Robust VHP Decontamination Control: Making Pharma Cleanrooms Decontamination Robust & Smarter

Cleanrooms for aseptic manufacturing of pharmaceutical drug products are the backbone of pharmaceutical companies. Vaporized hydrogen peroxide (VHP) is a decontamination technique that is often used during up-classification, e.g. after a periodic shutdown. The technique is widely used due to its ease of application, broad-spectrum efficacy and minimal environmental impact. Although the VHP process is highly efficient it is also a very delicate process that must be controlled to ensure compliance and avoid deviations due to material degradation. IPU combines process understanding with materials and surface engineering to optimize the delicate balance of efficacy, time consumption and risk of damage to surfaces in the production.

Precise Control of Environmental Parameters VHP kills and inactivates pathogens – but process control is complex and relies on process, periodic and site-specific conditions. Uncontrolled conditions can damage materials, leading to deviations and increased maintenance.

One size doesn’t fit all Although pharmaceutical production facilities may seem similar, they small differences are often what causes deviations. Production and maintenance routines, materials selection, cleaning cycles and overall risk profile all influence the approach and requirements for process control. Some facilities need to document high log-reduction by the VHP process, while having difficult to replace construction parts that are vulnerable to degradation by VHP, and here process understanding and control is of high value.

Safety and Smooth Production IPU’s recommendations help pharmaceutical clients avoid costly production stops, protect materials, and ensure regulatory compliance. Our experts identify which factors must be in control and translates insights into practical guidelines for operators and external providers.