

Airflow direction should be carefully chosen, to ensure that the operator does not contaminate the product, and also so that the operator is not put at risk by the product.

Point extraction alone is usually not sufficient to capture all of the contaminants, and general directional airflow should be used to assist in removing dust and vapours from the room.

Typically, in a room operating with turbulent airflow, the air should be introduced from ceiling diffusers, located at the door entry side of the room and extracted from the rear of the room at low level to help give a flushing effect in the room. Correct flushing of the rooms may be verified by airflow visualization smoke tests.

When dealing with particularly harmful products, additional steps, such as handling the products in glove boxes or using barrier isolator technology, should be used.

References:

Annex 5

Supplementary guidelines on good manufacturing practices for heating, ventilation and airconditioning systems for non-sterile pharmaceutical dosage forms

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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