GMP CIP工艺撬装系统 1.4435

Brinox LEP 12 CS6723 Paket4

Machine designation
BRINOX Process System / CIP Skid Type CS6700 (CS6723)
GMP CIP Process Skid 1.4435

Manufacturer
BRINOX Process Systems

Year of manufacture
2020

Technical Data
Design as a stainless steel process skid in hygienic execution.
Conductivity measurement 1–500 µS/cm, analog signal (AI), hygienic connection DN 50.
Flow measurement 0–18,000 kg/h, analog signal (AI), connection DN 25, sterile flange DIN 11864-2A.
Pressure measuring points −1 to 9 bar and −1 to 15 bar, analog signal (AI), hygienic connections DN 50 or ½", e.g. DIN EN ISO 228.
Temperature measuring points −50 °C to +200 °C, analog signal (AI), connection DN 32, welded according to DIN 11866/A.
Limit level sensors, digital (DI), hygienic connection DN 50.
Multiple position feedbacks with IO-Link / digital.
Pneumatically actuated on/off valves (DO) in stainless steel hygienic design.
Product-contact materials according to EN 1.4435 / 1.4404 (AISI 316L).
Documented surface roughness of product-contact surfaces Ra approx. 0.3–0.4 µm.

Application
Hygienic CIP and process plant for pharmaceutical and biotechnological applications. Suitable for cleaning process lines and vessels under GMP conditions.

Construction
Welded stainless steel skid with orbital welded piping.
Hygienic clamp and sterile connections.
Fully instrumented with flow, pressure, temperature, and conductivity measurement.
Pneumatic valve technology with digital feedback.
Components from renowned manufacturers such as Endress+Hauser, Gemü, Samson, SICK, and others.
Clean, GMP-compliant execution.

Condition
New. Original packaging. Unused.
Never installed or commissioned.

FAT / Documentation Status
Fully documented Factory Acceptance Test carried out.
Layout drawing inspection documented.
Maintenance and calibration accessibility check documented.
Surface roughness test documented.
Leak test documented.
Sensor calibration documented.
Welding documentation fully verified.

Complete Documentation List
FAT plan and FAT report.
P&I diagram.
Layout drawings.
Material lists for metals and polymers.
Material certificates 3.1.
WPQR, WPS, welder qualifications.
Welding protocols and isometrics.
Calibration certificates for measuring instruments.
Surface roughness measurement protocols.
Leak test protocols.
EU declarations of conformity for installed components.
Operating documentation.

Special Features
GMP-compliant, fully documented manufacturing.
High-quality instrumentation.
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Very low documented roughness values.
Immediately available.
Ideal for pharmaceutical, biotech, or contract manufacturers with high documentation requirements.

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