GMP skolalausnarhitunarkerfi á renni

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 Temperature Control Unit
Serial Number
1003572
Equipment Number
20022782
Tag Number
MR-INH-VPR61-KK6762
Year of Manufacture
2020

Technical Data

System Type
Pharma temperature control skid for precise temperature regulation of wash and elution solutions.
Constructed as a compact, multi-level stainless steel frame design 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
Industrial stainless steel frame construction

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

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

Main Components

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

Media

Chilled Brine Supply / Return
Wash Solution Process Medium
Control Air 6 bar

All media connections sealed at factory and packaged securely for transport.

Leak Testing

Performed as 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 according to EN ISO/IEC 17025
Measurement Ranges: –1 to 20 bar and 0 to 10 bar
Calibration performed

Documentation Scope
Bcedpfx Ajyl Iwtsd Dow

FAT Plan and Report
Deviation Report
Layout Drawing Check
Maintenance Inspection
P&ID
Leak Test Report
Calibration Certificates
Works Certificate 2.1 EN10204
Material List
As-Built Isometrics
Complete Turn-Over Package

Inspection Status

FAT performed
Pressure test passed
Calibrations available
PED-compliant design
Pharma documentation complete

Application

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

Condition

New system
Original packaging
Unused
Year of manufacture: 2020
Factory condition
Fully documented
Immediately available

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