Packaging: the trends of pharma
Protection of sensitive ingredients, innovatory dosing systems, quality control of the contents and container, flexible machines and complete lines… What does the pharmaceutical industry demand from packaging producers*.
* From a study made by Achema (Frankfurt, 15-19 June 2015)
Growth in the pharmaceutical and biotechnology industry continues at a dynamic pace. A large number of new diagnostic and therapeutic formulations are now being placed on the market. The role that innovation plays in this ferment is clear - in Germany alone 49 drugs marketed in 2014 were based on new active ingredients – and the effects on packaging, particularly primary packaging, are inevitable. The pharmaceutical industry demands advanced control techniques (of both the packaging and the filling process), “intelligent” packaging, pre-filled disposable syringes and packaging with built-in quality detectors and dose administration aids and a lot more, not to mention the indispensible anti-counterfeiting and anti-tamper and traceabllity measures.
Then there are external factors to consider during shipment and storage such as temperature, exposure to light, vibration ....
The importance is borne witness to by the following figure: last year in Germany alone 8832 spontaneous reports of quality deficiencies and undesirable side effects were submitted to the relevant authorities, nearly half of which linked to problems of packaging. It comes as no surprise that the safeguarding of the consumer is at the top of all the priorities of the standardization bodies and is guiding the R&D projects of the entire supply chain, packaging included.
The challenge of the proteins
The risk of quality degradation is a particular concern with medication that contains proteins. Proteins tend to unfold on surfaces and may interact with glass as well as with plastic, rubber or silicone components. Small amounts of the proteins in the formulation can be absorbed by the packaging material, impairing or altering the effectiveness of the medication. This is a particular concern with low-dose active ingredients. Thermal and mechanical stress during transport, storage and preparation can also significantly degrade the stability of proteins.
The challenges posed by proteic substances to the packaging industry are hence many and pressing in that these pharmaceuticals have to be administered parenterally. Particularly if in pre-filled syringes, where the medication comes into contact with more materials than is the case with other types of packaging. Not only is there a higher probability that liquid medicines will interact with materials in the primary packaging. There is also a greater risk of seepage, as shown by the recent case of a product withdrawn from the market because the organic compounds leached out of the uncoated rubber stoppers during storage. This resulted in precipitation and formation of micelles which in some cases led to serious immunological reactions in patients.
Creativity and service
Considering these problems, Schott designed a new syringe which reduces possible interaction between the active ingredient and the primary packaging, the intention is to provide a level of safety for sensitive active ingredients similar to that of pharmaceutical vials. The channel which connects the hub and the needle in the new syringes is made of flexible plastic. A seal keeps the liquid passageway closed during storage. The new design entails that the medication cannot come into contact with the metal needle or the adhesive in the syringe during shipment and storage. For added quality, tamper-proofing makes it immediately obvious whether the syringe is new or has already been used.
Developers show almost limitless creativity. A subsidiary of Harro Höfliger has developed a straw for children and the elderly which can be used to administer the active ingredient in pellet form. Patients can ingest the medication along with their favorite beverage. Exact dosing and a control filter ensure that the correct dose is taken.
Solution providers
Packaging is by no means excluded from the major trends in the process industry. The strategy is to supply solutions rather than products. Manufacturers must offer a broad range of technologies covering as much of the value-add chain as possible. Indeed number of acquisitions and partnerships in recent months reveal the tendency to offer one-stop shopping. Romaco (filling, dosing and packaging) acquired Innojet Herbert Hüttlin (granulation and coating of solid products for pharma); just before, in December 2014, Bosch Packaging announced the formation of a joint venture with the Indian company Klenzaids (clean rooms and systems for sterile environment processing).
Modularization and flexibility are a second major trend with the objective of maximizing services and rationalization. Generics producers and contract manufacturers in particular have to design their lines to handle small batches with minimal changeover time while delivering safe products. Suppliers can provide lines which can be expanded as needed or reconfigured to handle a wide variety of applications. This applies not only to the hardware but to the software as well. Groninger (filling and closing systems) is developing user interfaces which support quality control throughout the process for an average 25 - 100 stored formulations.
Quality and safety: 3 striking examples
Hence we reach the crucial matter of quality, that commits an ever growing number of stakeholders to satisfy evermore stringent contract obligations (and legal requisites). Here are three among many possible examples.
DIR Technologies has developed a new induction sealing inspection technique for pharmaceutical containers. During the sealing process, the system performs 100% sealing integrity inspection and fill level detection on pharmaceutical containers such as bottles, bags and sachets, taking quality assurance to a new level. Inspection takes place in real time using non-invasive highly sensitive thermal imaging technology through the closed cap. It will be possible in the future to localize defects during induction sealing with greater precision and pinpoint exactly where to take corrective action. The manufacturer claims that the system can handle high throughput rates without slowing down production.
The second impressive example is the work of a team of developers in Singapore, who have designed a self-expiring packaging which can automatically draw the user’s attention to the expiry date. The blister pack is made of multi-layer plastic. Warning symbols are printed on the innermost layer. The outer layer contains basic information such as the manufacturer’s logo. Once the expiration date has passed, the diffusible material between the layers disintegrates, exposing the warning symbols. The developers won the Red Dot Design Award for this idea. Among other things, the system could be very useful for older patients who are unable to read the expiry date which appears on the packaging in small print.
Lastly, another innovation was on display in 2014 at the last Lopec (printed electronics fair-conference organized by Messe München 26-28 May 2014). The packaging has built-in temperature sensors made of nanomaterials which can remind patients to take their medication.
Five years of growth
«In the coming five years, at world level, we forecast that the rate of innovation will settle to pre year 2000 levels. An average of 35 NCEs will be launched each year, for the most biological and orphan pharmaceuticals, that will have completely new trigger mechanisms». This is how Sergio Liberatore, general manager of IMS Health, opened the procedures for “Over the Horizon” in November, the annual conference on trends of the national and world pharmaceutical market.
The “pharmerging” counties and the US register the best performance, accounting for over 60% of the world pharmaceutical market and 80% of the contribution towards growth. Examining the ranking one is aware of the advance of the emerging countries, that generate 50% of the growth forecast from 2014 and 2018 and occupy half the positions of the top 20 rating. China is still in second place, followed by Brazil who is now in fifth position, overtaking France.
(Source: Aboutpharma Online)
Achema: rendezvous from june 15 to 19 Some 4,000 exhibitors from over 50 countries and 170,000 visitors from more than 100 countries, including 30,000 executives of the first 2 first levels of the corporate hierarchy, meet every three years at Achema - the international chemistry and biotechnology fair. The coming engagement is in Frankfurt (D) 15 to 19 June 2015, and as well as a full program of conferences on focal themes, the event also features three areas dedicated to as many fields of prospective interest with a transversal impact: BiobasedWorld, Innovative Process Analytical Technology (PAT) and IndustrialWater Management. The wide range of products on display will include machinery and equipment, components and technologies for processing and packaging the various chemical product families.
