Protection against counterfeiting
In the pharmaceutical field in particular, strict legal provisions and guidelines apply that are of extreme importance for all parties involved in the process and that at the same time mean tremendous investments for the affected companies. Since February 2019, prescription medicine in the EU has to be equipped with tamper-proof seals that ensure that the packaging has not been opened.
Serialisation on the packaging is now also a legal requirement. All affected packaging has to be equipped with a two-dimensional datamatrix code that uniquely identifies the medicine and confirms its authenticity. This code contains information on the batch number, the expiration date, the serial number and the national reimbursement number.
These new regulations have far-reaching consequences. In individual cases, production facilities have to be expanded, constructed or modified to accommodate new serialisation units. The expansion of the IT infrastructure in particular is a true feat of strength for many companies and is associated with high costs.
Körber Medipak Systems offers extensive solutions that protect patients against counterfeit medicine. Pre-serialised folding boxes with tamper-evident seals and targeted system solutions put a stop to counterfeit medicines in the legal value chain, as packages now visibly and unambiguously show whether they have been opened or not.
The silver generation
By 2050, global population will reach 9.7 billion[3] people; a mere 50 years later, this number is expected to increase to 10.9 billion, according to the most recent UN global population forecasts released in June 2019. In 2050, every sixth[4] person in the world will be over 65, with a total of 426 million people over the age of 80. This equates to triple the 2019 numbers, with 143 million people over 80.
These demographic changes also mean a rise in diseases that increasingly occur with age. These include diabetes, rheumatism, multiple sclerosis as well as dementia and Alzheimer’s disease. The affected patients require particular administration methods, depending on the type of complaint and symptoms. Pre-filled syringes and auto injectors help people with limited mobility regularly administer their medicine themselves.
The packaging industry offers smart packaging for patients whose sight and hearing are dwindling or who are losing their finger strength and motor skills. One of these innovations was created by pharmaceutical technology provider Romaco Siebler. In cooperation with foil experts Huhtamaki, Romaco Siebler developed Push Packs, which are equipped with special, accessible features and allow patients to easily push tablets out of the foil. “Push Packs are an affordable alternative to cold-formed aluminium-aluminium blister packs (AI/AI blister packs). As the packaging foils are a lot thinner, they require less material. This reduces packaging costs in direct comparison by up to 60 percent,” calculates Jörg Pieper, CEO at Romaco Holding.
Tailor-made medicine
Personalised medicine will change the global health system considerably in the years to come. Studies have shown that more than 70 percent[5] of all pharmaceuticals currently in development have been customised to meet the needs of specific patient groups. In cancer therapy, individual medicine is already common and is to supplement standard therapies in future. Scale-out solutions for machines and equipment enable the production of smaller batch sizes. Here, existing equipment is copied exactly for other locations. This requires clearly defined processes and machine technology with a high degree of automation.
More and more pharmaceutical manufacturers require flexible bottling and packaging systems that allow them to work on small batches with maximum efficiency. Bausch+Ströbel has a compact solution in their portfolio: the modular VarioSys production system is also suitable for application in laboratories with small batch sizes. “Flexibility is the first priority in all our designs. We achieve this by quick and easy module changes on the one hand and short cycle times when sterilising the isolator on the other,” explains Heiko Schwarz, who is responsible for the development of VarioSys in product management at Bausch+Ströbel.
Print your own tablets
Tablets fresh off the 3D printer are no longer a dream of the future. Spritam, a printed epilepsy treatment, was the first medicine to be approved by the Food and Drug Administration (FDA) in 2015. 3D printing processes allow manufacturers to adapt products exactly to patient needs whilst reducing time and cost factors in production, as machine components no longer need retrofitting.
Compared to conventional tablet presses, printed pills can also be equipped with a more porous surface, which helps them dissolve more quickly and without additional liquid intake. They can also be equipped with more active ingredients. This particularly benefits patients who have difficulty swallowing and who depend on various tablets. However, experts say it will be quite some time before patients can print their own prescription medicine, with an individual formula put together by their doctor, in the comfort of their own home. The current fields of application are limited exclusively to highly specialised, individual medicine.
Convenience and safety
Personalised medicine is a field that particularly affects the hospital and care sector. To ensure that patients receive the right drug cocktails whilst relieving carers of the task of putting the necessary medicine together, tablets may be blister-packed ready for use.
Blister pack machines in chemists and blister packaging centres pack the patient’s individual tablet mix in an airtight and hygienic strip of sacs and simultaneously ensure that the individual doses are labelled and delivered in the right order. This prevents wrong dosages and ensures that patients do not take the wrong tablets by mistake.
Cost pressure and systems efficiency
Despite all the positive market developments in the pharmaceutical sector, we must not forget that even though the industry is growing, the health care systems in several countries are subjected to tremendous cost pressure. Mandatory discounts, price limits and reimbursement models often force manufactures to lower their costs per package. Machine and systems manufacturers have to work on improving overall equipment efficiency. In Industry 4.0’s future, this means using integrated systems with reliable availability and a continually high product quality. This is the only way to ensure that providers can keep up with a dynamic market in the long run.
[1] https://de.statista.com/statistik/daten/studie/238023/umfrage/weltweite-arzneimittelausgaben/
[2] https://www.pharmaindustrie-online.de/case-studies/echtzeitkontrolle-von-aufreinigungsprozessen-fuer-biopharmazeutika-erstmals-moeglich
[3] https://population.un.org/wpp/Publications/Files/WPP2019_10KeyFindings.pdf
[4] https://population.un.org/wpp/Publications/Files/WPP2019_10KeyFindings.pdf
[5] The Personalized Medicine Report, PMC, 2017
