SOPs

Next Level SOPs – Sterile Compounding Facilities

When quality is built into a sterile compounding facility, an organization is able to uphold patient safety and stay current with the heightened regulatory expectations. These procedures detail the acceptance criteria required of a sterile compounding facility design and engineering controls and serve as the foundation of promoting sterility assurance in compounded sterile preparations.

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Description

Compounding sterile preparations rely heavily on the proper functionality of the cleanrooms and surrounding facility. If there are problems with the facility it will be nearly impossible to consistently and reliably reproduce compounds. Primary and secondary engineering controls such as the ISO 5 and ISO 7 environments must work as intended so that quality compounds are consistently produced. Air movement patterns, air changes per hour, velocity, particle counts, microbiological isolate limits, pressure differentials,  temperature, relative humidity, etc. must all meet defined industry standards or specifications. The rooms must be constructed of the proper materials. The layout must make sense such as limiting cross traffic between and within critical environments, separating material flow from personnel flow when possible, etc.

Next Level SOPs for Sterile Compounding Facilities detail the acceptance criteria required of the facility design and engineering controls. The procedures also have quality built in so your organization can stay current with the heightened regulatory expectations and uphold patient safety.

When you purchase this chapter you get access to:

  1. Facility Overview
  2. Sterile Compounding Facility and Engineering Controls
  3. Environmental Monitoring Program
  4. Microbiological Monitoring
  5. Cleaning and Disinfection of the Sterile Compounding Facility
  6. Facility Cleaning
  7. Pest Control: Use of Rodenticides, Insecticides, Fumigating Agents
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