Knowing how and when
IT support for tracking batches of bulk goods

Batch traceability remains a hot topic in pharmaceutical systems engineering. It is impossible to imagine production in today’s world without knowing who produced which batch as well as when and how it was made. An established pharmaceutical systems supplier has taken this trend on board and made substantial investment in its process control engineering department.

A series of events some time ago in the food, feed and pharmaceutical manufacturing sectors increased the focus on the subject of batch traceability, forcing legislators to act. In 2002, European Directive EU 178 was issued. To give companies time to react, a transition period lasting until January 1st, 2005 was granted. The deadline is rapidly approaching, and all companies affected must act. Traceability applies to all stages of production and extends to commerce and consumption.
EU 178/2002 requires that all entities provide transparency into their production chain, from product manufacturing right through to packaging. Although EU 178/2002 was created with the food and feed industries in mind, similar requirements have applied to the pharmaceutical industry for a long time in the form of FDA and GMP regulations. This example shows very clearly how batches need to be traced within the production process and what level of traceability is required.
The purpose of the regulations and directives is to protect consumers, ensure traceability and reduce the level of risk for producers. In case a recall becomes necessary, compliance makes it easier to limit the damage, and it is easier to zero in on the products that are affected. Quality control must extend to all processes in the supply chain. A recall system must be in place which covers all events and test/inspection results, from initial receipt of raw materials and production right through to shipping.
The only reasonable way to capture this data is to use an IT-based information
stream from the ERP system and associated subsystems. Batch traceability does not end in production. A warehouse management system provides information about incoming and outgoing shipments and storage locations. Transport management software and telematics mounted on vehicles monitor transportation of the goods. Batch tracking and traceability have a very significant influence on process engineering and process IT. The need to maintain traceability affects deliveries of raw materials in high volume pharmaceutical production. If silos are used, it makes sense to use a dual configuration.
There are two silos for each type of product, so that batches of carriers can be clearly separated. One batch is used up completely and then refilled to avoid overlap between batches. Otherwise, there is no way to ensure traceability. When deliveries are made in tank trucks, a special sampling device is integrated into the material transfer line. Samples are taken at regular intervals from each delivery. A sampling profile is available at the end of the unloading operation, and the material is not released to the process until the sample has been checked.

Conversion of the delivery containers
To maintain strict separation of purity classes in the pharmaceutical industry, the delivery receptacles (mostly sacks or big bags) are converted to internal containers. During this operation, it is useful to integrate screening systems into the conversion process to ensure that no contamination reaches production. It is particularly important that the exact weight of the converted raw materials is recorded, and a unique marking must be applied to the materials. Barcode labels and readable transponder systems are the solution of choice in this application. When this has been accomplished, the components are ready for the next step in the batch composition process. They have a unique identifier which ensures that batches cannot get mixed up. Transponder systems provide a good way of marking moveable containers so that they can be clearly identified at any time.
Information andidentification systems
The rapid rate at which new information technology and applications are being introduced continues to extend the coverage of machine-based information processing systems. In recent years, widespread use has been made of automatic identification systems in many service industries and in material acquisition, logistics, commerce, manufacturing and material flow applications.
Barcode systems
The most common barcode systems encode numeric or alphanumeric information in stripes using a visual pattern. The reflection variations generated by the stripes during laser scanning, for example, create a sequence of pulses in the optical receiver. Electronic circuits then interpret the flow of pulses as data. Over the years a number of barcode standards have been developed to meet a wide range of different requirements. Two-dimensional barcode have been designed in an attempt to place more information in a small space. Several one-dimensional barcodes are placed on top of each other or a dot matrix is used. The added information content makes it possible to transfer more data or enhance data integrity. By far the most common barcode is probably the EAN code (European Article Number) which was developed in 1976 specifically to meet the needs of the food retailing industry.
Optical character recognition
The abbreviation OCR stands for optical character recognition. So-called clear text readers are able to automatically recognize certain numbers or alphanumeric characters. Special character sets have been developed which both humans and automated machines can easily read. These character sets are important when there is a need for fast, reliable recognition. High cost and complicated readers compared to other ID methods have hampered widespread use of these systems.
RFID systems
Since data are stored on electronic media, RFID are closely related to smart card systems. Transponders, which are also called tag, code or data media, are mounted on the objects to be identified. No direct electrical contact is needed to supply power to the transponder or exchange data between the transponder and the reader. Instead, a non-contact system of magnetic or electrical fields is used to perform these functions. RFID systems have a number of advantages compared to
other identification systems, and they are expected to dominate new mass markets.
Composing batches without contamination
Containment systems are being used to an increasing extent in the pharmaceutical industry. Some of the goals are to increase batch size and reduce the amount of effort required for control and analysis, driving down costs. On these systems, filled linear container units of the type described above are placed onto Azo componenter systems. The systems are often mounted over a mobile floor-level scale carrying a batchtainer or an AGV which is controlled to suit the particular recipe. Signals are exchanged with no direct contact, ensuring correct batch composition. The system is primarily used to automatically prepare carriers in the pharmaceutical industry. The active ingredients are weighed with high precision at operator-controlled weighing stations (ManDos) fitted with barcode monitoring equipment, and they are then added to the batch, which was weighed automatically. It is very important to ensure that no ingredients can be excluded from the chain of identification and safeguards. For a system of this type, the design and functional specifications are generated as a collaborative effort during the planning stage. Testing is performed on the system hardware and the control software in the IQ phase (installation qualification) and the OQ phase (operational qualification) to ensure compliance with the specifications. The available documentation enables the operator to easily validate the pharmaceutical production process. The Kastor full-coverage process control and validation system gives pharmaceutical producers the assurance that they are able to meet the essential batch traceability and documentation requirements.