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Water sources, such as sinks or floor drains, are not permitted in the buffer area and should not be immediately adjacent to segregated compounding areas outside of a buffer area.A storage area outside the buffer and ante areas should provide adequate space for placement of sterile products and supplies.Properly designed, unidirectional airflow CAIs function in a similar manner as LAFWs, but the direct compounding area does not interact with room air because it is within a closed system, with the air sweeping particles away from the compounding site.Smoke tests of PECs assist a facility in verifying unidirectional airflow and lack of turbulence and reverse flows. If the CACI used for hazardous drug preparation is located outside the buffer area (see Architecture, below), it must be located in a segregated and dedicated area that maintains at least 0.01-inch water column negative pressure and maintains, at a minimum, 12 air changes per hour (ACPH).
PECs all rely on a special type of high-efficiency particle air (HEPA) filter that is ≥99.99% efficient in removing particles as small as 0.3 microns in size (the most penetrating particle size [MPPS], which refers to the largest-sized particle that may escape the filter, although particles of all sizes may be captured).The sterile compounding area includes a well-lit buffer area and ante area (both are secondary engineering controls) and an area for storage of sterile products and supplies.A buffer area (or “cleanroom”) is defined as an area where a PEC is located and where activities such as preparation, compounding, and staging of CSPs occur.State boards of pharmacy should be consulted to determine the current status of sterile compounding regulations, as there are significant differences in regulation among states.
The Centers for Medicare and Medicaid Services (CMS) Hospital Conditions of Participation and Interpretive Guidelines, the Joint Commission, the American Osteopathic Association’s Healthcare Facilities Accreditation Program, and DNV Healthcare’s National Integrated Accreditation for Healthcare Organizations all include statements concerning safe practices for storage and preparation of sterile compounds.) may all be subject to specific additional governance of sterile compounding practices, depending on the agencies regulating or accrediting the facility.
In most cases, extemporaneously compounded preparations must be prepared pursuant to a prescriber’s prescription for a specific patient.