نظام تعديل درجة الحرارة GMP موديل 1.4435

Brinox LEP 2.3 KK6752 Paket 7

Manufacturer: BRINOX Process Systems
Type: LEP 2.3
System Type: Temperature Control Unit for Washing and Elution Solutions
Year of Manufacture: 2020
Serial Number: 1003563
Device Number: KK6752
Design: Stainless Steel Skid, Pharmaceutical Construction
LEP 2.3 KK6752 Package 7

Technical Data

Design:
Compact, pre-assembled temperature control unit on a welded stainless steel frame (skid system)

Materials:
Product-contact: Stainless Steel 1.4435 / 1.4404
Non-product contact: Stainless Steel 1.4301

Piping System:
Orbital welding (pharmaceutical grade)
Fully welded construction
As-built isometric drawing available

Pressure Data:
Leak test using compressed air
Test pressure: 3.37 bar
Holding time: 1 hour
Result: Leak-free

Measurement and Control Technology:
Pressure measurement (PIR, PI, PIRC)
Temperature measurement (TI, TIRC)
Level measurement (limit)
Flow monitoring
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Position feedback
Motor control
On/Off pneumatic valves

Pressure sensor measuring range: 0–10 bar

Electrical Connection:
Control air: 6 bar
Automation-capable (PLT nodes fully documented)

Main Components:
2 process pumps
Plate heat exchanger
Finned tube heat exchanger
Expansion vessel
Multiple hygienic control and shut-off valves
Integrated instrumentation units

Cooling Medium:
Chilled brine (supply/return interfaces available)

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Dimensions / Weight

Construction: Compact skid unit
Industrial design for cleanroom/technical areas

(Transport and installation dimensions as per layout drawing)

Application Area

Temperature control of:
Washing solutions
Elution solutions
Process media in biopharmaceutical environments

Fields of Application:
Biotechnology
Plasma fractionation
GMP production facilities

Build / Construction

Welded stainless steel frame
Low-vibration pump mounting
Hygienic piping
Full implementation according to P&ID
Clear separation between product and non-product areas
Service and maintenance access tested

Mechanical SAT-IQ test performed
Metrological SAT-IQ test performed
P&ID diagram check completed
Layout drawing check completed

Condition

Manufactured in 2020
Industrial and pharmaceutical version
New, original packaging
Pressure tested
Sensors calibrated
FAT performed

FAT / Documentation

Available:
FAT plan and report
Deviation management
Layout check
P&ID check
Leak test
Sensor calibration
Service and accessibility inspection
EN10204 factory certificate
Material lists (LBM)
As-built isometry
Component lists (equipment & PLT nodes)

Special Features

Pharma-GMP compliant design
Complete validation documentation
Full traceability
Certified pressure testing
Calibration certificates from accredited laboratories
High-quality plant construction by BRINOX
High-end biopharma standard

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