What is required of sterile compounding personnel? How often should compounding facilities conduct training for their personnel? Watch this series to know more about USP 797’s requirements!
What is a critical requirement when compounding sterile preparations?
According to USP 797, all personnel involved in the compounding of CSPs must be initially trained and qualified by demonstrating proficiency in compounding CSPs.
All compounding personnel must complete the required training and must be able to demonstrate knowledge of principles and proficiency of skills for performing sterile manipulations while ensuring and maintaining appropriate environmental conditions via:
· Hand hygiene
· Garbing
· Cleaning and disinfection
· Calculations, measuring, and mixing
· Aseptic technique
· Achieving and/or maintaining sterility and pyrogenicity
· Use of equipment
· Documentation of the compounding process
- master formulation and compounding records
· Proper observation of the principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow in the ISO Class 5 area
· Proper use of primary engineering controls (PECs)
· Observation of proper material movement and personnel traffic in the compounding area
Personnel Training and Evaluation for compounding sterile preparations must be done at least every 12 months!
These are critical things a compounding pharmacist must know!
See you in next week’s Pharmacy Compounding 101 Series!
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Esco TaPestle Rx focuses on pharmacy compounding and radiopharmaceuticals handling applications. The primary goal of Esco TaPestle Rx is to promote awareness of safe practices compliant with international guidelines and to aid in the development of safe and proper practice areas, ensuring the welfare of the healthcare workers.
Esco TaPestle Rx is built on the legacy of two pharmacists whose oath is to consider the welfare of humanity and the relief of human suffering. Our primary concern is always fundamental in shaping our vision of elevating healthcare by providing access to life sciences tools in developing countries.
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