High Pressure Rupture Disc
Product Model: ZD-023 (Aseptic/Sterile Ready)
Material: 316L Vacuum Melted (low delta ferrite) Stainless Steel, Electropolished (Ra < 0.5 μm).
Key Feature: Designed, cleaned, and packaged for introduction into aseptic (sterile) processing environments.
Sterilization: Compatible with steam-in-place (SIP) up to 140°C and gamma radiation.
Certification: Supplied with documentation for installation qualification (IQ). Optional extractables/leachables data.
Typical Use: Aseptic bioreactors, fermenters, sterile buffer hold tanks, and final product filling lines in biopharmaceutical manufacturing.
Overview
In biopharmaceutical production, maintaining sterility from cell culture through to final fill is paramount. A rupture disc in an aseptic line cannot be a source of contamination. This aseptic process disc goes beyond standard hygienic design. It is manufactured from ultra-clean, vacuum-melted steel, finished to a mirror-like electropolish, and subjected to a validated cleaning and depyrogenation process. It is then bagged in a sterile barrier system (e.g., double-bagged with gamma-stable materials), ready for introduction into a Grade A/B cleanroom environment, supporting your product and regulatory assurance.
Features & Benefits
Sterile Barrier Packaging: Double-bagged or Tyvek® pouched, with inner bag sterilized and outer bag clean, for intact transfer into critical zones.
Ultra-Smooth, Cleanable Surface: Electropolishing minimizes microbial adhesion and facilitates effective sterilization.
Low Extractables Risk: Material selection and processing minimize the potential for leachables that could affect sensitive cell cultures or final product.
Validation Support: Documentation packages can support Installation Qualification (IQ) and Operation Qualification (OQ) protocols.
How It Works
Functionally identical to a standard sanitary forward-acting disc. The entire value lies in the assurance of cleanliness, sterility, and material compatibility provided from the factory to the point of installation in your critical process.
Specifications (Descriptive)
Sizes are common for bioreactor vent lines: 1.5", 2", 3" Tri-Clamp are most frequent. Burst pressures are typically low (0.5-2.0 barg) for tank protection. The disc membrane is 316L Vacuum Arc Remelted (VAR) steel for superior purity and consistency. All surfaces are electropolished to Ra < 0.4 μm. The aseptic version includes a certificate of cleaning (bioburden, endotoxin levels) and sterilization validation (for gamma or ETO). Standard gasket is platinum-cured silicone.
Q&A
Q: How do I install this without breaking sterility?
A: The disc is packaged for aseptic presentation. Following proper aseptic technique, the outer bag is removed in a Grade C area, and the inner sterile bag is passed into the Grade A/B zone. The disc is then aseptically removed and installed using sterilized tools.
Q: Can it be steam sterilized (SIP) in-line?
A: Yes, the design is SIP compatible. However, the temperature and pressure limits of the disc (both the membrane and the gasket) must be strictly observed during the SIP cycle. Exceeding these can activate or damage the disc.
Q: Is extractables/leachables testing available?
A: Yes, upon request, we can provide standardized extractables data for the disc assembly (membrane, holder, gasket) per relevant protocols (e.g., USP <1663>), which can be used in your overall product risk assessment.
About ZD Safety
We are a partner to the biopharma industry. Our aseptic process discs are manufactured under strict controls, understanding that they are not just safety devices but integral components in the chain of product quality and patient safety.
