Review on: THE PHARMACEUTICAL PACKAGING
4)Hazards encountered by package:
Hazards encountered by the package can be divided into three main groups—mechanical hazards, climatic or environmental hazards and biological hazards. The only exception is theft, which can be a serious risk with drugs and may demand special protection in certain cases.
4.1- Mechanical hazards:
4.1.1- Shock or impact damage:
Damage due to shock is usually caused by rough handling, during transport etc. Cushioning can be provided and a warning label may be useful. Restriction of movement and more careful handling should be made.
Fragile items may be broken, or collapsible articles crushed by compression, the usual procedure then being to protect with a rigid outer package. Top pressure or loading can distort inside. The crushing of a carton can make a product un- sealable even though no damage has occurred to the contents. This is more likely to occur during stocking in the ware house or during transport where vibration adds a further hazard. Compression can also occur in other situations like capping on a production line, when being carried home by the user etc.
Vibration consists of two variables-frequency and amplitude. Considerable vibration may occur during transport, especially with exported items. Damage may be external, such as the 'scuffing' of labels, but some products may be affected like the cracking of emulsions, abrasion of tablets, or segregation of mixed powders. Some times screw caps may be loosen or labels or decorations may abrade etc.
Although abrasion results form both regular and irregular forms of vibration , it is listed separately as the visual appearance of the product or package can be affected. eg: rectangular bottle in a carton will move up and down and from side to side. A round bottle in the same circumstances will suffer from an additional possibility of rotation.
4.2- Climatic or environmental hazards: Environmental conditions encountered by the package are likely to vary considerably, especially in articles for export to the tropical areas. In general, it is extremes of conditions that give rise to problems, and this is especially true of fluctuating conditions.
Extreme conditions may cause deterioration, low temperatures leading to aqueous solutions freezing and, hence, to fracture of containers. High temperatures increase diffusion coefficients, accelerating the entry of water vapor into hygroscopic products and the loss of volatile components. In addition, high, temperatures increase reaction rates and product breakdowns either by hydrolysis or oxidation. High temperature coupled with a high relative humidity will produce a slower effect if the temperature is lowered sufficiently to reach dew point. Contamination from liquid moisture can encourage mould and bacterial growth.
Moisture as liquid or water vapor may cause physical changes (e.g. color fading, softening, hardening etc) or chemical changes (hydrolysis, oxidation, effervescence etc). Although liquid moisture may cause obvious damage, water vapour may penetrate into a package, leading to hydrolysis, without visual changes. It is essential to check the water vapour permeability of materials to be used for packaging moisture-sensitive products; for example, plastics show considerable variation in this property. It may also act as a carrier for other contaminants like moulds and fungi.
Decrease in pressure, as in mountainous regions or during flight in non-pressurized transport aircraft, may cause thin containers to burst or strip packs to inflate.
4.2.4- Atmospheric Gases:
Gases from the atmosphere may diffuse into the package, leading to deterioration. Thus, oxygen will encourage oxidation, while carbon dioxide can cause a pH shift (un buffered solution in plastic bottle particularly Low Density Poly Ethylene (LDPE), which is relatively permeable to carbon dioxide) or lead to precipitation of some products (barbiturates from solutions of their sodium salts). Permeation of the common gases through plastic is typically in the ratio of 1:4:20 for nitrogen, Oxygen and Carbon dioxide respectively, nitrogen being more permeable. Odorous gases or volatile ingredients associated with perfumes, flavors and product formulation may also pass into or out of a package. If a volatile ingredient is lost from a flavor, an unpleasant odor or taste may result.
Light consist of wavelengths from the UV zones through the visible to infrared. A number of deteriorations are due to photochemical reactions particularly affected by the ultra-violet band of the spectrum. Such changes may not always be visible. Printed or deteriorated packaging materials may also suffer from discoloration ( white may go yellow, deeper colors may fade) and this may be seen as implying a change in the product efficacy or strength. Although light can be excluded by using selected material, tin plate, soil etc opacity and/or color may reduce penetration or filter out selected wavelength. The additional use of UV absorbers in plastics may also restrict light rays entering the packed it should also be noted that many products are protected by a carton, outer etc. Alternatively, an opaque outer packaging may be used, with a warming that the advantage that the latter may be transparent, permitting the contents to be inspected.
4.2.5-Solid airborne contamination( particulars):
Particulars matters present in the atmosphere will make the containers dirty during transport or storage. This can be prevented by outer wrappers or by anti static agents.
4.3- Biological hazards:
The packaging materials must be reasonably clean initially and when put together to form a finished package and restrict any further contamination as much as possible. In the case of sterile products the package and its closure must maintain a 100% effective seal against microbiological contaminants like bacteria, moulds and yeasts. Growth of yeasts is critical with sugar based products as fermentation may occur. Moulds will also grow on cellulose based materials like paper if these are kept under humid conditions. Care should be taken in order to avoid fluctuation in temperature.
4.4- Chemical Hazards:
The main risk of chemical hazard is due to interaction or in compatibility between the product and package. Compatibility investigations must basically cover any exchange that can occur between the product and the package and vice versa. These may be associated with interaction or contamination, covering migration, absorption, adsorption, extraction, corrosion, etc. where by ingredients may either be lost or gained. Such exchange may be identifiable as organoleptic changes, increase in toxicity/irritancy degradation, loss or gain of microbial effectiveness, precipitation, turbidity, color change, PH shift etc. These external influences may catalyze, induce or even nullify chemical changes.
The materials selected should have the following characteristics.
5)Packaging materials used in different formulations:
5.1-Paper and board:
The use of paperboard materials (cellulose fiber) remains a significant part of pharmaceutical packaging in spite of the facts that paper is rarely used on its own for a primary package. Cartons are used for a high percentage of pharmaceutical products for a number of reasons, increasing display area, providing better display of stock items and the collating of leaflets which would otherwise be difficult to attach to many containers. Cartons also provide physical protection especially to items such as metal collapsible tubes. Carton therefore tend to be a traditional of pharmaceutical packaging.
Regenerated cellulose film (trade names cellophane and rayophane ) are still used as an over wrapping material either for individual cartons or to collate a number of cartons. It is being substantially replaced by orientated polypropylene film. Although paper, even when waxed, has relatively poor protective properties against moisture, both paper and board (ointment, pill and tablets boxes) were once used widely for primary packages, particularly for dispensing operations.
5.2- Rubber based components:
Rubber components may be made from either natural or synthetic sources. Natural rubber has got good resealing (multi-dose injection), fragmentation and coring(description for the means by which particles are created when a needle is passed through a rubber) when compared to synthetic rubber; but is poor in respect to ageing and chances of moisture and gas permeation and the absorption of preservative systems is more. Sterilization by multiple autoclaving is also not possible. Synthetic rubbers tend to reverse all of these properties and some formulations actually contain natural rubber in order to improve re sealability, fragmentation and coring. Most rubber formulation are relatively complex and may contain one or more of the vulcanizing agents, accelerators, fillers, activators, pigments, antioxidants, lubricants, softeners or waxes. The main types of rubber used for pharmaceutical products include natural rubber, neoprene, nitrile, butyl, chlorobutyl, bromobutyl and silicone. Of these silicone is the most expensive and although the most inert, is readily permeable to moisture, gases and absorbent to certain preservatives. Rubber components are likely to contain more additives than plastics. Hence product-package interactions should be properly tested before they are used for injectable or intravenous type products. Rubber gaskets are also sound in aerosols and metered -dose pump systems . 5
5.3-Tamper resistant packaging:
The requirement for tamper –resistant packaging is now one of the major consideration in the development of packaging for pharmaceutical products As defined by the FDA "a tamper –resistant package is one having an indicator or barrier to entry which, if breached or trussing ,can reasonably be expected to provide visible evidence to consumers that tampering has occurred tamper –resistant packaging may involve immediate –container /closure systems or secondary –container /carton systems or any combination thereof intended to provide a visual indication of package integrity when handled in a reasonable manner during manufacture ,distribution ,and retail display ".
The following package configuration have been identified by the FDA as examples of packaging systems that are capable of meeting the requirements of tamper-resistant packaging as defined by FDA regulation
2. Blister package
3. Strip package
4. Bubble pack
5. Shrink seal and bands
6. Foil paper or plastic pouches
7. Bottle seals
8. Tape seals
9. Breakable caps
10. Sealed tubes
11. Aerosol containers
12. Sealed cartoon
5.3.1- Film wrapper:
Film wrapping has been used extensively over the years for products requiring package integrity or environmental protection. Film wrapping can be accomplished in several ways and varies in configuration with packaging equipment.
PHOTO 5.1: FILM WRAPPER MACHINE
Film wrapping machines can be generally categorized into the following types :
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