GMP Temperierskid 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
Equipment Number: KK6752
Design: Stainless steel skid, pharmaceutical-grade 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 design
As-built isometry available

Pressure Data:
Leak test with 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
Position feedback
Motor control
Open/Close valves pneumatic

Pressure sensor measuring range: 0–10 bar

Electrical Connection:
Control air: 6 bar
Automation-ready (instrumentation points 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:
Cooling brine (supply/return interfaces available)

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Dimensions / Weight

Design: Compact skid unit
Industrial version for cleanroom/technical area

(Transport and installation dimensions as per layout drawing)
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Application Area

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

Field of Application:
Biotechnology
Plasma fractionation
GMP production facilities

Build / Construction

Welded stainless steel frame
Vibration-damped pump mounting
Hygienic piping layout
Fully P&ID-compliant implementation
Clear separation of product/non-product areas
Service and maintenance accessibility tested

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

Condition

Year of Manufacture: 2020
Industrial and pharmaceutical-grade version
New, original packaging
Pressure tested
Sensors calibrated
FAT (Factory Acceptance Test) performed

FAT / Documentation

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

Special Features

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

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