CASE STUDIES - ACal Technologies

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⇓ Mitsubishi PLC Door Interlock & Pressure Monitoring System

⇓ BMS for HVAC and Facility Utilities

⇓ Mitsubishi PLC WFI System

⇓ EMS System

2 Overview

System Requirements

• The Door Interlock & Pressure Monitoring Control System shall comprise of a central electrical floor standing enclosure located in utilities area containing a Mitsubishi Q04UDHCPU modular PLC.

• Differential pressure indicating transmitters and all associated electrical components shall be enclosed within the same enclosure.

• The electrical enclosure shall allow for all field connections through disconnect fused terminals to associated components.

• The system shall incorporate one master 15” touch screen HMI located at the central electrical enclosure.

• Ten remote 10.4” touch screen HMI’s shall be located within the production rooms of the Facility.

• The HMI structure will be of a menu driven format selectable from the main display page. System.

• HMI’s will graphically represent each airlock indicating process timer values and using colour change for pushbutton, maglock, LED status including door positions whether opened or closed.

• Each HMI shall display associated room/airlock/AHU static pressures including high and low alarm set-points.

• System HMI’s shall provide group based hierarchal access for different tasks, accessed via password verification.
Security passwords shall be up to a maximum of 10 alphanumeric characters. The system shall monitor the controlled environmental pressures of the facilities process rooms, airlocks and AHU static pressures and shall control access to areas by limiting opening of one door at one time, preventing the simultaneous opening of any other door in the associated group, thus minimising microbiological and particulate contamination including aiding the control of airflow and pressurisation. The system shall be predominantly automated and will require minimal operator intervention. Thirteen local alarm strobe lights, located throughout the facility activate on occurrence of associated high or low pressure alarm conditions.

Documentation

All system documentation is generated in house and is project specific according to the URS. The documentation requested for this project include:

a. Functional Design Specification (FDS)

b. Hardware Design Specification (HDS)

c. Software Design Specification (SDS)

d. Factory Acceptance Test (FAT)

e. Installation Qualification (IQ)

f. Operational Qualification (OQ)

g. Validation Summary Report (VSR)

h. System Drawings

Project Hardware

Some of the main components used during the manufacture of this system

1. Rittal Baying System TS8 Enclosure Mild Steel Finish

2. Mitsubishi HMI E1151

3. Mitsubishi HMI E1071

4. Mitsubishi HMI E1043

5. Mitsubishi HMI E1101

6. Q312DB Mitisubishi Q Universal CPU high speed base with 12 I/O slots & PSU

7. Preventa Safety Relay

8. CPV14-VI Festo solenoid block 5/2

9. Sontay Presssure Transmitter 0-1000Pa

10. Sontay Presssure Transmitter 0-100Pa

11. Sontay Presssure Transmitter ±50Pa

2 Overview

A Medical Devices company is extending their existing building manufacturing plant to include a new manufacturing space, a new auditorium and office space facilities. A new Trend 963 supervisor will be installed and used to view and edit the site BMS data. The URS detail included the installation of six purpose built IQ3 Outstations located within the associated new facility areas within the building extension. The control system development, design, manufacturing, testing and verification will be in accordance with GAMP 5 Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The expansion project would include control for the following plant systems:

• Six AHU’s

• Six Extract Fans

• Chiller

• Duty/Standby Gas Boiler system

• AHU Heat recovery system

• Fan Coil Units

• Reheat Coils

System Requirements

• Five IQ3 Outstations to provide all required I/O points for six AHU’s and ancillary equipment.

• One IQ3 Outstation to provide all required I/O points for utilities control and monitoring.

• The Outstation enclosures shall allow for all field connections through disconnect fused terminals to all field devices.

• The system shall incorporate MSTP communication for control and monitoring of 3rd party FCU’s.

• Merge the existing site BMS and the expansion BMS network onto a virtual machine which can be accessed from any device connected to the site Ethernet.

• System critical alarms to be sent as SMS messages and emails to single or multiple users.

Documentation

All system documentation is generated in house and is project specific according to the URS. The documentation requested for this project include:

a. Functional Design Specification (FDS)

b. Hardware Design Specification (HDS)

c. Software Design Specification (SDS)

d. Factory Acceptance Test (FAT)

e. Site Acceptance Installation Verification (SAIV)

f. Site Acceptance Operational Verification (SAOV)

g. Validation Summary Report (VSR)

h. System Drawings

Project Hardware

Some of the main components used during the manufacture of this system

1. Rittal Baying System TS8 Enclosure Mild Steel Finish

2. IQ3 Excite Controller

3. IQ3 Excite 8UI

4. IQ3 Excite 16DI

5. IQ3 Excite 8AO

6. IQ3 Excite 8DO

7. Omron 10A 24vDC PSU

8. 750VA Transformer

9. Status PT100 Temperature Transmitter a. Wall Mount LCD Display b. Wall Mount Non LCD Display c. Duct Mount d. Pipe insertion

10. Rotronic HF520 Humidity Transmitter a. Wall mount LCD Display b. Wall mount Non LCD Display c. Duct Mount

11. Honeywell Isolation Damper Actuator

12. Honeywell Modulating Damper Actuator

13. Sontay PA-267 Presssure Transmitter a. ±50 Pa LCD Display b. ±50 Pa Non LCD Display c. 0-100 Pa d. 0-1000Pa

2 Overview

The WFI (Water for Injection) is comprised of one PLC/HMI based system, whose function is to provide monitoring and control of the WFI storage and distribution system. The WFI is a validated system and as such has been developed in accordance with GAMP 5 (Good Automated Manufacturing Practice) guidelines and shall be 21CFR Part 11 (Electronic Batch records and Electronic Signatures Regulations) compliant. The system is comprised of the following main components:

• WFI Storage Vessel

• Heat Exchangers

• WFI Control System (including Electronic Chart recorder & HMI)

• Six POU (Point Of Use) User HMI’s located throughout the facility

• Remote Pneumatic Valve Solenoid Panel using dedicated CC-Link

• Distribution Pumps

System Requirements

• The system controls WFI feed, through storage, and distribution of WFI to POU’s, and shall be predominantly automated and requires minimal operator intervention.

• One 15” E Series touch screen HMI is mounted on the door of the control panel in the facilities area.

• Six 6.5” E series touch screen HMI’s are located within the production rooms of the Facility.

• The system incorporates a thirty channel Yokogawa DX-Advanced paperless recorder for validation record purposes and solicits an operator response to alarm conditions.

• System HMI’s provide group based hierarchal access for different tasks, accessed via password verification.

• Each of the six remote HMI’s graphically represent it’s associated POU, displaying valve positions, tank level, WFI available status, current POU status (Ready/Interlocked/Flushing/Dispensing/Paused/Sampling/Draining) and incorporates a sampling softkey to initiate sampling operations.

• System pneumatically activated valves are controlled from two remote solenoid enclosures which are controlled on a dedicated CC-Link network from the central electrical enclosure.

• Filling will only initiate when WFI tank filling or sampling is not in progress and no interlock conditions prevail, the system returns to the offline state if any of the system interlock conditions occur.

• The system employs digital output signals to interface with the site Building Management System (BMS) to identify WFI healthy and common alarm status to solicit an operator response to alarm conditions.

Documentation

All system documentation is generated in house to GAMP 5 and is project specific according to the URS. The documentation requested for this project include:

a. Project Quality Plan (QP)

b. Functional Design Specification (FDS)

c. Hardware Design Specification (HDS)

d. Software Design Specification (SDS)

a. PLC I/O Matrix

b. PLC Alarm Matrix

c. Chart Recorder I/O Matrix

d. System Valve Matrix

e. Factory Acceptance Test (FAT)

f. Site Acceptance Test (SAT)

g. Operational Qualification (IOQ)

h. System Drawings

Project Hardware

Some of the main components used during the manufacture of this system

1. Rittal Baying System TS8 Enclosure Mild Steel Finish

2. Rittal AE Series 316 S/S Enclosure

3. Mitsubishi HMI E1151

4. Mitsubishi HMI E1071

5. Q03UDECPU Mitisubishi Q CPU

6. Q61P Mitisubishi Q Universal CPU high speed base with 12 I/O slots & PSU

7. Yokogawa 30Ch Paperless recorder

8. Sineax 4-20mA Isolator

9. Crydom Common Cathode Diode Module

10. ABB Opto-Coupler

2 Overview

The EMS will allow for continuous monitoring of a Distribution Centre warehouse area, Cold Store and Freezer Rooms with alarm activation during out of temperature specification conditions on individual sensors, provide audit trails and strong security features to comply with the Guidelines of 05 November 2013 on Good Distribution Practice of Medicinal products for human use (2013/C 343/01) and FDA regulation 21 Code of Federal Regulations (CFR) Part 11 and provide alarm functions and graphical trends of stored environmental conditions. The EMS was designed around a recent fit out to an existing warehouse building as part of the relocation of their Distribution unit for the distribution of finished pharmaceutical products. The system requires the EMS to monitor the temperature, humidity and pressure conditions of the following areas

• Warehouse

• Coldstore

• Conditioning Freezer

• Holding Freezer.

System Requirements

• The system is fitted with a single 10.4-inch TFT colour LCD display, and a single keypad for input.

• The EMS displays alarms in Non-Hold function. This function does not require a user to acknowledge alarms and automatically clears the alarm display when the cause of the alarm is no longer present, but the alarm record is maintained and available on the alarm summary function.

• Information within the audit history contains: Alarms, Error messages (failed attempts at access), power loss, and changes to configuration.

• An electrical lockable disconnect isolator is located inside the enclosure for future electrical works.

• On system alarm activation a visual & audio alert must be activated and deactivate when the cause of the alarm is no longer present.

• System critical alarms to be sent as SMS messages and emails to single or multiple users.

• The system must include a UPS for continuous monitoring during the event of a site power outage.

Documentation

All system documentation is generated in house to GAMP 5 and is project specific according to the URS. The documentation requested for this project include:

a. Project Quality Plan (QP)

b. Functional Design Specification (FDS)

c. Site Acceptance Test (SAT)

d. Installation Operational Qualification (IOQ)

e. System Drawings