Design Considerations for Electrical Control System Compliance for Eurping GMP washers

Introduction: GMP washers need to comply with pharmaceutical machinery regulations, software needs to be managed in terms of data logging and permissions, stability of the electrical system, material resistance and other considerations.

Purpose: The aim is to ensure that Eurping GMP washers can operate stably for more than ten years while completing the cleaning validation and guaranteeing the cleanliness of the apparatus, thus bringing more value to the user.

Mainly divided into the following points:

1. Eurping appliance cleaning machine control system: the use of German Siemens S7-1200PLC, TP700 Jingzhi screen or 12-inch industrial computer (Intel Atomx6413e Processor). Eurping can provide the following functions.

1.1 Support for OPC communication protocol

PLC controller on the provision of a standard general-purpose communication interface to spare.

1.2 Reserved ERP / MES communication interface (LAN network cable)

Connect SCADA system, provide free communication protocol and IP address, point table and corresponding technical

support, complete SCADA collection work.

1.3 LAN interface

The number can be more, user request.

1.4 NTP time server

The time calibration function ensures that the device time is always accurate by connecting with the customer service NTP time server.

LAN connection. If this server is not available, it needs to be switched on for 1 hour per week.

1.5 Trigger electronic signature

Modify records, procedures, wind pressure, water pressure and so on.

When was it modified? Who modified it? What was modified? Why was it changed? All will be recorded.

1.6 Backup system

It is recommended to backup once a month (optional automatic daily/monthly/yearly), memory 32GB, the remaining 64MB will send a reminder, each record occupies 2KB.

1.7 Export related records

Support the export of data in PDF format via USB memory stick, and the background operation during the export process will not interfere with the normal operation of the machine.

1.8 Four levels of authority allocation and management

1.9 Batch report U disk export, cleaning records, operation records, alarm records

2. Conductivity sensor: Germany burkert brand

2.1 Range: the final rinse water conductivity: 0-20us/cm; cleaning fluid concentration conductivity: 0-500ms/cm

2.2 The last injection of water rinsing, water and drainage conductivity difference ≤ 1.3us/cm

2.3 Cleaning agent concentration conductivity: general pharmaceutical workshop using sodium hydroxide solution single substance cleaning agent (see below), sodium hydroxide solution concentration and conductivity value curve, PLC can be achieved automatically control the end point judgement

2.4 Conductivity material: electrode for stainless steel 316L, sensor for stainless steel 316L and PEEK with FDA certification (CFR177.2415)

2.5 Interface: chuck quick connection

2.6 Roughness: surface electropolishing 0.4um

3. Eurping bottle using the Swedish Alfa Laval brand, circulating water pumps

3.1 Eurping in the circulating pipeline and pump matching, through the fluid dynamics calculation to solve the cavitation, high temperature circulating pressure attenuation and other issues;

3.2 The pump's mute effect: Eurping bottle through the tuning of Schneider frequency converter and Alfa Laval pumps, to achieve the best water pressure and noise minimum

3.3 Regulations and literature recommendations, the use of external mechanical sealing device, as described in references 1 and 3, can effectively avoid wear and tear silicon carbide involved in the water cycle. Due to the nature of silicon carbide, it may not be detected by conductivity and TOC (Total Organic Carbon) after wear, so the external design is particularly important.

3.4 Graphite mechanical seals are not recommended

4. Temperature sensors, pressure sensors, differential pressure sensors, pneumatic valves and other key components are used in the international first-tier brands of high-quality products

5. the components in the electrical cabinet are selected Schneider, AirTac and other internationally renowned brands.