BIOTECH Aseptic Safety Valve
On an aseptic process line or tank, the safety valve protects the installation against overpressure. In pharmaceuticals, biotechnology and cosmetics, this safety function must be combined with hygienic requirements: no dead zone, complete drainage, clean-in-place. The BIOTECH aseptic safety valve combines both.
Designed by H+ Valves, a Techné group company specialising in safety valves since 1981, the BIOTECH is the result of 30 years of collaboration with industrial partners. 1.4435 BN2 body, orifices Do10 to Do50, set pressure from 1 to 10 bar, range from -40 °C to +200 °C.
Inductive sensor for safety valve
BIOTECH aseptic safety valve, H+ Valves
Hygienic safety valve, no retention zone, CIP/SIP, Do10 to Do50
BIOTECH safety valve for process lines and tanks in pharmaceuticals, cosmetics and medical technology. Aseptic safety equipment suitable for liquids, gases and steam. Reduced dead zone, no retention zone, SIP/CIP clean-in-place via an integrated movable plug. DIN 11866 series C clamp connection, can be mounted on NA-Connect flanges. Flow orifices Do10 to Do50, set pressure from 1 to 10 bar, temperature range -40 °C to +200 °C. Certified ISO 4126, CE PED, FDA, USP Class VI, ATEX.
A truly aseptic safety valve
A conventional safety valve is not designed for asepsis. Its internal volumes, seat and spring create retention points that escape cleaning. On a pharmaceutical line, these dead zones are unacceptable: they retain product, escape CIP and compromise sterilisation.
The BIOTECH is designed for asepsis from the outset. Reduced dead zone, no retention zone, anti-migration sealing, optimal fluid drainage and complete cleaning of the chamber. It protects the installation against overpressure without introducing the hygienic weak point that an ordinary safety valve represents.
The movable plug, for CIP/SIP and inspections
The BIOTECH incorporates a movable plug that allows clean-in-place and sterilisation-in-place phases, as well as periodic inspections, without removing the valve. This is what distinguishes an aseptic safety valve from one that is merely clean.
The movable plug opens the chamber to the flow of CIP solutions and SIP steam, ensuring complete cleaning of the internal chamber, where a conventional safety valve retains unswept volumes. It also allows periodic inspection of the valve, a regulatory operation on safety equipment, without dismantling the line.
Pharmaceutical-grade surfaces and materials
High-quality polishing goes below Ra 0.8 µm, down to Ra 0.2 µm, to meet the most demanding applications. Product-contact surfaces follow the finish logic of a pharmaceutical circuit.
The body and internals are in 1.4435 BN2 as standard, the reference grade in the pharmaceutical industry, with 316L 1.4404 stainless steel as an option. The spring is in 302 stainless steel, with Hastelloy as an option for aggressive media. The disc and diaphragm are in EPDM or PTFE as standard, with FKM, silicone, FFKM or PTFE as options.
| Component | Standard | Option |
| Body | 1.4435 BN2 | 316L stainless steel (1.4404) |
| Internals | 1.4435 BN2 | 316L stainless steel (1.4404) |
| Spring | 302 stainless steel | Hastelloy |
| Disc / Diaphragm | EPDM / PTFE | FKM, Silicone, FFKM, PTFE |
Compactness and connection compatibility
The BIOTECH is ultra-compact, reduced in size while maintaining performance, which makes it easier to install on lines and tanks where space is limited. The clamp connection follows DIN 11866 series C, aligned with ASME BPE.
The design is compatible with flush-mounted fittings, and mounting on NA-Connect flanges is possible. Full component traceability is ensured by laser marking, in line with pharmaceutical qualification requirements.
Technical specifications
| Characteristic | Value |
| Function | Aseptic safety valve, overpressure protection |
| Fluids | Liquids, gases and steam |
| Applications | Pharmaceuticals, cosmetics, medical technology |
| Flow orifice | Do10 to Do50 |
| Set pressure | 1 to 10 bar |
| Temperature | -40 °C to +200 °C |
| Connection | DIN 11866 series C clamp, mounting on NA-Connect flanges |
| Seat | Standard EPDM or metal |
| Surface finish | Ra below 0.8 µm, down to Ra 0.2 µm |
| Cleaning | SIP / CIP via integrated movable plug |
| Traceability | Laser marking of components |
Dimensions
Dimensions according to flow orifice Do. Flow area, inlet and outlet clamp diameters, and overall dimensions A, B, C. Orifices Do32 to Do50 were under development at the date of the sources.
| Do | Area (mm²) | Inlet clamp | Outlet clamp | A | B | C |
| 10 | 78 | 25 | 25 | 32,5 | 39,5 | 109 |
| 15 | 177 | 25 | 50,5 | 34,5 | 45 | 130,5 |
| 20 | 314 | 50,5 | 50,5 | 43,5 | 60 | 166,5 |
| 25 | 490 | 50,5 | 50,5 | 43,5 | 60 | 181 |
Certifications
The BIOTECH complies with ISO 4126, the standard for safety devices for protection against excessive pressure. It carries CE marking under the Pressure Equipment Directive PED 97/23/EC, now 2014/68/EU, FDA and USP Class VI compliance for product-contact materials, Regulation (EC) 1935/2004, and ATEX approval 94/9/EC, now 2014/34/EU, for explosive atmospheres.
The certificates supplied cover calibration, 3.1 material certificate, FDA and USP Class VI gaskets, and roughness. H+ Valves is ISO 9001 and ISO 14001 certified.
Frequently asked questions
What makes this safety valve aseptic?
The design with no retention zone, complete drainage, and above all the integrated movable plug that opens the chamber to CIP and SIP. A conventional safety valve retains dead volumes that cleaning does not reach; the BIOTECH is swept completely.
How is periodic inspection carried out?
The movable plug allows periodic inspections without removing the valve or opening the line. Regulatory inspection of safety equipment is therefore carried out without breaking the asepsis of the circuit.
Which set pressure?
The standard range is from 1 to 10 bar, to be defined according to the operating pressure and the maximum allowable pressure of the installation to be protected. The set point is established during adjustment, with H+ Valves handling machining, testing and assembly-adjustment in-house.
Which disc material should I choose?
EPDM or PTFE as standard, depending on the fluid. FKM, silicone, FFKM or PTFE as options for aggressive fluids or high chemical requirements. The choice follows chemical compatibility and temperature, as for any product-contact sealing element.
Can it be mounted on a NovAseptic installation?
Mounting is possible on NA-Connect flanges, in addition to the DIN 11866 series C clamp connection. Flush-mount compatibility makes integration on existing hygienic lines easier.