The Challenge
A major pharmaceutical company in Research Triangle Park, NC recently constructed a greenfield production
facility to manufacture and package a new cancer drug produced from a highly potent compound on an aseptic
filling line utilizing isolator technology. Avid Solutions was given the job of implementing a unified
control system to automatically coordinate and track the operations of all the equipment for component
preparation, formulation, filling and packaging plus the building’s HVAC and utility systems. From the
user requirement specifications to the coding, configuration and documentation, Avid was responsible for
developing a control system that was not only functional, but operator-friendly and FDA-compliant.
The Approach
To meet all these objectives, Avid and the client chose a control platform based on programmable logic controllers
(PLCs) from Allen-Bradley and supervisory control software from Invensys Wonderware. The system was equipped with
a redundant PLC and HMI network as well as a redundant communications.
Using the ISPE’s Good Automated Manufacturing Practices, Avid personnel interfaced the control system to all the utilities, including water for injection, purified water and steam plus the plant’s seven air handling units using over 1500 inputs and outputs (I/O). For the filling lines, the I/O count topped 2400. These data points are used to coordinate the operations of more than 40 independent machines, including filtration units, part washers, autoclaves and fillers built by several different OEMs. Automatic clean-in-place and steam-in-place functions maintain the sterility required for pharmaceutical applications.
Avid’s I/O network provides a variety of supervisory functions from the correct sequence of operations and end-of-run reporting to equipment status, raw material tracking and electronic cleaning logs. Avid also implemented a manufacturing execution system (MES) to translate process orders into the specific material tracking and batch data required by the control system and its operators. The MES was designed per the S88 model which governs the procedures, operations, phases, and equipment allocation in the PLCs.
The MES manages process recipes needed by the OEM equipment and records all details of each recipe transaction. It also collects status information from the compounding, filling, and packaging operations such as “ready for compounding”, “compounding” and “compounding complete”. Operators use barcode scanners and portable computer terminals to manually track all the assets required for the batch process - vials, caps, stoppers, trays, etc.. The MES uses the operator inputs to generate an audit trail for documenting cleanliness, sterility, material tracking and lot genealogy for every step of the production process. All operator functions are regulated with ID’s and passwords that can be entered at any operator terminal anywhere in the control system.
The Results
The Avid solution coordinates every step of the production process and allows operators to interact with every machine
through a single, unified interface. Batch data is automatically archived to document how much of which products were
produced when. The facility meets the FDA’s 21 CFR part 11 electronic records requirements for the current product
line-up and offers sufficient flexibility to accommodate different products in the future.
Actavis
APP Pharmaceuticals
Biogen Idec
Eisai
GlaxoSmithKline
Hospira
Medimmune
Novo Nordisk
Pfizer
Sandoz
Talecris
United Therapeutics
Fluid Bed Dryers
Solution Delivery
Electronic Batch Records
Film Coating
CIP / SIP
Blenders and Fitz Mills
Freeze Dryers
HVAC
Lyophilizers
Product Milling
Building Automation
Test Documents
Validation Execution
Packaging & Inspection
USP / WFI
