מיכל שקיעה GMP בנפח 1500 ליטר, נירוסטה 1.4435

BRINOX BH6724-BH1001 Paket 22

BRINOX 1,500 L Main 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 Number: 1003457
Year of Manufacture: 2020
Condition: As new / unused
CE Marking: CE 0036

TECHNICAL DATA

Product Type: Main 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

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

FAT – Factory Acceptance Test (08/2020)
The vessel underwent a complete documented FAT at the BRINOX plant. Tests performed included:

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

DESIGN

• Double jacket for heating/cooling
• Horizontal design
• High-grade pharmaceutical finish
• Fully constructed from 316L stainless steel in product-contact areas
• Mirror-polished internal surface
• GMP-compliant, documented weld seams
• Large manway with swing cover
• Multiple clamp and flange connections
• Spray ball / CIP connections
• Prepared for instrumentation (pressure, temperature, sensors)
• Insulated jacket with connections
• Heavy-duty flange base
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• Lifting lugs and transportation version
• Project-specific build for CSL Behring (Project SPHINX)

CONDITION

• Never in productive use
• Direct from project surplus
• Absolutely as-new interior
• 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 protocols
• Roughness measurement protocols
• Calibration certificates for measuring instruments
• GMP deviation protocols
• Fully signed FAT protocols
• Operating and maintenance manuals

All documentation is complete and well-structured.

• Pharmaceutical active substance processes
• Precipitation and reaction processes
• Buffer and solution preparation
• Sterile liquid processes
• Biotechnology
• GMP production facilities
• Ultra-pure media

SPECIAL REMARKS
This is a high-quality BRINOX process vessel in true pharmaceutical project quality, built for CSL Behring, with full PED Module G individual inspection, FAT 2020 documentation, and comprehensive GMP documentation. Not a standard tank, but certified project quality for sterile applications. Immediately available.

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