מיכל טרום-מילוי לתעשיית התרופות 1000 ליטר, מסוג 1.4435

BRINOX BH6721-BH1001 Paket 18

BRINOX 1,000 L Pre-Filling Tank – 1.4435 – Double Jacketed – PED Module G – TÜV SÜD – FAT – 2020 – As New

Manufacturer: BRINOX d.o.o.
Type: SVMBBl-1000
Tag No.: BH6721-BH1001
Serial No.: 1003453
Year of Manufacture: 2020
Condition: As new / unused

TECHNICAL DATA
Product type: Pre-filling tank / process vessel
Nominal volume: 1,000 liters
Total volume: 1,400 liters
Empty weight: 762 kg

Product-contact material: 1.4435 (AISI 316L pharmaceutical grade)
CE Marking: CE 0036

Permissible pressure PS: -1 / +3 bar
Test pressure PT: 5.4 bar
Permissible temperature TS: -10 °C to +150 °C

Fluid group: 1
Design according to AD 2000 code

Pressure vessel in accordance with PED 2014/68/EU
Category IV
Module G – Individual inspection
Notified Body: TÜV SÜD Industrie Service GmbH (ID No. 0036)

TÜV acceptance including final inspection and pressure test fully documented.

FAT – Factory Acceptance Test

The vessel underwent full FAT testing and approval at the manufacturer’s site.

Tests carried out include:
• Pressure test in accordance with PED
• Visual inspection of all weld seams
• Non-destructive testing (RT, PT as per test plan)
• Dimensional and drawing check (as-built)
• Internal roughness measurement (Ra ≤ 0.8 µm)
• Calibration test of pressure gauges
• Verification of markings
• Complete documentation review

FAT protocols fully available.

DESIGN FEATURES
• Cylindrical, horizontal tank
• Double jacket for heating/cooling
• Internally electropolished and passivated
• High-gloss product contact surface
• Pharmaceutical-grade weld seams
• Manhole DN 500
• CIP connections
• Safety valve
• Pressure gauge
• Bottom diaphragm valve
• Agitator port (DN 200)
• Multiple spare ports
• Heavy-duty trunnion/pivot bearing
• Transport and lifting devices

DOCUMENTATION – fully complete and well structured

Comprehensive, project-specific quality and manufacturing documentation available, including:
• EU Declaration of Conformity and warranty certificates
• TÜV certificate with acceptance report (Module G)
• TÜV design test and certification
• 3.1 material certificates
• Welder lists and welding procedure qualifications (WPQR/WPS)
• Non-destructive testing reports (RT, PT, etc.)
• Analysis certificates for welding consumables and gases
• Company qualification certificate
• Roughness protocol
• Surface treatment report
• Dimensional accuracy report
• Internal pressure test report
• Calibration certificates for pressure gauges
• Reports and EU conformity of installed components
• Parts list assembly
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• Component drawings
• Operating and maintenance manuals

Complete digital documentation portfolio available.

CONDITION
• Never used in production
• Stock item
• Internal surface absolutely as new
• No corrosion
• No signs of use
• As-new industrial condition
• Immediately available

SUITABLE FOR
• Pharmaceutical solutions
• WFI / PW systems
• Buffer and media preparation
• Sterile liquid processes
• GMP production plants
• Biotechnological applications

SPECIAL FEATURE

High-quality BRINOX pharma-manufacturing with complete PED Module G individual acceptance by TÜV SÜD, CE 0036 marking, and full FAT test documentation.

Not a standard tank, but a quality project vessel with comprehensive GMP-compliant documentation.

Immediately available.

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