History

The AHU-6 and MAU-1 HVAC system includes Air Handling Unit (AHU-6) and Make Up Air Unit (MAU-1).  AHU-6 was purchased from York International in October 1994.  AHU-6 was designed and installed to supply recirculating air to rooms: 123–125.  MAU-1 was purchased as part of the building and operated to supply make up air to the AHU-6 and rooms 120-125, 111, 113, 114, 117, 118,and both service corridors.  

Description

The major equipment / components of the AHU-6 and MAU-1 HVAC system include Air Handler Unit AHU-6, Make Up Air Unit MAU-1, Humidifier H-1, twelve (12) reheat coils RHC-1-RHC-9 and RHC-19 – RHC-21 and fourteen (14) exhaust fans EF-1 - EF-12, and EF-15 - EF-17.

AHU–6 is a recirculating air handling unit, which provides a constant volume of airflow to rooms 123,124, and 125.  It is equipped with a Pre Cooling coil, Preheat coil and 65% efficiency air filters. AHU-6 provides airflow using outside air from MAU-1 mixed with return air.

MAU-1 provides conditioned air to rooms 111, 113, 114, 117, 118, and 120-125 utilizing 100% outside air. It is equipped with one (1) reheat coil and two (2) cooling coils.  It has 35% efficiency pre-filters and 95% efficiency bag filters, it also utilizes eleven (11) Variable Air Volume controllers VAV-A, B, C, D, E, F, G, H and VAV-j, K and L. one (1) Steam Humidifier H-1 located in the supply air duct downstream from MAU-1 provides humidification 

The system is designed to provide personnel comfort. Performance criteria for the system are:

Temperature: 70°F ± 5°F

Humidity: 20-80% R.H.

Rationale

This protocol will be performed utilizing 21 CFR 210 & 211, ICH Q-7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001,.

Upon final approval of this IQ Protocol and Summary Report it will replace the previous IQ study and render it obsolete. The system will also be placed under formal change control in accordance with Company XChange Control Program summarized in Standard Operating Procedure DNAP/QM/012 entitled “Change Control System”.