New Modern Injectable Manufacturing Facility Clean Utilities Turnkey with EU GMP Standard Located in Paraguay

News & Insights2023-12-04

Prosalud Farma´s (PSF) new modern manufacturing plant was officially inaugurated with a prestigious opening ceremony on November 17, 2023, in Ypacaraí, Paraguay. PSF is one of the leading pharmaceutical companies in Paraguay. Its products cover a broad range of therapeutic areas. The new plant is the first and only factory in Paraguay that manufactures large-volume injection, with a built-up area of over 20,000m2 and meets EU GMP requirements.

The AUSTAR team was tasked with a turnkey basis project (from Engineering and Construction to C&Q) on an installation for clean utilities and solution preparation. The main product scope includes:

▪Purified Water Generation/Storage, Tank/Distribution and Loop System;

▪WFI Generation/Storage Tank/ Distribution and Loop System;

▪Solution Preparation A-300L

▪Solution Preparation B-5.000L

▪CIP system

The clean utilities are equipped with all the technologies for purified water and highly purified water technologies from AUSTAR Group. The water treatment room layout management, and the skid design for each equipment have been conceived to ensure a modernized appearance by considering human engineering, maintenance access, and full automation. The preparation systems incorporate AUSTAR advanced manufacturing technology and automation expertise to ensure efficient, high-quality production of parenteral solutions, allowing our client to achieve their batch requirements while maintaining multi-line production with CIP/SIP (Cleaning In Place / Sterilization In Place) in process.

"We are extremely satisfied with the project results," said Dr. Fernando Rienzi, CEO of Prosalud Farma . "The system has been operating smoothly, and it has greatly improved our production efficiency. We appreciate AUSTAR's professionalism and expertise demonstrated for such an advanced solution."

AUSTAR Group is an advanced technology-based pharmaceutical engineering solution provider with comprehensive knowledge and experience in life-science process technology, applications, industry regulatory rules and practices, being able to help customers address issues in quality, compliance and operation excellence and dedicated to providing equipment-engineering-service-consumables turnkey solutions and to promoting industry advancement and create value.

PW / WFI distribution System- Skid Mounted