Transferring a Drug in Solution

Working in a specified laminar airflow workstation or clean room (collectively known as primary engineering controls, PECs) does not ensure sterility of a compounded preparation. These PECs provide an ultraclean work area but do not provide sterility. So procedures need to be followed that will minimize the microbial burden as much as possible. For example, products that are placed in these PECs for assembly or compounding are sterilized beforehand or the completed preparation will be sterilized in a final step. Aseptic techniques are used to minimize potential contamination by microorganisms, particulate material, endotoxins, and pyrogens during these manipulations. Many of the procedures that are required in compounding CSPs are mandated by USP–NF, but some of the procedures are best practice extensions of the requirements of USP–NF. Each compounding facility will consider what is required and what is “better” in their individual operation.

At a minimum, personnel should know how to transfer drugs in solution in vials or ampules into commonly utilized containers such as large volume parenterals (LVP) or small volume parenterals (SVP). Those techniques are highlighted in this section.