The basic requirement in pharmaceutical industry is safety and security and achieving the same is challenging task. RFID technology is pharmaceutical domain is a win-win situation. In this article we will learn about RFID, its working and principles. After getting to know about RFID, we will outline the application of RFID in pharmaceutical industry.
We are all familiar that technology is growing day by day and creating a positive impact on our lives. Being a bio-technologist it’s our duty on how to exploit the latest technology in the area of research in a positive way. Recent advances in biotechnology include new processing and control systems. Technologies applied in the processing must assure the quality and safety of the final product one such latest technology in the service is RFID.
SO WHAT ACTUALLY IS RFID AND ITS PRINCIPLES?
Radio frequency identification (RFID) is a state of the art technology that uses electromagnetic fields attached to a tag to identify objects. These tags are typically used for product tracking and product identification. RFID is a growing trend in the health care industry, driven by a greater emphasis on patient safety that has ever been seen before. RFID technology can help ensure that every patient is treated properly and that patients get the services they pay for.
Radio-frequency identification (RFID) is the wireless non-contact use of radio-frequency electromagnetic fields to transfer data, for the purposes of automatically identifying and tracking tags attached to objects. The tags contain electronically stored information. Some tags are powered by and read at short ranges (a few meters) via magnetic fields (electromagnetic induction). Others use a local power source such as a battery, or else no battery but collect energy from the interrogating EM field, and then act as a passive transponder to emit microwaves or UHF radio waves (i.e electromagnetic radiation at high frequencies). Battery powered tags may operate at hundreds of meters. RFID tags are used in many industries but let us focus on bio-pharma industry.
AFTER KNOWING ABOUT RFID IT IS ALSO IMPORTANT TO KNOW ABOUT ITS WORKING.
1. a scanning antenna
2. a transceiver with a decoder to interpret the data
3. a transponder- the RFID tag- that has been programmed with information.
The scanning antenna puts out radio-frequency signals in a relatively short range. The rf radiation does two things that are it provides a means of communicating with the transponder (the RFID tag) and it provides the RFID tag with the energy to communicate (in the case of passive RFID tags).
This is an absolutely key part of the technology, RFID tags do not need to contain batteries, and can therefore, remain usable for a very long period of time ( may be decades).
The scanning antennas can be permanently attached to a surface. suppose an RFID tag passes through the field of scanning antenna, it tracks the activation signal from the antenna. RFID are available in two types one is active RFID tags which have its own power source another type is passive RFID which do not require batteries. The basic advantage of active RFID tags over passive is, even though the reader is faraway still he will get the signal.
This technology recently has expanded, and it is implemented in biomedical field. It is excited to know that RFID- enabled insulin pump is wireless and patient- friendly.
Let us see how RFID is employed in insulin pumps.
RFID ENABLED INSULIN-PUMPS
Insulin pumps are small programmed devices that delivers insulin in two ways:
1. In a steady measured and continuous dose(the “basal” insulin)
2. As a surge (“bolus”) dose , at your direction, around meal time.
Doses are delivered through flexible plastic tube called a catheter. With the help of a small needle, the catheter is pierced through the skin into the fatty tissue and is taped in place. The insulin pump is not an artificial pancreas ( because you still have to monitor your blood glucose level), but pumps can help some people achieve better control, and many people prefer this continuous system of insulin delivery over injections. Pumps can be programmed to release small doses of insulin continuously (basal), or a bolus dose close to mealtime to control the rise of blood glucose after a meal. This delivery system most closely mimics the body’s normal release of insulin.
Now, a Boston-based technology firm claims that they have succeeded, as other pump makers have, their system is the only one of its kind to use radio frequency identification (RFID) to link its pump and glucose testing through wireless system. The two are wireless which are linked together using near-field communication (NFC).
NFC is an RFID -based wireless communications standard that allows the transmission of data at a frequency of 13.56 MHz between devices situated within 10 centimeters of each other. This technology combines the functions of a contact-less reader, a contact-less card and peer-to-peer functionality on a single chip. When using the prototype RFID device, a patient pricks his skin with a lancet or needle, places a drop of blood on a test strip and inserts the strip into a glucometer, a small portable machine used to check the glucose level of the blood. The glucometer records the blood-sugar reading, and if it indicates a higher-than-normal glucose concentration, the device will then recommend a bolus dose of insulin. (a bolus dose is an extra amount of insulin taken to cover an expected rise in blood glucose, often related to a meal or snack.) If the patient decides to accept the dose, he passes the glucometer—which contains an NFC-based chip and antenna—near the insulin pump (also embedded with an NFC-based chip and antenna). The recommended dosage data is wireless passed to the insulin pump, which delivers the drug via a subcutaneous catheter, as per the recommendation.
RFID IN PHARMACEUTICAL INDUSTRY
While the majority of critical manufacturing operations of inject-able pharmaceuticals e.g. most (bio-pharmaceuticals) occurs in specialized clean areas, proper design and maintenance of non-critical areas (e.g. storage, labeling and packing areas) is also vital to ensure overall product safety. Specifications are normally written by QC personnel. They detail the exact qualitative and quantitative requirements to which individual raw materials or product must conform.
For example, specifications for chemical raw materials will set strict criteria relating to the percentage active ingredients present, permitted levels of named contaminants, etc. Specifications for packing materials will, for example, lay down exact dimensions of product packaging cartons; specifications for product labels will detail label dimensions and exact details of the label text, etc. Specifications for all raw materials are sent to raw material suppliers and, upon their delivery, QC personnel will ensure that these raw materials meet their specifications before being released to production (the raw materials are held in ‘quarantine’ prior to their approval). Final product specifications will also be prepared. Manufacturing formulae should clearly indicate the product name, potency or strength, and exact batch size. It lists each of the starting raw materials required and the quantity in which each is required. Each product will also have its own labeling and packing instructions, indicating: the label to be used, and its exact text. Exact packing instructions (e.g. how many units of product per pack, how many packs per shipping carton, etc.)
A copy of the label to be used is generally attached to the documents, to allow the supervisor and operators to verify easily that the correct label has been dispensed for the product in question. Maintenance of adequate and accurate records forms an essential part of GMP. For any given batch of product, records relating to every aspect of manufacture of that batch will be retained. These records will include: specification results obtained on all raw materials; batch manufacturing, processing and packaging records; QC analysis results of bulk and finished product. These records, along with samples of the finished product, must be retained in the facility for at least 1 year after the expiry of that batch. Now suppose the label is misplaced or there are chances of malfunctioning or human error while labeling. Hence in order to avoid this RFID gives the solution.
ROLE OF RFID IN COUNTERFEIT MEDICATION?
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients or none, may be improperly processed within the body (e.g., absorption by the body), may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake packaging and labeling. Medicines which are deliberately mislabeled to deceive consumers—including mislabeled but otherwise genuine generic drugs—are counterfeit. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimize the impact of counterfeit drugs.
By using RFID technologies and by monitoring where and when products are manufactured, along with where they’re shipped to and providing the means to verify their authenticity, the chances of unregistered counterfeit items making their way into the supply chain are greatly reduced. Uhf RFID tags typically operate in the 840-960 MHz frequency band. Unlike the hf variety, UHF RFID functions well in either the Near or far field and offers read ranges from close contact to several meters. With far field coupling, there is an electric field coupling of energy between a reader and tag. And with the near-field component, there is a magnetic inductive coupling of energy between the reader and tag. The antennas are typically constructed with a simple dipole, loop, or patch antenna, and both near field and far field coupling are often combined in a single antenna.
The useful energy can be quite extensive and can thus achieve a relatively long RFID read range. Information about the source of a drug, its name, federal manufacturer registration number, business address, the quantity, dosage, form and strength, the transaction date(s), sales invoice number, container size, number of containers, expiration date, lot number, shipping information, and the name and address of the person(s) certifying delivery or receipt. Finally, if the prescription drug is returned to the manufacturer or wholesaler, that too will be documented.
NOW PHARMA COMPANIES ARE USING RFID, LET US SEE ONE CASE STUDY OF PURDUE
Purdue pharmaceuticals were among the first pharmaceutical companies to adopt RFID as a technology to combat counterfeiting. Through RFID the company wanted to serialize and track and trace its products. In the following year, Purdue produced the very first batch of RFID tagged oxycontin. Oxycontin was the major product of Purdue Pharmaceuticals. The usage of RFID has only increased with time. In 2007 Purdue crossed the 2 million mark in RFID tagged oxycontin. The problems faced by Purdue were mostly related to the number of tags and the durability of tags. The tags went through various packaging methods and had to be sustainable. Though Purdue was open to both bar coding and RFID, the latter technology proved to be the more effective one.
RFID has successfully combated counterfeiting to a large extent for Purdue. The pharmaceutical company next wants to use it on the item level to make the processing even more efficient. RFID sensors are also used to monitor the temperatures of refrigerators, blood coolers, blanket warmers, and other heating or cooling appliances. Temperature variations can damage various medications and drugs. It also reduces manual labor costs. While it would have been earlier the staff that would check the temperatures and manufacturing information of each and every device, the whole process is automated through RFID. pharmaceuticals can be tracked during its progress through warehouses.
Now we see how RFID technology acts smartly in various fields of Bio-Pharma. we have seen how the whole process is automated which reduces manual cost and makes process simpler. The major benefits of RFID technology in the pharma industry are greater speed and efficiency in stock rotation and better tracking of products throughout the chain, resulting in improved on-shelf availability at the retail level and enhanced forecasting.Also Hiding techniques could be used with RFID to offer efficient expiry date management, pharmaceutical tamper detection, and fraud detection and prevention.
POINT OF VIEW ON RFID TECHNOLOGY
We have already discussed the positive impact of RFID but we need to ask few questions related to this topic before RFID is implemented in our day-to-day lives. We have seen how RFID is implemented in insulin pumps but, do we really need to get attach to devices that lets people know that you have diabetes?
Its obviously an technology and not something magical that will solve all the diabetic persons problem.
The risk am seeing here is suppose a patient gets attach to a device, will it just monitor his blood-glucose level or will it also track other basic information. We are in a era where everything is tracked hence the major concern arises over here is persons privacy and safety.
Comment below your concerns related to this technology.