Blister Packs
Child resistant packaging, Definitely not child’s play!
Child resistant packaging, Definitely not child’s play!
Children are naturally attracted to brightly coloured medication and it only takes a second to pop a pill, but this innocent act could lead to tragedy. Child resistant packaging is one optimum solution to this situation. Usha Sharma traces a new trend in the industry.
Pharma industry needs reliable and speedy packaging solutions that can deliver a combination of product protection, quality, tamper evidence, patient comfort and security requirements. Meeting all these challenges child-resistant (CR) packaging, is designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time but not difficult for normal adults. Such packaging is called child-resistant, rather than childproof, because some children will be able to open it. US and Korean regulatory bodies have already enforced CR packaging guidelines for all pharma products, while efforts are on in the European Union (EU) to develop unified standards across the EU countries .
Avinash Mandale, Global Chief Marketing Officer Bilcare
Avinash Mandale, Global Chief, Marketing Officer Bilcare explains CR packaging’s vital need saying, “CR packaging is essential from the children’s safety angle. Every pharma product needs to be CR packed because it can prevent a child from accidental consumption or misuse of the medicine. For example; if the patient is suffering from diabetes there are chances that his son/daughter may accidentally consume diabetes pills and their sugar level may go down which can lead to a fatal situation.”
In India few leading pharma companies like; Ranbaxy, Cipla, Dr Reddy’s Laboratories, Lupin, USV Wockhardt, Ipca Laboratories, Aurobindo, Strides Arcolab, Indoco Remedies etc, are already using CR packaging but it is mainly meant for generic export markets.
Giving the rationale for the increasing need for CR packaging, Ranjit Shahani, Vice Chairman and Managing Director, Novartis India, reasons that, “CR caps are mandatory for most products in US. Generic players in India, into export to US have to use CR caps with high density polyethylene (HDPE) containers and as US generic drugs markets have shown very good growth compared to other branded drugs, the potential is very vast.”
Debdeep Bhattacharya, Director Ess Dee Aluminium
CP packaging is often available in the form of Ecobliss wallet packs with dose guard labels, CR caps and closures, few customised and tailor-made packs and so on. Normally, the standard CR pill boxes remind the patient to take the medicine at right time. However, the usage of such pill boxes is limited as the medication is transferred from the primary pack to such pill boxes as per the requirement. While designing a CR pack to suit requirements, the challenge lies in commercial production of high volumes at high speeds. Presently, the most common CR packaging available is known as ‘push through’, which needs higher effort to take out the medicine and thus a child would most probably give up after a few attempts. Conventionally, foil available in the market is peelable foil. In a ‘peel and push packaging’ the tablets need to be pushed. However, these two foils are not senior friendly either.The lidding material has a peelable coating and is sealed to the blister using heat and pressure. The packaging and its contents can then be sterilised. Lidding material can be die- cut in any shape required. These materials are compatible with common sterilisation methods such as ethylene oxide (ETO), gamma ray sterilisation, beta ray sterilisation and steam sterilisation. Stressing on the uses of CR foils, Debdeep Bhattacharya, Director, Ess Dee Aluminium says, “CR lidding means safety, security and convenience in preventing children from gaining access to medication. As regulations come into effect, it is important to increase the barriers for children, while simultaneously allowing easy access for seniors.”
Regulation
In the USA, CR packaging is result of the Poison Prevention Act (PPA) passed by the US Congress in 1970. The purpose of the law is to decrease the opportunity of children to gain access to substances, resulting in accidental poisoning. In addition, the PPA extends to all states or localities in the USA and is the one standard applied for all applicable products. The European standard only covers packages containing paracetamol, aspirin and medicines which containing 24 mg of iron.
Commenting on CR packaging regulation Bhattacharya says, “US and European testing methodologies are not very different but there are substantial differences in the additional requirements and criteria. US drugs need to be labelled CR, including determination that if ingested by a child, the drug toxicity level would not cause harm or injury. This is not a consideration in determining the type of package used in Europe.”
He further highlights that, “In the US, protocol testing methods were developed primarily to address cap-and-vial closures as this was the preferred packaging format in the 1970s with unit dose formats being virtually non-existent. Today, there is a significant bias towards unit dose formats such a blister and strip packaging. During the protocol development era, it has been estimated that blister use and unit of use packaging formats represented less than 20 per cent of US drug packaging.”
Chakravarthi AVPS, Managing director Ecobliss India Pvt Ltd
Highlighting global CR packaging trends, AVPS Chakravarthi, Managing Director, Ecobliss India says, “Currently legislation exists for commercial products in Europe for UK, Germany and Italy and the Netherlands. The US is the biggest market with extensive legislation and potential litigation. On the clinical trial front all US trials have to use trial samples with CR packaging, but there is no requirement elsewhere in the world.”Commenting on mandatory guideline of CR packaging in India, Mandale says that, “The US and Korea regulatory body has already made it a compulsion and very soon other regions will follow. In India, I assume that it will take some more time to come in force. It would be better if pharma industry does follow the guideline; but I am assuming that it will take some more time to come as an Act and become a regulatory compulsion on each pharma company. Whereas, in the European market regulatory body’s discussions are on going.”
Bharat Mehta, Managing Director Super Label Manufacturing
”If Government is looking from safety point of view of child by preventing accidental use of tablets, then it must be mandatory. It should make it mandatory in India as well, for all formulations harmful for children,” says Bharat Mehta, Managing Director, Super Label Manufacturing.
Preferred solution
CR market is growing with more and more companies developing packaging solutions. As arthritic patients find bottles difficult to open, blister packs with thicker foil or paper/foil laminates are also very difficult for such adult patients to access. Also, these are cumbersome, size limiting and expensive. Ecobliss Pharmaceutical wallets 
supported by dose guard and dose guard labels applied directly onto the blisters provide the best cost effective compliance solution and it is for blisters which have the advantage of excellent CR and senior friendly access. The regular Alu-Alu or blister packs are the ones mostly in general use. Chakravarthi enlarges the usage of CR and its cost effective ways saying, “The CR packaging needs to be cost effective and should not add too much to the packaging cost while complying with requirement. And it should be feasible at high volumes and high productions speeds as well.”
Eric Souberiran, Business Managing Director Rexam Pharma Packaging
“Alu-Alu packaging would be confined to a smaller quantity of products and service a niche segment. The need of the hour is to facilitate bulk packaging to reduce costs in the generic market which is being achieved through the use of HDPE containers fitted with CRC caps, observes Eric Souberiran, Business Managing Director, Rexam Pharma Packaging India.
On the cost front, Mehta says, “To change from current mode of packaging to CR packaging, one needs to understand the advantage as against cost. Indian pharma industry is still quite driven by cost. Normally, the price difference between a product using CR packaging a product normal packaging is a reasonably big difference but depending on size and volume of the products.”
”It is a new trend seen in the industry and is emerging differentially. The key reason is to differentiate from other packaging, which is happening in the Indian pharma industry. Indian pharma players are realising that packaging differentiation will make them stand out in the competitive market. And CR packaging will be good for differentiating. I see big pharma giants protecting their brand concealing with CR packaging and these can help the pharma companies to differentiate themselves from their competitor,” analyses Mandale. “The price difference in CR packaging is minor compared to the safety gains.” adds Souberiran. Shahani opines that export oriented Indian pharma companies have implemented CR packaging, but the concept remains underdeveloped in the local markets.
Reaching globally
Many Indian pharma companies are currently exporting their generic drugs to the US or those planning will have to essentially look at bulk packaging, while, keeping in mind the US FDA regulations. “In the near future, Indian pharma companies are going to be strong contenders in the US generic market, which would necessitate use of CR caps. This coupled with the fact that the pharma consumer in India will also evolve over a period of time makes it necessary for them to pursue this packaging trend. HDPE containers with CRC caps are a perfect fit to meet the demands of this market. So the trend is very positive and we see more and more companies adopting this packing in future,” avers Souberiran.
Suggesting a user friendly point of view, Mandale comments that, “The existing leading foil should evolve into a new form of design solution, which can be provided as a CR pack. The future trend is that CR packaging should be senior friendly, eco friendly and cost effective as well.”
Chakravarthi sum up the potential when he predicts that, “We see this market (CR) expanding from the US across the world as soon as a cost effective solution is provided.”
Reckitt Benckiser Healthcare (UK) Ltd, uses Ecobliss cold seal wallets for their clinical trials
Reckitt Benckiser Healthcare (UK) Ltd – Ecobliss Website Case Study
Reckitt Benckiser, the largest pharmaceutical and healthcare company in the Netherlands, has adopted the Ecobliss cold-seal packaging system for a clinical trial of one of their market leading medicinal brands.
The healthcare facility, based in Hull, UK, has invested in a desktop Ecobliss Jiggle Roller (EJR) 350/500 machine to manually seal their blister packs into cold-seal wallet cards – which are also supplied by Ecobliss Pharma.
It is the first time Reckitt Benckiser have utilised Ecobliss cold-seal technology, which allows for improved efficiency, speed and flexibility in their product packing process.
Furthermore, the simplicity and the compact design of the finished wallet pack (pictured) offers the patient ease-of-use and portability – two vital factors in ensuring the stated dosage is taken and completed correctly.
This clinical study is to be sent to the USA, which means as a legal requirement, the packaging will need to be in certified child resistant packaging. To aid compliance, Ecobliss Pharma – supported by GP Solutions (UK) Ltd – will provide the wallet card with a Dose GuardTM Peel & Push child resistant senior friendly (CRSF) secondary barrier pre-applied on the back. Dose GuardTM is approved to an F4 CR rating; however, developments are currently in place in order for it to achieve F1 status.
To complete delivery of all the packaging components required for this study, GP Solutions will also supply Reckitt Benckiser with tamper evident labels and outer cartons.
July 20th 2009, Clamshell, a double blister with card inside
The best theft protection for retailers, but in many cases a nightmare for consumers to open.
Clamshell blisters, are extremely popular with retailers due to the fact that there is almost no packaging that gives better protection against in-store theft. To increase the theft protection of clamshell blisters even further, very often security labels such as HF or ultrasonic alarm tag labels are positioned inside the plastic packaging. Unless customers are equipped with scissors or a knife, this kind of packaging is extremely difficult to open in the store thus giving the best protection against pilferage.
The downside of extremely good theft protection is that, once at home, clamshell blisters are very hard to open, even when using a knife or scissors. Unfortunately many cases are known where customers get injured while opening clamshell blisters.
Clamshell blisters are widely used to pack up-value consumer goods, sold in a DIY, or self selling (warehouse) environments. Products such as electronics, computer hardware, sanitary accessories, automotive parts etc. are often packed in a clamshell blister.
Materials
Clamshell blisters usually consist of a thermoformed front blister and a back blister (or flat plastic sheet) with a piece of cardboard or paper trapped between the blisters.
Depending on the size of the blister and the desired strength, the thickness of the plastic can be adapted to the specific requirement. The plastic is usually a PVC, PET-A, PET-G or PET GAG. The insert piece that carries the communication and product information is made of printed paper or cardboard.
Sealing
Clamshell blisters can either be sealed, using high frequency sealing, ultrasonic sealing or simple heat sealing. The choice of sealing depends on the type of plastic that is being used.
In case PVC, PET-G or PET-GAG (Glycol modified polyethylene terephthalate) is used, it is possible to use induction or radiant heat sealing. The best heat-sealing results can be achieved in case the patent pending hot-cold technology is used. The advantage of this hot-cold technology is that the sealed blister flanges will not become brittle and that they will become flat and strong after sealing. Conventional heat sealing is possible, but expect blister flanges to become a bit brittle and curled.
In case A-PET is used, high frequency sealing or ultrasonic sealing are the best sealing techniques.
Reclosable Clamshell blisters
It is also possible to choose a fold-over type of clamshell blister that can be closed, simply by clicking the front and back blister together. This type of clam shell blister is very popular as no machines are needed to close the pack. Also opening and re-closing for demonstrating a product is simple to do.
Recycling
A clamshell blister is very suitable for recycling. The two materials, card and blister are not bonded together. The paper part and plastic part of the package do not contaminate eachother and can be disposed separately in the according waste streams. Some consumers may dislike this kind of packaging, because of the large plastic part, but an alternative packaging with the same properties is often hard to find. The plastic part should have a material identification marking, 
indicating which type of plastic is used. This is done to enable consumers to choose the correct waste stream. In Germany and some other countries packaging taxes are very high when using plastic.
Gruener Punkt
Heat seal face blister – Blister directly bonded to card
Heat seal face blister pack ( blister-to-card )
Within the various options available in the range of blister packaging, heat seal blister packs are by far the most commonly used type worldwide. The reason for this is obvious. Heat seal blisters consist of only two pieces of material, a single piece of board and a blister. Heat seal blister packs are therefore very economically to produce. The board of which the blister card is produced is coated with a layer of heat seal coating. Generally there are two main types of coatings in use to produce heat seal cards. These are water-based heat seal coatings and solvent based heat seal coatings. With today’s advanced technologies most coatings are suitable to seal both, PET blisters or PVC blisters, using the same coating.
In average the bond strength of solvent based coatings is better that the strength of water based coatings, but if all the guidelines for the use and processing are being respected, both types of coatings give good sealing results. Please pay attention to the producers warranty on heat seal blister cards. Once the production of the cards is ready, heat seal cards should not be kept in stock for a period longer than 6-12 months. In high humidity countries it is advisable to have the cards packed in such a way that moisture can not penetrate into the blister cards (plastic wrap around the cards before putting them in a outer box). Heat seal coatings are hygroscopic, meaning that they attract moisture. The disadvantage of moisture in the coating is that in the sealing process. Moisture in heat sealing cards causes undesirable air enclosures/ bad bonding spots in the area where the blister is being sealed.
The variety in heat seal cards and blisters is endless. The cards can be of any shape and size and the same goes for the blisters. Depending on the desired quality feeling, the thickness of the two materials can vary from very thick and strong to extremely light weight and thin.
Packaging process:
First the blister is placed onto a bottom tray, than the product(s) are added to the blister. The blister card is placed between the spring loaded pins located in the bottom tray. Now the sealing cycle can start. During the heat seal cycle the blister is bonded (under heat and pressure) to the heat seal coating on the blister card.
Packaging is done on heat sealing machines. These machines apply heat and pressure during a prefixed period of time. A typical heating cycle seal takes approximately 2-5 seconds at a temperature of 130°-150° Celsius. Tooling is usually build up as following: The bottom tool is usually a aluminium or wooden tray with rubber and spring pins to position the blister and card. A typical top tool is a Teflon coated (or covered) aluminium heat sealing plate.
In case the blister pack is sealed through the back a generic top plate can be used for sealing. This is by far the most used option. (radiant heating). In case sealing takes place by applying heat directly on the flange of the blister a dedicated sealing tool is used. (impuls sealing). You can learn more about heat sealing radiant and impuls sealing machines by visiting http://www.blistermachines.com/
Availability: World wide many printing companies are producing heat seal cards. Please make your choice carefully and choose for quality suppliers. Numerous problems can occur in the heat sealing process, and worse, with packed products in the market. These problems are mostly the result of getting inconsistant quality of heat seal cards, but also from not having the right type or good quality heat sealing machines.
Sanofi-Aventis prepared for cold seal wallet packaging
Sanofi-Aventis, one of the world’s leading pharmaceutical companies is preparing for the partial transfer of heat sealing to Ecobliss cold seal packaging.
The R&D facility of Sanofi-Aventis in Montpellier (France) has recently expanded with a brand new facility designated for clinical trial activities. The Sanofi clinical trial packaging service, an innovation oriented entity, is constantly improving its processes for a high degree of quality and flexibility, and will be equipped with five Ecobliss ERP 350/450+ machines.
This type of equipment is designed for perfectly sealing Ecobliss cold seal wallets as well as heat sealing wallets.
Cold sealing and heat sealing in one machine, yet another proof of the ingenuity of Ecobliss Equipment!
The first of the five machines has been successfully installed in September 2008, the remaining ones have been supplied in the course of 2009.
Dose Guard Child resistance Solutions for Pharmaceutical wallets
Dose Guard Child resistance Solutions for Pharmaceutical wallet
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GP Solutions (UK) Ltd has developed a patented and proven technology, which provides child resistance and senior friendly compliance to the new European Standard – ISO EN 14375 for non-recloseable pharmaceutical packaging.
The product, Dose Guard™, is a self-adhesive barrier that utilises a unique “peel & push” mechanism to allow controlled access to each tablet. Dose Guard™ is suitable for application directly onto pharmaceutical wallets.
The combination of multi-part adhesive patterns and die-cutting technology provides child resistance and senior friendliness for most blister pack formats. This is without the need for re-tooling and expensive time consuming stability studies that would be associated with changing the blister contact materials.
Blister Packaging
Blister packaging has proven to be the ideal, self selling packaging for producers and retailers and are still gaining over box packaging. Customers are attracted by a clear and clean presentation of the packed product. The blister bubble shows the actual product and protects it from damaging and tampering. Combined with product information printed on the blister card blister packaging is the perfect, self selling combination!
Blister packaging is used by DYI stores, warehouses, electronics industry, automotive industry, food industry, pharmaceutical industry etc.
Folding (or double) card with trapped blister
This type of blister packaging is a combination of a sealable fold-over blister card and a transparent blister. The blister is trapped between two pieces of board that are bonded together. After joining this type of package makes a beautiful highly visible presentation of your product.
Sealing can be done using heat- or cold sealing technology.
Heat sealing:
Folding blister cards are coated (inside) with a heat-sealable coating. The blister is trapped between two pieces of board that are bonded under heat and pressure without
Cold sealing:
Folding cards are coated (inside) with a pressure sensitive cold seal adhesive. The blister is trapped between two pieces of board that are bonded under pressure without using any heat. Only pressure is required to make a perfect board to board bond. This makes the packing process simple, quick and very cost effective. A range of very simple to highly automated packaging equipment is available to support this packing process.
Sliding blister pack
A sliding blister consists of a blister with folded flanges on three sides and a card. After placing the product into the blister a matching card made of cardboard is used to close the pack. This type of blister pack can closed and reopened very easily by sliding the card between the folded flanges of the blister (like a drawer). No machines are required for packing.
Skin Pack
Skin pack, or skin packaging, is a type of carded packaging where a product (or products) is placed on a piece of paperboard , and a thin sheet of transparent plastic is placed over the product and paperboard.
The printed paperboard usually has a heat-seal coating. The plastic film (LDPE, PVC, ionomer, etc.) is softened by heat and draped over the product on the card. Vacuum is sometimes used to assist a firm fit. The film bonds to the heat-seal coating on the paperboard. The skin-packed piece then may need to be cut into individual units.
Skin packaging somewhat resembles a blister pack, with the major difference being that the plastic surrounding the product is formed over the product, instead of being pre-formed.
Pharmaceutical blisterpackaging
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. In the USA, blister packs are mainly used for packing physician samples of drug products, or for Over The Counter (OTC) products in the pharmacy. In other parts of the world, blister packs are the main packaging type since pharmacy dispensing and re-packaging are not common. A series of blister cavities is sometimes called a blister card or blister strip as well as blister pack. In some parts of the world the blister pack is known as a Push-Through-Pack (PTP). 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.
Medical blisters
Medical Blister trays differ from Pharmaceutical blister packs in that these are not push-through packs. The thermoformed base web is made of a thicker plastic sheet, generally between 500µ to 1000µ and can not be collapsed, thus forming a solid tray. The lidding film provides a peel-open feature and is generally porous to allow sterilisation. Such medical blister packs are used for medical devices, used in hospitals.