Annex 1 and Sterile Filtration

- Annex 1
- Sterile Filtration
- PUPSIT
- Filter Technology and Test Methods
- Product-specific Filter Validation

Content

Aseptic manufacturing including sterilization via filtration has become increasingly important with modern biological medicinal products and is now an integral part of daily production. The current draft of Annex 1 reflects this and dedicates a total of 15 paragraphs to the topic in Chapter 8. The requirements and explanations are significantly more detailed compared to the previous version. In this online seminar, we will discuss the assessment of these planned requirements and their possible implementation.

After a brief review of the basics of sterile filtration, the requirements of the currently valid Annex 1 from 2009 will be compared with the proposed requirements in the draft version 12 from February 2020. What is new, what remains, and what should the user already prepare for today? This includes, among other things, the shift from filtration to filtration systems and the integration of the filtration system into a contamination control strategy. But promising aspects such as the matrix approach to filter validation, the description of redundant filtration, and the use of filtration in campaign operation will also be discussed in the seminar.

We will also look into the history and show how filter technology and test methods have developed over the past 30 years and how the focus of the Annex 1 draft has logically evolved from this.
What continues to provoke controversy in the industry is the so-called PUPSIT: Post-sterilization, pre-use integrity testing, which is also assessed very differently by authorities depending on the region. In the online seminar, we will not only examine the current stance of the Annex draft but also explain the background of how this requirement came about, in which cases it can be useful, but also what risks are associated with its implementation and what options or obligations may arise for the user in the future.

For scientific classification, the documents published by PDA and BPOG in the "Points to Consider" series are very helpful. Based on this data, it is possible to conduct a well-founded risk analysis. In doing so, the product-specific characteristics must not be overlooked.

The product-specific filter validation with all its facets will also be addressed in this online seminar.

The new requirements for gas and vent filters, which may still raise questions, should not be overlooked.

During virtual panel discussions by various organizers (ISPE, Concept Heidelberg, A3P), authorities' representatives have expressed their views on the topic. We will also address these statements.

Finally, an attempt will be made to summarize the positions of the industry, which were given in the comments submitted to the EMA. There has been very effective cooperation among all involved industry organizations.

This online seminar is aimed at colleagues who are encountering the topic for the first time as well as experienced industry representatives from production, development, and quality departments.

When?
June 10, 2021
1:30 PM – 3:00 PM

Where?
Online workshop

Participation fee
€100 – for ISPE members
€200 – for non-members