Review on: THE PHARMACEUTICAL PACKAGING
14)Standard and speciality packaging solution for the pharmaceutical industry:
Attractive, wallet based speciality packaging solution are developed by Rondo along with the sister company Dividella. These solutions are used for child resistant package (CRP) and also ensure safe shipment.
Advantages of these are:
- The contents of the package are clearly visible
- The products are easily accessible
- Product leaflet lie on top of the products.
- All package component can be replaced easily in the package.
- Additional information can be printed on the other side of the cover.
14.1-Traceable Solutions for Medical Packaging:
The demand for safety and integrity in the area of medical packaging has taken on new and significant implications in the past two or three years. Child safety, correct dosage, patient traceability, tampering and diversion of pharmaceuticals are always an area of concern, medical packaging. Now, major additional concerns of drug counterfeiting and concerns around terrorism bring a new sense of urgency to medical packaging manufacturers and hospitals, clinics, assisted living facilities, doctors' offices and, the individual consumer.
Proponents of unit dose packaging like the Healthcare Compliance Packaging Council (HCPC), the National Quality Forum (NQF) and others recognize that packaging plays a major role in safeguarding healthcare. And of course, various government agencies, most notably the Federal Food and Drug Administration (FDA) have very stringent packaging regulations and enforcement. The pharmaceutical industry in particular will be one of the drivers of new packaging identification technology like RFID, expected to be a viable means of medical packaging traceability. And though RFID is an evolving technology it will be some number of years before it is an individual solution at the unit dose level, as it is currently being used at the pallet and case levels due to costs and still to be solved technology issues. Bar coding and RFID technologies co-exist for several years.
There are considerable steps yet to be taken to ensure packaging traceability. At this point, for example, only some manufacturers have affixed unit-of-use barcodes to hospital injectable drugs and / or intra venous solutions. Tracing pharmaceuticals from their origin at a chemical plant to the patient bedside is the ideal, and may be eventually attainable when RFID is completely embedded throughout the medical packaging world. While safety and compliance are critical issues, the drive to keep costs under control and manufacture and package product in the most efficient manner is an additional dimension that manufacturers, as well as pharmaceutical distributors, pharmacies and others must constantly address. Convenience at the point of usage also drives certain packaging requirements, particularly in a hospital, clinical or assisted living environment.
Traceable packaging can address many safety as well as business concerns. In an ideal packaging environment, with full traceability from process to patient (or consumer) these concerns can be addressed:
• Fraudulent Products - Drug counterfeiting is a problem that must be addressed. Internet drug sales contribute to this issue. The World Health Organization estimates that fraudulent drugs generate $32 billion dollars in annual earnings for drug counterfeiters.
• Expired Products- Medicines sold as fresh after their expiration dates is a problem easily addressed if traceable packaging is implemented.
• Diverted Products - Again, a system of traceable packaging can keep track of pharmaceutical product locations in the complex distribution system(26).
If we look at a few concerns within clinical, hospital or assisted living settings there are several issues addressed through traceability. For example:
• The wrong medicine to the wrong patient - In an assisted living facility it is estimated that approximately 44 percent of the patients require seven or more medications per day. With the level of medications dispensed in hospitals and clinics on a daily basis, making sure the correct medicine goes to the correct patient every time is a critical issue.
• Incorrect Dose - The issues are obvious here and traceability, where the dosage is one of the identified properties, is a solution.
• Drug Incompatibility - Being aware of other medications taken by patients, or conditions like food requirements are concerns that can be addressed to some extent by traceable packaging.
These are just a few of the areas where packaging traceability can add value from a business perspective:
• Supply Chain Management - The ability to track inventories, ensure proper supplies, and improve inventory management are all benefits, particularly as RFID packaging becomes available at the individual bag level.
• Inventory Control - A key part of supply chain management, tracking inventory throughout the cycle, will result in definite cost saving realizations.
• Drug Recalls - The ability to better manage drug recalls is a benefit not only to the manufacturer but to the government as well. Traceability will ease this complex process.
While we have pointed out a few of the concerns and the accompanying benefits that traceable packaging can provide to the medical packaging industry and the consumer, there are many steps yet to be taken.26
14.2-Rondo - fluted trays:
For all low fragile product needs, whether they are made from glass, metal, plastic or wood, anything that needs special packaging considerations and still should be clearly visible, with the help of rondo fluted trays. The contents can be easily removed and put back after every use.
Together with consumer friendly carton boxes "Rondo -fluted trays" offers many advantages:
- Products are clearly visible
- Products are easily removable
- Additional information can be printed on the inside cover of the package
The paperboard packaging solutions developed are all erected, filled automatically on the packaging line from die cut flat blanks. Later they are provided with a tamper evident seal. NeoTop 904 is used for ampoules, vials, pre-filled syringes or small tubes. NeoTop 304 is used for:
Ampoules 1 vials I to 100 ml
o Cartridges / syringes - bottles up to 52 mm diameter
o Inhalers, nasal sprays, pens and other applications
Reverse Side Printing:
Marketing experts around the world have come to realize that the inside of the package can be successfully utilized to bring more information to their customers. Depending on the branch, there are different goals that can be achieved. For example: the pharmaceutical industry can put a product description or a pictogram, the cosmetic industry has a place to enhance the product attractiveness.
15)Coding in pharmaceutical packaging:
Coding and marketing have many functions in pharmaceutical packaging. They provide expiry dates for perisable products, lot and date codes to aid in tracing and recalls, bar codes, sales messages and other important information .A barcode (also bar code) is a machine readable representation of information in a visual format on a surface. Originally barcodes stored data in the widths and spacings of printed parallel lines, but today they also come in patterns of dots, concentric circles, and hidden in images. Barcodes can be read by optical scanners called barcode readers or scanned from an image by special software. Barcodes are widely used to implement Auto ID Data Capture (AIDC) systems that improve the speed and accuracy of computer data entry. While traditionally barcode encoding schemes represented only numbers, newer symbologies add new characters such as the uppercase alphabets.
15.1-Technology of barcodes:
A linear barcode is a binary code (1s and 0s). The lines and spaces are of varying thickness and printed in different combinations. To be scanned, there must be accurate printing and adequate contrast between the bars and spaces. Scanners employ various technologies to "read" codes. The two most common forms are lasers and cameras. Scanners maybe fixed position, like most supermarket checkout scanners, or hand-held devices, often used for the taking of inventories. There should be (but typically is not) a distinction drawn between the code, which is a structure for the conveyance of data, and the symbol, the machine-readable representation of the code: The code is text, which can be translated into a multiplicity of languages - English; French, Japanese, symbol.26
The mapping between messages and barcodes is called a symbology. The specification of a symbology includes the encoding of the single digits/characters of the message as well as the start and stop markers into bars and space, the size of the quiet zone required to be before and after the barcode as well as the computation of a checksum.
- Continuous vs. discrete: Characters in continuous symbologies abut, with one character ending with a space and the next beginning with a bar, or vice versa. Characters in discrete symbologies begin and end with bars; the intercharacter space is ignored, as long as it is not wide enough to look like the code ends.
- Two-width vs. many-width:Bars and spaces in two-width symbologies are wide or narrow, how wide a wide bar exactly has no significance as long as the symbology requirements for wide bars are adhered to (usually two to three times more wide than a narrow bar). Bars and spaces in many-width symbologies are all multiples of a basic width called the module.
15.3-Scanners (barcode readers) :
The earliest, and still the cheapest, barcode scanners are built from a fixed light and a single photosensor that is manually "scrubbed" across the barcode. A later design, the "laser scanner," uses a polygonal mirror or galvanometer-mounted mirror to scan a laser across the barcode -initially only in a straight line, but eventually in complicated patterns so the reader could read barcodes at any angle. In the 1990s some bade reader manufacturers began working with digital cameras to capture barcodes, both linear and 2D. That technology has since been perfected and now often surpasses laser scanners in performance and reliability. More recently, off-the-shelf digital cameras now have enough resolution to capture both 1D and 2D barcodes. Increasingly companies are looking to incorporate barcode scanning software into camera phones.
Historically, pharmaceutical packaging requirements focused exclusively on preserving the quality of the enclosed medication and increasing the products shelf lives. These requirements are now being extended to cover such criteria as the prevention of product tampering and counterfeiting, the assurance of product dispensing accuracy, child protection and the promotion of patient compliance with product dosage schedules. Pharmaceutical noncompliance is a tremendous problem in the US, resulting in an estimated $100 billion expense every year while being blamed for the deaths of over 1,25,000 Americans annually (342 people every day). Ten percent of all hospital admissions are the result of pharmaceutical noncompliance and 23% of all nursing home admissions are as a result of people's inability to take their medications as prescribed. In February 2004, FDA published the final version of 21 CFR Parts 201, 606 and 610 to reduce the number of medication errors in hospitals and healthcare settings. The rule specifies that the packaging of all human drugs be labelled with a linear bar code containing the National Drug Code (NDC) number that serves as a universal product identifier. This 10 digit code identifies the labeler/vendor, product, trade package size, the specific strength, the dosage and the formula for a specific firm.
According to the Healthcare Compliance Packaging Council (HCPC), the National Quality Forum (NQF) and FDA, the implementation of unit dose blister and strip packaging places a further restraint on the intentional or accidental misuse of pharmaceuticals. Furthermore, the European Union (EU) specifies that all prescription drugs dispensed directly to patients be in a unit dose packaging. FDA describes unit dose packaging as the only packaging format that can accommodate bar codes on packaging labels for each dosage of medication dispensed to patients. Coding and marking technologies for the primary packaging of pharmaceuticals must constantly evolve to meet the emerging industry trends and associated regulations. Bar coding methods have been traditionally chosen according to three main criteria:
15.4-Thermal transfer and inkjet printers:
Thermal transfer and inkjet printers are more appropriate for production line bar code printing. Specifically, thermal transfer printers produce high quality, legible and clear bar codes, as well as other types of codes. Because ink is not involved, there is never any quality degradation during the process. Moreover, such printers are virtually maintenance free while they can also be connected to a software network for record keeping purposes, which helps with validation. The main drawback of this technology is that although it can be set up quickly, it lacks printing speed.
Inkjet printers are the fastest and least expensive units available on the market. Unfortunately, there are considerable limitations to what they can print. In addition, they require frequent maintenance and can be quite messy. Another major downfall is that the print fades after successive use. Water-based inkjet fluids tend to streak and blur, while non water, soluble inkjet fluids produce a shine that reflects to the scanner and affects how the bar code is read.27
15.4.2-Dot -Matrix printers:
Dot -Matrix printers produce low-quality codes with low contrast, although this depends on the ribbon used.
Laser printers are off-line devices requiring a separate label applicator. They are subjected to toner flaking, meaning that they are unreliable for long-term bar code printing.
15.4.4-Laser marking by ablation:
Laser marking by ablation is more recent method uses a high powered beam to ablate the bar code onto the label by burning away a black ink patch to form the white spaces by exposing the underlying substrate material. However, this method results in high emission levels and can also create problems for bar code resolution levels.
15.5-Radio frequency identification (RFID):
Radio frequency identification (RFID) is one of the biggest trends to hit packaging in years. Radio Frequency Identification (RFID) is a powerful technology that promises to streamline supply chains and transform the retail ecosystem.It promises a slew of benefits to manufacturers and retailers alike, including unprecedented control over the supply chain and enhanced product security. The FDA has stepped up its efforts to improve the safety and security of the nation's drug supply by encouraging use of a state-of-the-art technology that tags product packaging electronically. The technology, called radiofrequency identification, or RFID, allows manufacturers and distributors to more precisely track drug products through the supply chain. RFID makes it easier to ensure that drugs are authentic, and it also creates an electronic pedigree-a record of the chain of custody from the point of manufacture to the point of dispensing. Electronic pedigrees will improve patient safety and protect the public health by allowing wholesalers and retailers to rapidly identify, quarantine, and report suspected counterfeit drugs and conduct efficient, targeted recalls. An RFID tag may be a little sticker that can be attached to an object. The tag contains an antenna that enables it to receive and respond to a radiofrequency query from an RFID device called a transceiver. Most RFID tags in use today do not have their own power supply. The radiofrequency query induces a tiny electrical current in the antenna, permitting the tag to send a brief response, usually just an ID number. Such RFID tags are quite small. The smallest tags are now commercially available measure 0.4 ´0.4mm and are thinner than a sheet of paper. They start at about $0.40(40 cents)a tag.
By outfitting drug packages with RFID tags, drug companies, distributors, and pharmacists can trace the path the drugs take from the time they are produced to the moment they are dispensed RFID involves the use of electronic tags with computer chips that can store data. The tags, affixed to pallets, shipping cases or individual packages, transmit their data to reading systems, enabling shipments to be recorded and tracked throughout the supply chain. Some forms of tags are battery-powered, but "passive" or "backscatter" tags are more common; these derive their power from the reader's signal.
Auto Labe's Model 110SR RFID label applicator uses the latest radio frequency identification (RFID) reader technology for encoding EPC data directly to an RFID label prior to application. This is an apply-only solution for customers who do not require online printing of RFID labels. The 110SR drive system uses the latest technology to provide consistent and accurate label placement. In November 2004, the FDA published a compliance policy guide for industry on implementing RFID studies and pilot programs. Acting FDA Commissioner Dr. Lester M. Crawford says the agency's actions were designed with one main goal: "to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy".
Purdue Pharma (Stamford, CT), the maker of OxyContin and Palladone, among other prescription and non-prescription drugs, last November was one of the first to launch a pilot program to integrate RFID tags at the item-level for two of its largest customers: Wal-Mart and drug wholesaler H.D. Smith. The pilot, which places RFID tags on the labels for 100-tablet bottles of OxyContin, is just the start of Purdue Pharma's major RFID initiative and multi-layered security approach. The drug manufacturer is also pursuing other overt and covert measures to safeguard its products. The goal: To transform the way Purdue Pharma packages and ships medications in order to deter counterfeiting and diversion, and to track the authenticity and safety of its products throughout the entire pharmaceutical supply chain.
The U.S. Food and Drug Administration (FDA) is also concerned about the counterfeiting trend; it released a report last year to promote and assist companies looking to adopt RFID throughout the drug-distribution system. While the FDA maintained drug counterfeiting isn't yet a widespread problem, it acknowledged that the number of FDA investigations surrounding counterfeit cases is on the rise. The FDA now looks into more than 20 cases a year since the year 2000, up from around five annually in the 1990s. The report, which do not specify any deadlines for RFID's use. The RFID technology showed the most promise as a means for tracking and tracing a drug's "pedigree" – a record of the drug as it moves through the supply chain showing it was manufactured and distributed under safe and secure conditions. As a result, a drug purchaser could immediately determine critical factors such as a drug's authenticity, where it was intended for sale and whether it was previously dispensed. The FDA sketched out a timeline for RFID implementations, predicting that a variety of companies would conduct feasibility studies in 2004 and 2005, with more widespread adoption and deployment of RFID throughout the pharmaceutical supply chain by 2007. 28
The shift towards this technology has to a large extent being dictated by large buyers like WAL–Mart, Retail gaint WAL–Mart began the use of RFID tagging last year to replays barcodes. The technologies is the more advanced version of bar coding and is likely to result in greater cost savings in the long run by improving the efficiency of the supply chain .
The scope of the compliance guide is based on information the FDA obtained concerning RFID feasibility studies examining the use of this technology for various business purposes, including inventory control and tracking and tracing of drugs. To encourage these studies, the guide announces the FDA's intention to exercise enforcement discretion if certain studies trigger regulatory requirements.
· A manufacturer, repackager, relabeler, distributor, retailer, or others acting at their direction will attach RFID tags (chips and antennae) to only immediate containers, secondary packaging, shipping containers, and/or pallets of drugs that are being placed into commerce. There is no limit to the number of tags or readers that may be used in the study.
· RFID will be used only for inventory control, tracking and tracing of products, verification of shipment and receipt of such products, or finished productauthentication.
· RFID will not be used to fulfill existing FDA regulatory requirements (e.g., fulfillment of labeling or Current Good Manufacturing Practice requirements, provision of chemistry, manufacture, and control information, storage of information in fulfillment of a regulatory requirement, or performance of label and product reconciliation).
· Information, storage of information in fulfillment of a regulatory requirement, or performance of label and product reconciliation)29
· RFID will not be used in lieu of current labeling control systems to ensure correct labeling processes.
· The study will use "passive," "semi-active," or "active" tags.
· Information will be written to the tag at the time the tag is manufactured (e.g., "read only" tags), after the tag is manufactured but before it is affixed to a drug's container (e.g., "read-write tags"), or after the tag is affixed to a drug's container. The tags will contain a serial number (e.g., an electronic product code) that uniquely identifies the object to which the tag is attached, and may also contain other information such as storage and handling conditions, information from the FDA approved label and labeling, lot number, and product expiration date.
· The tags will not contain or transmit information for the healthcare practitioner.
· The tags will not contain or transmit information for the consumer.
· A seal containing a logo, an inventory control message unrelated to the product (e.g., a message informing the custodian that the package contains an RFID tag), and/or a unique serial number may be placed over the RFID tag or elsewhere on a drug's immediate container, secondary packaging, and/or shipping container.
· The addition of the RFID tag and seal will not block, obscure, or alter any of the product's existing and approved label and labeling information.
· The RFID tag will not substitute for, replace, or interfere with a linear bar code. Participants will "read" the tags as needed to identify the product and/or conduct the study.
· The tag readers will work by emitting electromagnetic energy at radio frequencies of 13.56 megahertz, 902-928 megahertz, or 2.4 gigahertz, and at powers in compliance with regulatory requirements of the Federal Communications Commission (i.e., 1-4 watts effective iso tropically radiated power).30
PHOTO 15.2: RFID LABEL APPLICATORS
Packaging should provide protection, identification, information, convenience and compliance for a product during storage, carriage, display and until such time the product is consumed. A thorough background about the product, the market, the distribution system and other facilities available have to be considered while selecting a packaging material. Pharmaceutical packaging should look into concerned issues like child safety, correct dosage, patient traceability, tampering and diversion of pharmaceutical products. Now, major additional concerns of drug counterfeiting and concerns around terrorism bring a new sense of urgency to medical packaging manufacturers and hospitals, clinics, assisted living facilities, doctors' offices and, the individual consumer. Considerable steps have to be taken to ensure packaging traceability. Some manufacturers have affixed the use of barcodes to pharmaceutical products. Tracing pharmaceuticals right from their origin at a chemical plant to the patient beside may be attainable when Radio Frequency Identification (RFID) is embedded throughout the pharmaceutical packaging and makes it easier to ensure that the product is authentic and thereby improves the efficiency of drug supply chain.
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