Pharmacy cleanroom project management considerations: an experience-based perspective.
2001; National Institutes of Health; Volume: 5; Issue: 3 Linguagem: Inglês
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Medical Device Sterilization and Disinfection
ResumoDuring the last 25 years, many pharmacy professionals installed cleanrooms before they were recommended by the pharmacy profession or even deemed necessary by the Food and Drug Administration (FDA) for drug and medical device manufacturers. Today, many state boards of pharmacy do not specifically mandate that cleanrooms or other controlled environments be used for the preparation of sterile products. In the ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, 1 the American Society of Health-System Pharmacists (ASHP) has outlined recommendations about the facility and environment in which sterile products should be prepared to ensure their highest quality. Pharmacists as a profession continue the struggle to assess whether the cleanroom management process, which includes staff, procedures, a facility, equipment, and materials, affects the quality of pharmacy-prepared sterile products. Controversial issues include:
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