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Pharmacy compound USP

Primary Partner Plus Services

In addition to the Premium Partner services, ReguGuard℠ offers the Premium Partner Plus services, which encompass additional compliance contract management services. The flat fees for these extra contracts will be determined based on the specifics of each contract provided.

1 

Personnel knowledge and competency of core skills assessment contract

  • Assign personnel to a comprehensive, web-based, USP chapter <797> and <800> standards didactic competency evaluation program:

  • Interactive education courses and testing.

  • Unlimited access to ACPE-approved, on-line continuing education.

  • Education material kept up-to-date as regulations change.

2

Personnel garbing and hand hygiene competency assessment contract

  • Perform initial and ongoing personnel garbing and hand hygiene competency assessment:

  • Visual observation of hand washing, garbing, and compounding.

  • Gloved fingertip and thumb sampling (GFT). 

  • Media-fill testing. 

  • Surface sampling of the direct compounding area.

3

Facilities and engineering control certification contract

  • Test and certify facilities and engineering controls to International Standard Organization (ISO) and USP chapter < 797> standards:

  • Airflow testing.

  • Room air exchange rates. 

  • Pressure differentials.

  • HEPA filter integrity testing.

  • Temperature and relative humidity testing. 

  • Total particle count testing.

  • Dynamic airflow smoke pattern testing.

  • Calibrate magnehelic gauges.

  • Viable impact volumetric airborne particulate sampling.

  • Surface viable particles sampling.

  • Primary engineering control (PEC) testing and certification.

4

Cleaning and disinfecting services

  • Clean and disinfect sterile compounding rooms to International Standard Organization (ISO) guidelines:

  • Offer comprehensive decontamination services to maintain a consistent process for collecting, analyzing, and plotting key data to detect variances.

  • Use of trained and supervised technicians.

  • Handle periodic cleanings, including nightly, weekly, or monthly service options.

  • Maintain an ongoing on-site quality control inspection.

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