Safety Valve model D7 (PN 60)
DN8 (1/4") - DN10 (3/8") | Orifice 7mm
Industries > Pharmaceutical, Chemical, and Healthcare
Safety Valves for the Pharmaceutical, Chemical, and Healthcare Industries
Safety and Reliability for the Pharmaceutical, Chemical, and Healthcare Industries
Safety valves designed to ensure maximum control and regulatory compliance.
Industry Requirements
Suitability for the Pharmaceutical, Chemical, and Healthcare Industries
In the Pharmaceutical, Chemical, and Healthcare industries, the use of basic stainless steel components is insufficient. It is essential to employ specific connections, such as Tri Clamp ASME BPE (BS 4825) and DIN 32676, designed to ensure hygienic and secure mounting. Additionally, compliance with FDA and ASME BPE standards is crucial, as these regulations define specific diameter-to-length ratios for the passage, facilitating the internal cleaning of components. This ensures hygiene and sterility of the surfaces in contact with the process fluid, reducing the risk of contamination and ensuring maximum operational safety.
Pneumatic Actuator
The pneumatic actuator on safety valves plays a crucial role in the Pharmaceutical, Chemical, and Healthcare industries, especially in processes requiring high hygiene and sterility standards. With its action, it allows remote flushing of CIP (Clean-In-Place) and SIP (Sterilize-In-Place) fluids, enabling the internal cleaning and sterilization of the valve without disassembly. This process ensures the removal of any product residues inside the PSV, preventing cross-contamination and maintaining optimal hygienic conditions for the processing of sensitive products. The use of the pneumatic actuator thus ensures precise control of cleaning operations, improving the reliability and safety of the entire production plant.
Materials and Process Fluids
In the Pharmaceutical, Chemical, and Healthcare industries, the compliance of materials and seals with FDA and USP Class VI standards is essential to ensure process safety and integrity. Process fluids, such as high-temperature steam and aggressive chemicals, can interact with the materials of the valves and seals, compromising their mechanical properties and releasing contaminants into the product. FDA certification ensures that materials are non-toxic and free from harmful substances, while USP Class VI compliance guarantees biocompatibility and no adverse effects when in contact with drugs and healthcare products. The use of certified materials prevents deterioration, reduces the risk of cross-contamination, and ensures the highest purity and safety in the production process.
Where Are Safety Valves Located?
In the pharmaceutical, chemical, and healthcare industries, safety valves are installed in critical equipment to ensure pressure control and operational safety. For example, they are found in dental sterilizers and sterilization autoclaves, where they regulate steam pressure to prevent overpressure that could compromise the sterilization process or damage the equipment.
Similarly, they are used in industrial sterilization systems within the pharmaceutical and chemical industries, where precise pressure control is essential to ensure the safety of personnel and the quality of the products being processed.
Challenges and Critical Issues in the Industry
Tri Clamp Connections
The Tri Clamp fitting is essential in the pharmaceutical, chemical, and healthcare industries, providing hygienic and quick connections. Compliant with ASME BPE and DIN 32676 standards, it allows for fast assembly and disassembly without tools, facilitating cleaning and maintenance. The absence of internal threads or dead spaces reduces the risk of contamination, ensuring maximum hygiene and operational safety.
What is Nuova General's Solution?
Our valves can be equipped with Tri Clamp connections, designed in compliance with international standards ASME BPE and DIN 32676-A. These standards define strict requirements for ensuring safe and hygienic connections in pharmaceutical, chemical, and healthcare applications.
Specifically, we offer fittings that comply with ASME BPE Part SD – 3.11.1, which stipulates a valve body length-to-inner diameter ratio of less than 2.0. This ensures an optimal design to facilitate cleaning of internal components and minimize contamination risks.
Additionally, we provide valves with fittings meeting FDA 21 CFR Part 177.2600 requirements, ensuring compatibility with food and pharmaceutical fluids and maximum safety for the final product.
This way, we meet the needs of facilities requiring high hygiene and reliability standards, ensuring full regulatory compliance.
Certified Materials for the Pharmaceutical, Chemical, and Healthcare Industries
In the pharmaceutical, chemical, and healthcare industries, using materials compliant with FDA and USP Class VI standards is essential to ensure safety, purity, and long-term durability. The choice of materials is therefore crucial to supplying safe and suitable components for the industry needs.
What is Nuova General's Solution?
Our valves are made with 100% Italian materials, ensuring full traceability and the highest quality standards. Each component is carefully selected to be suitable for aseptic environments, ensuring reliable and long-lasting performance.
We use high-corrosion-resistant stainless steel 316L, ideal for applications with aggressive chemicals and steam. For pressure parts, we provide a material certificate 3.1 upon request, ensuring maximum transparency and regulatory compliance. Additionally, our seals are USP Class VI and FDA certified, ensuring compatibility with process fluids and total operational safety.
Valves with Pneumatic Actuator
Internal cleaning of safety valves is a crucial aspect in the pharmaceutical, chemical, and healthcare industries, as ensuring the hygiene of valves is essential to avoid contamination. Therefore, it is vital to open the valve remotely, allowing the flushing of CIP (Clean-In-Place) and SIP (Sterilize-In-Place) fluids. This process allows for complete cleaning and sterilization of the PSV, removing any residues and ensuring the plant remains compliant with the high hygiene and safety standards required by the industry.
What is Nuova General's Solution?
Nuova General safety valves, with a set pressure up to 8 barg, can be equipped with a pneumatic actuator. This device enables the valve to be opened remotely via a pneumatic system, allowing for internal cleaning of the safety valve. Additionally, a proximity sensor can be installed on the actuator to provide an electrical signal confirming the proper operation of the actuator. Alternatively, the valve can be provided with a test lever or test nut, allowing for manual activation and direct verification of its operation and fluid flushing.
Certifications and Standards for the Pharmaceutical, Chemical, and Healthcare Industries
.jpeg "Pharmaceutical, Chemical, and Healthcare certifications")
The ASME BPE, FDA, and USP Class VI certifications are crucial for ensuring safety, quality, and compliance in the pharmaceutical, chemical, and healthcare industries.
-
ASME BPE (Bioprocessing Equipment): This standard defines the requirements for the design and fabrication of components used in biotechnological processes, ensuring high standards of cleanliness and sterility.
-
FDA Certification (Food and Drug Administration): The FDA certification guarantees that materials and equipment in contact with pharmaceutical or food products comply with strict U.S. safety and compatibility regulations.
-
USP Class VI Certification: This certification ensures that polymer materials used in medical and pharmaceutical applications are biocompatible and free from health risks.
Compliance with these standards is essential to reduce contamination risks, enhance process efficiency, and guarantee the highest product quality.
Nuova General Safety Valve Range Recommended for Pharmaceutical, Chemical, and Healthcare
Safety Valve model D10/C (PN 60)
DN20 (3/4") - DN25 (1") - DN40 (1"1/2) | Orifice 10mm
Safety Valve model G14/L (PN 60)
DN20 (3/4") - DN25 (1") - DN40 (1"1/2) | Orifice 13,5mm
Safety Valve model G20/L (PN 60)
DN25 (1") - DN40 (1"1/2) - DN50 (2") | Orifice 20mm
Safety Valve model G25/L (PN 60)
DN40 (1"1/2) - DN50 (2") | Orifice 25mm
Safety Valve model B38/LL (PN 40)
DN50 (2") - DN65 (2"1/2) | Orifice 38mm
Why Choose a Nuova General Instruments Safety Valve?
Choosing a Nuova General Instruments safety valve means relying on a product designed and manufactured according to the highest quality and safety standards. In addition to our years of experience and continuous focus on innovation, we offer a range of dedicated services to support our customers at every stage, from product selection to after-sales assistance:
• ⚡ Fast Delivery: Standard production within 10 business days, with a Fast Track option for shipments in just 5 days.
• 📦 Flexible Lot Sizes: We provide both single valves and large batches up to 1000 units, always ensuring top quality.
• 🎨 Customization: Laser marking, colored caps for calibration identification, and removable barcode labels for simplified management.
• ✅ Third-Party Testing: Option to obtain 3.2 test certificates from prestigious organizations such as INAIL, TUV, RINA, LLOYD, DNV, and ABS.
• 📄 Online Certificates: Immediate and unlimited access to technical documentation of the valves through our dedicated portal.
• 🛠️ Product Samples: Ability to test our valves before placing regular orders, with specialized technical support.
Catalogs Download
NEED TO REPLACE A NUOVA GENERAL VALVE?
If you already know the serial number of the valve to be replaced, click here.
WANT TO RECEIVE A QUOTE FOR NUOVA GENERAL VALVES?
Follow the steps on our quote generator and receive an immediate, accurate, and detailed offer.