Characteristics Features of Industry Which Influence the Pharmaceutical Packaging
Content
• Definition Of Packaging
• Industrial Packaging Market Outlook.
• Stability Testing and Compatibility Testing Of Packaging Materials.
• Stage S in the Development of a Package Product Combination.
• Qualification and Quality Control of Packaging Components.
• Standard and Specialty Packaging Solution for the Pharmaceutical Industry.
Characteristics Features of Industry Which Influence the Pharmaceutical Packaging
Packaging:
• Packaging means the wrapping or bottling of products to make them safe from damages during transportation and storage. It keeps a product safe and marketable and helps in identifying, describing, and promoting the product.
• “Packing is the preparation of product or commodity for proper storage and/or transportation. It may entail blocking, marking, sealing, strapping, weather proofing, wrapping, etc.”
Industrial Packaging Market Outlook
• Global industrial packaging market size was valued at 53,743 million in 2016, and is expected to garner 69,787 million by 2023. Industrial goods are heavy, bulky, and sensitive to external atmosphere.
• Thus it is necessary to conserve the product for longer time during storage and transportation specifically with hermetically sealed packaging and secured from external contamination.
• Rise in building and construction activities in majority of the emerging economics especially in India and china. Rise in food and beverages industry to meet the demand of growing population and rapid growth of exports, which requires superior packaging standards for the international market are the major factors that are expected to the market growth during forecast period.
• In the global pharmaceutical industry, the efficient transport of drugs not only depends on the means of storage and mobility but primarily on the packaging of the drug. However, there are a few factors common to pharmaceutical packaging irrespective of the product’s classification.
• The packaging standard required in the pharmaceutical industry is superior to other industries because pharma packagers need to maintain product standards and quality, which includes the requirements of uniformity, purity, side effects, shelf life, safety, integrity, and efficiency, among others.
• Manufacturers must possess an in-depth understanding of every characteristic of the product, including formulation, dosage form, physical and chemical properties. That information needs to be amalgamated with manufacturing, packaging, marketing, distribution, product end use and profitability projections.
For ease of convenience, we can classify the location factors into two: geographical factors and non-geographical factors.
Geographical factors
– Raw Material
– Technology
– Power
– Labor
– Transport
– Storage and Warehousing.
– Marketing Feasibility
– Characteristics of Land and Soil.
– Climate.
– Precipitation and Water Resources.
– Vulnerability to Natural Resources.Non-geographical Factors
– Capital investment.
– Availability of loans.
– Investment climate.
– Government policies/regulations.
– Influence of pressure groups.
Explanation:
Capital or huge investment is needed for the establishment of industries.
Government policies are another factor that influences industrial location.
The government sets certain restriction in the allocation of land for industries in order to reduce regional disparities, to control excessive pollution and to avoid the excessive clustering of industries in big cities.
The location that has better banking facilities and Insurance are best suited for the establishment of industries.
Uniformity:
Refers to the quantity between and within batches of products encompassing the impurities, excipients and ingredients. The term refers to minimizing variation between the items or doses, etc.
However, variations in uniformity post storage are related to the changes in the drug/product, environment or the packing of the product.
Uniformity is the foundation of batch processing and manufacturing, and packaging plays a major role.
Purity:
Refers not only to the percentage of the active ingredient but also the level of impurities.
Similar to how innovative analytical techniques have made the identification of impurities practical, their elimination has been aided by modern chemical techniques.
Pharma packaging helps prevent the drug from exposure to impurities.
Integrity:
Ensures the package contains the correct product quantity and quality, and that the package meets necessary specifications and is properly labeled.
Integrity is all about controlling efficient production and ensuring product quality.
Minimizing side effects and maintening shelf life are important factors in the process of manufacturing packaging for pharmaceuticals.
The type, size, chemical properties, physical properties, material, etc., All contribute in determining effective packaging
– A good packaging has the characteristic of not being too heavy nor is it of the design and size that may create inconvenience to the buyers of products.
So, convenience is a feature of good package.
Security:
Packaging to be good must be so done that absolute security for the protection of the product is assured.
Adaptability:
Packaging is said to be good where it does not present any difficulty for keeping it in the almirah or refrigerator.
This adaptability of packaging is definitely one of its characteristics.
Dependability:
A good packaging should have such a characteristic that it creates confidence in the minds of the buyers that the contents must be of standard quality.
Status:
A good packaging definitely adds prestige to the person who carries products well packaged.
This is an additional characteristic that good packaging should have for better marketing.
Aesthetic:
A good packaging bears the mark of aesthetic sense. This sense adds a lot to the status of the customer.
A shelf package or retail package must attract immediate attention.
The true product story is one of the features of shelf package and this will create consumer confidence.
The package should be clean, sanitary with protective seal. Convenience constitutes one of the most distinguishing features of shelf package and customers must have the feeling that the packagers have a good value to them.
The degree of protection required
• Active pharmaceutical ingredients are usually more stable than when they are formulated into dosage forms.
• Decomposition occurs due to the presence of excipients, moisture, oxygen, light, temperature etc.
• Degradation of the dosage form can also be as a result of the formulation process used during formulation.
• The degree of protection required is a function of the formulation in question and for this reason; the packaging material used for photosensitive material should possess the ability to protect the formulation from light.
• This is also applicable to hygroscopic, easily oxidized drug products and so on.
Cost
In order to make your drugs affordable, cost effectiveness of packaging materials should be considered.
Manufactures should endavour not to compromise the integrity of their formulation while cutting cost rather they should look for a better way to reduce cost which can by reduction of wastage of packaging material.
Convenience
How easy is it for a patient to use a formulation in terms of size, weight, method of opening or reclosing if appropriate during administration of the dosage form should be considered while choosing packaging material for a dosage form.
Legibility
The legibility of printing is an important factor to consider while choosing and designing a package for your formulations as it serves as a source of information and identification of a formulation as explained in the importance of giving your product a perfect finish.
Stability Testing and Compatibility Testing
The stability testing of pharmaceutical products and compatibility testing of packaging materials is an integral part of R&D in pharmaceutical 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.
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
Enhancing product traceability is one of the critical improvements any company can make in their supply chain management process.
Traceability integrates inventory, transportation, and timely delivery while affecting the overall cost.
For a long-term customer satisfaction strategy focused on product packaging, companies need to enhance their traceability and deliver such improvements to customers through supply chain labelling and packaging.
Increased costs of supply chain management will end up being paid by the consumer, while traceability and labeling improvements, on the other hand, might even enhance sales through packaging enhancement.
All of these demonstrates value to customers.
Countless marketing studies lts in many aspects of the supply chain.
It can increase product efficiency, smoothen the handling of materials at the production floor, ensure the efficient use of modern supply chain technology like stackers and pallets, creates better operational activities at both the plant and the warehouse, and makes for an easier damage control process, inventory management, cycle counts, and space usage.
Stage S in the Development of a Package Product Combination:
Product formulation:
All formulations are required to be documented and stored.
It is therefore necessary to make certain that all packaging materials are defined and that all packaging parameters (torque, heat, seal etc) are identified, controlled and documented (all part of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) during formulation studies)
Consideration of container materials:
It is important to have a basic knowledge of all packaging materials, their properties, characteristics etc. and the process by which they are fabricated/ decorated as a packaging container or component, as well as how these and any subsequent process may affect their properties.
Pack feasibility tests:
This is the stage where a product is tested in a range of possible package, usually over a range of conditions from say 200C to 450C, together with alteration in temperature –humidity range.
In addition to the storage tests indicated above the immersion of pieces of package or package components if plastic, in the product or a stimulant i.e. an extractive-type-test may also be employed.
Extractive tests are usually mandatory for plastics used for injectables and ophthalmic products.
Feasibility tests usually extend over a period of 1-12 months.
Only after a period of normally 3-6months any decision about the package is taken.
Pre formulation:
Pre formulation studies are essential for all packaging components. This provide information relating to the limitations of the packaging material.
Formal stability test:
Formal stability test is conducted only after a suitable package –product combination is selected.
By conducting the formal stability test, the shelf life of a product can be determined.
Normally three large-scale batches of product in each package is selected.
For long term stability test purpose the temperature is maintained at 250C with a relative humidity of 60% and in case of accelerated stability test, the temperature is maintained at 400c with a relative humidity of 75%. The samples are kept over a period of 5 years and examinations are conducted at the intervals of 0 (optimal), 3,6,9,12,18,24,30,36,48 and 60 months.
The data generated are send to the regulatory authorities as part of the marketing authorization application.
Ongoing stability:
This consist of repeated stability on random batches from production in order confirm that the shelf life does not change during the manufacture of each batch.
Complaints:
This is the final means of monitoring the success of the product and pack.
It is somewhat similar to the monitoring and recording of adverse reactions in that it is a safeguard to both the company producing the drug and the person receiving it.
In all the above tests analytical and packaging technological support is essential to check both the product and the package.
Qualification and quality control of packaging components:
A packaging system found acceptable for one drug product is not automatically assumed to be appropriate for another.
Each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use.
The type and extent of information that should be provided in an application will depend on the dosage form and the route of administration.
Protection:
A container intended to provide protection from light or offered as a light-resistant container must meet the requirements of the USP<661> Light Transmission test.
The procedure requires the use of a spectrophotometer, with the required sensitivity and accuracy, adapted for measuring the amount of light transmitted by the plastic materials used for the container.
The ability of a container closure system to protect against moisture can be ascertained by performing the USP <661> Water Vapor Permeation test°.
Compatibility:
Components compatible with a dosage form will not interact sufficiently to change the quality of the product or its components.
A leachability study designed to evaluate the amount and/or nature of any chemical migrating from the plastic material to the pharmaceutical product should be implemented.
Analytical techniques such as Liquid Chromatography/ Mass Spectrometry to evaluate nonvolatile organics, Gas Chromatography/Mass Spectrometry (GC/MS) to evaluate semi volatile organics, and Inductively Coupled Plasma (ICP) spectroscopy to detect and quantitate inorganic elements should be a part of this study.
Coupling MS to LC and GC methods provides a definitive and effective tool for identifying unknown impurities and degradation products.
Other changes such as pH shifts, precipitates, and discoloration, which may cause degradation of pharmaceutical product must be evaluated.
Safety:
All packaging components should be constructed of materials that will not leach harmful or undesirable amounts of substances to which a patient will be exposed during drug treatment.
- However, an extraction study should be one of the first considerations. Isolation is accomplished through sample preparation, followed by incubation in solvents at well-defined and well-controlled times and temperatures.
- Sample preparation is an area in which an experienced chemist’s knowledge of chemical procedures is indispensable.
Standard And Specialty Packaging Solution For The Pharmaceutical Industry:
Traceable Solutions for Medical Packaging:
The demand for safety and integrity in the area of medical packaging has taken on new and significant implications in the past two or three years.
Child safety, correct dosage, patient traceability, tampering and diversion of pharmaceuticals are always an area of concern, medical packaging.
Rondo – fluted trays
For all low fragile product needs, whether they are made from glass, metal, plastic or wood, anything that needs special packaging considerations and still should be clearly visible, with the help of rondo fluted trays.
The contents can be easily removed and put back after every use.
Coding in pharmaceutical packaging:
Coding and marketing have many functions in pharmaceutical packaging.
They provide expiry dates for products, lot and date codes to aid in tracing and recalls, bar codes, sales messages and other important information.
Barcodes can be read by optical scanners called barcode readers or scanned from an image by special software.
Barcodes are widely used to implement Auto ID Data Capture (AIDC) systems that improve the speed and accuracy of computer data entry.
Symbologies:
The mapping between messages and barcodes is called a symbology.
The specification of a symbology includes the encoding of the single digits/characters of the message as well as the start and stop markers into bars and space, the size of the quiet zone required to be before and after the barcode as well as the computation of a checksum
Technology of barcodes:
A linear barcode is a binary code (1s and 0s). The lines and spaces are of varying thickness and printed in different combinations.
To be scanned, there must be accurate printing and adequate contrast between the bars and spaces.
Scanners employ various technologies to “read” Codes. The two most common forms are lasers and cameras.
Thermal transfer and inkjet printers:
Thermal transfer and inkjet printers are more appropriate for production line bar code printing.
Specifically, thermal transfer printers produce high quality, legible and clear bar codes, as well as other types of codes.
Because ink is not involved, there is never any quality degradation during the process.
Moreover, such printers are virtually maintenance free while they can also be connected to a software network for record keeping purposes, which helps with validation.
The main drawback of this technology is that although it can be set up quickly, it lacks printing speed.
Inkjet Printers:
Inkjet printers are the fastest and least expensive units available on the market. Unfortunately, there are considerable limitations to what they can print.
In addition, they require frequent maintenance and can be quite messy.
Another major downfall is that the print fades after successive use.
Water-based inkjet fluids tend to streak and blur, while non-water, soluble inkjet fluids produce a shine that reflects to the scanner and affects how the bar code is read.
Dot-Matrix printers:
Dot -Matrix printers produce low-quality codes with low contrast, although this depends on the ribbon used.
Laser printers:
Laser printers are off-line devices requiring a separate label applicator.
They are subjected to toner flaking, meaning that they are unreliable for long-term bar code printing
Radiofrequency identification (RFID)
Radio Frequency Identification (RFID) It promises a slew of benefits to manufacturers and retailers alike, including unprecedented control over the supply chain and enhanced product security.
The technology, called radiofrequency identification, or RFID, allows manufacturers and distributors to more precisely track drug products through the supply chain.
RFID makes it easier to ensure that drugs are authentic, and it also creates an electronic pedigree-a record of the chain of custody from the point of manufacture to the point of dispensing.
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