The Pharmaceutics and Compounding Laboratory

Introduction Routes Equipment Critical Sites Primary Engineering Controls Laminar Air Flow Workbenches Biological Safety Cabinets Isolators Clean Rooms Devices and Supplies Aseptic Techniques Additional Considerations

Clean Rooms

One method of protecting the critical sites is to use a device that creates an ISO Class 5 environment, a direct compounding area (DCA), and completing all of the compounding operations inside that device. LAFWs, CAIs, and CACIs are examples of DCA. A cleanroom is another example because the entire room is the DCA with ISO Class 5 environment.

If the cleanroom is an ISO Class 5 environment, there need to be additional barriers around the room that reduce the particle burden, and provide a staging area for the materials and activities necessary to prepare CSPs. The additional barrier is called a buffer area. Air quality in this area is ISO Class 7 and the activities appropriate for the area include the preparation and staging of components and supplies. The ante-area is the area outside of buffer area and should have ISO Class 7 or 8 air quality. Activities in this area include personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling and other high particulate generating activities.

The proper design of cleanrooms must take in to consideration work flow, efficiency and personnel comfort factors such as temperature, lighting and noise. The risk level of the CSP also is a consideration. What's more, Chapter <797> allows several exceptions to installing a cleanroom. For example, immediate-use CSPs can be prepared at the patient's bedside or in fast-paced treatment areas such as emergency rooms, operating rooms, therapeutic radiology, cardiac catherization, and respiratory therapy. Allergan extracts may be prepared in allergy clinics as long as standards are met. Pharmacy satellites and outpatient treatment centers preparing low-risk level CSPs with 12-hour or less beyond-use-dates are exempt as well. These CSPs can be compounded in segregated areas without an ante-area. However, the segregated area must contain a device that provides unidirectional airflow of ISO Class 5 quality air. The area should also limit personnel activities and traffic, and avoid materials that are extraneous to sterile. The pharmacy in those settings must place ISO Class 5 PEC in a restricted access buffer area with an ISO Class 7 environment if low-, medium-, or high-risk level aseptic compounding is to be performed. Last but not least, pre-sterilization procedures for high-risk level CSPs must be completed in no worse than an ISO Class 8 quality air environment.