Flat Rupture Disc
Product Model: ZD-FL13 (Sanitary Flat, Sterile Ready)
Material: 316L or 316LVM Stainless Steel, all wetted surfaces electropolished (Ra < 0.5 µm).
Connections: Tri-Clamp (Sanitary Clamp) with bevel seat design for aseptic make-up.
Key Feature: Designed, cleaned, and packaged for introduction into sterile (aseptic) processing suites. Supports Steam-in-Place (SIP).
Pressure Range: 0.3 barg to 6 barg.
Primary Use: Aseptic fermentation, sterile buffer and media hold tanks, biopharmaceutical product transfer lines, and fill-finish applications.
Overview
In biopharmaceutical manufacturing, maintaining sterility from start to finish is critical. This sanitary flat rupture disc is engineered beyond standard hygienic design for full integration into aseptic processes. Featuring high-purity 316LVM steel, mirror-electropolished finishes, and sterile Tri-Clamp connections, it is manufactured under cleanroom conditions. After a validated cleaning and depyrogenation process, it is double-bagged within a sterile barrier system (SBS), ready for aseptic introduction into Grade A/B environments. It provides reliable overpressure protection without risking contamination of the valuable biological product.
Features & Benefits
Sterile Barrier Packaging: Double-bagged (inner sterile bag, outer clean bag) for safe transfer into critical zones without compromising sterility.
Aseptic Connection Design: Tri-Clamp connections allow for secure, crevice-free, and steam-sterilizable joint make-up within isolators or cleanrooms.
Ultra-Smooth, Cleanable Surfaces: Electropolishing minimizes microbial adhesion and facilitates effective CIP and SIP procedures.
Full Documentation: Can be supplied with certificates for material (e.g., FDA 21 CFR), cleanliness (bioburden, endotoxin), and sterilization (gamma/EO).
How It Works
Functionally, it is a pre-scored flat disc for controlled, low-fragment opening. Its entire value lies in the assurance of sterility and material suitability. It is installed using aseptic techniques, and its flat profile is often advantageous in space-constrained skids or behind sterile filters.
Specifications (Descriptive)
Common sizes are 1", 1.5", 2", 3" Tri-Clamp. Burst pressures are low, suitable for tank protection (0.5-2.5 barg). All wetted metals are 316LVM, electropolished to Ra < 0.4 µm. Gaskets are platinum-cured silicone. The aseptic version includes Certificates of Analysis for cleaning validation (specified bioburden and endotoxin limits) and may be pre-sterilized via Gamma irradiation with dose-metric indicators.
Q&A
Q: How is this different from a standard sanitary rupture disc?
A: The standard sanitary disc (like ZD-009) is "hygienic" and cleanable. This aseptic version is "sterile ready," meaning it undergoes a validated process to achieve and document a sterile state, is packaged to maintain it, and is intended for direct use in the core sterile process area.
Q: Can it be steamed in-line (SIP)?
A: Yes, the materials and design are SIP-compatible. However, the temperature and pressure limits of the disc membrane and gasket during the SIP cycle must be strictly adhered to, as exceeding them can activate or damage the disc.
Q: What is the procedure for aseptic installation?
A: Following proper aseptic technique: the outer bag is removed in a Grade C area; the inner sterile bag is passed into the Grade A/B zone; using sterilized tools and gloves, the disc is aseptically removed and connected to the pre-sterilized pipeline.
About ZD Safety
We are a trusted partner to the bio-pharma industry. Our aseptic flat discs are more than safety devices; they are critical components in your chain of sterility, manufactured with the rigor and documentation your quality system demands.
