General

The purpose of Facility Net is to collect, display, and record timed measurements from a variety of equipment. This software is designed as a standard package to monitor manufacturing environments or processing areas and to provide quality assurance report to prove that the specified manufacturing or process environment remains within the control limits imposed upon it. Facility Net software is a supervisory, control, and data acquisition based software as interpreted by the GAMP Category 4 configurable software definition.

Requirements

Facility Net operates on a PC computer under Windows 2000 or Window XP. One of these operating systems must be installed on the central data storage computer system referred to as a Real Time Station (RTS). There are no specific quality requirements. The software is maintained to comply with GAMP, Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture, Version 4, December 2001.

Customer Verification

Each FMS system is prepared according specific customer requirements. The system installation is verified with respect to the customer's order.

Company Standards

The design process conforms to the requirements of the BS EN ISO9001:2000 international quality system standard. Facility Net to Ethernet Instrument Traffic The PMS Ethernet protocol utilizes defaults that are assumed on the receiving side of the connection. This means that the default values need not be sent which makes the packets vary in size depending on the contents. An example of this is in the Data message where no actual count data is transmitted if the counts are zero. Multiple PMS Ethernet messages can be sent in one packet. Instruments like the ENODE and Lasair® II can queue data which will be transmitted when the Facility Net application reconnects to the instrument.

Configuration

Initial instrument configuration is normally performed once. The mechanism used is UDP/IP. This can be executed via either Multicast or Unicast.

Initialization

Instrument Initialization can occur when the application is first started or anytime the instrument is reconfigured. Reconfiguration can occur during runtime. Some instruments are reset prior to reconfiguration. Packet from Facility Net:

Message: Date/Time, Set Configuration, Get Configuration, Get Status Length: Approx. 300 bytes (To ENODE this could be 2K) Packet from Airnet: Message: Configuration Length: Approx 300 bytes (From ENODE this could be 2K) Packet from Airnet/ENODE Message: Status Length: Approx 115 bytes Packet from Facility-Net: Message: Status Length: Approx 115 bytes Packet from Facility Net: Message: Set LED on Airnet/Set Digital Output on ENODE Length: Approx 87 bytes

Data Processing

The Ethernet instrument transmits data when the internally processed sample interval is complete. No polling for data is required.

Note: Particle counter sample points may utilize "Zero count sample interval" which will reduce traffic. ENODE digital input sample points are sent on change (exact conditions are setup in the instrument and in Facility Net). ENODE Analog Inputs are all treated as separate sample points and each have their own sample interval. Packet from Airnet®/ENODE® Message: Data Length: Approx 147 bytes

Status & Date/ Time Processing

Facility Net requests status every two minutes from each Ethernet instrument, Facility Net will add a date/time every thirty minutes to the status request packet. Packet from Facility Net: Message: Get Status Length: Approx 87 bytes Or Packet from Facility Net: Message: Get Status, Date/Time Length: Approx 130 bytes Net Packet from ENODE: Message: Status Length: Approx 115 bytes