Hoang Tam - Installation of MOBILE MIXING TANK for the PHARMACEUTICAL PRODUCTION PROCESS Project of Partner SANOFI VIETNAM 03/2020
In GMP-compliant pharmaceutical manufacturing, equipment sterility and precision are critical factors determining the quality of each batch of medicine. In March 2020, Hoang Tam affirmed its position by successfully completing the design, fabrication, and installation of a MOBILE MIXING TANK for the PHARMACEUTICAL PRODUCTION PROCESS project of its partner, SANOFI VIETNAM. This project not only required the highest level of precision mechanical engineering but also underwent rigorous testing procedures according to international sterile standards such as ASME BPE and FDA.

Background and Stringent Requirements from Sanofi Vietnam

Sanofi is one of the world's leading multinational pharmaceutical corporations, owning a modern manufacturing facility in the Saigon Hi-Tech Park in Ho Chi Minh City. This factory operates under extremely strict quality control standards from both the Ministry of Health of Vietnam and international health organizations.

In March 2020, to upgrade and optimize the production capacity for specific liquid pharmaceutical lines, Sanofi Vietnam set the challenge of fabricating a mobile mixing tank system. This equipment had to flexibly move between Grade A, B, and C cleanrooms while ensuring absolute sterility throughout the formulation, homogenization, and liquid medicine transfer processes.

Technical requirements from Sanofi's expert team included:

• Fabrication materials must have clear Material Test Reports (MTR), with priority given to SS316L stainless steel for parts in direct contact with the product.
• The internal surface roughness of the vessel must reach a Ra value < 0.4 µm, treated by mechanical polishing combined with electropolishing.
• The vessel design must completely eliminate "dead legs" to prevent bacterial accumulation and facilitate easy cleaning.
• Capability to integrate Clean-In-Place (CIP) and Sterilize-In-Place (SIP) systems using high-temperature saturated steam.
• A complete set of validation documents to support the factory's IQ/OQ qualification processes.

Technical Challenges and Design Solutions by Hoang Tam

As a company with many years of experience in high-precision stainless steel fabrication for the pharmaceutical industry, Hoang Tam's engineering team approached the project with the utmost caution and expertise.

Application of Magnetic Drive Mixer Technology

For traditional mixing vessels that use an agitator shaft penetrating the top or bottom of the tank, the risk of leakage at the mechanical seal is always a major concern in the pharmaceutical industry. Just a tiny dust particle or a micro-crack in the seal can ruin an entire batch of medicine worth billions of VND.

To thoroughly resolve this issue, Hoang Tam advised using a bottom-mounted Magnetic Drive Mixer (Magnetic Drive Mixer). This technology transmits force via a magnetic field through the stainless steel vessel wall, entirely eliminating the need for a mechanical shaft to penetrate the tank body. This solution ensures 100% absolute hermetic sealing, completely eliminating the risk of cross-contamination from the external environment.

Optimized Design for Mobility and Operation

The trolley frame system of the mobile mixing vessel is constructed from robust SS304 stainless steel, incorporating heavy-duty casters specifically designed for cleanroom environments. These wheels feature anti-static properties, produce zero dust during movement, and are equipped with a secure brake locking system.

A Local Control Panel is also integrated directly onto the frame. The electrical enclosure complies with the IP65 waterproof standard, allowing for external washing and sanitization without affecting the internal electronic components. The HMI screen intuitively displays operating parameters such as mixing speed, liquid temperature inside the vessel, and real-time volume measured via load cells.

ASME BPE Compliant Fabrication Process at the Manufacturing Workshop

After the 3D design drawings were approved by Sanofi, the fabrication process of the mobile mixing vessel was deployed at Hoang Tam's specialized manufacturing workshop under close supervision.

Incoming Material Control

All SS316L stainless steel sheets used for the vessel body and lid were officially imported from reputable manufacturers in Switzerland and Japan. Each batch of material was accompanied by a Mill Test Certificate (MTC). Before undergoing laser cutting, the surface of each steel plate was covered with a protective film to prevent scratches.

Automatic Orbital Welding Technology and Weld Treatment

Process piping welds on the vessel lid and bottom were performed using manual Gas Tungsten Arc Welding (TIG) by internationally certified welders, combined with automatic orbital tube welding machines. The welding process was constantly purged with 99.999% pure Argon gas on the inside to protect the weld root from oxidation (purging gas protection).

Upon completion, 100% of the welds underwent borescope inspection to evaluate penetration and internal surface smoothness. Any welds failing to meet requirements were immediately rejected to ensure no impact on the final product quality.

Surface Treatment using Electropolishing Technology

The internal surface finish of the mixing vessel is a vital factor for pharmaceutical equipment. After mechanical polishing achieved a roughness of Ra 0.5 - 0.6 µm, the mixing vessel was moved to the electropolishing (EP) stage.

The EP process utilizes direct current in a specialized acid bath to selectively dissolve microscopic peaks on the metal surface. This results in a flawless mirror finish on the vessel's interior with a Ra index under 0.4 µm, while creating a chromium-rich passive layer with high chemical resistance, helping the tank withstand harsh cleaning chemicals in CIP procedures.

On-Site Installation, Commissioning, and Validation Process

In March 2020, the equipment was carefully packaged using multi-layer shrink wrap and transported to the Sanofi Vietnam factory for installation and commissioning.

Site Acceptance Testing (SAT) at the Client's Facility

After positioning the equipment in the utility installation area, Hoang Tam's technical team and Sanofi's QA/QC experts conducted the Site Acceptance Test (SAT) procedure. The inspection items included:

• Pressure/Leak Testing: The vessel was pressurized with nitrogen gas to guarantee there were no leaks at the tri-clamp connections and diaphragm valves.
• Temperature Distribution Testing: Saturated steam was introduced into the vessel jacket to evaluate the heating capacity and temperature uniformity of the internal liquid.
• CIP Riboflavin Cleanability Testing: A fluorescent indicator was sprayed through a 360-degree rotating spray ball, followed by a UV light inspection to verify cleanliness, ensuring no blind spots or unwashed areas remained.
• Control Panel Operational Testing: Testing emergency stop scenarios, mixing motor overload protections, and the accuracy of PT100 temperature sensors.

Provision of a Standardized Handover Data Book

An indispensable part of the project's success was the comprehensive equipment handover data book compiled by Hoang Tam. This documentation serves as a critical legal and technical basis for Sanofi to perform GMP validation, including:

• Material Certificates of Conformity (CoC, MTR) for stainless steel and FDA-compliant gaskets.
• Welding Log accompanied by a Weld Map.
• Welder Qualification Certificates.
• Roughness Test Report for actual surface finishes.
• Borescope Inspection Report with photo/video evidence.
• Operation and Maintenance (O&M) Manuals.

Sustainable Values Brought to Partners by Hoang Tam

The successful and on-time handover of the Mobile Mixing Tank system to Sanofi Vietnam in March 2020 is a clear testament to Hoang Tam's capabilities in designing and fabricating industrial pharmaceutical machinery. Operating stably and efficiently, the equipment has helped Sanofi reduce turnaround time between production batches and ensure the highest level of biosafety for pharmaceutical products.

Earning the satisfaction of a stringent multinational corporation like Sanofi has solidified Hoang Tam's brand reputation in the high-quality industrial vessel fabrication market in Vietnam. We remain committed to partnering with pharmaceutical, food, and chemical enterprises by providing optimal technical solutions, dedicated maintenance services, and international-standard stainless steel products.

Contact Information

For detailed technical advice and quotations for mixing tanks and high-grade stainless steel industrial vessels, please contact:

Hoang Tam
Address: Lot L1, Street 8, Le Minh Xuan Industrial Park, Tan Nhut Commune, Ho Chi Minh City, Vietnam
Hotline: +84933049069
Phone: +84933049069
Email: contact@hoangtamsse.com
Website: hoangtamsse.com