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BRINOX LEP 2.3

Manufacturer
BRINOX d.o.o.

Project Number
Ksdpfx Aboyl Iwtj Iedh
B-0001113-LEP2.3

Module
M024

Product Name
LEP2.3 – Wash Solution Temperature Control Unit

Serial Number
1003572

Equipment Number
20022782

Tag Number
MR-INH-VPR61-KK6762

Year of Manufacture
2020

Technical Data

System Type
Pharmaceutical temperature control skid for precise temperature regulation of wash and elution solutions.
Constructed as a compact, multi-level stainless steel frame assembly with fully integrated pump, heat exchanger, and valve technology.

Dimensions
Length: 1920 mm
Width: 1365 mm
Height: 1840 mm

Design
Fully pre-assembled, insulated temperature control skid
Pharmaceutical design according to GMP requirements
Robust industrial stainless steel frame construction

Materials
Product-contact parts: Stainless steel 1.4435 / 1.4571
Frame construction: Stainless steel 1.4301
Welds according to EN ISO 13920 D

Insulation
All pipelines and components fully insulated
Closed-cell high-performance insulation with black protective jacket

Main Components
PU1021 Process Pump
PU9203 Cooling Medium Pump
WT1001 Plate Heat Exchanger
WT1011 Finned Tube Heat Exchanger
BH9701 Expansion Vessel
Pneumatic Control Valves
GEMÜ Stainless Steel Ball Valves
Pressure Transmitters
Temperature Measurement Points
Pressure Gauges
Electrical Connection Box with Warning Labels
Stainless Steel Cable Trays

Media
Cooling Brine - flow and return
Wash Solution - process medium
Instrument Air - 6 bar

All media connections factory sealed and packaged for transport.

Leak Testing
Performed as a pressure test with compressed air.

DP-01
Medium: Compressed Air
Test Pressure: 3.15 bar
Pressure Drop: 0.13 bar
Date: 27.07.2020
Result: Passed

DP-02
Medium: Compressed Air
Test Pressure: 3.28 bar
Pressure Drop: 0.07 bar
Date: 26.07.2020
Result: Passed

Pressure hold time: 1 hour each
No leaks detected

Calibration Certificates

Calibration laboratory: LOTRIČ Metrology
Certificates in accordance with EN ISO/IEC 17025
Measurement ranges: –1 to 20 bar and 0 to 10 bar
Calibration performed

Scope of Documentation

FAT plan and report
Deviation report
Layout drawing review
Maintenance inspection
P&ID diagram
Leak test report
Calibration certificates
Factory certificate 2.1 EN10204
Material list
As-built isometry
Turn-over package complete

Inspection Status

FAT performed
Pressure test passed
Calibrations available
PED compliant design
Complete pharmaceutical documentation

Application

Temperature control of wash and elution solutions in biopharmaceutical production plants
Suitable for GMP environments

Condition

New equipment
Original packaging
Unused
Year of manufacture: 2020
As-new condition
Fully documented
Immediately available

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