1. Customer Overview

A certified pharmaceutical enterprise based in Buenos Aires, Argentina, equipped with ISO 7 sterile clean workshops and compliant with ANMAT South American pharmaceutical supervision standards. The company specializes in sterile powder and lyophilized drugs, supplying local medical institutions and exporting to multiple South American countries. The customer’s old discrete production line featured low automation and no process buffering, causing serious powder dusting, unstable filling accuracy and insufficient compliance. Unable to meet growing order demands and export standards, the enterprise upgraded to our full sterile automatic linked production line in 2026.

Contact Person: Matías Rodríguez, Production & Technical Director

Cooperation Timeline: Contract signed in January 2026, FAT machine inspection in China in April 2026, official production launched in May 2026

Equipment Configuration: Automatic vial washing machine, sterile drying oven, high-precision powder filling machine, buffer accumulation machine, online coding machine, vertical labeling machine linked production line

2. Core Production Pain Points

The original standalone equipment operated independently with heavy manual dependence, achieving only 800 bottles per shift. Traditional washing and drying processes failed cleanroom standards, resulting in severe powder dusting and high material loss. Unstable filling accuracy caused high defective rates and ANMAT compliance risks. Switching between 5ml and 10ml vials required full-line shutdowns with poor production flexibility. European and American imported equipment was overpriced, with slow after-sales response and long spare parts cycles in South America.

3. Customized Solutions

Tailored to the customer’s requirements for sterile production, compliant traceability and flexible production changeover, we customized a low-dust, high-precision fully automatic linked production line with seamless operation:

1. Vial Washing Machine & Sterile Oven

Built with full stainless steel, adopting dual water and air washing to thoroughly clean vials. Closed-loop constant-temperature hot air drying realizes complete sterilization, avoiding powder moisture absorption and caking caused by residual water, and ensuring a sterile filling environment.

2. High-Precision Powder Filling Machine

Equipped with precision screw metering and fully enclosed dustproof structure, it controls filling errors within ±1% to reduce raw material waste significantly. It supports no-bottle no-filling operation and one-click specification switching to realize flexible multi-specification production.

3. Integrated Coding & Labeling Machine

Synchronized with the entire production line, it accurately prints pharmaceutical traceability information to avoid batch confusion. Servo high-precision labeling and automatic defect rejection ensure a 100% qualified rate, fully meeting South American export traceability compliance requirements.

Comprehensive Supporting Services

Equipped with a full Spanish operating system and supports 24-hour continuous production. We provide overseas on-site installation, professional training, free spare parts and long-term reliable after-sales support.

4. Customer On-Site FAT Inspection & Acceptance

The customer’s technical team visited China for official FAT inspection. They verified equipment materials, configurations and production processes, and completed full performance tests including full-load mass production, specification switching and stability testing. The equipment operated smoothly without jams or dust emission, with all precision and linkage indicators qualified. We completed on-site parameter debugging and hands-on operational training. The customer confirmed full compliance with ANMAT standards and signed the official acceptance report.

5. Project Achievements

1. Capacity Improvement: Single-shift output increased from 800 bottles to 2,800 bottles, fully meeting peak-season and foreign trade order demands;

2. Cost Reduction & Efficiency Improvement: Single-shift operators reduced from 7 to 2, greatly lowering labor costs and raw material waste;

3. Qualified Compliance & Quality: Full-process sterile production delivers stable quality, passing South American pharmaceutical inspection and export filing;

4. Flexible & Efficient Production: One-click specification switching plus buffer system improves changeover efficiency by 70%, supporting diversified flexible production scheduling.

6. Customer Testimonial

Matías Rodríguez, Production & Technical Director

“Traditional European and American equipment is expensive and cannot solve persistent dusting and precision problems, while local after-sales services in South America are extremely inefficient. This customized linked line perfectly solves our long-term production bottlenecks with professional dustproof structure and stable buffer system. It runs reliably with simple operation and excellent compatibility with the Spanish system. Since launch, the equipment has operated almost fault-free. The improved production capacity and yield have exceeded our expectations and effectively reduced production costs. This is a highly reliable cooperation, and we will continue long-term partnership for future capacity expansion.”

7. Case Summary

Customized for overseas ISO 7 clean workshops and ANMAT pharmaceutical standards, this fully automatic vial powder production line integrates vial washing, drying, powder filling, buffering, traceability coding and precision labeling. It effectively solves core industry problems including powder dusting, unstable precision, compliance difficulties and slow model switching. We provide one-stop services including customized solutions, factory inspection, overseas installation and localized after-sales support, fully adapting to automatic mass production of various sterile pharmaceutical powder products.