Monday, July 9, 2012
Tamper resistant packaging
Introduction: Packaging is a very important marketing strategy to glamorize product in order to attract the consumer’s attention. Sometimes packaging is so important that it cost more than the product itself in order to lure the consumers to buy it. Packaging should definitely be included in the 4 major P’s of marketing (product, place, promotion and price). Most consumers judge a product by its packaging before buying. So it is logical to say attractive packaging is crucial in order to get the first time buyers to buy products. Without attractive packaging, manufacturer’s first step to enter the market is crushed if the packaging is ugly. Having attractive packaging doesn’t mean manufacturers should neglect quality either. In fact, it is necessary to make high quality products in order to have repeated sales. Converting first time buyers into loyal customers should be the main goal of business and packaging is the door to it. What is packaging? Packaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports, informs, and sells. Package labeling is any written, electronic, or graphic communications on the packaging or on a separate but associated label. Package development considerations: Package design and development are integral part of the new product development process. Alternatively, development of a package can be a separate process, but must be linked closely with the product to be packaged. Package design starts with the identification of the following requirements: structural design marketing shelf life quality assurance logistics legal regulatory graphic design end-use environmental, etc. Packaging engineers need to verify that the completed package will keep the product safe for its intended shelf life with normal usage. Packaging processes, labeling, distribution, and sale need to be validated to comply with regulations and have the well being of the consumer in mind. Sometimes the objectives of package development seem contradictory. For example, regulations for an over-the-counter drug might require the package to be tamper-evident and child resistant. These intentionally make the package difficult to open. Tamper resistant packaging: Tamper resistance is resistance to tampering by either the normal users of a product, package, or system or others with physical access to it. There are many reasons for employing tamper resistance. Tamper resistance ranges from simple features like screws with special heads, more complex devices need special tools and knowledge. Tamper-resistant devices or features are common on packages to deter package or product tampering. In some applications, devices are only tamper-evident rather than tamper-resistant. Tamper-evident describes a device or process that makes unauthorized access to the protected object easily detected. Seals, markings or other techniques may be tamper indicating. Safety: Nearly all mains appliances and accessories can be opened with the use of a screwdriver (or a substitute item such as a nail file or kitchen knife). This prevents children and others who are careless or unaware of the dangers of opening the equipment from doing so and hurting themselves (from electrical shocks, burns or cuts, for example) or damaging the equipment. Sometimes (especially in order to avoid litigation), manufacturers go further and use tamper-resistant screws, which cannot be unfastened with standard equipment. Tamper-resistant screws are also used on electrical fittings in many public buildings primarily to reduce tampering or vandalism that may cause a danger to others. Packaging: Resistance to tampering can be built in or added to packaging. Examples include: Extra layers of packaging (no single layer or component is "tamper-proof") Packaging that requires tools to enter Extra-strong and secure packaging Packages that cannot be resealed Tamper-evident seals and features The tamper resistance of packaging can be evaluated by consultants and experts in the subject. Also, comparisons of various packages can be made by careful field testing of the lay public. Why tamper resistant packaging is needed? Psychologists called the killer so strange that their normal guidelines "just don't work." And now, more than 26 years after Tylenol capsules laced with potassium cyanide killed seven people in the Chicago area, the Tylenol murders still have enough people scratching their heads that the FBI reopened the case and is taking a fresh look at old suspects. The murders started in September 1982, when the parents of Mary Kellerman gave the 12-year-old a painkiller when she woke up complaining of a cold. She died hours later. Postal worker Adam Janus died in another Chicago suburb later that morning. Janus' brother and his brother's wife, complaining of headaches while mourning Adam, died too. In a few days the death toll grew — the only link being that each victim had taken Extra-Strength Tylenol. (See the top 10 unsolved crimes.) On testing, each of the capsules proved to be laced with potassium cyanide at a level toxic enough to provide thousands of fatal doses. Police were baffled — the pills came from different production plants and were sold in different drug stores around the Chicago area. Their conclusion was that someone was most likely tampering with the drug on the store shelves. The deaths set off a nationwide panic, as stores rushed to remove Tylenol from their shelves and worried consumers overwhelmed hospitals and poison control hotlines. Chicago police went through the streets with loudspeakers, warning residents of the dangers of taking Tylenol. Johnson & Johnson, the drug's manufacturer, spent millions of dollars recalling the pills from stores. The tampering inspired hundreds of copycat incidents across the U.S. The Food and Drug Administration tallied more than 270 different incidents of product tampering in the month following the Tylenol deaths. Pills tainted with everything from rat poison to hydrochloric acid sickened people around the country. Some copycats expanded to food tampering: that Halloween, parents reported finding sharp pins concealed in candy corn and candy bars. Some communities banned trick-or-treating all together. Police never arrested anyone for the original Tylenol murders, but tax consultant James Lewis wrote a letter to Tylenol's manufacturer in October 1982 demanding $1 million to "stop the killings." Lewis had a strange past. He had been charged with a 1978 Kansas City murder after police found the remains of one of his former clients in bags in his attic; charges were dropped after a judge ruled that the police search of Lewis' home was illegal. But police could never tie him to the Tylenol killings and he denied committing them. Lewis was convicted of extortion for the letter and spent more than 12 years in federal prison. Richard Brzeczek, the Chicago police superintendent at the time, said it was unlikely Lewis would ever be prosecuted for the killings themselves. But when the FBI reopened their investigation in early February, the focus shifted back to Lewis. His Cambridge, Mass. office was searched as well as a storage unit he had rented nearby. The FBI has been tightlipped about the reason for the search and has not named Lewis in conjunction with the reopened investigation. Police still have some of the tainted Tylenol capsules from the original killings and are hopeful some DNA can be recovered from the pills for testing. The killings did have a measurable, positive impact, however: a revolution in product safety standards. In the wake of the Tylenol poisonings, pharmaceutical and food industries dramatically improved their packaging, instituting tamperproof seals and indicators and increasing security controls during the manufacturing process. The result has been a dramatic reduction in the number of copycat incidents — although it may be of little solace to the families of the seven killed in Chicago. But now, as the FBI brings modern technology to bear on a case long gone cold, perhaps they can hope again for something else tangible: at long last, some criminal charges. Fig: Tylenol capsules are removed from the shelves of a drug store after reports of tampering in February of 1986. In response to the September 1982 cyanide poisonings in Chicago, the Food and Drug Administration (FDA) has issued tamper resistant packaging requirements for all over-the-counter (OTC) drug products and certain cosmetic products. The OTC drug products that are covered by these regulations include oral, nasal, ophthalmic, rectal and vaginal drug products. Child-resistant packaging: Child-resistant packaging or C-R packaging is special packaging used to reduce the risk of children ingesting dangerous items. This is often accomplished by the use of a special safety cap. It is required by regulation for prescription drugs, over-the-counter medications, pesticides, and household chemicals. In some jurisdictions, unit packaging such as blister packs is also regulated for child safety. e.g – push and screw caps peel-off and push through blister package Difficulty opening: Child-resistant packaging can be a problem for some aged individuals or people with disabilities. Regulations require designs to be tested to verify that most adults can access the package. Some jurisdictions allow pharmacists to provide medications in non C-R packages when there are no children in the same house. Requirements: The regulations are based on protocols of performance tests of packages with actual children, to determine if the packages can be opened. More recently, additional package testing is used to determine if aged individuals or people with disabilities have the ability to open the same packages. Often the C-R requirements are met by package closures which require two dissimilar motions for opening. Hundreds of package designs are available for packagers to consider. Film wrappers – Transparent: A transparent film with distinctive design is wrapped securely around the entire product container ensuring the product is completely sealed and a secure tight fit is achieved. The wrapper must be ripped or broken to gain access to the product. Sealing of a film wrapper with overlapping end flaps is acceptable only if the ends cannot be opened and released without leaving visible evidence of entry. A secure tight film may be achieved by a heat shrink type process or other means. Film bags: Transparent cellulose, film front paper back, and polypropylene bags in various formats to provide more information and samples. Formats include: Flush-cut bag with lip Bag with flap Bag with flap and self-seal strip Bags with bottom gusset Bags with internal captive flap – pillow Pack Eurotabs and Moulded Hooks can be supplied to hang these bags on display. Boxes: Transparent boxes in PVC with lids Transparent boxes in PVC - side opening Tubes in PVC Sheets cut to size: Film sheet cut to size Fig: PVC film for pharmaceutical packaging Rolls: Film rolls - display packaging in roll format for individual packaging and presentation Pack labeling: It includes labels, security hologram stickers, warranty seals, tamper-proof authentication products, high end labels and general purpose labels. It provides security to the potential problem of someone tampering with the product before it gets to the end user. Apply a small label onto the closure system of the bottle Apply a label onto the carton Apply tape onto the shipping box Blister packs: Blister pack is a term for several types of pre-formed plastic packaging used for small consumer goods, foods, and for pharmaceuticals. The primary component of a blister pack is a cavity or pocket made from a formable web, usually a thermoformed plastic. This usually has a backing of paperboard or a lidding seal of aluminum foil or plastic. A blister that folds onto itself is often called a clamshell. Blister packs are commonly used as unit-dose packaging for pharmaceutical tablets, capsules or lozenges. Blister packs can provide barrier protection for shelf life requirements, and a degree of tamper resistance. The difference between strip and blister is that strip doesn't have thermo-formed or cold-pressed cavities. The cavity is formed around the piece of product at a time when it's dropped to the sealing area between sealing moulds. In some parts of the world the blister pack is known as a Push-Through-Pack (PTP). The main advantages of unit-dose blister packs over other methods of packing pharmaceutical products are the assurance of product/packaging integrity (including shelf life) of each individual dose and the possibility to create a compliance pack or calendar pack by printing the days of the week above each dose. Blister packs also hinder the use of OTC drugs in the manufacture of illegal drugs. Bubble pack: The product and container are sealed in a plastic bubble and mounted in or on a display card. The plastic and / or card must be ripped or broken to gain access to the product. The backing material cannot be separated from the bubble or replaced without leaving visible evidence of entry. Bubble pack seals must be intact and complete and sealed all the way around. Pouches and sachets: Pouches: Flat Pouches: Flat pouches also known as pillow packs are widely used for office and restaurant service. Ground coffee or powdered mixes can be packed in it. Available in multiple solid colors for easy sorting of different blends or flavors. Stand-Up Pouches: Zip lock feature is available. Instead of a photograph, you can show the actual color, shape and size of the coffee, tea or whatever item you wish to place inside. That’s advertising and packaging in one! Sachets: It is a disposable one time use package. Induction sealing: Induction sealing, otherwise known as cap sealing, is a non-contact method of heating a metallic disk to hermetically seal the top of plastic and glass containers. This sealing process takes place after the container has been filled and capped. Leak prevention/protection: A common application for flat sealing heads are to seal containers in the food and beverage industry to prevent leaks and extend shelf life. Some shipping companies require liquid chemical products to be sealed prior to shipping to prevent hazardous chemicals from spilling on other shipments. Freshness: Induction sealing keeps unwanted pollutants from seeping into food products, and may assist in extending shelf life of certain products. Pilferage protection: Induction-sealed containers help prevent the product from being broken into by leaving a noticeable residue from the liner itself. Pharmaceutical companies purchase liners that will purposely leave liner film/foil residue on bottles. Food companies that use induction seals do not want the liner residue as it could potentially interfere with the product itself upon dispensing. They, in turn, put a notice on the product that it has been induction-sealed for their protection; letting the consumer know there was a liner on the plastic bottle prior to purchase. Sustainability: In some applications, induction sealing can be considered to contribute towards sustainability goals by allowing lower bottle weights as the pack relies on the presence of an induction foil seal for its security, rather than a mechanically strong bottle neck and closure. Pre-filled syringe: A plastic prefilled syringe (10) including a syringe body (11) and a plunger assembly (12), the syringe body (11) having opposed first (13) and second (14) ends and an inner wall (16) defining a cylindrical chamber (15) which contains an injectable solution (100), the first end (13) of the syringe body (11) being sealed by a closure and the second end (14) incorporating an opening (18), the plunger assembly (12) including a plunger shaft (22) extending through said opening (18) and a stopper (24) secured at an end of said shaft (22) within said chamber, the plunger assembly (12) being movable within the chamber with the stopper (24) being operable to seal the opening (18) wherein the plunger assembly (12) includes barrier means (26 and 29) on said shaft (22) the barrier means (26 and 29) being adapted, in conjunction with a part of the syringe body (16 and 19), to inhibit access to the injectable solution (100) through the opening (18). Conclusion: The fight against counterfeiting, tampering and diversion of pharmaceuticals is a global and complex challenge. No doubt, the traditional definition of drug safety has acquired the additional dimension of drug security-or more precisely, security of the supply chain and custody of the chain. Only a cross-functional and integrated approach can be successful in defeating counterfeiting and fraud as well as the diversion of pharmaceutical products. The use of security technologies in packaging does not prevent counterfeiting. Instead, it primarily supports product authentication, provides an indication of a drug's purity and allows the supply chain to be tracked. This enables pharmaceutical companies to raise the hurdle for criminals and to protect their most valuable assets: customer health, confidence and satisfaction.