Following the flow

Willi Weidmann and Dieter Herzig, of AZO, discuss batch traceability and reporting, and the challenges facing bulk materials handling

Several incidents in the food, pet-food and pharmaceutical industries in recent years have brought the subject of goods flow reporting into the spotlight.In 2002 legislators decided to take action with European regulation EU 178, which states that companies have to keep a full audit trail of production.

EU 178/2002 was devised with the food-processing and pet-food sectors in mind following the BSE crisis, but it has actually applied to the pharmaceutical industry for some time.

To make it possible for businesses to take up this challenge with the correct equipment and systems, a transitional period was granted until January 1, 2005. With this date fast approaching, however, all affected companies within all affected industries must now be prepared. Approved production processes, from manufacture to distribution, must be in place with batch validation procedures and records for all stages of production, right up to trade and consumption.

consumer protection

Regulations from bodies such as the FDA and GMP already exist. These have already gone some way to making batch reporting and tracking general practice within manufacture. Such rules and regulations are about consumer protection and proof of origin, as well as about minimising the risk for the producers. Damage can be limited, for example, in the case of recall campaigns and the corresponding products restricted in a better way with better audit procedures.

The issue is quality control of all processes within a supply range. This means from the supply of raw materials, through production and up to delivery, all sequences and results have to be recallable for controls. An economical and faultless reporting system is possible only with an IT-supported information tool from ERP software (Enterprise Resource Planning) and connected sub-systems.

Batch traceability does not end with production. A warehouse management system reports on storage levels and stock control. Ideally, the transport of materials will be controlled by transport management software with a 'telematic' kit on board each vehicle. Batch reporting and tracking does significantly influence process technology and process-IT functions. These subjects are now considered in line with bulk materials handling:

Process technology is particularly relevant to raw material supply for high throughput in the pharmaceutical industry. When silos are needed it is appropriate to have a double-design, i.e. use two silos for each product type. This allows clear separation of the supplied substances for batches.

One batch can be completely processed and only then refilled in order to prevent contamination, otherwise authentic tracking will not be guaranteed. For supply through silo vehicles, the filling lines can be equipped with special sampling units that withdraw cycle samples of each supply quantity automatically. At the end there is a cross section of samples that will be released for the following process only after checking.

Due to the rigorous separation in classes of purity within the pharmaceutical industry, the supplied packaging, mostly bags and Big Bags, is often transferred into internal bins or containers. Here, it is necessary to integrate screening systems to guarantee no contamination gets into production.

Even more important is that the reconfigured raw materials are precisely weighed and registered by floor scale and clearly marked with barcode labels, readable by transponder systems. The components are then ready for the batch preparation process, clearly marked for identification and any room for error is removed. It is important to equip moveable bins, such as containers, with transponder systems so that identification can happen at any time.

The rapid development of new information technology and its operational use has led to a growing need for supportable process-IT systems. In several industries, purchase and distribution logistics, tracking, production, material flow and automatic identification systems have become popular.

Conventional barcode systems consist of a number of dark stripes and bright breaks, which encode numerical or alpha numerical information according to a defined scheme. Barcodes are normally read by optical laser scanning. The different reflections of dark stripes and bright breaks result in an impulse sequence for the optical receiver, which corresponds to the sequence of stripes and breaks. An electronic evaluation interprets these impulses as data.

During production, several barcode strands are raised in order to fulfil the requirements for application. Two-dimensional bar-codes have also been developed in order to provide more information within a smaller space. Several one-dimensional bar-codes can be placed above each other or a matrix image can be defined.

The higher the content of data transferred the better. The widely circulated bar-code will be the EAN-Code (European Article Number) which was developed for food trade industries in 1976.

OCR is when optical character readers are able to recognise certain numbers or alphanumerical signs automatically. Therefore, special fonts that can be recognised by the human eye are now easily recognised by machines too. These fonts are important if a fast and safe recognition is required. However, the extensive distribution of these systems is slowed down by by their high cost factor and by reading units, which are complicated in comparison with other ID-methods.

Since data is also recordable on an electronic data medium, Radio Frequency Identification (RFID) systems are closely linked with chip card systems.

The objects to be identified will be named by installed transponders as tag, code- or data medium.The power supply of the transponder as well as the data exchange between transponder and reading unit is not done by galvanic contacts but by means of magnetic or electromagnetic fields, contact-free.

RFID systems are currently winning new mass markets due to their numerous advantages when compared with other identification systems.

Containment systems, particularly in the pharmaceutical industry, are becoming more and more common due to their success in increasing batch size, reducing efforts for control and analysis, together with cost savings. For instance, containers on the Azo Componenter-system are arranged in linear order and in most cases a linear moveable bottom scale with Batchtainer or an AGV (automated guided vehicle) pass below the dosing points. According to the given formula, signals are exchanged without direct contact and ensure safe batch preparation. The system described is used mainly for the automated provision of ingredients in the pharmaceutical industry.

Active ingredients are weighed precisely at barcode controlled operator guided weighing places (ManDos) and added to the automatically weighed batch. It is important that no components are excluded from the identification and protection sequence.

Design and function specifications for feeding systems are decided during the pre-production planning phase and are ensured by constant checks of the system hardware and control software during the IQ-phase (installation qualification) as well as during the OQ-phase (operation qualification).

close cooperation

Consequently the available documentation makes it possible for pharmaceutical production processes to validate their products for the customer. The process-leading and visualisation system 'Kastor' (for real-time robot navigation) guarantees the security of a batch, essential for pharmaceutical production in terms of reporting and documentation.

The partnership of Azo with hsh-Systeme to form a new company hsh-Systeme fuer Prozess-IT GmbH, means the company has found a competent partner with long-term experience in the pharmaceutical and food sector.

Azo is now in a position to implement all functions that are relevant for the customer in close cooperation and arrangement with process technology. This in turn offers maximum production safety and benefit to the customer in terms of progressive pharmaceutical production.