Moduli i temperimit GMP 1.4435

Brinox LEP13.2 KK6771 Paket 11

Manufacturer: BRINOX Process Systems
LEP13.2 KK6771 Package 11
System type: Temperature Control Unit – LEP13.2 AS Storage
Project: Ammonium Sulfate Supply and Disposal
Unit: KK6771
Year of manufacture: 2020
Serial number: 1003622
Equipment number: 20022749
LEP13.2 – AS Storage Temperature Control Unit

TECHNICAL DATA

Product: LEP13.2 – AS Storage Temperature Control Unit
Medium: Ammonium sulfate
Design: Pharmaceutical / GMP
Product-contact materials: 1.4435 / 1.4301 stainless steel

Dimensions (L x W x H):
approx. 1900 x 1545 x 1580 mm

Control air supply:
6 bar (AIP)

Tested pressure range:
up to approx. 3–4 bar (Leak test documented)

MAIN COMPONENTS

2x centrifugal pumps
Horizontal shell-and-tube heat exchanger
Electric flow heater
Expansion vessel
Pressure and temperature measurement points
Pneumatic control valves
Manual ball valves (GEMÜ)
Stainless steel control cabinet / terminal box
Fully insulated piping

APPLICATION

The temperature control unit is used for precise temperature regulation in the ammonium sulfate storage system of a pharmaceutical production facility.

Suitable for:

- Pharmaceutical production environments
- GMP-regulated systems
- Media temperature control systems
- Turn-over package integration

DESIGN / CONSTRUCTION

- Complete, pre-assembled skid unit
- Stainless steel frame construction
- Compact design with unobstructed maintenance access
- Fully piped and insulated
- Clear labeling of all measuring points and fittings
- Pharmaceutical-grade execution as per CSL Behring customer specification
- P&ID checked
- Layout checked
- Multiple documented leak tests
- Calibrated measuring devices with certificates

The system is fully assembled and prepared for seamless integration into existing pharmaceutical installations.

CONDITION

- As-new / Project system
- Year of manufacture: 2020
- FAT completed
- Pressure test passed
- Complete documentation available

COMPREHENSIVE DOCUMENTATION

Includes, among others:

- Factory certificates according to EN 10204
- Material lists
- EU declarations
- Inspection reports
- Documentation of installed equipment
- I&C documentation
- As-built isometrics
- User manual
- Calibration certificates

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SPECIAL FEATURES

- Project-specific pharmaceutical design
- GMP-compliant manufacturing
- Complete skid-mounted construction
- Compact footprint (approx. 1.9 x 1.5 m)
- Maintenance-friendly layout
- High-quality piping insulation
- Ideal for technical areas close to cleanrooms

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