GMP temperatūros reguliavimo skidas 1.4435

Brinox LEP 2.3 KK6752 Paket 7

Manufacturer: BRINOX Process Systems
Type: LEP 2.3
System type: Temperature control unit for wash and elution solutions
Year of manufacture: 2020
Serial number: 1003563
Device number: KK6752
Design: Stainless steel skid, pharmaceutical-grade construction
LEP 2.3 KK6752 Package 7

Technical Data

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

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

Piping system:
Orbital welding (pharmaceutical grade)
Fully welded design
As-built isometric drawings available

Pressure data:
Leak test with compressed air
Test pressure: 3.37 bar
Hold time: 1 hour
Result: Leak-free

Measurement and control technology:
Pressure measurement (PIR, PI, PIRC)
Temperature measurement (TI, TIRC)
Level measurement (limit value)
Flow monitoring
Position feedbacks
Motor control
On/off pneumatic valves

Pressure sensor measuring range: 0–10 bar

Electrical connection:
Control air: 6 bar
Automation-ready (PLT 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 (inlet/outlet interfaces available)

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Dimensions / Weight

Design: Compact skid unit
Industrial-grade for cleanroom/technical areas
(Transport and installation dimensions according to layout drawing)

Application Area

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

Fields of application:
Biotechnology
Plasma fractionation
GMP production facilities

Construction / Configuration

Welded stainless steel frame
Low-vibration pump installation
Hygienic piping layout
Full implementation according to P&ID
Clear separation of product and non-product areas
Service and maintenance accessibility verified

Mechanical SAT-IQ test performed
Metrological SAT-IQ test performed
P&ID (R&I) diagram review completed
Layout drawing review completed

Condition

Year of manufacture 2020
Industrial and pharmaceutical grade
Brand new, original packaging
Pressure tested
Sensors calibrated
FAT performed

FAT / Documentation

Available:
FAT plan and report
Deviation management
Layout review
P&ID (R&I) review
Leak test
Sensor calibration
Maintenance and accessibility review
EN10204 factory certificate
Material lists (LBM)
As-built isometric drawings
Component lists (equipment & PLT points)

Special features

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