Jayanti Sawant, Consultant,Pharma Packaging Development, examines the transformation that is undergoing in the pharma packaging industry and explores its future path
Packaging technology with respect to pharma sector goes hand in hand with product development and supply chains. Its presence is felt constantly until the consumption of the drug by the patient or end-user. Hence, patient compliance is the most significant criteria of any packaging solution.
The scenario in this sector is fast changing with a growing market, globalisation, evolving regulatory requirements, competition and revolutions in digital technology like artwork management softwares, track and trace, QR codes, RFID, anti-counterfeiting measures, tamper-evident measures etc.
To understand the evolution and today’s scenario, it is important to review how technology has changed and evolved over time.
1. Traditional blister pack to Combipack (Refer Image 1 &2 -catering to patient compliance and product protection and ease of transportation ) The best eg. Birth control pills.)
2. Looking at bottles, right from heavy glass to light weight plastic bottles, one can identify many changes, right from glass packs to plastic bottles, to changes within the glass bottles.
The adaption or transition from traditional packs to current days’ pack has the following:
- Reduced transportation cost
- Product safety and efficacy enhanced as breakages during transit reduced drastically with light weight plastic
- Aesthetics of the pack for enhanced brand image
- Ease of handling during operations
- Customer compliance – ease of opening the cap of plastic bottle vs glass bottle
The modern packaging industry is under huge pressure to constantly evolve to meet new environmental standards and to create products that are lighter in weight than their
predecessors, meet customer compliance.
This amazing transformation has taken place over years gradually and packaging technologists have played a vital role from conception of the product to commercialisation.
The milk market and dairy products are a perfect example of this transformation
In 1980, milk bottles were made of glass and mostly delivered to the doorstep by milkmen. From glass bottle to plastic bottles to tetra packs, the journey has been fast evolving.
3. The plastic revolution (mid-1980s and early-1990s)
Plastic was perfect because it was lighter, so it could be transported easier, and it had the ability to be made even lighter still with the right technology. Not only that, but it didn’t break as easily, and it was compatible with many formulations as well.
The medicines in glass, tablets as mini bulk packs were seen in PVC blisters, HDPE bottles with child resistant caps. To that end, we have seen high density polyethylene (HDPE) and polyethylene terephthalate (PET) become key to success.
Need for evolution
These re-engineering developments have expanded the job responsibilities of a packaging technologist.
This modification took place gradually, with enormous impetus in last 10 years due to digital technology.
Today, packaging technology is an independent cell. Decades ago it was a mere day to day function of QC, today it’s an active department in the industry playing vital role in all developments and acts as the centre point of coordination during all the new developments.
Functions of packaging
Packaging performs five basic functions:
- To protect a product from damage or contamination
The product must be protected against being dropped, crushed, and the vibration it
suffers during transport.
The product must also be protected against the climate, including high temperatures, humidity, light and gases in the air.
- To contain or hold the product and to avoid spillage or leakage during various stages of production and till it reaches the end user and he/she consumes it effectively.
- To identify the product
Packaging is the main way products are advertised and identified. To the manufacturer, the package clearly identifies the product inside and it is usually the package that the customer recognises when shopping.
- Protection during transport and ease of transport
A package should be designed to make it easy to transport, move and lift. A regular shaped package (such as a cuboid) can be stacked without too much space being wasted between each package. This means that more packages can be transported in a container thereby systematising logistics and supply chain.
- Stacking and storage
The shape and form of the package determines how efficiently they can be stacked or stored in warehouses or at distributors’ inventory.
Categories of pharma packaging materials
Primary Packaging Material (PPM) – is the material that first envelops the product and holds it i.e., those package components and subcomponents that actually meet the product, or those that may have a direct effect on the product shelf life e.g., ampoules and vials, prefilled syringes, IV containers, BLISTER foils and base films etc.
Secondary Packaging Material (SPM )- as the name suggests, is outside the ambit of the primary packaging and used to group primary packages together e.g., cartons, boxes, shipping containers, injection trays, shrink wraps etc.
Tertiary Packaging Material – is used for bulk handling and shipping e.g., barrel, container, shippers, etc.
Thus, with various market trends in technology, customer needs, regulatory compliances the role of packaging development has also evolved and can be defined as a cell based on various job responsibilities.
Job responsibilities of packaging development cell
a) R&D Packaging
This team is a part of R&D functions where product and packaging development take place simultaneously. In many organisations it is merged under R&D. However, recently giant organisations which are hard core research based have R&D PKGG as a different cell all together, dedicated to selection, evaluation, testing of primary PM freeze vendors for primary packaging material.
Packaging is an important component in the development of various drug formulations in pharma industry and has a close relationship with pharma preparation which is a major concern to the drug stability and safety.
The selection of packaging material is made based on its efficacy and performance characteristics in preserving the quality, potency and safety of the pharma products. The stability testing of pharma products and compatibility testing of packaging materials is an integral part of R&D in pharma industry.
The stability of a drug in solid and liquid dosage forms depends on the efficacy of the packaging materials to protect the drug from chemical degradation and changes in physical characteristics such as appearance, hardness, friability, dissolution, disintegration, weight variation, moisture contents and mechanical durability, i.e. all those factors that have a say in its shelf life.
This is particularly necessary for the storage of the products under accelerated conditions. It has been observed that the use of substandard packaging materials by some pharmaceutical industries leads to stability problems, packaging materials – drug interaction, poor efficacy to moisture barrier and formation of hazardous materials.
In order to study the effect of environmental factors on the packaging efficacy of solid and liquid dosage form preparations, there’s a study of stability of a number of selected pharma products in packaging materials using glass, aluminium foil, plastic, paper and other materials as primary or secondary packaging material to determine the extent to which these materials are effective in providing protection to the product and in maintaining its desirable physical and chemical characteristics under the proposed storage conditions.
It is intended to evaluate the shelf lives of the products stored in different packaging materials and examine their efficacy and performance characteristics in maintaining the product integrity for a prolonged period of storage. This job responsibilities of many Indian manufacturers is still a part of R&D whereas many giant manufacturers have moved on with the setting up of R&D packaging along with a product development team.
b) Artwork Development Team Or Commercial Packaging Development
Once the product is developed and ready for commercialisation, the R&D team hands over the product for commercialisation.
From here, the process of artwork development, approval processes through various departments like R&D, QA, QC, production, marketing for designing and branding, regulatory and medical starts.
This team looks into data collection for artwork development which comprises
- Text matter for artworks
- Dimensions – for primary, secondary, tertiary packs
- Dimensions for primary packaging material – is decided by change parts available. Hence the team should have good knowledge about operations involved in filling and packing of the product.
- PMS – packaging material specification development.
- BOP – bill of material development for first commercial run.
- Artwork approval, release, shade card approval etc.
- Database creation and management – it refers to storage in hard and soft copies of documents like – artworks copies, PMS, drawings of change parts and packaging materials. For e.g. drawing of glass ampoule or vial, blister mock ups etc.
- Technical developments like change parts, complaint evaluation, transit trials etc.
This is a challenging job for the leaders which they have been carrying out extremely assertively and efficiently .Overall , the role of packaging development team can be seen as given below
This team also plays a very vital role in coordination for all new developments.
In most of the organisations in India, this cell caters to all the developmental activities including the one mentioned under
A) R&D – packaging
C ) INPROCESS QC FUNCTIONS – IPQC cell
This cell is an integral part of manufacturing plant under QA and QC which mainly looks into:
- Release of printed PM for production
- Testing of PM
- Evaluate complaints and CAPA
- Setting up standard testing procedures
- Carry out engineering/production trials for new developments in co-ordination with team A and TEAM B.
This comprises change part development and evaluation , product filling, sealing (capping ) and packing trials.
- Simulate shipper packing or conduct dummy trials
Thus the role of packaging development as a cell has undergone several changes within the organisation as well. Refer flow chart below:
However, it is of paramount importance that packaging leaders address the various packaging functions under one roof without fragmentation. This is a challenging job for the leaders which they have been carrying out extremely assertively and efficiently. Overall, the role of packaging development team can be seen as given below (See Chart 2).