Participating in a global market means meeting global standards, which are particularly stringent in the pharmaceutical and medical device sectors.
Implementing Good Manufacturing Practices
For example, one Australian pharmaceutical manufacturer decided to upgrade its automation and control system, driven by the need for the latest batch control technologies. The new system had to demonstrate ongoing compliance with pharmaceutical Good Manufacturing Practices (GMP) and incorporate the ISA''s S88 standard, which defines a common set of models and terminology that can be used to describe and define batch manufacturing systems in accordance with GMP. Many pharmaceutical companies around the world are standardizing on the S88 methodology. The Australian company is standardizing on Rockwell Automation, with Rockwell Software RS BizWare Batch providing the S88 batch control capability.
System integrator Dickinson Autocon Systems was selected to design and implement the batching, automation, and control solution. The broad requirements of the new system were the integration of a dedicated S88-based module control system with a plantwide manufacturing control communications network and the company''s enterprise network.
According to the manufacturing operations manager, plant operations were easily translated to the S88 control philosophy, which uses a methodology known as modular batch automation. This breaks down each manufacturing module into procedures (an overall strategy or recipe, made up of unit procedures), unit procedures (a set of operations defining a production sequence within the recipe), operations (a set of phases defining a process sequence within a unit), and phases (the smallest element of control, usually driving equipment and control elements).
The project team divided the manufacturing operations into seven S88 equipment units: bulk silo filling, material dispensing, granulation and drying, solution preparation and dosing, dry additions, blending, and dense phase transfer.
The new control system centered on an Allen-Bradley ControlLogix system with dual processors for dedicated plant control. DeviceNet was used to link the various weigh-scales and Allen-Bradley Flex I/O modules to the controller, allowing easy incorporation of the original wiring into the system. "We tried to group all the I/O according to the S88 units, the idea being that any faults could be easily traced back to a particular node," notes Philip Reid, systems manager at Dickinson Autocon.
Meanwhile, the upgrade allowed the pharmaceutical company to introduce new safety systems at the plant, says the firm''s project engineer. "We''ve introduced a dedicated safety controller to the DeviceNet communications network," he says. "This is an independent system for monitoring emergency stops, plus safety contacts and switches and removing power when necessary, according to the Australian Standard for Safeguarding of Machinery, AS4024."
RSView32 provides supervisory control of the module. Three RSView clients located on the plant floor are linked to an Ethernet control network local to the module, as is a wireless bar code scanner. The manufacturing batch server sits in the server room, running RSBizWare Batch software. Both the batch and supervisory servers are part of the Ethernet network, which is connected to the manufacturing module by the Ethernet link. The batch server and RSView are linked on Ethernet by a manufacturing database server and a logging server, with all four linked to the pharmaceutical company''s regional enterprise communications network.
Together, these six servers share information to ensure recording of electronic validations and batch events. Compliance with the FDA''s 21 CFR Part 11 standard, which specifies how companies in FDA-governed industries handle electronic records and electronic signatures, is also mandatory for all companies exporting pharmaceutical products to the U.S.
"Whenever an operator does something, the system has to record who carried out the action and from which terminal," says Reid. "The addition of ingredients also has to be verified by one or two people; the system is capable of using multiple electronic signatures and bar code identification. We built interfaces into Batch and RSView, so that at various stages of the process it will prompt for an electronic signature before anything can proceed."
The automation solution has been chosen for other manufacturing modules at the plant. "We''ve taken control of the plant through RSBatch and RSView," says the project engineer. "We alleviated the risk to the plant, and the project was validated on that alone. But there are also massive benefits in control and monitoring, and the validated electronic control means that we can know when, how, and why something has happened," the engineer observes. (For more, click here.)
Following the Rules on Components
Stringent standards imposed by the FDA and others also cover medical parts manufacturers, dictating the need for turnkey processes capable of producing highly intricate components to a finished state. Omni Components specializes in multi-axis precision machining including M/A Swiss, M/A lathe, vertical milling, waterjet cutting, and turnkey assembly. Today, manufacturing of medical-related components accounts for more than 20% of Omni''s overall business.
The company turned to Flow International for help in this sector. Using the Bengal waterjet cutting machine, Omni can produce finished flat components or cut stock metals to near-net shapes. One example is a ¼ in. thick titanium plate used in producing a medical application frame component with long slots and thin walls. This technology enables difficult shapes to be produced at the pre-machine blank stage with minimal distortion, without heat-affected zones and with maximum utilization of raw material.
"Our medical industry clients require turnkey solutions that can take components and assemblies to higher levels of completion with less labor cost," says Omni president Rick Holka. "The waterjet provides us the ability to produce intricate finished components out of a variety of materials." (For more, click here.)
Verifying the Inspections
Blen-Cal Electronics Industries Inc develops and manufactures inspection devices for the packaging and pharmaceutical industries, including glue line inspection, label placement, label alignment, bar code inspection, and label glue inspection. U.S. standards for quality control require manufacturers to review all products prepared for shipment. Blen-Cal chose Schneider Electric PLC and HMI solutions to help meet those standards.
In conformance with FDA labeling mandates, the systems must verify all types of 1d and 2d codes including the RSS and composite symbologies, as well as be able to read up to three different codes per package; maintain an inventory of good, bad, and no reads; and mark or eject the offending package and stop the production line when necessary. The system also requires Teach and Test modes. These devices are installed on existing production lines, and must be mountable and made operational with minimal downtime.
G.C.F. Inc designed and provided the hardware and the software program required for the system, which uses Schneider Electric''s Compact Twido PLC and a Schneider/Telemecanique Magelis touchscreen HMI. Each scanner is assigned its own Twido PLC to allow for the flexibility needed for the application. The second communication port option is used to communicate with a single Magelis HMI using Modbus RS485, minimizing cost when using multiple scanners. (For more, click here.)