The pharma industry globally continues to face challenges both from product need and all activities along the supply chain. Challenges also vary from country to country and region to region. With the emergence of newer packaging materials and forms as well as machinery and technology, the industry desires deployment of these for better product protection and compatibility. Also the benefits they could offer both to the industry and consumer/patient.
The Indian pharma industry has been on a growth path and provides an excellent platform for employment-both in the bulk drug and formulations generic and ethical (branded) notwithstanding the per capita consumption is still low when compared to the developed worlds. Although the need is felt, yet the R & D expenditure in India is still in single digit as compared to many other countries that could vary between 10 to 15 per cent.
The industry is highly fragmented and has severe price competition besides being under government price control. The growth rate is estimated at around 20 per cent in respect of bulk and 15 per cent in respect of formulations.
From the packaging perspective the same can be categorized as primary addressing to protection, safety, anti-spurious, aesthetics, marketing and conforming to FDA and IP regulations. As for the secondary/transport packaging, the factors will be dosage needs, dealers preference, distribution and transport worthiness (supply chain requirements).
Packaging media are primary, secondary and tertiary (transport). The common primary ,packages are the strip, blister, glass vials and ampoules, glass/PET/HDPE bottles. The secondary ones are folding board cartons and E fluted CFB boxes. Tertiary and transport packages are essentially the corrugated fibreboard packages. Bulk drugs and fine chemicals generally use flexible bulks (woven/laminated woven synthetic sacks), metal kegs/pails and drums, plastics jerry cans, pails and drums, fibre board drums, multiwall paper sacks and FIBCS. Besides these the industry uses a large varieties of ancillary packaging which primarily include labels (cut labels, pressure sensitive and shrink sleeves), caps and closures (screw caps-RSNP, ROPP, Lug cap, snap-on/fit, and speciality caps). The variety of caps also include CRC (child resistant caps), EFC (Elder friendly caps) and dosage/metered caps). Others are snap fit/press on plugs, rubber and alu seals. Whereas the most requirements are pre-printed on the container, labels etc, coding and marking is done either on line or of line.
Contact coding in principle is replaced by Inkjet (non contact) and laser coding, of late, is slowly being adopted. The label material is either paper or film. Filmic/transparent see through are becoming popular. PS labels also are increasingly used instead of wet glue lables. Closures are made from tinplate/TFS/Aluminium/plastics (LDPE/HDPE/PP/EVA/EVOH). Other significant component is wads-cork, paperboard poly/PVC lined cork/board, PVC compound and EPE. They ensure better product package compatibility and adds to effectiveness of caps (prevention of leakage). Inducion sealing on the neck is also adopted. Facing materials in wads are saran, PVDC, PET, AL/Tinfoil. Wadless closures also are practiced that includes moulded PE/PP-Snap-in/push in/clip on. Transport packs closure are generally effected by BOPP tape and reinforcement is through synthetic (generally PET) straps.
While palletisation is adopted as part of inhouse/warehousing storage the consignments are moved generally by road and rail without pallets. However in respect of exports, palletisation is used. Unitisation of consignment, is achieved through shrink and stretch wrapping both transport packs and pallets.
Packaging line operations particularly the primary packs is by and large automated and the packaging machinery systems are both domestic and imports. However the secondary and tertiary packaging are both manual and semi automatic, so also online/end of line unitization (shrink/stretch) and reinforcement applications.
Medical device packaging
They need sterilization either by gas injection or radiation. The prime requirements are : stringent quality assurance, environmental control and validation. The essential parameters with reference to materials and technologies are: physical/mechanical properties, opening characteristics , biological compatibility, (microbial barrier characteristics), chemical & sealing features, hygiene, optical properties (transparency/opacity), amenability to sterilization and supply chain requirements. The common materials used are Tyvek, peelable paper lidding, , EVOH & pressure sensitive materials. They also should be easily disposed off.
The counterfeit menace
Counterfeit drugs affects health, hygiene and life, product-brand-company image, and confidence. The industry needs to be always ahead in innovating and implementing anti-counterfeit measures and the system needs to be dynamic to leave the counterfeiter behind. This essentially is R & D and innovations- in material sciences, process and technology.
The anti-counterfiet measures generally revolve round package design, holograms and smart and intelligent labels. Concepts in package design will be glue flapped ends, tear off flaps, holographic cartons, metallised cartons, shrink and over-wrapping, tamper evident stickers, Ceka systems and shrink sleeves. As part of package component (s) the measures could be Alufoil blister lid with hologram, strip foil with hologram, PVC blister with hologram, holographic strip –on line to PVC blister, tamper evident holographic seal and induction cap seal with hologram . Serious attempts are made through smart and intelligent labels and labeling practices. Some highlights would be:
Automation in supply chain including track & trace, data capture and remote reading: The choices will include bar coding, peel and place codes or numbers, snowflake codes, matrix codes, magnetic or optical codes, electronic product code & RFID smart labels.
Process control and transport condition indicator: These are achieved through temperature indicating labels and shock indicators. Extremely useful for products sensitive to heat/cold conditions and impacts in transit.
Product authentications: These labels are based on invisible print or codes, special designs or images, holographic images, biological/DNA coding, hidden prints and RFID labels.
Others for identifying thefts, tampering,unlawful copying freshness indications/product deterioration etc: The technology adopted is RFID/EMID/AMID,Magnetic or optical coding, shrink sleeves, peel and reveal labels, scratch and reveal and use of themochromic inks etc.
Success of any of these technologies is essentially governed by consumer education, mass awareness, retailer education, supply chain control, stringent measures on offenders and speedy clearances of cases.
Bar coding
Bar code is a symbol formed with white and black bars structured in a specific format so as to contain a predefined piece of information. It is an inventory management tool and can be a tool within the organization or in any supply chain activity or distribution network or retail ends. It could be numerical or alpha numerical. A variety of bar code systems are available. They are devised as EAN or UPC. Some typical ones are EAN-13, EAN-8, EAN-128. The benefits offered include: Unique identification of an article universally, easy data interchange between the trading partners, ease in using variable data like batch numbers, quantity etc.
Radio Frequency Identification
A basic RFID system consists of three components:
- An antenna or coil
- A transceiver (with decoder)
- A transponder (RF Tag) electronically programmed with unique information.
The process involves:
- The antenna emits radio signals to activate the tag and read and write data to it.
- Available in a variety of shapes and sizes. Can be built into a door frame to receive tag data from persons or things passing through the door, or mounted on an interstate toll booth to monitor traffic passing by on a freeway.
- Antenna is packaged with the transceiver and decoder to become a reader which can be configured either as a handheld or a fixed-mount device.
- RFID tags come in a wide variety of shapes and sizes.
- Animal tracking tags, inserted beneath the skin.
- Tags can be screw-shaped to identify trees or wooden items.
- Credit-card shaped for use in access applications.
- The anti-theft hard plastic tags attached to merchandise in stores.
- Or a heavy-duty 5-by-4 by 2 inch rectangular transponders used to track intermodal containers or heavy machinery, trucks and railroad cars for maintenance and tracking applications.
Advantages:
- Non contact, non-line of sight nature of the technology.
- Tags can be read through a variety of substances such as snow, fog, ice, paint and other visually and environmentally challenging conditions, where barcodes or other optically read technologies cannot work.
- RFID tags can also be read at remarkable speeds, in most cases responding in less than 100 milliseconds.
- The pharma industry has witnessed quite a few new developments in the packaging field. To mention a few:
- PET bottles making inroads into bottle packaging with advantage of unbreakability and compatibility.
- Endeavours in progress as replacement for glass vials.
- Advantage of reduced weight.
- Flashless HDPE containers
- Filmic and security labels.
- Preformed plastics packaging for unit dosages containing PVC based material and Al.foil lidding.
- LDPE/HDPE bags for bulk drugs.
- Ease peelable lidding films made for PE containers-with high dimensional and temperature stability.
- Cold formable blister packs for high barrier properties made of Nylon, PVC and Aluminium.
- Laminate of combinations from BOPP/PET/PE.
- Styrene Acrylonitrile (SAN) moulded bottles.
- Polysulphane-plasticized PVC collapsible tubes
- for thicker wax/oil type ointment.
- 7 layer Nylon based co-extruded films and other nylon based composites for syringe packaging.
- Blister foils for radiation sterilization/ETO gas sterilization.
On the packaging machinery and systems, the industry uses both machines of domestic and overseas origin. The debate varies. While some consider that imported ones are more reliable and of long shelf life with better accuracy and speed. Others feel confident of locally sourced ones machinery which is also considered good enough for current productivity needs.
However the industry also feels that both material suppliers and machinery sources need to extend better participation in terms of more intensive R & D and innovation.
In majority of the pharma sector s while the primary packaging is all automated, the secondary bulk packaging and end of line are by and large manual or at best mechanical or semi automatic. These include units being inserted into primary carton, label insertion, carton erection and closing and case/shipper packaging. It is also identified that as the companies go into expansion programmes with higher productivity and more product mixes the local material and machinery should seize the opportunities and gear up with more versatile systems.
The other specific area and to be in line with global practices and changing regulations ,the industry should seriously address to implementing auto track and trace system.
Environment & sustainability- The environment will remain a major issue for the packaging industry. Issues involving recycling, reducing the amount of waste going to landfill and source reduction will remain on the agenda of all governments.
- The driving forces are threefold-the consumer, commercial interests and government legislation. On the commercial side, supply chain factors will play a key role.
- Packaging is not waste-It preserves and protects products reducing their environmental impact.
- Sustainability is more than recycling.
- Energy impact is an important consideration in achieving sustainability.
(The author is Secretary General of IPMMI and
Chief Executive of IFCA)