Clean room monitoring

At the middle of 2004 an important customer from the pharma industry took into commission the turnkey production plant "New Freeze Drying Facility (NFF)".

In this modern production facility with approx. 4.600 m² area, the customer is aseptically filling sterile solutions into medicinal flasks. They are subsequently freeze-dried, closed and crimped. The production takes place under clean room conditions according to the regulations of the pharma industry (EU GMP and FDA).

The end-user needs clean rooms. A clean room monitoring system is applied for the supervision of the clean room conditions. The application comprises a data acquisition and visualization system as well as a process

control section providing quality relevant process data.

The signals are displayed on three data acquisition units in all and transmitted to acentral location via Ethernet. At this locationis a PC with visualization interface - a SCADA server which also contains the raw data, linkages and limit values.

Alarms are shown in different ways:

	Messaging via the monitor
	Activation of signal horns and stack lights
	Various alarm contacts

Features and benefits

	Easily expanded to include further measuring points and production areas
	Historical data synchronization
	Department-based user management
	Audit trail with various query options
	Standard report functions
	21 CFR Part 11 conform
	FDA audited system

The clean room monitoring system comprises a SCADA server and client monitoring station. The data are acquired via Ethernet TCP/IP from data manager Memograph S RSG12.

::Enlarge picture

System overview of Pharma Solution Monitoring Package

The monitoring system includes:

	Dust particle counters for two size categories
	Integrated differential pressure, temperature, humidity and air flow measurement
	Door surveillance through contact system
	Audio and visual annunciation

Production conditions are observed with the monitoring system. Measured values that are out of the specified limit value range produce audio and visual alarms. Furthermore, complete documentation of relevant data is possible.

The delivery included measuring devices for the registration of room pressure, temperature and humidity. The measuring equipment for dust particle counting was also provided. A local data buffer was added for the link as well as several paperless recorders for local display. The FDA-conform paperless recorders are connected via the company intranet to the SCADA server provided by Endress+Hauser. Data are read from the Memographs (paperless recorders) via the network, clearly displayed on themonitors and saved according to GMP rules.

Endress+Hauser provided:

	Project management
	Basic, detail and implementation engineering
	Supply of measuring technology
	Complete monitoring system
	Qualification: - Design qualification - Factory Acceptance Test (FAT) - Commissioning - Installation Qualification (IQ) - Calibration of measuring points - Operational Qualification (OQ)
	Training and instruction
	Within the scope of maintenance,
	Endress+Hauser recalibrates all delivered
	devices on an annual basis.

Clean room monitoring

Monitoring of clean room conditions

at FERRING GmbH, Kiel, Germany

Case Study

CS002S/04/en/09.06

Clean room monitoring

Flexible solutions for pharmaceuticals

and other regulated industries

Innovation Brochure

IN006S/04/en/03.07

In preparation