Collaboration automates environmental monitoring in pharmacy cleanrooms to streamline workflows and support safer compounding practices

Wolters Kluwer Integrates Sonicu Platform Into Simplifi 797 to Support USP Compliance

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André Rebelo
Director, External Communications
Wolters Kluwer Health
+1 (781) 392-2411
andre.rebelo@wolterskluwer.com

The United States Pharmacopeia’s (USP) newer compliance guidelines for compounding pharmacies include more stringent requirements for cleanroom environmental monitoring. To better support customers’ adherence with the new documentation standards, Wolters Kluwer Health is integrating data from the Sonicu continuous environmental monitoring platform into Simplifi 797, its robust USP compounding compliance solution.

“We’re continually striving to improve the Simplifi+ suite so our customers can more easily maintain pharmacy compliance – from the cleanroom to all the places medications are stored,” said Karen Kobelski, Vice President and General Manager of Clinical Surveillance Compliance & Data Solutions, Wolters Kluwer Health. “We’re excited to integrate the proven capabilities of Sonicu monitoring technology into our USP compliance solution because it helps our customers maintain compliance more efficiently so they can spend more time on patient care.”

Automatic monitoring & documentation save pharmacy teams time

As part of the USP Chapter 797 compounding guidelines, pharmacies must document daily ambient temperature and humidity as well as air pressure differential measurements across compounding areas.

Capturing these values requires time that could be invested on other pharmacy or clinical tasks and places an unnecessary burden on the team to diligently document these readings.

With this integration, pharmacies using Simplifi 797 can increase the efficiency and accuracy of daily temperature, humidity, and pressure documentation through automatic environmental conditions capture, saving valuable team time and reducing the risk of being out of compliance with USP and the potential for errors.

“Integrating documentation for environmental monitoring into a single system is the right decision—not only to streamline processes and save time but also to help ensure quality and medication safety,” said Glen Gard CPhT-Adv, CSPT, FNHIA National Director of Sterile Compounding & Pharmacy Compliance, and Simplifi 797 user. “I’m always looking for ways to improve the efficiency of my team and this approach helps provide USP compliance confidence in healthcare settings where medications are compounded and stored.”

Single platform integration streamlines regulatory audits

Simplifi 797 maintains an accurate historic log of metrics captured by Sonicu sensors, providing relevant documentation for a USP inspection or accreditation survey in one application.

Remote readings and alerts empower pharmacy teams to protect their medication assets 24/7 while remediation steps help ensure each site remains in compliance.

“Pharmacy leaders have a multitude of challenges they grapple with today, such as staffing and medication shortages –compliance audit worries due to documentation errors shouldn’t be one of them,” said Joe Mundell, Chief Revenue Officer at Sonicu. “By simplifying temperature and environmental monitoring, we make regulatory compliance easier and less burdensome.”

Learn more about the solution at the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting & Exhibition in Booth #1101 in New Orleans, LA from December 8-12.

For more information about Wolters Kluwer, please visit: www.wolterskluwer.com.

About Wolters Kluwer

Wolters Kluwer (EURONEXT: WKL) is a global leader in information, software solutions and services for professionals in healthcare; tax and accounting; financial and corporate compliance; legal and regulatory; corporate performance and ESG. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with technology and services.

Wolters Kluwer reported 2023 annual revenues of €5.6 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 21,400 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.

For more information, visit www.wolterskluwer.com, follow us on LinkedIn, Facebook, YouTube and Instagram.

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