Since the latest revision of EU GMP Annex 1, guidelines for ‘good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use’ came into effect, Pre-Use Post-Sterilisation Integrity Testing (PUPSIT) has become a standard requirement for biopharmaceutical manufacturers who implement sterile filtration processes.
PUPSIT helps to ensure that sterilising filters are intact and functional before product use, reducing the risks of contamination and product loss. However, incorporating PUPSIT can itself introduce complexity and operational challenges for biopharmaceutical manufacturers, which, if not carried out effectively, can pose risks to patients and damage a business's reputation and finances. Operators are also required to complete additional training to ensure process efficiency – which can be resource intensive for companies.
The main challenge identified when implementing PUPSIT is the complexity of the manifold and the components necessary to execute the integrity test efficiently. Implementing PUPSIT involves increasing the number of connections, where each added joint on the sterile side of the filter presents a greater risk of contamination or leak, particularly under the increased pressures required for integrity testing.
The main challenge identified when implementing PUPSIT is the complexity of the manifold and the components necessary
In addition, the bubble point or diffusive flow methods of filter integrity testing entail the wetting of the filter, to prevent gas flow through dry areas. Through inconsistent implementation of this step, companies may find that they are not wetting the filter sufficiently, not using an efficient volume of liquid, or flushing excessive amounts to waste, which can prove costly and may impact the integrity test outcome.
Ultimately, if an integrity test registers a fail after use, entire product batches may be lost, impacting supply and damaging business reputation.
With these challenges, and the potential for human error inherent in the manual implementation of PUPSIT, it’s no surprise we’re seeing more biopharmaceutical manufacturers looking at how automation can be applied to PUPSIT integration.
The role of automation
Workflows can be simplified and the PUPSIT process made more efficient by the introduction of automated filtration systems.
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