1500L 1.4435 GMP çökeltme tankı

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 mark: 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
Jacket Operating Pressure: according to design
Temperature Range: –10°C to +150°C

Pressure vessel in accordance 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 BRINOX with a documented FAT.
Tests carried out included:

• Delta-ferrite testing of weld seams (compliant, no deviations)
• Surface roughness testing (Ra internal ≤ 0.8 µm, compliant)
• Visual inspection of all product-contacting surfaces
• Pressure test as per specification
• Documentation check
• GMP deviations management (non-critical points, all closed)
• Measuring devices with valid calibration certificates

DESIGN FEATURES

• Double jacket for heating/cooling
• Horizontal design
• High-quality pharmaceutical finish
• All product-contact parts fully in 316L stainless steel
• Mirror-polished internal surface
• GMP-compliant, documented welds
• Large manway with swing cover
• Multiple clamp and flange connections
• Spray ball / CIP connections
• Instrumentation ready (pressure, temperature, sensors)
• Insulated jacket with connections
• Solid 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 use
• 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)
Bcedpfx Absykn Iie Sjw
• Delta ferrite test reports
• Roughness measurement reports
• Calibration certificates for measuring devices
• GMP deviation logs
• FAT protocols, fully signed
• Operating and maintenance manuals

Documentation is complete and well-structured.

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

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

Bu ilan otomatik olarak tercüme edildiğinden bazı çeviri hataları oluşmuş olabilir.