FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam 2025 - Free NABP Practice Questions and Study Guide

Buffer rooms serve a critical role in cleanroom environments, particularly in pharmaceutical and biotechnology settings. They are designed to provide a controlled environment where the risk of contamination can be minimized before materials move into the more stringently controlled areas, such as the aseptic processing areas, which are typically classified as ISO 5.

ISO classification for cleanrooms categorizes environments based on the maximum permissible particle levels in the air. For a buffer room, the classification is usually ISO 7. This standard allows for a higher level of particulates than what is allowed in ISO 5, reflecting the buffer room's function as a transition space. It is a controlled area where materials can be prepared, allowing for adequate air cleanliness while still being less stringent than the aseptic areas, which require the purest conditions to ensure sterility.

Designating buffer rooms as ISO 7 supports effective operational workflows while still maintaining a focus on contamination control, enabling safe handling and preparation of materials before they enter more critical areas.