Packing and Labelling of Pharmaceuticals By: Piyush Tripathi

Packing and Labelling of Pharmaceuticals By: Piyush Tripathi

The development and implementation of machinery was responsible for one of the great advances in human history, the industrial revolution. Machinery is critical to the production of much of the Nation’s goods and services because nearly every workplace in every industry uses some form of machinery.

While people never use or even see most of the machinery that makes their lifestyles possible, they use the products it makes every day. The machinery manufacturing industry is comprised of industry segments machinery designed for a particular industry—called special purpose machinery: agriculture, construction, and mining machinery manufacturing; industrial machinery manufacturing; and commercial and service machinery manufacturing. The other segments make machinery used by many different industries—called general purpose machinery: ventilation, heating, air-conditioning, and commercial refrigeration equipment manufacturing; metalworking machinery manufacturing; engine, turbine, and power transmission equipment manufacturing; and other general purpose machinery manufacturing.


Packing and Labeling
The development and implementation of machinery was responsible for one of the great advances in human history, the industrial revolution. Machinery is critical to the production of much of the Nation’s goods and services because nearly every workplace in every industry uses some form of machinery.
While people never use or even see most of the machinery that makes their lifestyles possible, they use the products it makes every day. The machinery manufacturing industry is comprised of industry segments machinery designed for a particular industry—called special purpose machinery: agriculture, construction, and mining machinery manufacturing; industrial machinery manufacturing; and commercial and service machinery manufacturing. The other segments make machinery used by many different industries—called general purpose machinery: ventilation, heating, air-conditioning, and commercial refrigeration equipment manufacturing; metalworking machinery manufacturing; engine, turbine, and power transmission equipment manufacturing; and other general purpose machinery manufacturing.
Grocery bags were known in the 17th cent.; however, it was not until the 19th cent. that practical bag-making machinery was developed. That century saw the emergence of metal cans (1810), setup boxes (1844), folding cartons (1879), and the Owens bottle machine (1899). Early in the 20th cent., marketing-oriented packaging began to evolve and branding, quality, storage and handling, and point-of-sale display became important attributes. By the end of World War II, packaging had become a major medium of advertising and marketing. In recent years, consumer advocates have argued that packages should contain more information on nutrition, unit costs, and contents. The Fair Packaging and Labeling Act of 1966 gave the Food and Drug Administration authority to determine that packages are labeled accurately; the 1990 Nutrition Labeling Act required packages to contain more nutritional information, forcing companies to relabel about 75% of all goods carried by supermarkets. Environmental concerns have led to the passage of state and local laws requiring that some types of packages (notably bottles and cans) be recycled. Manufacturers are attempting to allay further regulation by developing and using packages that cause less damage to the environment.
The Art and science of packing and labeling can be explored as technology of enclosing and protecting product for sale, storage, and distribution. Packing process is a design, evolution, as well as a co-ordinate system of preparing goods for supply, sale, and transport logistics to the end user of the products. Packing is most crucial for sale, product presentation, information, preserves, transportation and most importantly identity of brand.

Labeling or marking is more or less electronic or graphical communication, informative, eye catcher, Brand promotion, means for any product to be sold in the market.

Marketing –
Attractive, fine finished packing and labels can encourage potential buyers to purchase the product. Graphic images, bright contrast color, Physical design have important and constantly evolving phenomenon for several decades. In the run for sale, display, marketing communication and graphic design plays an important roll.

Security –
A Good packing is important for it reduces risk for shipment. Tamper resistance packages can be evident feature to help indicate any tampering. Package embezzle can also be avoided, along with more resistant indicating seals. Authentication seals and security printing can be used to help indicate that the package and contents are not counterfeit. More advanced form of packing also has anti-theft devices, such as dye packs, RFID (Radio-frequency identification) tags, electronic article surveillance tags that can be activated or detected by devices at exit points and require specialized tools to deactivate. Such can prevent not only losses but also an adaptive means of improvised packing.

Containment or agglomeration –
Any product may it be liquid, powder and granular material requires containment. Viz. smaller objects are typically grouped together in one pack for reasons of efficiency. For example, one combined box for mango requires less physical handling the packing them individually.

Portion Control –
Individual Packing or single serving packs, single dosage packing has precise amount of contents to control usage. Commodities packed in bulk (Viz. Salt, Sugar, spices) are packed in more suitable size for individual household usages. This also adds to inventory selling as 1 ltr. Pack of sealed milk, rather then having people bring in their own containers to fill themselves.

Convenience –
Design of packages with features that can add to convenience in handling, storage, opening, distribution, sale, opening, use, dispensing and reuse.

Physical Protection –
Quality packing ensures protection from miss-handlings, wastage, shock, compression, temperature, to preserve the material packed.

Barrier Protection –
Barrier from external agents, and contaminants, is a must. The Crucial factor in design of packing is to prevent product and have extend shelf life. Modified atmosphere or controlled atmospheres are also maintained in some food package, keeping contents clean, fresh, sterile, and safe for intended use.

Information transmission –
Package and label communicate how to use, handle, transport, recycle or dispose the package or product. Food, Pharmaceuticals, Medical, Chemical Products, requires guidelines for usage and information required by governments. Package and label also track and trace purposes of the product.

Industry
In pharmaceutical industry machinery manufacturing have evolved in mid 70's when Indian government introduced very high import duties and restrictive import licensing policies. Engineers had the skills and now the support of industry and associations were form to cater the domestic market for better improvement as perhaps the only route for the pharmaceutical industry to enhance production and cater to the growing demands of the domestic market.

Foreign manufactures had a stronghold on the market but today the Engineering excellence of Indian manufactures had turn table not only to the domestic market but all have proved to the world our capabilities. Indian Pharmaceutical industry stands fifth largest producer of drugs and pharmaceutical after USA, Japan, Europe and China.

Pharmaceutical machinery manufactures have understood the concept behind the process involvement for development of drug, machinery are developed as per client process requirement. Need for such development required in-depth study and monitoring process requirements of clients. Machinery manufactures updated their facilities by latest automated machinery for manufacturing parts, in addition to this there are also other visible trends that can explain committed interest of Indian machinery manufacturers further:

- Manufactures are going for CNC machine to get quality output

- Use of efficient and modern gadgets in the machine, like, VFD, PLC etc.

- Quality approvals and Trademarks, getting ISO approval and international certificate approval for quality manufacturing are also a part of dedication.

- To adapt and implement prototype machines are imported by manufactures.

- Tie-up & Collaboration for technology transfer with international manufactures.

- Expanding high tech facility to meet rising global demand.

Labeling Technology
Packing and labeling technology have evolved from semi-automated process to complex still simpler fully automatic ones. Introduction of automation a use of control systems (such as numerical control, programmable logic control, and other industrial control systems), in concert with other applications of information technology (such as computer-aided technologies [CAD, CAM, CAx]), to control industrial machinery and processes, reducing the need for human intervention. In the scope of industrialization, automation is a step beyond mechanization. Whereas mechanization provided human operators with machinery to assist them with the muscular requirements of work, automation greatly reduces the need for human sensory and mental requirements as well. Processes and systems can also be automated.

Engineers strive to combine automated devices with mathematical and organizational tools to create complex systems for a rapidly expanding range of applications and human activities. Incorporating such complex interfaces specialized hardened computers, referred to as a programmable logic controllers (PLCs), are used along with synchronized flow of inputs from sensors and events with the flow of outputs to be actuated for particular event. Many roles for humans in industrial processes presently lie beyond the scope of automation. Human-level pattern recognition, language recognition, and language production ability are well beyond the capabilities of modern mechanical and computer systems. Tasks requiring subjective assessment or synthesis of complex sensory data, such as scents and sounds, as well as high-level tasks such as strategic planning, currently require human expertise. In many cases, the use of humans is more cost-effective than mechanical approaches even where automation of industrial tasks is possible.

Human-machine interfaces (HMI) or computer human interfaces (CHI), formerly known as man-machine interfaces, are usually employed to communicate with PLCs and other computers, such as entering and monitoring temperatures or pressures for further automated control or emergency response. Service personnel who monitor and control these interfaces are often referred to as stationary engineers.

Manufacturing companies, purpose of automation has increased to reduce costs increase productivity; to broader issues such has increasing quality and flexibility in the manufacturing process. Earlier automation simply increased productivity and reduced cost, moreover costs of automation were high and often could not be recovered by the time entire new manufacturing process replaced the old ones. Unlike today where technology has not only overcome the barrier of cost but also has molded itself as an efficient process means.

Labeling and Labels classification:
• Heat activated adhesives: for example, "in-mold labeling" can be part of blow molding containers and employs heat activated adhesives. Hot melt adhesives are also used.
• Pressure sensitive adhesives (also called PSA or self-stick) are applied with light pressure without activation or heat. PSA labels often have release liners which protect the adhesive and assist label handling.
• Rivets used to attach information plates to industrial equipment
• Shrink wrap for printed shrinkable labels placed over packages and then heated to shrink them.
• Sewing for clothing, tents, mattresses, industrial sacks, etc.
• Wet glue (starch, dextrin, Polyvinyl acetate (PVA or PVAc) is a rubbery synthetic polymer., etc) or water moisten able gummed adhesive
• Yarn or twine for tying on a label

Label type requires process machine, with the label up gradation, machines have also evolved. Labels can be supplied:
• Separately (Cut form)
• On a roll
• On a sheet

Many labels are pre-printed by the manufacturer. Other has printing applied manually or automatically at the time of application. Some labels have protective overcoats, laminates, or tape to cover them after the final print is applied. This is sometimes before application and sometimes after. Labels are often difficult to peel and apply. Most companies use a Label dispenser to speed up this task. Specialized high speed application equipment is available for certain uses. Graphic, color and pictures requires base of ink and base stock color choices commonly conform to the Pantone Matching System (PMS) colors. The system is very dominant in the label printing industry. Additionally specialty inks such as metallic, UV ink, magnetic ink, and more are available. Ink is usually transparent however it can be made opaque. It has been known for certain companies to patent "their own" color. Digital labels use process colors to replicate Pantone solid colors.

Most commonly used applicator sticker machines for high speed application has created brand stickers attached to products to identify as coming from certain company. Mainly used to describe characteristics of the products that are not simple and requires precise explanation for promotion and sale, mainly used in pharmaceutical industry.

Packing development consideration
Packing design and development are often thought as an integral part of product development and process. Development of a component can be a separate process, but must be linked closely with the product to be packaged. Identification of all the requirements, Structural design, marketing, shelf life, quality assurance, logistics, legal, regulatory, graphic design, end-use, environmental, etc. The design criteria time targets, cost constraints and resources need to be established and agreed up on. Package design may take place within a company or with various degree of external packaging engineering, contract engineers, consultants vendor evaluation, independent laboratories, contract packagers, total outsourcing etc. some sort of formal project planning and project management methodology is required for all but the simplest package design and development program. An effective quality management system and verification and validation protocols are mandatory for some type of packaging and recommended for all, for example regulation for an over the counter drug might require the package to be temper evident and child resistant, and these intentionally make the package difficult to open. The intended consumer, however, might be handicapped or elderly and be unable to readily open the package. Meeting all goals is a challenge.

Package development involves consideration for sustainability, environmental responsibility, and applicable environmental and recycling regulation. It may involve a life cycle assessment which considers the material and energy inputs and outputs to the package, the package product, the packing process, the logistics system, waste management. Etc. It is necessary to know the relevant regulatory requirements for point of manufacture, sale and use.

The traditional Three R’s reduce, reuse, and recycle are part of waste hierarchy which may be considered in product and package development.

Packaging Machines
Selecting appropriate packaging machinery includes: technical capabilities, labor requirements, worker safety, maintainability, serviceability, reliability, ability to integrate into the packaging line, capital cost, floor space, flexibility (change-over, materials, etc.), energy usage, quality of outgoing packages, qualifications (for food, pharmaceuticals, etc.), throughput, efficiency, productivity, ergonomics, return on investment, etc.

Packaging machines in pharmaceutical industry are classified in to segments depending on industry for which the functional machinery is required. Companies operating in this sector perform the following principal work cycles.

1) Production procedures common to all types of pharmaceutical forms:
a) Weighing of active principles and excipients;
b) cleaning-sterilization of plant systems and work areas.
2) Production of solid pharmaceutical forms.
3) Production of semi-solid pharmaceutical forms.
4) Production of liquid pharmaceutical forms.
5) Packaging lines for the various pharmaceutical forms.

From warehouse to material handling and general process of weighing followed by Granulate preparation or solution preparation, then division in to various form of process viz. tablet capsule production, Suppository, ointment, cream production to container sterilization, then filling sealing of containers to forming tablet or capsule all the process till final packing of product for safe transport after label all is done either by automated or semi automated machines. This vast range of machinery segment covers most important constituent of product forms which we use very commonly without understanding the process involved behind it.

In many production plants, pharmaceutical manufacturers have developed a high degree of automation. Milling and micronizing machines, which pulverize substances into extremely fine particles, are used to reduce bulk chemicals to the required size. These finished chemicals are combined and processed further in mixing machines. The mixed ingredients may then be mechanically capsulated, pressed into tablets, or made into solutions. One type of machine, for example, automatically fills, seals, and stamps capsules. Other machines fill bottles with capsules, tablets, or liquids, and seal, label, and package the bottles. Demand for machinery is expected to remain strong. Machinery is important for all industries because it boosts their productivity, and advances in technology will make machinery even more efficient and thus more desirable.

Article By:
Piyush Tripathi
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