Navigating the 2024 Changes in USP <601>: How MSP Can Support Your Compliance

The 2024 revisions to USP <601>, which provides guidance on Performance Quality Tests such as Delivered Dose Uniformity (DDU) for orally inhaled and nasal drug products (OINDPs), bring significant changes that impact how testing is conducted. Understanding these updates is crucial for maintaining compliance with the recommended guidelines. Here’s a look at the key changes and how MSP, a Division of TSI®, can assist.
 

Key Updates in USP <601>

Expanded Applicability of Two-Way Solenoid Valves: Previously, the recommendation for a two-way/two-port solenoid valve with an opening response time was limited to powdered formulations. However, the updated USP <601> now extends this to all OINDPs.

Updated Requirements for Vacuum Pumps: The updated USP <601> guidelines also address the performance recommendation for vacuum pumps used in DDU testing. The vacuum pump must be capable of drawing air through the complete assembly at critical (sonic) conditions. This is essential for maintaining the accuracy of the test and achieving reliable data.
 

How MSP, a Division of TSI®, Can Help

To help you navigate the updated USP <601>, MSP, a Division of TSI®, offers state-of-the-art solutions through Copley Scientific’s range of inhalation testing products:

Advanced Testing Equipment: The Critical Flow Controller TPK 100i and Breath Actuation Controller BAC 100i from Copley Scientific are designed to meet the guidelines for DDU testing. Both devices feature electronically operated, timer-controlled two-way solenoid valves. These valves provide precise control over airflow volume, duration, and delay, ensuring that your testing setup aligns with the latest guidelines.

Seamless Integration: MSP’s solutions are designed to integrate smoothly into your existing testing systems, allowing for a hassle-free upgrade. Whether you’re dealing with powdered, liquid, or aerosol formulations, our equipment is adaptable to various testing scenarios across all OINDP categories.

Expert Support: In addition, MSP offers expert support to assist implementation. Our team is available to help you understand the changes, integrate our solutions, and ensure that your DDU testing is conducted to the highest standards of accuracy and reliability.
 

Partner with MSP for Seamless Compliance to USP <601>

The 2024 updates to USP <601> bring important changes to the DDU testing of OINDPs, including the expanded use of two-way solenoid valves, timer-controlled mechanisms, and updated vacuum pump performance. MSP, a Division of TSI®, is committed to supporting your OINDPs performance quality testing through our advanced testing solutions and expert guidance.