Pharma Industry  |  

RFID – Beyond compliance

Radio frequency identification (RFID) has befitted quite a few industries and is successfully making headway in the pharmaceutical sector.

Many sectors today are making unprecedented use of the RFID, one of the most anticipated technologies in recent years, to track, secure and manage items right from the raw material stage till the procurement of the product. Manufacturers especially benefit from RFID because the technology can make internal processes more efficient and improve supply chain responsiveness. Since this technology offers numerous benefits proper implementation becomes essential as the stakes for RFID implementations are high – for both expenditures and benefits. According to a study by AMR Research, early RFID adopters in the consumer goods industry reduced supply chain costs between three and five per cent and increased their revenue by two to seven per cent because of the added visibility RFID provided. Today’s world of pharmaceutical industry is determined by standards, guidelines and laws. In order to meet these regulations, a high quality control standard of the products must be maintained during the production process. The automation technology helps secure processes and ensures quality. Continuously producing a specification and quality assured product requires strict monitoring and identification within plants, of processes as well as of agents and additives. This inevitably causes a rethinking process in the field of recording and identification technology. An alternative solution is saving the data in a memory chip, which can be transmitted wirelessly from a read device. Wireless transmission of data and energy to the electronic data carriers is referred to as RFID. The technology RFID systems are used to wirelessly exchange information between a tagged object and a reader/writer. However the reader/writer is normally interfaced with an automation platform (a PLC or a PC). This makes it possible for the tag to indirectly become the part of a totally integrated automation setup. An RFID system is comprised of the following components- ? Tags (also called transponders) includes a semiconductor chip (These are RFID memories and normally specified w.r.t the memory size. The size does matter, as the data volume to be stored in the tag will depend upon the process/application. The tag also always has an integrated antenna as an information receiver/sender ? Read/write devices (also called interrogators, or simply, readers) - These devices convert the data electrically sent to it from an automation solution into RF and transmit it to the tag. The data received from this tag through RF is converted into electrical and sent back to the automation solution. ? The RF transmit and receive job is done by an antenna which may be an integral part of the read/write device or can be remote (physically displaced), connected to the read/write device through cable. There are two types of tags namely active and passive; most of the tags get the energy from the read/write device through another RF frequency channel (Passive Tags) while some tags (primarily used in locating applications) have battery within for the energy requirement (Active tags). RFID tags can be attached to virtually anything – from a semi tractor, to a pallet, a case, to an item on a store shelf. If multiple tags are present in the field, more efficient RFID implementations have anti-collision algorithms, which determine the order of response so that each tag is read once and only once. For read/write tags, the read range is typically greater than the write range. Active tags are capable of much longer ranges than passive tags. For example, 433MHz active tags can transmit data of about 300 feet but passive tags at the same frequency are typically readable from up to 25 feet. Application example During the manufacturing process in a typical pharmaceutical plant, intermediate and finished products are repeatedly filled into mobile containers and intermediately stored. One aspect of process control is the monitoring of these mobile containers, since a mix-up between these containers may have fatal consequences during refilling as well as during the application of substances. The main focus of this application is directed at monitoring mobile containers which are included within a process control system by means of an RFID system. The RFID technology can withstand the high stress-impacts on the containers during the production process. Apart from high stress resistance, the RFID technology also provides further clear advantages as compared with other identification technologies. Typical automation solution The existing labelling (e.g.: signs, barcode, etc) of the containers are replaced by RFID transponders (which contain the memory chip). In a CIP (cleaning in place) plant the mobile containers are subjected to a cleaning process and process-relevant data such as date, time and cleaning status and are subsequently written to the RFID transponder which is impossible to implement in conventional identification techniques! In a production process, the RFID transponders are read out. It is checked for example, whether the correct container exists or the basic cleaning has been performed properly and does not date too far back. Requirements ? Quality control 1. Quality control ensures meeting organisational and technical requirements in all phases of the production. 2. The production processes would be optimized. The processes too will run safely and the communication between the individual plants would be ensured. 3. Optimisation by means of RFID technology enables higher efficiency, safety and simplification of complex processes. The pharmaceutical industry will benefit from the advantages provided by the RFID technology by increased quality and improved meeting of regulations. ? RFID system In a pharmaceutical process containers are partially subject to extreme conditions. In order to guarantee, that the process runs without problem, the following requirements to transponder and read device must be fulfilled: Heat resistance During the cleaning process, the container temperature rises to approx. +130 °C and this temperature is maintained for 30 minutes. During the sanitisation the container may shortly even be heated up to +200 °C. Since the transponder is not directly subjected to these temperatures, it must be heat resistant up to maximum 80°C. Cold resistance Since the container must be partly intermediately stored in cold storages, the transponder must withstand ambient temperatures of -25 °C. Reading from and writing to the transponder at these temperatures must be ensured. Installation on metal One of the most important requirements is the installation on stainless steel casings, i.e. the application directly on the container. Since the large metal surface partly absorbs the radio waves and hence influences the functionality, a transponder must be selected which can be mounted onto the container without loosing any of its functionalities. Data security The data of the transponder must be protected from unauthorised access and from manipulation. Acid and alkaline resistance Since corroding chemicals for killing bacteria and microorganisms are used in the cleaning processes, the transponders must also have a certain resistance against acids and alkalines. The concentration of the chemicals depends on the process. Saving application data Another important part shall be the saving of process-relevant data. The safety of the process is ensured by requesting data. The transponder shall contain the following data: Container name / number, batch number, cleaning status, time stamp and product. Protection type (IP) The protection against entering dust, press water over an unlimited period of time and the complete protection against touch shall be ensured. The transponder shall hereby have a protection class up to IP 68. Since the read device is not directly subjected to unfavorable conditions, a protection type of up to IP 65 is sufficient. EMV (industrial standard) The limit values demanded in the guidelines must be met. This includes resistance against internal electrical interference, against external electromagnetic interference, and the electromagnetic radiation and electromagnetic impact from the electronic environment. Regulatory Compliance Companies that transport or process hazardous materials, food, pharmaceuticals and other regulated materials could record the time they received and transferred the material on an RFID tag that travels with the material. Updating the tag with real-time handling data creates a chain-of-custody record that could be used to satisfy FDA, DOT, OSHA and other regulatory reporting requirements. RFID tags are also an effective way to satisfy the tire traceability requirements of the TREAD Act. Thus, as seen RFID can provide immediate and tangible benefits throughout the production cycle up to the supply chain. Organisations who take the time to understand the technology’s capabilities and limitations can increase their inventory visibility while streamlining their operations. By understanding the technology well, one can ensure that the decisions made minimise any errors and maximise profits.

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