GMP pencuci larutan pemanas skid

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 – Washing Solution Temperature Control Unit
Serial Number
1003572
Equipment Number
20022782
Tag Number
MR-INH-VPR61-KK6762
Year of Construction
2020

Technical Data

System Type
Pharma temperature control skid for the precise temperature control of washing and elution solutions.
Constructed as a compact, multi-tiered stainless steel frame design with fully integrated pump, heat exchanger, and valve technology.

Dimensions
Length 1920 mm
Width 1365 mm
Height 1840 mm

Version
Completely pre-assembled, insulated temperature control skid
Pharmaceutical-grade design in accordance with GMP requirements
Industrial stainless steel frame construction

Materials
Product-contacting parts: Stainless steel 1.4435 / 1.4571
Frame construction: Stainless steel 1.4301
Welding in accordance with EN ISO 13920 D

Insulation
Completely insulated pipelines and apparatus
Closed-cell high-performance insulation with black protective casing

Main Components
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PU1021 Process pump
PU9203 Cooling medium pump
WT1001 Plate heat exchanger
WT1011 Finned tube heat exchanger
BH9701 Expansion vessel
Pneumatically actuated control valves
GEMÜ stainless steel ball valves
Pressure transmitters
Temperature measuring points
Pressure gauges
Electrical connection box with warning label
Stainless steel cable trays

Media

Cooling brine supply/return
Washing solution (process medium)
Control compressed air 6 bar

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

Leakage Tests

Performed as pressure tests 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

Scope of Documentation

FAT plan and report
Deviation form
Layout drawing inspection
Maintenance inspection
P&ID diagram
Pressure test
Calibration certificates
Manufacturer's certificate 2.1 EN10204
Material list
As-built isometry
Complete turn-over package

Inspection Status

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

Application

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

Condition

New unit
Original packaging
Unused
Year of construction 2020
Factory condition
Fully documented
Immediately available

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