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1250.4 Compounding Area for Parenteral Solutions
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The pharmacy shall have a designated area for the preparation of sterile products for dispensing which shall:
- In accordance with Federal Standard 209 (b), Clean Room and Work Station Requirements, Controlled Environment as approved by the Commission, Federal Supply Service, General Service Administration meet standards for Class 100 HEPA (high efficiency particulate air) filtered air such as laminar airflow hood or clean room.
- Have nonporous and cleanable surfaces, ceilings and ceiling tiles, walls, floors and floor coverings.
- A sink with hot and cold running water must be within the parenteral solution compounding area or adjacent to it.
- 5.1 An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative adjacent areas.
- 5.2 An ISO class 5 cleanroom.
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