Pharbaco Sets New Standard for Smart Pharmaceutical Manufacturing

The pharmaceutical industry in Vietnam – like many other nations – is subject to a wide range of regulations set by the Drug Administration of Vietnam including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacy Practices (GPP), and Good Storage Practices (GSP), delivering consistent quality throughout the supply chain.

Manufacturers must also comply with GMP-EU, a globally recognised standard established by the European Medicines Agency (EMA), which sets stringent guidelines for cleanroom classifications, process validation, quality control, and documentation to confirm the safety and efficacy of medicinal products.

Pharbaco, a leading pharmaceutical manufacturer in Vietnam, faced the challenge of building an ISA-95-compliant facility— an advanced, fully integrated manufacturing plant following the ISA-95 international standard for automation. This standard helps to ensure business and production systems work seamlessly together and deliver efficiency, traceability and regulatory compliance.

In Vietnam, the pharmaceutical sector is expected to grow to US$9.4 billion by 2027, as per a KPMG report. The country’s pharmaceutical industry is subject to a wide range of regulations set by the Drug Administration of Vietnam (DAV) including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacy Practices (GPP), and Good Storage Practices (GSP), delivering consistent quality throughout the supply chain. Pharmaceutical manufacturers in Vietnam must also comply with GMP-EU, a globally recognised standard established by the European Medicines Agency (EMA), which sets stringent guidelines for cleanroom classifications, process validation, quality control, and documentation to help ensure the safety and efficacy of medicinal products.

To meet these regulations, Pharbaco partnered with Qui Long, an engineering company in Vietnam specializing in Heating, Ventilation and Air Conditioning (HVAC) and cleanroom technology. Qui Long is a Gold OEM partner in our PartnerNetwork™. Together, Rockwell Automation and Qui Long implemented an advanced air purification system tailored to pharmaceutical manufacturing requirements for strict control over air quality and compliant with GMP-EU cleanroom classifications. 

Precision, Compliance, and Efficiency in Pharma Manufacturing

Pharmaceutical manufacturing demands rigorous quality control and environmental monitoring. Pharbaco needed:

• Regulatory Compliance and Validation – Follow GMP-EU standards for the pharma industry with detailed documentation, thorough testing (installation, operation, performance) and regular audits.
• Controlled Cleanroom Environment – Maintain strict air quality and pressure controls to meet Grade A-D cleanroom standards for pharmaceutical production
• Integrate Advanced Technology and Processes – Implement automation solutions that streamline compliance while improving operational efficiency

Automation-Driven Air Purification

By leveraging Rockwell Automation’s smart manufacturing solutions, Pharbaco successfully achieved:

• Compliance with GMP-EU Annex Standards – Utilising FactoryTalk® Historian, the system captures, stores, and analyses critical environmental data.
• Optimised Facility Design for Cleanroom Efficiency – Advanced HVAC automation and air filtration systems regulate environmental conditions with real-time precision.
• Integrated Scalable Smart Manufacturing Solutions – ISA-95 automation including building management systems (BMS) and programmable logic controllers (PLCs), helps connect IT systems such as inventory and planning with factory operations like machines and production processes. This helps to deliver seamless data flow, smooth coordination, consistent performance, and compliance with industry regulations in manufacturing.
• Smart HVAC System with Automatic Climate Control – The HVAC system integrates a smart data miner that can import weather forecasts daily or use historical climate data to adjust air temperature and humidity dynamically. This real-time adaptation optimises climate control while significantly reducing energy consumption. By minimising power usage for compressors and chillers, Pharbaco maintains target environmental conditions at the lowest possible energy cost.