Case Study: Custom Peristaltic Pump Silicone Tube for a Vietnamese Pharmaceutical Client

Background

Rui Xiang Precision Pump Co., Ltd., a leading manufacturer of peristaltic pump solutions, specializes in designing and producing high-performance silicone tubing for peristaltic pumps. In early 2025, a Vietnamese pharmaceutical company discovered Rui Xiang’s expertise through a Google search for “peristaltic pump customization.” The client, a mid-sized manufacturer of intravenous (IV) fluids and biopharmaceuticals, found an article on Rui Xiang’s independent website detailing advanced silicone tubing solutions for precision fluid transfer. Intrigued by our capabilities, they reached out to inquire about a customized peristaltic pump silicone tube tailored to their specific production needs.

Client Requirements

The Vietnamese client required a long-life, platinum-cured silicone tube for their peristaltic pump systems used in sterile IV fluid production. Their specific requirements included:

1.High Biocompatibility: The tubing had to meet USP Class VI and FDA standards to ensure safety for pharmaceutical applications, with no risk of leaching or contamination.

2.Extended Lifespan: The tubing needed to withstand continuous operation (up to 12 hours daily) under high-frequency roller compression, with a minimum lifespan of 2,000 hours to reduce downtime and maintenance costs.

3.Precise Dimensions: An inner diameter (ID) of 4.8 mm and a wall thickness of 1.6 mm were required to achieve a flow rate of 100–500 mL/min with ±1% accuracy.

4.Chemical Resistance: The tubing had to resist mild acidic and alkaline cleaning solutions used in their clean-in-place (CIP) system.

5.High Transparency: The tubing needed to be transparent for real-time monitoring of fluid flow to detect air bubbles or particulates during production.

6.Sterilization Compatibility: The tubing had to endure repeated autoclaving at 135°C and chemical sterilization without degradation.

Rui Xiang’s Customization Process

Upon receiving the inquiry, Rui Xiang’s technical team initiated a comprehensive consultation process to address the client’s needs:

1. Requirement Analysis

7.Our engineers conducted a detailed discussion with the client via video calls to understand their peristaltic pump model (a medium-flow industrial pump with a YZ15 pump head) and operational environment (cleanroom with controlled temperature and humidity).

8.The client provided samples of their current silicone tubing, which exhibited premature wear after approximately 800 hours, leading to frequent replacements and production interruptions.

9.We analyzed the client’s flow rate requirements and confirmed the need for precise dimensional control to ensure compatibility with their pump head and flow accuracy.

2. Material Selection

10.Rui Xiang recommended platinum-cured silicone tubing due to its superior biocompatibility, low extractables, and extended lifespan compared to peroxide-cured alternatives.

11.The selected material complied with USP Class VI, FDA 21 CFR 177.2600, and ISO 10993 standards, ensuring safety for IV fluid production.

12.The tubing was formulated to resist mild acidic (pH 4–6) and alkaline (pH 8–10) cleaning agents, with a proprietary additive to enhance tear resistance under high-frequency compression.

3. Design and Prototyping

13.Using advanced CAD software, our team designed a silicone tube with an ID of 4.8 mm (±0.05 mm) and a wall thickness of 1.6 mm (±0.05 mm) to match the client’s pump head and flow requirements.

14.The tubing was engineered with a reinforced outer layer to improve durability under roller compression while maintaining flexibility and transparency.

15.We produced three prototype batches with varying durometer hardness (50A, 55A, and 60A Shore) to test elasticity and wear resistance under simulated operating conditions.

4. Testing and Validation

16.Prototypes were tested in Rui Xiang’s in-house laboratory using a peristaltic pump setup replicating the client’s operating conditions (600 RPM, 12-hour cycles, and 25°C ambient temperature).

17.The 55A Shore hardness tubing demonstrated optimal performance, achieving a lifespan of 2,500 hours without significant wear or loss of elasticity.

18.Chemical resistance tests confirmed compatibility with the client’s CIP solutions, and autoclave tests (50 cycles at 135°C) showed no degradation in transparency or mechanical properties.

19.Flow tests verified a stable flow rate of 100–500 mL/min with ±0.8% accuracy, exceeding the client’s specification.

5. Production and Quality Control

20.After client approval, Rui Xiang manufactured the tubing in a Class 100,000 cleanroom to ensure compliance with pharmaceutical standards.

21.Each batch underwent rigorous quality checks, including dimensional verification, tensile strength testing (≥9 MPa), and elongation testing (≥400%).

22.The tubing was pre-sterilized using ethylene oxide (ETO) and packaged in double-layered, vacuum-sealed bags to maintain sterility during shipping.

Implementation and Results

The customized silicone tubing was delivered to the client’s facility in Ho Chi Minh City in March 2025. Rui Xiang provided on-site technical support during the initial integration to ensure seamless compatibility with the client’s peristaltic pump systems. Key outcomes included:

23.Extended Lifespan: The tubing achieved an operational life of over 2,500 hours, a 3x improvement over the client’s previous tubing, reducing replacement frequency by 70%.

24.Enhanced Production Efficiency: The precise flow control (±0.8% accuracy) minimized dosing errors, improving the consistency of IV fluid production.

25.Regulatory Compliance: The tubing passed the client’s internal biocompatibility tests, ensuring compliance with Vietnamese and international pharmaceutical standards.

26.Cost Savings: The extended lifespan and reduced downtime lowered maintenance costs by approximately 40%, as reported by the client.

27.Improved Monitoring: The high transparency allowed operators to detect and address air bubbles instantly, enhancing production safety.

Client Feedback

The Vietnamese client expressed high satisfaction with Rui Xiang’s tailored solution. They highlighted the tubing’s durability, ease of sterilization, and precise flow performance as key factors in improving their production line efficiency. The client also appreciated Rui Xiang’s responsive technical support and willingness to customize the tubing to their exact specifications. Following the success of this project, the client signed a long-term supply agreement with Rui Xiang for additional tubing sizes and pump accessories.