#USA #CS Analytical #Clifton #USP 661.1 #USP 661.2

CS Analytical Hosts Follow-Up Q&A Webinar on USP 661.1 and 661.2

In response to the overwhelming demand following their previous successful webinar, CS Analytical Laboratory will conduct a follow-up Q&A session scheduled for December 10, 2025. This session aims to address the numerous questions received from clients regarding the USP 661.1 and USP 661.2 guidelines, which govern the testing associated with plastic-based packages in the pharmaceutical and biotechnology sectors.

The original webinar, held on October 29, was met with great enthusiasm and quickly sold out, highlighting the significance of these topics among industry professionals. As part of their commitment to supporting clients in navigating the complexities of compliance, CS Analytical is making this next session open and accessible at no cost.

What to Expect in the Q&A Session
During this one-hour live event, participants will have the opportunity to engage directly with experts from CS Analytical, including Ronak Patel, the Chemistry Services Laboratory Manager, and Brandon Zurawlow, the Chief Operations Officer. They will delve into various important aspects including:

• - Understanding USP 661.1 and 661.2: An overview of how the new guidelines will influence current and future plastic packaging systems.
• - Addressing Challenges: Discussion about the current challenges faced in complying with these new regulations and practical approaches for overcoming them.
• - Testing Requirements: Detailed explanation of the applicable testing standards and sample requirements necessary for both material and system-level evaluations.
• - Responsibility for Compliance: Clarification around who is responsible for ensuring that compliance data is generated and maintained.
• - Open Q&A: An open floor where attendees can raise specific questions about their packaging systems, whether they concern common configurations, new materials or novel system designs.

Background on USP 661.1 and 661.2
The upcoming changes to USP 661.1 and 661.2 will officially take effect on December 1, 2025. The USP 661.1 chapter primarily focuses on characterizing the materials used in packaging systems, while USP 661.2 concentrates on the plastics employed in these systems. This distinction is crucial for companies aiming to guarantee compliance with the highest standards, particularly in the highly regulated environments of pharmaceuticals and medical devices.

CS Analytical's Expertise
CS Analytical Laboratory stands out as the world's only FDA-regulated laboratory specializing exclusively in the testing of drug and medical device packaging. Their team consists of leading experts in USP and EP requirements as well as pioneering methodologies for container closure integrity (CCI) testing. With a full suite of laboratory services, CS Analytical can guide companies through the complexities of regulatory compliance, offering invaluable support from feasibility studies to method validation.

Register for the Webinar
Participants interested in attending the session can register online. This is an excellent opportunity for professionals in the pharmaceutical, biotechnology, and medical device industries to interact with regulatory experts and gain insights into the imperative guidelines affecting their packaging systems.

For further information, feel free to contact CS Analytical at [email protected].

Taking part in this Q&A offers not only education but also a chance to clarify doubts and gain in-depth knowledge about essential regulatory changes that will impact the industry moving forward.