by Thom Doherty

Businesses providing regulated aseptic compounding services require stringent quality control measures, and good manufacturing practices (GMP) provide the framework for implementing critical quality control processes. Automation, which provides unparalleled product and process repeatability, is increasingly seen as a solution for compounding centers and hospitals to meet the requirements of highly-regulated manufacturing environments.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (jointly referred to as PIC/S) lead the international development of GMP standards for medicinal products. The Australian Therapeutic Goods Administration (TGA), that government’s regulatory authority for therapeutic goods, has adopted the PIC/S guidelines as the legally-enforceable manufacturing principles for all Australian compounders.

In a significant development for compounding centers in the EU and other PIC/S nations, the TGA recently approved a GMP production process for manufacturing IV chemotherapy doses that includes RIVA automated compounding technology.

RIVA is a fully automated compounding system that prepares syringes and IV bags in an aseptic environment. The system meets the PIC/S requirements for Grade A laminar airflow, air containment and continuous particle monitoring at all critical sites. These are all essential factors in approving automation in a PIC/S or GMP environment.

Equally important, as production needs increase, maintaining strict compliance to manufacturing standards can become challenging. The adoption of automation helps ensure compliance while providing other critical advantages. Specifically, automation: 1) ensures accuracy and aseptic compounding processes; 2) allows hospitals and compounding centers to reduce reliance on human/ manual compounding; and 3) increases both patient and staff safety.

In addition to these benefits, existing RIVA customers have realized substantial efficiency gains in their pharmacies. Coupled with lean workflows, high-volume central-fill pharmacies using RIVA have reduced waste and production time.

RIVA is the most technologically advanced solution available today for safe and accurate medication manufacturing, whether in a full GMP compounding facility or hospital pharmacy. The cutting-edge technology allows users to meet the most stringent PIC/S quality control standards to implement a GMP-compliant workflow process that enhances safety, increases efficiency and reduces costs.

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Thom Doherty is Chief Technology Officer of Intelligent Hospital Systems in Winnipeg, designer and manufacturer of RIVA a Fully Automated IV Compounding System.