Copyright © 2010 E‐Technologies Group
Automation & Validation
Solutions for the
Biopharmaceutical Industry
E‐Technologies Group provides engineering solutions across multiple
industries, adapting to meet the diverse scheduling needs of its clients. In
one case, a biopharmaceutical company making a new drug to treat a
common, serious disease selected E‐Technologies Group to design and
implement a large automation solution for a complete greenfield facility,
and to provide FDA‐required validation services for automation
deliverables throughout the manufacturing plant.
Background
In 2006, a biopharmaceutical company began building a manufacturing facility to produce a
new product. This manufacturing facility would be this client’s first facility capable of
producing a drug in quantities needed to support global commercial distribution. It would
incorporate single‐product manufacturing areas, filling/capping areas, packaging areas, a final
product storage area, and process and mechanical facilities.
E‐Technologies Group has proven experience in automation and integration services for
regulated clients and was an obvious choice for system integration. From project inception, E‐
Technologies Group has served as the sole‐source control systems integrator for this client. E‐
Technologies handles the making, batch, utilities, filling, and packaging systems integration;
process control; facilities management systems; and all required support documentation.
E‐Technologies also provides validation services for this client. These services range from
master planning to protocol execution for third party vendor‐built equipment and stick‐built
control systems that have been custom‐engineered by E‐Technologies Group.
Copyright © 2010 E‐Technologies Group
Services Provided by E‐Technologies Group
E‐Technologies Group developed the automated systems and design deliverables required to
support these operations: the Supervisory Control and Data Acquisition (SCADA) System,
Process Control System (PCS), and Facilities Management System (FMS). These systems are
described in more detail below.
SCADA System. This system controls the production process and utilities with continuous,
discrete, and batch software programs. These programs include both automatic and manual
modes for obtaining, processing, and managing production line data, as well as batch process
control, alarm management, and historical data/event collection for the process, clean
utilities, plant utilities, and HVAC equipment. Terminal sessions for end‐user operators are
provided over a redundant Ethernet communication network, and all operator entries are
recorded for 21 CFR Part 11 compliance audit purposes. The SCADA system is designed to be
S88 compliant.
PCS System. This system provides automated control, monitoring and management of the bulk
manufacturing process, clean‐in‐place (CIP) and steam‐in‐place (SIP) operations, along with
associated utilities, such as those used for water intended for injection, clean steam, and
solvents. This PLC‐based system is also designed for S88 compliance and achieves input/output
communication via redundant ControlNet Networks (except for motor control center
communication, provided through DeviceNet).
FMS System. The Facilities Management System provides control of major building systems,
including the HVAC system. Environmental monitoring of clean rooms—including relative
humidity, temperature, and differential pressure—is provided, as well as incoming power
monitoring and appropriate shutdown and restart of utility power systems for specific
applications. This PLC‐based system is divided into validated and non‐validated systems for
critical and non‐critical areas, and is connected to its own physically isolated field panels.
Network communication is redundant over ControlNet, except for motor control center
communication provided via DeviceNet.
Altogether, the current system includes 23 Human Machine Interfaces (HMIs), 20
Programmable Logic Controllers (PLCs), and approximately 8,000 input/output (I/O) points.
These numbers continue to grow as additional requirements are added for new phases of
construction.
Copyright © 2010 E‐Technologies Group
Validation Services. E‐Technologies Group’s full‐time, in‐house validation staff is made up of
experienced validation engineers and specialists. This team has provided validation master
planning, project management, commissioning support, Factory Acceptance Testing (domestic
and international), Site Acceptance Testing, SOP development, impact assessments, risk
assessments, qualification protocol development and execution, and summary reporting. All
validation activities are based on current FDA industry guidance, the most recent GAMP
methodologies, and standard practices for the integration of commissioning and qualification
activities. Additionally, all validation activities are aligned with the quality procedures and
requirements established by the client.
Scope of Services
The scope of services provided by E‐Technologies Group includes:
• Functional Requirement Specification (FRS)
• Detailed Design Specification (DDS)
• PLC/HMI Software Development
• Software Factory Acceptance Testing (SFAT)
• Instrument Check‐Out (ICO)
• Automation Check‐Out (ACO) Support
• Automation Operational Qualification (AOQ) Protocol Development
• Validation Planning and Project Management
• FAT and SAT Testing
• Validation Protocol Development and Execution
• Validation Summary Reporting
• Integration of packaged systems, such as WFI Still, Clean Steam Generator, Air
Compressor, RO/DI System, Switchgear & Generators with the appropriate utility or
process system.
• Contracting the fabrication of PCS & FMS control panels
• Specification, purchase, staging and deployment of the SCADA system servers, HMIs and
engineering workstations
• HVAC Control
Copyright © 2010 E‐Technologies Group
Client Benefits
The solutions provided by E‐Technologies Group have allowed this biopharmaceutical client to
meet stringent production and scheduling demands for the medication it developed and
brought to market, and to meet federal regulatory requirements for the manufacture of drug
products for human consumption. Moving forward, E‐Technologies Group will continue to
provide this client with robust automation systems and regulatory services to meet the client’s
manufacturing and quality requirements.