GMP yıkama çözeltisi ısıtma skidi

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 Designation
LEP2.3 – Washing 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 washing and elution solutions.
Constructed as a compact, multi-level stainless steel frame 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 surfaces: Stainless steel 1.4435 / 1.4571
Frame construction: Stainless steel 1.4301
Weld execution according to EN ISO 13920 D

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

Main Components

PU1021 Process pump
PU9203 Cooling medium pump
WT1001 Plate heat exchanger
Ledpfx Aasyl Iwtj Iorh
WT1011 Finned tube heat exchanger
BH9701 Expansion vessel
Pneumatic control valves
GEMÜ stainless steel ball valves
Pressure transmitters
Temperature measurement points
Manometers
Electrical terminal box with warning labeling
Stainless steel cable trays

Media

Chilled brine supply / return
Washing solution process medium
Control compressed air 6 bar

All media connections sealed at factory and packed secure for transport.

Leak Tests

Performed as pressure testing 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 as per 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 check
P&ID diagram
Leak test
Calibration certificates
Manufacturer’s certificate 2.1 EN10204
Material list
As-built isometry
Complete turnover package

Testing Status

FAT completed
Pressure testing passed
Calibrations available
PED-compliant design
Complete pharmaceutical documentation

Application

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

Condition

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

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