PUPSIT in Practice - Online Training Recording

PUPSIT is not a simple system to implement. Many companies face technical, spatial and organisational challenges. Existing systems in particular are often not easily adapted for PUPSIT implementation. While some manufacturers have already successfully implemented PUPSIT, others are still struggling or need to create a well-founded risk analysis to justify an alternative approach or the avoidance of PUPSIT altogether.

To understand the relevance and complexity of this topic, it is essential to look at the regulatory background. The revised Annex 1 of the EU Guidelines for Good Manufacturing Practice (GMP), which came into force in 2023, introduced significantly more detailed and stringent requirements for the manufacture of sterile medicinal products. One of the key additions is the reinforced expectation that PUPSIT should be performed unless a scientifically justified and documented risk assessment can be provided as to why it is not feasible or necessary.

PUPSIT is a critical quality assurance step in sterile filtration processes. It involves performing an integrity test on the sterilising-grade filter after sterilisation but before use. This ensures that the filter has not been damaged during sterilisation (e.g., by heat or pressure) and will function as intended when product is passed through it. The purpose is to confirm the filter’s integrity before it comes into contact with the product, thus minimizing the risk of contamination and ensuring product sterility.

Despite its importance from a regulatory and patient safety standpoint, the implementation of PUPSIT in practice can be complex. Many systems in aseptic production environments were not designed with PUPSIT in mind. Significant redesigns, investment and operational adjustments are often required to adjust these systems to allow for reliable and validated PUPSIT procedures. Furthermore, space limitations in cleanrooms, the need for additional equipment, and changes to SOPs and training programs all add to the burden.

This seminar will address these issues from multiple perspectives. It begins with an overview of the regulatory framework and the expectations that inspectors bring to audits regarding PUPSIT and Annex 1 compliance. It then moves on to practical aspects, discussing how companies can approach implementation, what challenges they may face, and how to navigate them.
 

Finally, it presents a structured, risk-based methodology for evaluating whether PUPSIT is required and how to integrate it into existing processes if needed. By combining regulatory insight, practical guidance, and risk-based thinking, the program provides valuable orientation for decision-makers in pharmaceutical manufacturing who are faced with the critical question: “PUPSIT – yes or no?”