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Tamper Evident Bags: Healthcare Uses

12/11/2014

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There are issues related to tamper evident packaging int he healthcare industry. Tamper-evidence in healthcare packaging refers to processes or technologies that help prevent or identify unwanted or unauthorised entrance into a package.

Healthcare in the past used to revolve entirely around hospital care. Today, healthcare often revolves around the home - a situation that has largely resulted from cost constraints and the introduction of maintenance-type drugs for treating chronic conditions such as arthritis, cancer, multiple sclerosis and other diseases that require frequent medication.

Many of these maintenance therapies are delivered by injection, and it has become increasingly necessary for patient-friendly administration systems. These systems must ensure that the potency of the drug be tamper-evident, help deter counterfeiting, promote compliance with the recommended dosing regimen, ensure the dosing accuracy, and be as safe, easy to use and painless as possible.
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Tamper Proofing: Child-resistant Packaging

12/1/2014

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Child-resistant packaging refers to special packaging used to reduce the risk of children ingesting dangerous items. This special packaging is achieved by the use of special safety caps or packs that cannot be opened by children.

These child-resistant safety features are required for prescription drugs, over-the-counter medications, pesticides and household chemicals. The regulations for child-resistant packaging are based on protocols and performance tests of packages with actual children to determine if the packages can be opened. Additional package testing has also been done more recently to determine if aged individuals or people with disabilities have the ability to open the same packages.

In a press release, the U.S. Consumer Product Safety Commission stated that "There is no such thing as child-proof packaging. So you shouldn't think of packaging as your primary line of defense. Rather you should think of packaging, even child-resistant packaging. as your last line of defense."

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Press and twist cap packaging
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Tamper Proofing: Safety Issues

12/1/2014

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No single solution can be considered as 'tamper proof' and very often multiple levels of security need to be addressed in order to reduce the risk of tampering. Some of those considerations may include the following:
  • Identifying who potential tamperers might be and access what level of knowledge, tools, materials, etc. might be available to them.
  • Identify all the feasible methods of unauthorised access into a product, package or system and in addition to the primary means of entry, also consider secondary or 'back door' methods.
  • Determine ways to control or limit access to products or systems.
  • Improving tamper resistance by making tampering more difficult and time-consuming.
  • Include tamper-evident features to assist in identifying tampering.
  • Educate people on what to watch for that will indicate evidence of tampering.
  • Length of time available for tampering, particularly in transit, so that anyone intending to tamper with tamper resistant products do not have a window of opportunity to do so. This will make it more difficult for them to have the time to open the packaging, examine or remove items.
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Tamper Evident Case in the News: Heinz Baby Food 1989

12/1/2014

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Great Britain faced its worse case of food tampering in 1989, when slivers of glass, razors blades, pins and caustic soda were found in products of two of the nation's largest baby food manufacturers, H.J. Heinz and Cow & Gate. The scare began with a blackmailer trying to extort $1.7 million from Heinz, and then escalated as copycats capitalised on the initial report. More recently, in 2004, two jars of baby food were found to be contaminated with ground castor beans which contain trace amounts of the poison ricin. One of the jars contained a note warning that the baby food had been contaminated.

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Tamper Evidence in the News: The Mars Bar Case

12/1/2014

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In 2005 a recall of Mars bars cost MasterFoods more than $1.3 million in lost sales.



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Tamper Proofing Closures

12/1/2014

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Tamper proofing closures are made in such a way that they cannot be interfered with or changed. various types of packaging are designed with different tamper proof closures and the packaging uses an indicator or barrier to entry that is distinctive by design. The labeling statement on the packaging or container alerts the consumer to the specific tamper resistant features used.

The following are some of the approved tamper resistant closures used by manufacturers:
  • Bottles - breakable caps, paper strip seals, rings with bridge seals, non-twist off crowns, twist off crowns, shrinkable seals, foil overwrap and cork finish.
  • Cans - pull tabs and screw caps.
  • Capsules - sonic welding, banding and sealing techniques using solvents and/or low temperature heating. Capsules are required to be contained within a package which has a tamper resistant feature, for example a blister pack.
  • Tetra Pak - rings with bridge, seals, and twist off caps.



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Tamper Evidence in the News: Oronamin C 1985

12/1/2014

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In April 1985, people in Japan began dying after consuming popular drinks that usually appeared to be dispensed from vending machines.

the death toll across Japan may be as high as 12, making the so-called 'vending machine murders' possibly the deadliest product tampering case in history. Many more people became seriously ill.

The most frequent tampered drink was Oronamin C, an energy drink with added vitamins which sells in the billions every year. The drinks had been laced with paraguat, a herbicide and at the time the vending machines would sometimes give out two drinks as a marketing strategy.

Police suspected that the killer usually left the poison drink in the machines' dispenser slot and they also suspected that some of the deaths might have been suicides of the work of copycat killers.

The case remains unsolved.






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Tamper Evident Case in the News: Fentanyl 1998

12/1/2014

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Sometimes tampering can be motivated by a drug addict's desperation. In 1998, a cardiac intensive care unit in the United Arab Emirates saw an outbreak of Serratia Marcescens bacteria. Investigators traced the bacteria to vials of Fentanyl, a potent narcotic. A respiratory therapist addicted to the drug had extracted the Fentanyl for himself and replaced the liquid with water, which had been contaminated with the bacteria.

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Tamper Evident Packaging Design Features - Pharmaceuticals

12/1/2014

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As a result of the Tylenol Crisis of 1982 the FDA implemented regulations for manufacturers of medicines, food and other products, to use induction sealing and other methods to help provide evidence of tampering.

Some of these methods include break-away components which cannot be reattached, customs seals, tapes, labels, RFID (Radio-frequency identification) tags, blister packs, etc.

Packaging that tears open raggedly or cannot be resealed is sometimes used to assist in identifying that a package has been tampered with. Often multiple layers are used because no single layer or device is 'tamper-proof'. Unique custom indicators need to be changed regularly because they may become subject to counterfeiting.

Consumers and end-users need to be aware that they should watch for signs of tampering both at the primary means of entry and at secondary or 'back door' locations on a package.


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Tamper Evident Packaging Design Features - Food Uses

12/1/2014

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Tamper evident food packaging continues to take on a higher profile as processors, retailers and consumers fret about the possibility of bio-terrorism and other threats to the food supply. Product damage caused by consumers opening packages to sample products is a very costly problem and has fueled interest in tamper evidence.

The focus on tamper evidence is well founded. Malicious tampering can be incredibly expensive for the victimised company.

Many manufacturers and processors now use induction sealing to seal the top of plastic and glass containers. This process takes place after the container has been filled and capped and it keeps unwanted pollutants from seeping into food products and may also assist in extending the shelf life of certain products.

Flat pouches, also known as pillow packs, are widely used for office and restaurant service and is usually what ground coffee and powdered mixes are packed in.

After the high profile case of baby food poisoning jars of food started appearing with a metal bubble-top lid known as a 'safety button' which popped out if the jar was opened and stayed flat if it was in pristine condition. Newer jars of food now tend to come with a plastic wrap around the edge of the lid.
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