LIGHTHOUSE

Science-based holistic approaches to help sterile product manufacturers follow new container closure integrity requirements set forth by the revised EU Annex 1 for cold chain storage and transport.

https://www.pharmtech.com/pt_w/revised-eu-annex

The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, was finalized on August 25, 2022, and includes new requirements for ensuring the container closure integrity (CCI) of sterile pharmaceutical products. This webinar will present how sterile product manufacturers can prepare themselves for the new regulations using a science-based holistic approach to ensure good CCI, and includes a description of CCIT methods that can be used for frozen products needing cold chain storage and transport.


Learn in detail how the new requirements of the revised EU Annex 1 may impact your strategy for ensuring the container closure integrity of sterile pharmaceutical products.

Gain understanding of the advantages and disadvantages of container closure integrity (CCI) testing methods and why a science-based holistic approach to ensure good CCI is important.

Learn how cold chain storage and transport can impact the container closure integrity of sterile pharmaceutical products.

 began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100% container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.

Webcasts

Webinar Date/Time: Tuesday, February 28th, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET


Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1: A Science-Based Holistic Approach

http://promo.mjhlifesciences.com/biopharmacongress/

The COVID-19 pandemic has disrupted the routine of in-person events, the need for sharing information and building key supplier connections for bio/pharmaceutical development and manufacturing has never been greater.

The 2020 Bio/Pharma Virtual Congress event will connect bio/pharma formulation, development, manufacturing, and quality experts with a full day of technical presentations, panel discussions, interviews, and vendor meetings, through an interactive portal.

This online event will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry.

Adare, Aizon, BASF, Beckman Coulter, Catalent, DocuSign, Honeywell, Lighthouse, Lonza Pharma and Biotech, LSNE, Mikart, Nelson Labs, Qualicaps, Shimadzu, suez and VAI

Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT

On demand available after airing until Nov. 11, 2021.

*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021

2020 Bio/Pharma Virtual Congress

http://www.pharmtech.com/pt_w/closure_integrity


	Are you revising your container closure integrity (CCI) testing strategy? Regulators are paying closer attention to the proper design of robust CCI studies. This webcast will introduce the headspace gas ingress testing approach, a robust detection method of critical leaks. This rapid, non-destructive, analytical measurement can be scientifically validated and is an upgrade to the blue dye test. Topics to be discussed include the following:

		Evolution in industry best practices and regulatory requirements for CCI testing

		Introduction to headspace gas ingress testing

		Advantages of the headspace gas ingress testing method compared with blue dye testing

		Method development and the use of positive controls

		Receive an update on industry best practices for container closure integrity (CCI) testing

		Learn about headspace gas ingress testing and how it compares to blue dye testing

		Learn about method development and how to validate this CCI test method

Derek Duncan, PhD, Director Product Line, LIGHTHOUSE

 Wednesday, Mar. 18, 2020 at 11:30am EDT | 8:30am PDT | 3:30pm GMT | 4:30pm CET

	On demand available after airing until Mar. 18, 2021.

Imagine a blue dye test that uses a tracer gas in place of the dye. Headspace gas ingress testing is a robust detection method of critical leaks. Drug developers considering an upgrade to blue dye testing can learn more about this test method in this webcast. 
Live: Wednesday, Mar. 18, 2020 at 11:30am EDT | 8:30am PDT | 3:30pm GMT | 4:30pm CET
On Demand: available after airing until Mar. 18, 2021.
Register free: http://www.pharmtech.com/pt_w/closure

LIGHTHOUSE

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