Overview

This document presents technical details and product descriptions related to the Philic CAD valve family and associated process equipment designed for pharmaceutical and biotech applications. The focus is on clean and aseptic design principles, ensuring compliance with stringent CIP (Clean-In-Place) and SIP (Sterilize-In-Place) requirements.

Main Sections and Summaries

1. System Components and Instrumentation

The document includes a complex schematic of process units such as air and vacuum units, temperature control units, loop sampling points, CIP-SIP units for tanks TK1 and TK2, preparation vessels, holding tanks, filling rooms, and associated piping and instrumentation. Key instrumentation includes temperature sensors (TE, TT, TC, TR), pressure indicators (PI), flow transmitters (FT), pH analyzers (AI), and valves (Vxx series).

Materials specified for piping and components include stainless steel (EN 1.4435-BN2) and PTFE USP Class VI-121°, ensuring compatibility with aseptic processing.

2. Valve Range and Design Philosophy

The CAD valve family offers a wide range of valve types and assemblies tailored for pharmaceutical and biotech processes. The valves are designed to achieve:

• Zero dead legs to prevent product hold-up and contamination
• Flush flow design for effective cleaning and sterilization
• Compact and modular assemblies for efficient process layout
• Compliance with CIP-SIP cycles

Valve materials are limited to two key materials (EN 1.4435-BN2 stainless steel and PTFE) to simplify validation and ensure process reliability.

3. Valve Types and Assemblies

• Shut-Off Valves: Designed for flow control in aseptic applications with a common body and diaphragm design.
• Loop Assembly: Preassembled valves for point-of-use applications, configurable with or without SIP satellite valves, and sampling options for bottles or expandable bags.
• Bottom Tank Assembly: Tank outlet valves available with short or long diaphragms, compatible with jacketed vessels and extended body valves.
• Deep Tube-Sprayball Sparger: Multi-function equipment for feeding fluids or gases into preparation vessels, integrating CIP spray ball and optional gas barbotage for enhanced cleaning and preparation.
• Bottom Point Assembly: Ready-to-use assemblies allowing separate condensate drainage and flexible sensor ports.
• Flow-Through Valves: Enable fluid feed or withdrawal with consistent piping size.
• Diverting Valves: Allow feeding or diverting fluids between common and multiple pipelines with customizable configurations.
• Tank Weldable Valves: Designed for welding onto vessel covers or bodies, featuring long diaphragms for flush flow and easy pipe connections, including jacketed vessels.
• Take-Off on Pipe Valves: Facilitate fluid take-off or feed from piping with valves smaller than the main pipe size.

4. Product Benefits and Validation Support

The CAD valve family offers several critical benefits for aseptic processing:

• Full compliance with CIP-SIP cleaning and sterilization cycles
• Elimination of unused piping portions to reduce contamination risk
• Flush flow design to minimize product hold-up and facilitate cleaning
• Wide range of valve configurations to meet diverse application needs
• Extensive technical documentation to support process validation
• Simple, reliable, and easy-to-validate process systems

5. Recommendations and Customization

Specialist support is available for selecting appropriate valves or designing tailored valve assemblies to optimize process systems. Standard preassembled valves and assemblies are offered to accelerate construction, while custom solutions can be rapidly designed and delivered.

Critical Parameters and Specifications

• Materials: EN 1.4435-BN2 stainless steel and PTFE USP Class VI-121°
• Valve sizes and piping dimensions commonly referenced: 25.4x1.65 mm, 19.05x1.65 mm, 38.1x1.65 mm
• Operating conditions include WFI (Water for Injection) at 85°C, nitrogen at pressures of 0.5 to 3.5 bar, and CO2 stripping during preparation
• Temperature control ranges from 4°C to 85°C

Conclusion

The Philic CAD valve family and associated assemblies provide a comprehensive solution for aseptic pharmaceutical and biotech processing. Their design emphasizes cleanability, minimal product hold-up, and compliance with stringent CIP-SIP protocols. The modular and customizable nature of the valves supports efficient process design and validation, making them suitable for critical applications requiring high standards of hygiene and process control.