Hidden Causes of Fluid Handling Hoses failures in Pharma and Biopharmaceutical Manufacturing Process

Introduction - Fluid Handling is a most important and highly regulated process in Pharmaceutical Industry where even the smallest omission can have disastrous effects.?

Hoses are among of the many key components in these processes that ensure fluids are transferred safely and efficiently. However, the risks associated with hose failures are often overlooked. In this blog post, we take a peek at the hidden dangers of hose failures in pharmaceutical manufacturing, addressing the potential challenges and how to handle them.

1. Chemical Compatibility

Chemical compatibility is critical in pharmaceutical manufacturing since hose materials must withstand the chemicals they transport without degradation. Using hoses that have properties that are chemically incompatible with the substances they transport could result in chemical reactions that compromise hose integrity and product purity. Production losses can be minimized by selecting the appropriate hose for the specific fluid handling

application. In one recorded case, a pharmaceutical company's fluid transfer hoses disintegrated caused by chemical incompatibility, leading to a severe production halt. The degradation resulted in fluid contamination, causing a costly shutdown and cleanup operation. This occurrence illustrates the need of understanding the chemical composition of the substances conveyed, as well as the materials used in hose construction. Chemical reactions among incompatible hose materials and delivered chemicals can cause a variety of issues:

Hose Material Degradation: Chemical processes can cause the hose material to degrade, allowing particles to enter the product. E.g. Elastomer/Polymer materials surface and the construction of hose get damage.

Contamination: Degraded hose material can contaminate pharmaceutical products, thereby causing production batch loss, compromises product integrity.

Leaks and Failures: Chemical incompatibility can cause hoses to brittle, crack, or expand, resulting in leaks or total hose failure.

Material Compatibility Study: ?

?Conduct a thorough analysis of the materials/media used in manufacturing and their compatibility with potential hose materials or hoses.?

?Utilize resources such as chemical compatibility charts and manufacturer recommendations to select suitable or compatible hose materials.

2. Temperature and Pressure

Understanding the temperature and pressure requirements of the process is essential to selecting the appropriate hose. Check the specific temperature range and pressure conditions needed for the application. This will help identify a hose that is compatible with the process, ensuring optimal performance and preventing potential issues during operation.

Probable Causes and Precautions for Temperature and Pressurized Fluid Transfer in Pharmaceutical and Biopharma Hoses

Probable Causes

• Exceeding Temperature Tolerance
• Thermal Expansion and Contraction
• Pressure Surges and Spikes
• Improper Hose Selection
• Fatigue Due to Constant Pressure
• Material Incompatibility with Pressurized Fluids
• Insufficient Hose Reinforcement

Precautions

• Use Temperature-Resistant Materials
• Ensure Pressure Compatibility
• Install Pressure Relief Devices
• Monitor Temperature and Pressure
• Select Reinforced Hoses
• Optimize Hose Routing
• Adhere to Manufacturer Guidelines
• Prevent Thermal Shock
• Inspect Regularly for Wear and Tear
• Train Personnel

By addressing these causes and implementing these precautions, you can ensure reliable, safe, and long-lasting hose performance in pharmaceutical and biopharma manufacturing under high-temperature and pressurized fluid transfer conditions.

3. Maintaining Sterility

Sterility in hoses is crucial in the pharmaceutical industry to ensure product safety and quality. Hoses that come into contact with sterile substances must be regularly sterilized using methods like autoclaving or chemical treatments. These practices are key to preventing cross-contamination and preserving the sterility of pharmaceutical products.

• Material Selection

Use FDA-compliant, non-reactive, and high-purity materials like PTFE or silicone.

• Cleaning & Sanitization

Implement CIP (Clean-in-Place) and SIP (Sterilize-in-Place) protocols.

Avoid crevices where contaminants can accumulate.

• Proper Handling

Minimize contact with non-sterile surfaces.

Use dedicated hoses for specific fluids to prevent cross-contamination.

• Storage Practices

Store hoses in clean, controlled environments off the floor.

Use sealed covers to protect from contamination.

• CIP/SIP Process Chart

4. Microbial Contamination

Among the most significant risks of hose failures in pharmaceutical manufacturing is microbial Contamination. Improperly selected or maintained hoses can become breeding grounds for bacteria and other microorganisms. These contaminants can compromise product safety and quality, leading to severe health risks for production batches which causes financial loses to the organization.?

Microbial Contamination in pharmaceutical manufacturing can occur at various stages, from raw material handling to final product packaging. Hoses, which are frequently used to transport liquids and gases, can easily harbor microorganisms if not properly maintained. These microorganisms can form grow bacterial growth inside the hoses, which are resistant to cleaning and can continuously contaminate products passing through them.

Steps to Minimize Microbial Contamination

Process engineers and maintenance managers play a key role in reducing microbial contamination in fluid handling hoses. Here are key actions they can take:

1.?? Proper Hose Selection

-?? Choose hoses with antimicrobial properties and smooth inner surfaces to reduce bacterial growth.

-?? Ensure hoses are compatible with the substances they transport, as some materials or hose design can promote microbial growth. Ensure Hoses are manufactured in Cleanroom to get contamination free.

2.?? Regular Cleaning and Sterilization

-?? Implement a routine cleaning schedule using appropriate agents to remove micro contaminants and kill microorganisms.

-?? Sterilize hoses through autoclaving or sterilization methods to eliminate remaining microbes.

-?? Perform regular microbiological testing to monitor cleaning effectiveness.

3.?? Preventive Maintenance

-?? Set up a maintenance program to inspect hoses for wear, damage, or contamination.

-?? Replace hoses periodically or when signs of degradation or contamination appear.

5. Hose Fittings Challenges

Hose Fitting Challenges - Key Considerations for Proper Handling

• Sanitation & Cleaning

Select fittings designed for easy cleaning (CIP/SIP compatible) and Avoid crevices that could harbor microbial growth.

• Choose Fittings according to process needs

Fittings are available in Fixed types which can not be removed only can be discarded with hose and are available in Re-usable type which can be connect and disconnect easily

• Pressure and Temperature Resistance

Verify hose and fitting specifications align with process requirements, Prevent leaks or failures under extreme conditions.

• Connection Integrity

Check for proper torque and sealing to avoid loose connections, Use clamps or crimped fittings specific to pharmaceutical standards.

• High Performance Materials

Ensure Fittings are made from SS 316L grade of Stainless steel, Surface roughness must be less than <0.5 μm

• Traceability

Ensure all fittings have clear marking/identification and documentation, Align with GMP compliance for tracking and audits.

6. Hoses Selection based on Process Needs

7. Regulatory Compliance & Quality Control:

In the fast-paced world of the pharmaceutical sector, regulatory compliance serves as a compass to steer success. Adhering to best practices improves not only legal compliance, but also safety, quality, and customer trust such as FDA, GMP, USP, Extractables Study etc.

Companies that follow tight standards can develop safer and more effective medicines. Compliance also promotes consumer, healthcare provider, and investor trust, which is critical to the industry's long-term viability.

Best Practices for Handling

Train personnel in correct fitting and detachment techniques.

Regularly inspect hoses for wear, cracks, or corrosion.

Store hoses off the ground in a clean, controlled environment.

Automation and Digitalization

The Internet of Things (IoT) describes connecting any device to other connected devices and the internet, or other communications networks. This allows all devices to collect and share data about their environment and how they are used. In short, IoT makes things smart.

Pharmaceutical manufacturers are gearing up to make new tech central to their operations. More than half (54%) of leaders said they planned to increase spending on new tech by up to 10% in 2024. (According to site : Pharma Manufacturing).?

Few Examples: from Manufacturing Category: Intelligent automation is revolutionizing pharma manufacturing by enhancing quality control, reducing downtime, optimizing inventory, and cutting costs.

Key applications include:

Quality Control: Automated systems with sensors and cameras detect defects in real-time, improving product quality and reducing recalls.

Predictive Maintenance: Machine learning predicts equipment issues, reducing downtime and improving efficiency.

Thank you,

Darshan Gandhi (Hand Phone: +91 86910 13939) Sr. Manager International Sales & Marketing +91 913666 058347Email: [email protected] ; Web: www.amipolymer.com