1500L 1.4435 GMP nusodinimo talpa

BRINOX BH6724-BH1001 Paket 22

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

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

Product type: Primary Precipitation Vessel / Process Vessel
Nominal volume: 1,500 litres
Total volume: 1,785 litres
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

Pressure vessel complying with PED 2014/68/EU
Module G – Individual inspection
Inspection by notified body 0036

FAT – Factory Acceptance Test (08/2020)
The vessel was fully tested at the BRINOX plant as part of a documented FAT.
Tests carried out include:

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

DESIGN FEATURES

• Double jacket for heating/cooling
• Horizontal design
• High-quality pharmaceutical execution
• Entire product-contact area made of 316L stainless steel
• Mirror-polished internal surface
• GMP-compliant, documented welds
• Large manway with swing lid
• Multiple clamp and flange connections
• Spray ball / CIP connections
• Instrumentation ports prepared (pressure, temperature, sensors)
• Insulated jacket with ports
• Massive flanged base
• Lifting lugs and transport construction
• Project manufactured for CSL Behring (Project SPHINX)

CONDITION

• Never used in production
• From project surplus
• Internally absolutely as new
• No corrosion
• No signs of use
• Industrial as-new condition
• Immediately available

DOCUMENTATION

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

• EU Declaration of Conformity
• TÜV inspection documents
• PED Module G documentation
• 3.1 material certificates
• Welding documentation (WPS/WPQR)
• Delta ferrite test records
• Roughness records
• Calibration certificates of measuring devices
• GMP deviation records
• Fully signed FAT records
• Operating and maintenance documentation

Documentation is complete and structured.

• Pharmaceutical API processes
• Precipitation and reaction processes
• Buffer and solution preparation
• Sterile liquid processes
• Biotechnology
• GMP production plants
• High-purity media

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

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