Over the years the importance of packaging in the pharma industry has grown multi-fold. This has assumed greater significance as a pack is increasingly involved in terms of product administration whereby it is difficult to segregate between the product and package. This is necessary to safeguard a company under the general product liability requirement and the patient.
While dealing with pharmaceuticals packaging, one has to pay specific attention like areas of directives, guide lines, national and global standards which constantly undergo changes. The subject of packaging will witness more and more complexity with the passage of time and thus need greater attention to address the new challenges.
Specific factors that would go into the consideration /development of a package are the product uniformity in terms of quantification of active ingredients, minimal variation, purity, qualitative and quantitative integrity, minimal or nil side effects, good stability in terms of shelf life, all these also conforming to statutory regulation.
The major factors that influence the pack selection would include – the patient/ market type needed, dosage form, mode of administration, consumption pattern, POP needs, besides the product and its characteristics. The mode of administration and the pack are related to the product. Often the pack has to act as the dispensing aid or device. The product pack relationship needs less emphasis as mutually they have a synergy and partnership.
The term pack would include all essentialities and would constitute primary (generally with which the product is in contact), secondary and tertiary, besides the ancillary ones. Each of these contribute to serve a purpose and put together is the total system. The system is the functional mix of the pack viz economical, presentation, information, identification, and convenience, containment, compliance, and protection besides environ aspects.
Package disposal has become increasingly important as more often used packages are considered as a major source of litter adding to environ imbalances. This has become more significant due to the increasing use of plastics because of their verities, permutations and combinations possible to meet specific end use applications and new concepts and developments, and most of these being not possible through glass or metal.
The pack development activities must support to reach to the solutions aimed at the ultimate task providing confidence ensuring that the product remains satisfactory in its complete life till usage. There is no second thought that pharmaceutical packaging would continue to receive and demand greater attention to details, probably more than any other products.
With the product liability and enlarging administrative role of the pack continuously rising to a higher responsibility level which would also intensify identification and development of the right pack would also become more and more “challenging” with all stake holders to contribute.
Standards required w.r.t materials /types/ process / application etc. never would be stagnant and upgradation would be the watchword and would be inevitable considering growing stringency in respect of safety, tighter control and related facets- with the highlights on product- pack security and integrity , extractability / leaching / migration between the pack and product, anticounterfeiting /tamper evidence /tamper identification, safety in relation to child resistance, convenience with built in safety in relation to elders, dosage/ delivery/ and means of application.
It is a known fact that major changes started in the field of packaging only after the second world war. To site a few: strips pack appeared in 1953, Aerosols, squeezepack and blisters appeared in early 1960s, Pumps in 1970s, child resistance in mid 1970s, elder friendly packs in early 1980s.
The journey has continued with more innovations obviously aided by newer materials, machineries, concepts and more and more funds made available. Because of the stringent requirements, regulatory measures, patient requirement the lead time from drug discovery to product launch is also substantially increased. It is also known that the ratio of development and marketable products in the pharma/drug sector is much lower as compared to many other products like the food. This is also augmented as finding the right compromise of all facts steadily increase.
As compared to food (fresh and processed) the package quantum required by the pharma sector is relatively low and more often skillwise per unit quantum would still be lesser. But at the same time the demand for higher standards, higher performance requirements are more creating an interesting interlogue on purchase prices. It is equally true of speciality packaging machines required by the pharma industry. More often some of the machines developed for food sector are modified to meet the pharma packaging lines. Notwithstanding this , the expertise ultimately required by the pharma sector has carved a niche by itself.
The industry has also witnessed shifts and trends-a typical is glass and metal paving way to plastics, strips to blister, direct sterlisable packs, glass and metal to composites, more and more towards PS and shrink labels form wet glue labels .Major influencing factors in respect shifts and trends would revolve round “product trends influencing pack trends,” change and trends in packaging materials, forms process and machinery, changes in systems packaging and special consideration with highlights on patient security, protection against spurious products, package waste disposal and the like .
In respect of products there has been attempts to move form liquid to solids, barring the fact that where children and elders may not be respective to swallowing. Liquids however will continue as essential form for injectebles – unit as well as multi-dose. However in respect of unit dose where a preservative could be done away with the trend is cartridge tubes, disposable syringes, and prefilled syringes/that offer certain distinct advantages. Plastics ampoules produced on blow fill seal equipment has gained popularity. Equally true of vials for expensive biotechnology products. Plastics continue to make inroads for multi-dose liquid products though glass enjoys the virtues of clarity and sparkle and inertness with specific reference to retention of certain preservatives. Yet another influencing trend is OPD (original pack design) where the need is for smaller packs for solid dose forms.
There is a decline in respect of glass, metal and composites but the industry has been a reversal in respect of plastics, paper & board films, foil and laminates. These materials along with metallised substrates, coatings, and co- extrudates will be part of overall growth.
Shrink and stretch materials are set to find increased applications in secondary and in the overall supply chain. Considerable changes are also witnessed in the packaging process viz form – fill – seal process for liquids and semi – liquids, faster strip and blister packaging with on line cartoning and coding, higher material specification enabling faster machine operations and minimal waste other special considerations one would see as trends would relate to – tamper evidence systems, child resistance and elder friendly packaging, security coding (such as edge slits, coloured edges, printed edges, punched hole codes, bar codes, colour bar codes, RFID, inkjet and laser codes, and holograms, printing inks as specific identifiers etc.
PS labels with filmic based ones has proved to be a boon in the labelling lines offering better materials choice and being receptive to more substrates. Lowering contamination possibly to nil level has become order of the day with higher standards of cleanliness and hygiene, all aimed at to lower both bio-burden and particulates. Although sterilization technologies are well established a constant review is needed with the dynamics and varieties of various packaging materials. Computer dispensing and costing, original pack dispensing (patient packs), monitored dosage or controlled dosage systems, are yet technologies set to be used in larger measure.
Pharmaceutical packaging is very intense and demand high and in depth knowledge of products and also all facets of packaging including highly sophisticated quality evaluation and assessment facility with clearly drawn-up procedures. Consumer pressure with social and societal responsibilities are the highlights of the needs. GMP/CGMP, Security and integrity , intensity and directives and compliance needs with guide further trends resulting in increased technology and improved practices. Pharma packaging and all related inputs- out put required has opened up newer and possibly ever-growing opportunities to the packaging fraternity towards more and more R&D, planning and innovations.
(The author is Chairman, SIES School of Packaging, Nerul, Navi Mumbai )