1500L 1.4435 GMP padajoča posoda

BRINOX BH6724-BH1001 Paket 22

BRINOX 1,500 L Primary Precipitation Vessel – 316L – Double Jacket – PED Module G – FAT 2020 – Like New

Manufacturer: BRINOX d.o.o.
Type: SVMBI-1500
Tag No.: BH6724-BH1001 Package 22
Serial Number: 1003457
Year of Manufacture: 2020
Condition: Like new / unused
CE Mark: CE 0036

TECHNICAL DATA

Product type: Primary Precipitation Vessel / Process Vessel
Nominal volume: 1,500 liters
Total volume: 1,785 liters
Empty weight: approx. 866 kg

Product-contact material: 1.4435 (AISI 316L pharmaceutical grade)
Jacket material: Stainless steel

Operating pressure vessel: -1 / +3 bar
Test pressure vessel: 5.4 bar
Operating pressure jacket: as per design
Temperature range: -10 °C to +150 °C

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Pressure vessel in accordance with PED 2014/68/EU
Module G – Individual inspection
Inspected by notified body 0036

FAT – Factory Acceptance Test (08/2020)
The vessel was fully tested at the BRINOX factory as part of a documented FAT.
Tests performed included:

• Delta ferrite test of weld seams (compliant, no deviations)
• Surface roughness test (Ra internal ≤ 0.8 µm, compliant)
• Visual inspection of all product-contact surfaces
• Pressure testing as specified
• Documentation verification
• GMP deviation management (non-critical points, fully closed)
• Measuring equipment with valid calibration certificate

EXECUTION

• Double jacket for heating/cooling
• Horizontal orientation
• High-quality pharmaceutical design
• All product-contact areas in stainless steel 316L
• Mirror-polished internal surface
• GMP-compliant, documented welds
• Large manway with swing cover
• Multiple clamp and flange connections
• Spray ball / CIP connections
• Instrumentation prepared (pressure, temperature, sensors)
• Insulated jacket with connections
• Heavy-duty flange bottom
• Lifting lugs and transport configuration
• Project build for CSL Behring (Project SPHINX)

CONDITION

• Never used in production
• Direct from project surplus
• Internally absolutely as new
• No corrosion
• No signs of wear
• Industrial mint condition
• Immediately available

DOCUMENTATION

Complete project-related quality and manufacturing documentation available, including:

• EU Declaration of Conformity
• TÜV inspection documents
• PED Module-G documentation
• Material certificates 3.1
• Welding documentation (WPS/WPQR)
• Delta ferrite test reports
• Roughness measurement logs
• Calibration certificates for measuring devices
• GMP deviation reports
• Fully signed FAT protocols
• Operating and maintenance documentation

Documentation is complete and well-structured.

• Pharmaceutical active ingredient processes
• Precipitation and reaction processes
• Buffer and solution preparation
• Sterile liquid processing
• Biotechnology
• GMP-compliant production facilities
• High-purity media

SPECIAL FEATURE
This is a premium BRINOX process vessel manufactured for CSL Behring in genuine pharmaceutical project quality, with full PED Module-G individual inspection, documented FAT 2020 and complete GMP documentation. Not a standard tank – but certified project quality for sterile applications. Immediately available.

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