GMP ogrevalni skid za pralno raztopino

BRINOX LEP 2.3 KK6762 Paket 9

Manufacturer
BRINOX d.o.o.
Project Number
B-0001113-LEP2.3
LEP 2.3 KK6762 Package 9
Module
M024
Product Description
LEP2.3 – Wash Solution Tempering Unit
Serial Number
1003572
Equipment Number
20022782
Tag Number
MR-INH-VPR61-KK6762
Year of Manufacture
2020

Technical Data

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

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

Design
Fully pre-assembled, insulated tempering skid
Pharmaceutical design in accordance with GMP requirements
Industrial stainless steel frame construction

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

Insulation
Completely insulated piping and equipment
Closed-cell high-performance insulation with black protective covering

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
Bodpsyl Iwtofx Ag Tecw
Pressure Transmitters
Temperature Measurement Points
Pressure Gauges
Electrical Junction Box with Warning Labels
Stainless Steel Cable Trays

Media

Cooling brine supply/return
Wash solution process medium
Control compressed air 6 bar

All media connections factory-sealed and securely packed for transport.

Leak Testing

Conducted 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 holding time: 1 hour each
No leaks detected

Calibration Certificates

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

Documentation Scope

FAT plan and report
Deviation form
Layout drawing check
Maintenance inspection
P&ID diagram
Leak test
Calibration certificates
Factory certificate 2.1 EN10204
Material list
As-built isometrics
Complete turn-over package

Test Status

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

Application

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

Condition

New system
Originally packed
Unused
Year of manufacture: 2020
Factory condition
Fully documented
Immediately available

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