Overview

The Fresenius Kabi  is one of the largest manufactures of oncological products in the world. The company has state of art  manufacturing facility at Baddi, Himachal Pardesh.

They were looking for a VHP system capable of providing 6 Log reduction in the Grade B Area, cRAB, & Lyo unloading isolator of Cyto Injection Facility.

The Problem

• Retro fit AHU & BMS in system.
• Multiple AHU’s in one zone
• Since Facility was in Production : All work like AHU modifications , BMS up gradations , VHP System installation, IQ/OQ and Cycle Development had to be completed in limited down time.

The Solution

STERIS Life Sciences, USA is a leader in cleaning validation and infection prevention and has supplied VHP M1000-T4 Unit all across the world. It is supported by STERIS` Indian associate Unipharma Products Pvt Ltd in India.

VHP M1000-T4 A pharmaceutical-grade VHP system for fast, continuous, large-enclosure bio decontaminationin applications such as pharmaceutical, aseptic filling, and those requiring integration into an AHS/HVAC system.

The 6 Log reduction cycles of decontamination were developed and validated for different zones of Fresenius Kabi, manufacturing plant by hooking up VHP M1000-T4 with HVAC System and BMS and were validated with relevant method to challenge Bio-decontamination.

After Care

Unipharma currently Looks into service requirement of equipment at Fresenius Kabi. Engineers team from Unipharma India, take care of all support requirements related to STERIS` Life Sciences equipment.

Key Points

1. The Fresenius Kabi Baddi manufacturing plant is dedicated for formulation of cytotoxics products; approved by USFDA, MHRA, ANVISA. Its products have regulatory approvals in more than 30 countries. The team was looking to collaborate with a partner with domain knowledge of their requirements for Decontamination of different large zones of plant.
2. Reliability and Validation of Results after Every Use with 6 Log Reduction for Decontamination along with Services, Spares Maintenance incase of breakdown were most important.
3. Fresenius Kabi team observed that STERIS` VHP M1000-T4 Bio-decontamination System most suitable decontamination equipment for their purpose.
4. The Engineers team from Unipharma India have been successfully managing and maintaining the systems in tandem with the team.