Basic design of Air Handling Unit (AHU) Design

There are different sizes and types of Air Handling Units. Some will fit in a closet or within a ceiling space, while others will require a mechanical room or will need to be placed on the roof of a building. Within all of them, however, there is at least one fan and one method of conditioning the air.

These are the basic components in an AHU: Fans, Coils, Filters, Heaters, Humidifiers, Dampers, Mixers, and Enthalpy/Desiccant Wheels. There are other fixtures in an AHU for controls purposes, but basically these are the components you will see on most AHUs.

Perform Installation Qualification (IQ) in Pharmaceutical Industry

Following qualification study to be perform during Installation qualification but not limited to

·         Training sheet (For keep the training attendance )

·         Purchase order verification (To match with PO)

·         Drawing verification (To verify GA drawing, Electrical drawing etc.)

Perform Operation Qualification (OQ) in Pharmaceutical Industry

Following activity shall be performing during the Installation qualification of <Equipment Name> but not limited to.

General test

o   Availability of IQ test report verification

o   Standard operating procedure verification

o   General function test

Guidance to Qualification and Validation towards Global Pharmaceutical Practice

“Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

QUALIFICATION

The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of GMP. This normally constitutes Design Qualification or DQ.

Design qualification

The first element of the validation of new facilities, systems or equipment could be design qualification (DQ). Design qualification should provide documented evidence that the design specifications were met.

The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of GMP. This normally constitutes Design Qualification or DQ. The compliance of the design with GMP should be demonstrated and documented.