מיכל טרום-מילוי לתעשיית התרופות 1000 ליטר, מסוג 1.4435

BRINOX BH6723-BH1001 Paket 19

BRINOX 1,000 L Pre-Fill Tank – 1.4435 – Double Jacket – PED Cat. IV Module G – TÜV – FAT – 2020 – As New

Manufacturer: BRINOX d.o.o.
Type: SVMMBI-1000
Tag No.: BH6723-BH1001
Serial No.: 1003454
Year of Manufacture: 2020
CE Marking: CE 0036
Condition: As new / unused

TECHNICAL DATA

Product type: Pre-fill / process vessel
Nominal volume: 1,000 L
Total volume: 1,400 L
Net weight: approx. 610–762 kg

Product contact material: 1.4435 (AISI 316L)

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

Design according to AD 2000

Pressure vessel in accordance with PED 2014/68/EU
Category IV
Module G – Individual inspection
Notified body: TÜV SÜD
Identification number: 0036

TÜV CERTIFICATION

EU Declaration of Conformity (Module G)
Certificate no.: Z-EU-SI-LJU-20-05-2702107-19125214
Inspection report no.: P-EU-SI-LJU-20-05-2702107-19125214

Final inspection in accordance with PED Annex I No. 3.2 carried out
Pressure test in accordance with Annex I No. 3.2.2 carried out
Acceptance without deviations
Permissible load cycle count: 10,000 cycles (1.3 bar)
Acceptance date: 20.05.2020

FAT – Factory Acceptance Test

Complete works FAT carried out:

• Pressure test
• Visual inspection of weld seams
• NDT testing (RT/PT)
• Dimensional inspection
• Surface roughness measurement (≤ 0.8 µm)
• Calibration test
• Documentation review

FAT fully documented.

DESIGN

• Cylindrical, horizontal pressure vessel
• Double jacket for heating/cooling
• Internally electropolished
• Pharmaceutical-grade weld finish
• Manhole DN 500
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• CIP connection
• Safety valve
• Pressure gauge
• Multiple process and measuring nozzles
• For pressurised and vacuum operation

CONDITION

• Never used in production
• Factory tested
• TÜV Module G certified
• As-new industrial condition
• No signs of use
• Immediately available

DOCUMENTATION

Complete structured documentation available, including:

• EU Declaration of Conformity
• TÜV certificate with inspection report
• TÜV design assessment
• FAT protocols
• Material certificates EN 10204 3.1
• WPS/WPQR and welders’ lists
• NDT reports
• Surface roughness protocols
• Internal pressure test
• Measurement reports
• Calibration certificates
• Parts list and drawings
• Operating and maintenance manuals

Digital documentation folder available.
• Pharmaceutical solutions
• WFI / PW systems
• Buffer and media preparation
• Sterile liquid processes
• GMP installations
• Biotechnology

High-quality BRINOX pharmaceutical specification with PED Cat. IV Module G individual inspection by TÜV SÜD (CE 0036) and complete FAT documentation. Not a standard tank – tested project quality. Immediately available.

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