Christian Ballabio, product manager, Pharmaceuticals, ILAPAK, offers a guide to flow wrapping pharmaceuticals and medical products and suggests how to overcome some of the challenges


low wrapping pharmaceuticals and medical products is a highly specialised

area, owing to the production environment, legislative demands and level of seal integrity required. Many considerations have to be taken into account, from hygiene, through to quality control and product tracking. Today, flow wrapping is increasingly used in the pharmaceutical and medical industries to create an overwrap that provides additional barrier protection, in some cases, allowing the use of cheaper materials in the primary pack. For example, packaging blisters in a flow wrap enables the use of blisters made from ALU-PVC combinations instead of more expensive ALU-ALU. Typically, the wrapping material will incorporate an aluminum layer, to provide a barrier to light, moisture and oxygen. This material presents a number of challenges when creating hermetic seals, owing to its thickness and rigidity. There are various sealing techniques to choose from: conventional heat sealing, ultrasonics and hot air sealing; each has its strengths for specific applications. Ultrasonic sealing is finding increasing favour in the pharmaceutical industry because it is a cold sealing technique, eliminating challenges around temperature. Ultrasonics is popular with contract manufacturers, as it is capable of switching easily between different wrapping materials. The higher capital cost of an ultrasonic sealing unit can be justified by superior performance – high speeds can be achieved regardless of substrate. That’s not to discount other sealing

methods such as hot air sealing, which is often the method of choice for monolayer films. Conventional heat technology relies on the thin layer of sealant on the internal face of the film, usually just a few microns thick, to allow the heat seal, while the outer layers are made with other materials (PET, NYLON, etc) capable

with even high speed blister lines. Temperatures of up to 250˚C are needed to create the high integrity hermetic seals required by the pharmaceutical industry, higher than in other industries. Such extreme temperature sealing introduces the risk of substrates melting and sticking to the jaws. On ILAPAK’s flow wrappers, all heated parts are coated with a special treatment that enables a high quality seal to be achieved, without sticking effects and/or any aesthetic impact on finished packs. The flow wrapper will often need to be

of resisting direct heat without melting/ sticking. In monolayer materials that is not possible and the heat inertia is higher therefore to reach sealing point all the material (inside and outside faces) has to be melted, with all relative risks of sticking , leaking etc. To overcome this issue, hot air is used, blown from outside on the film to melt the sealant, creating a hermetic seal but without making direct contact with the substrate itself. Pharmaceutical lines typically operate at

higher speeds than other industries – 400 ppm is not uncommon for blister lines. This creates a challenge for producing hermetic seals, particularly when sealing thicker substrates, as they require high pressure and high temperatures which usually go hand in hand with long contact times and precise control. ILAPAK surmounts this issue through its dedicated roller and jaw configuration: multiple roller modules in sequence (use of up to five) combined with a transversal sealing solution with modular multiple jaws. This roller arrangement allows temperature sealing management through progressive application of heat (with overall/average lower temperatures), whilst using multiple jaws to create the transversal seal enables prolonged dwell time without compromising production speed. ILAPAK’s top-of-the-range Delta 6000 flow wrapper can comfortably pack at speeds of up to 400ppm, keeping pace

ILAPAK’s Delta 6000 flow wrapper can comfortably pack at speeds of up to 400ppm, keeping pace with even high speed blister lines

designed to comply within the relevant clean room classification/specifications, ISO 5, 6, 7 or 8, for example. For this type of environment, a flow wrapper that won’t generate any dust particles or exhaust air is actually a must. Ensure your flow wrapper supplier uses FDA-rated lubricants, that compressed air systems are fitted with filters that are fine enough to trap particles and that parts that create mechanical friction are enclosed in guards with gaskets to avoid dust particles escaping into the environment. Any flow wrapper destined for a

Make sure you choose an equipment supplier who knows the industry. ILAPAK has experience in supplying flow wrappers to the pharmaceutical and medical industries, with a client list that includes Pfizer, Boehringer Ingelheim, Baxter, Mylan, Fresenius, GSK, and many other big names

pharmaceutical or medical device environment must also be able to withstand rigorous cleaning and hygiene regimes. Look for machines on which all product contact parts are constructed from high grade 316 stainless steel or FDA-rated plastic only. A device that can generate and print 2D datamatrix, barcodes, pharmacodes (usually a thermal transfer printer or laser coder) will be needed for products that fall within the remit of the EU Falsified Medicines Directive (FMD). Any flow wrapper will also need to comply with 21 CFR Part 11. Think about the level of validation documentation and support you require from your flow wrapper supplier; do you want to manage your own validation or do you want support in carrying out this procedure? If the flow wrapper is to form part of an automatic line, product handling and feeding will need to be considered. If the flow wrapper is to be integrated with other operations such as blister packaging and cartoning in an automated workflow, there is the question of whether to source the complete line from a single supplier or purchase various machines from different suppliers. As part of the IMA Group, ILAPAK can offer its flow wrappers as a complete line solution, which means users can reap the benefits of a single source supply.


 PROCESS & CONTROL | SEPTEMBER 2019 11

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