PFA-Lined Valves for Pharmaceutical & Biopharma Manufacturing

Contamination-Free Flow Control for API Synthesis, Sterile Processing, and GMP-Compliant Production

Pharmaceutical and biopharmaceutical manufacturing demands absolute control over product purity and process sterility. From active pharmaceutical ingredient (API) synthesis to final formulation, aggressive chemicals including strong acids, solvents, and cleaning agents must be handled without introducing contamination or compromising batch integrity.

GFT9 manufactures PFA-lined valves, sample valves, and sight glasses from our Clean Room Series—featuring electropolished stainless steel bodies combined with virgin PFA linings. These components provide the chemical resistance, cleanability, and documentation standards required for GMP-compliant pharmaceutical production environments.

Our products serve critical functions across the pharmaceutical value chain: chemical transfer in API synthesis, sterile sampling for quality control, process monitoring in formulation, and Clean-in-Place (CIP) system integration.

View Clean Room Product Range

Why Pharmaceutical Manufacturing Requires PFA-Lined Components

Pharmaceutical production presents unique material compatibility challenges. Process fluids range from highly acidic (hydrochloric acid, sulfuric acid) to strongly alkaline (sodium hydroxide cleaning solutions), with organic solvents (dichloromethane, alcohols, acetone) used throughout synthesis and purification stages.

The Contamination Challenge:

Conventional metallic valves—even high-grade stainless steels—can leach metal ions into process streams when exposed to aggressive chemicals. In pharmaceutical applications, even trace contamination at parts-per-billion levels can compromise product quality, trigger batch rejection, or create regulatory compliance issues. Metal ion contamination is particularly problematic in API synthesis where it can catalyze unwanted reactions or appear as impurities in final products.

Additionally, surface roughness in conventional components creates areas where product residue accumulates, complicating cleaning validation and increasing cross-contamination risk between batches.

Why PFA is the Solution:

PFA (Perfluoroalkoxy Alkane) provides complete chemical inertness across the full range of pharmaceutical process chemicals:

• Resists all mineral acids (HCl, H₂SO₄, HNO₃) at elevated temperatures
• Withstands organic solvents including chlorinated compounds, alcohols, and ketones
• Compatible with oxidizing agents used in cleaning (sodium hypochlorite, hydrogen peroxide)
• Non-reactive surface prevents product adhesion and simplifies cleaning validation
• FDA-compliant materials suitable for pharmaceutical contact applications
• Zero extractables or leachables that could contaminate product streams

By combining electropolished stainless steel bodies with virgin PFA linings, GFT9 Clean Room Series products deliver the mechanical strength required for process pressures while maintaining the chemical purity pharmaceutical applications demand.

Applications Across Pharmaceutical Production

Pharmaceutical manufacturing facilities require chemically resistant components at multiple process stages. GFT9 Clean Room Series products serve critical functions throughout API synthesis, formulation, and support systems.

API Synthesis and Chemical Processing

Active pharmaceutical ingredient production involves multi-step chemical reactions using aggressive reagents. PFA-lined ball valves control feed streams of acids, bases, and solvents, while sight glasses enable safe visual monitoring of reaction progress and phase separations. Control valves regulate flow rates in continuous processing applications.

Sterile Sampling and Quality Control

In-process sampling is essential for batch release and quality assurance. PFA-lined sample valves enable sterile extraction of process fluids without contaminating the batch or exposing operators to hazardous materials. The smooth PFA surface ensures representative samples without carryover from previous extractions.

Clean-in-Place (CIP) Systems

Pharmaceutical equipment must be thoroughly cleaned between batches to prevent cross-contamination. CIP systems circulate aggressive cleaning agents—including sodium hydroxide, phosphoric acid, and oxidizing sanitizers—through process equipment. PFA-lined valves withstand repeated exposure to these chemicals without degradation or surface damage that could harbor residue.

Solvent Recovery and Purification

Pharmaceutical facilities recover and purify solvents for reuse. These systems handle concentrated organic compounds at elevated temperatures, requiring valves that maintain integrity without contaminating the recovered solvent streams.

Water for Injection (WFI) Systems

Ultra-pure water systems supplying pharmaceutical production require valves that introduce no contamination. PFA-lined components maintain water purity from generation through point-of-use distribution.

Clean Room Series for Pharmaceutical Applications

  • PFA Lined Control Valve NPS 1½ NPS 1½ - Valve with pneumatic multi-spring actuator for fast, cost-efficient operation. - High quality industrial valve by GFT9

    PFA-Lined Ball Valves – Spheron9

    Reliable shut-off and flow control for pharmaceutical process systems. The Spheron9 features an electropolished stainless steel body (1.4408/CF8M) with full PFA lining of all wetted surfaces. The smooth, non-porous PFA surface prevents product adhesion and simplifies cleaning validation.

    • Sizes: DN15 to DN100
    • Pressure Rating: PN16 / ANSI 150
    • Temperature Range: -20°C to +150°C
    • Body: Stainless Steel 1.4408, electropolished finish available
    • Operation: Manual lever, pneumatic, or electric actuator
    • Certifications: PED 2014/68/EU

    [View Spheron9 Range →](/collections/pfa-ball-valve-stainless-steel-rfq)

    View Ball Valve Range View Control Valve Range 
  • PFA Lined Ball Check Valve NPS 8 NPS 8 - On vertical mounting up to 60°, the center-guided ball closes the valve automatically. - High quality industrial valve by GFT9

    PFA-Lined Sample Valves – Provaron9

    Sterile sampling for quality control and process monitoring. The Provaron9 sample valve enables contamination-free extraction of process fluids for laboratory analysis. The PFA-lined sample chamber and flow path ensure representative samples without cross-contamination between extractions.

    • Sizes: DN15 to DN50
    • Pressure Rating: PN16 / ANSI 150
    • Temperature Range: -20°C to +150°C
    • Body: Stainless Steel 1.4408
    • Sample Volume: Adjustable
    • Design: Dead-space minimized for pharmaceutical applications

    [View Provaron9 Range →](/collections/pfa-sample-valve-stainless-steel-rfq)

    View Sampling Valve Range  
  • PFA Lined Sight Glass NPS_10 NPS_10 - Sight glass mounts vertically or horizontally for easy installation in any environment. - High quality industrial valve by GFT9

    PFA-Lined Sight Glasses – Videron9

    Visual process monitoring without contamination risk. The Videron9 sight glass features a PFA-lined stainless steel body with borosilicate glass windows, enabling safe observation of process fluids, flow verification, and level monitoring in pharmaceutical systems.

    • Sizes: DN25 to DN100
    • Pressure Rating: PN16
    • Window Material: Borosilicate glass
    • Body: Stainless Steel 1.4408
    • Applications: Flow indication, level monitoring, visual inspection

    [View Videron9 Range →](/collections/pfa-sight-glass-stainless-steel-rfq)

    View Sight Glass Range  
  • PFA Lined Strainer NPS 6 (on request) NPS 6 (on request) - Main view - High quality industrial valve by GFT9

    Custom PFA Solutions & Development Partnerships

    Beyond standard valve products, GFT9 offers custom PFA lining solutions for specialized pharmaceutical applications. We work with pharmaceutical equipment manufacturers, engineering firms, and end users to develop application-specific components.

    Our engineering team welcomes development partnerships for:
    • Custom port configurations and connection types
    • Specialized sampling systems for particular process requirements
    • Integration with existing pharmaceutical equipment
    • Prototype development for new applications

    Whether you need a modified standard product or a completely custom solution, contact our engineering team to discuss your requirements.

    [Contact Engineering Team →](/pages/contact)

    View Custom Made Solutions  
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Technical Specifications for Hydrogen Applications

Technical Specifications

Size Range (DN) DN 15 – DN 100
Size Range (NPS) ½" – 4"
Pressure Rating (DIN) PN 16
Pressure Rating (ANSI) Class 150
Temperature Range -20°C to +180°C (-4°F to +356°F
Extended range on request
Body Material (Standard) -
Body Material (Clean Room) Stainless Steel 1.4408 (CF8M), 1.4571, electropolished finish available
Lining Material Virgin PFA (Perfluoroalkoxy), cleanroom processed
Lining Thickness 2.5 – 3.5 mm
Face-to-Face Standard EN 558-1
Flange Standard (DIN) EN 1092-1
Flange Standard (ANSI) ASME B16.5
Certifications PED 2014/68/EU, ISO 9001:2015, FDA/USP Class VI material compatibility
Custom Engineering Available:
Electropolished surfaces (≤0.8 µm Ra), material certificates 3.1, custom configurations. Development partnerships welcome.

Chemical Compatibility

Chemical Compatibility

Chemical Formula Concentration Max Temp Rating

Hydrofluoric Acid

 HF All concentrations 150°C

Sulfuric Acid

 H₂SO₄ All concentrations 200°C

Phosphoric Acid

 H₃PO₄ All concentrations 150°C

Nitric Acid

 HNO₃ All concentrations 120°C

Hydrogen Peroxide

 H₂O₂ All concentrations 80°C

Ammonium Hydroxide

 NH₄OH All concentrations 100°C

PFA provides ultra-high purity (UHP) performance with minimal extractables. Contact us for SEMI F57 compliance documentation. |

Excellent Full resistance, suitable for continuous use Good Suitable for most applications Limited Verify for specific conditions

Proven Performance in Pharmaceutical Production

GFT9 Clean Room Series products are installed in pharmaceutical manufacturing facilities across Europe, serving applications from small-scale API synthesis to large-volume formulation plants. Our components support production of both chemical-based pharmaceuticals and biopharmaceutical products.

Quality Documentation:

Pharmaceutical projects require comprehensive documentation for validation and regulatory compliance. GFT9 provides complete documentation packages including:
• Material certificates (EN 10204 Type 3.1)
• PFA lining certificates with batch traceability
• Pressure test reports per EN 12266-1
• Declarations of conformity
• Surface finish certificates for electropolished components

Our documentation supports FDA, EMA, and other regulatory inspection requirements.

Read the Full Project Story →

German Engineering for Critical Applications

  • Manufacturing Excellence:

    All GFT9 products are manufactured in Germany under strict quality control. Our facility in Kempen combines traditional valve manufacturing expertise with modern PFA lining technology, ensuring consistent quality across every component.

  • Documentation and Traceability:

    Hydrogen projects demand comprehensive documentation for safety compliance and operational records. GFT9 provides complete documentation packages including material certificates (EN 10204 3.1), test reports, declarations of conformity, and—for control valve projects—digital valve passports with QR code access to lifetime records.

  • Technical Support:

    Our engineering team understands the specific requirements of hydrogen applications. From initial specification review through commissioning support, we work alongside project teams to ensure our products meet exact application needs.

  • Flexible Delivery

    With standard products available from stock and custom solutions delivered within project timelines, GFT9 supports both urgent replacements and planned capital projects.
About GFT9

Discuss Your Pharmaceutical Project Requirements

Whether you're specifying components for a new pharmaceutical facility, upgrading existing equipment, or developing custom solutions for specialized applications, our technical team is ready to support your project.

Contact Options:

Email: sales@gft9.shop
Phone: +49 2152 9154990

We support projects from initial specification through delivery, with technical consultation available for material selection, sizing, and application engineering.

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