This is a non-personnel services contract to provide environmental testing and certification of all primary engineering controls (PECs) and secondary engineering controls (SECs) used for the preparation of compounded sterile preparations (CSPs) and hazardous drugs (HDs) for G.V. (Sonny) Montgomery VAMC (GVSMVAMC). This contract will be for a Base Year and Four 1 year Option Periods. The GVSMVAMC has both hazardous and non-hazardous sterile drug compounding areas with primary engineering controls (PECs) and containment primary engineering controls (C-PECs). The PECs include laminar airflow workbenches (LAFW) and compounding aseptic isolators (CAI) for all non-hazardous sterile drug compounding and the C-PECs include compounding aseptic containment isolators (CACIs) for hazardous sterile drug compounding. In addition, the Government requires personnel certification testing of gowning and garbing, gloved fingertip and thumb testing, and media fill testing. The testing and certification must be performed in accordance with USP <797>, USP <800>, CETA and FDA guidelines.
