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Glass containers are among the primary packaging material that has found use in the pharmaceutical industries. A large number of pharmaceutical formulations have been packaged using glass containers glass containers and they are usually the first choice of packaging materials. Glass is an inorganic material (mostly silicates) or mixture of materials which when heated up and then cooled, solidifies without crystallization.
Glass is principally made up of silica (59-80%) with varying degree of calcium oxide (5-12 %) sodium oxide (12-17 %) aluminium oxide (0.5-3.0 %), barium oxide, boric oxide, potassium oxide, and magnesium oxide. The high melting point of glass is due to the presence of silica. The melting point and melt viscosity of the glass is modified by the addition of oxides.
Glass containers are classified into Type I glass, Type II glass, Type III glass and Type IV glass based on their degree of chemical/hydrolytic resistance to water attack. The degree of attack is dependent on the degree of alkaline release under the influence of the attacking media.
This is a type of glass container that contains 80% silica, 10% boric oxide, small amount of sodium oxide and aluminium oxide. It is chemically inert and possess high hydrolytic resistant due to the presence of boric oxide. It has the lowest coefficient of expansion and so has high thermal shock properties.
Uses of Type I glass containers
Type I glass is suitable as packaging material for most preparations whether parenteral or non-parenteral.
They can also be used to contain strong acids and alkalis
Read Also: Plastic Containers for Pharmaceutical Use
This is a modified type of Type III glass container with a high hydrolytic resistance resulting from suitable treatment of the inner surface of a type III glass with sulfur. This is done to remove leachable oxides and thus prevents blooming/weathering from bottles. Type II glass has lower melting point when compared to Type I glass and so easier to mould.
Uses of Type II glass containers
They are suitable for most acidic and neutral aqueous preparations whether parenteral or non-parenteral.
This is an untreated soda lime glass with average chemical resistance. It contains 75% silica, 15% sodium oxide, 10% calcium oxide, small amounts of aluminium oxide, magnesium oxide, and potassium oxide. Aluminium oxide impacts chemical durability while magnesium oxide reduces the temperature required during moulding.
Uses of Type III glass containers
They are used as packaging material for parenteral products or powders for parenteral use ONLY WHERE there is suitable stability test data indicating that Type III glass is satisfactory.
They used in packaging non-aqueous preparations and powders for parenteral use with the exception of freeze-dried preparations
It is also used in packaging non-parenteral preparations.
This type of glass container has low hydrolytic resistance. This type of glass containers are not used for products that need to be autoclaved as it will increase erosion reaction rate of the glass container.
Uses of type IV glass containers
It is used to store topical products and oral dosage forms
Glass containers are formed through the following methods
Blowing &#; this involves the use of compressed air to form the molten glass in the cavity of a mold.
Drawing &#; this involves the pulling of molten glass through dies that shape the soft glass into ampoules, vials etc.
Pressing &#; The glass is formed by the use of mechanical force which presses or forces the molten glass against the ride of a mold.
Casting &#;the force of gravity or centrifugal force is used to initiate the formation of molten glass in the cavity.
Hydrolytic resistance test
i. Glass Grains test &#; used to distinguish Type I glass from Type II and Type III glass
ii. Surface Glass Test &#; used to distinguish Type I and Type II glass containers from Type III glass container. It is based on hydrolytic resistance of the inner surfaces of glass containers.
iii. Surface Etching Test/Comparison of Glass Grains Test and Surface Glass Test data &#; this is to determine whether high hydrolytic resistance of Type I or Type II glass containers are due to inner surface treatment or due to the chemical composition of the glass containers
Light/spectral transmission for coloured glass containers
Arsenic release &#; used to detect the presence of arsenic in aqueous parenteral preparations
There are various factors that influence selection process of glass containers as primary packages. These factors include:
Limit of alkalinity and hydrolytic resistance of the glass container
Thermal expansion properties of the glass container (freeze-drying)
Sensitivity of the glass container to barium or calcium ions
Glass containers are mainly used in packaging liquid preparations due to their rigidity and their superior protective qualities
Its high transparency allows easy inspection of its contents.
It offers better protection because it is relatively impermeable to air and moisture.
It is chemically resistance to most medicinal products.
Coloured glass (amber glass and red coloured glass) can protect its content from ultraviolet rays and certain wavelengths.
Glass containers can be easily sterilized using heat.
Glass containers are expensive to manufacture
They are fragile and relatively heavy
During heat sterilization, some types of glass containers have the tendency of shedding some part of the silica into the formulation.
Nasa P. (). A Review on Pharmaceutical Packaging Material. World Journal of Pharmaceutical Research, 3(5): 344-368.
Pillai S. A., ChobisA D., Urimi D. and Ravindra N. (). Pharmaceutical Glass Interactions: A Review of Possibilities. Journal of Pharmaceutical Sciences and Research, 8(2), 103-111.
Shivsharan U. S., Raut E.S. and Shaikh Z. M. (). Packaging of Cosmetics: A Review. Journal of Pharmaceutical and Scientific Innovation, 3(4), 286-293.
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The design and development of appropriate packaging for pharmaceutical products are vital to ensure the safe transportation, storage, and administration of medicines, some of which could be life-saving. Pharmaceutical packaging is mainly constructed of plastic or glass. Glass is often preferable due to its properties that allow for easy sterilization and visibility of the product it contains. Here we discuss how glass is used in pharmaceutical packaging and what benefits its use brings.
The pharmaceutical industry has used glass to produce safe and secure packaging for its vast array of products for many decades. This firm reliance on one material has been due to the various benefits it offers. Over the years, four main types of glass have been developed for use in pharmaceutical packaging.
Type 1: ultra-resistant borosilicate glass. This type of glass is chemically inert and highly resistant. Boron and aluminum-zinc molecules are used in borosilicate glass to replace the alkali&#;s and earth cations, resulting in a glass that is durable enough to contain strong acids and alkalis.
Type 2: surface treated soda-lime glass. This type of glass is even more chemically inert than borosilicate glass. Sulfur treatment is carried out on the soda-lime glass surface to prevent the weathering of the packaging it is used to create.
Type 3: regular soda-lime glass. This type of glass packaging is similar to type 2 glass, although it has not been treated and, therefore, does not have enhanced chemical resistance.
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Type 4: general purpose soda-lime glass. Usually, this type of glass is only used to create packaging for products intended for oral or topical use.
It is common for glass to be colored to protect products from ultraviolet rays that can impact their function and efficacy. Amber and red are the most common colors used to block these harmful rays.
The use of glass in pharmaceutical packaging has many benefits. First, glass is incredibly resistant to temperature. This glass property is highly valuable to the pharmaceutical industry, whose products frequently need to be kept at certain temperatures to ensure that they are not damaged and their properties remain unchanged. Therefore, glass can be used to maintain the optimal temperature of the products it encases.
Glass is non-reactive to chemicals. It is a material that will not jeopardize the content&#;s purity, even when its outside surface becomes exposed to other products and chemicals.
Pharmaceutical products are composed of specific, calculated mixtures of molecules. Potential contamination of these products poses a significant risk to the people these medicines treat. Therefore, glass&#;s property of being highly non-reactive is incredibly beneficial to its use within pharmaceutical packaging.
Certain types of plastic, another commonly used material in pharmaceutical packaging, are reactive. This means that they cannot be used to package all kinds of pharmaceutical products as they can react with the products they are designed to package. Scientists investigate the chance of potential reactions before deciding on the most appropriate packaging option. As glass is non-reactive, it is often chosen as the safest option.
Another benefit of using glass in pharmaceutical packaging is that it does not leak like certain types of plastic (which can leak a chemical called Bisphenol A or BPA). It has been suggested that contamination of pharmaceutical products with BPA can negatively affect the brain and blood pressure. While clinical studies have yet to be conducted to confirm this link between BPA leakage and poor health outcomes, glass choice as a material for pharmaceutical packaging eliminates this risk.
Glass can also easily be sterilized and face high temperatures without denaturing, destroying bacteria and germs.
Finally, glass has several other properties that give it advantages as a pharmaceutical packaging material. For example, glass is not only tough and durable, but it can also be easily labeled and molded into bespoke shapes and sizes.
Glass has many benefits as a pharmaceutical packaging material. While some experts foresee that the commonly used glass and elastomeric closure systems may eventually become outdated as scientists seek more effective barriers to protect life-saving therapies, glass will likely continue to be a key material in this sector.
The future of pharmaceutical packaging will see eco-friendly options being embraced, with recycled glass being a significant material. There is a current focus on developing strong, durable, safe, and sustainable pharmaceutical packaging. Bottles for tablets, syringes, and other pharmaceutical and medicinal products will likely continue to rely on glass for decades to come.
Glass packaging is highly common for use in the pharmaceutical industry. They offer an abundance of benefits, which is essential for the longevity, concentration, and safety of what is stored inside.
They are ideal for packaging solutions are they are easy to sterilize, great for protecting the contents from ultraviolet rays, do not react with chemicals inside, and are often transparent to easily see what&#;s inside.
Although all types of glass can offer the above benefits, it is important to be aware that there are various types of glasses and all offer different properties, prices, use, manufacturing, and availability.
To find out more about the types of glasses, what they offer, how they are used, and more, then continue reading.
How Are Glass Containers Made?
Glass containers for pharmaceutical practices are created using various methods. The most common include:
Blowing &#; compressing air into molten glass.
Drawing &#; pulling molten glass through dies that shape the glass.
Pressing &#; moulds the glass using mechanical force.
Casting &#; uses the force of gravity to force and initiate the shape of the glass.
All methods are then tested before use, to ensure that the glass container will be safe and effective for pharmaceutical use.
What Is Type I Glass?
Type I glass consists of various elements, all of which are great at resisting chemicals of strong acids and alkalis.
It is made up of 80%silica, 10% of boric oxide, and small quantities of both sodium oxide and aluminium oxide.
All type I glass containers are suitable for both parenteral and non-parenteral preparations.
What Is Type II Glass?
Type II glass containers are very similar to type III glass, so much so that they are considered as modified type III glass containers.
Like type I containers, and type III, type II has a high hydrolytic resistance, which makes them highly resistant to hot water. This makes them suitable to resist reactions and therefore, helps the contents to remain in their original state.
The difference between type II and type III glass containers is that the inside of type II containers is treated with sulfur.
The difference between type II and type I glass containers is that type II glass has a lower melting point. They are great at protecting the contents from weathering. However, type II glass is much easier to mould yet less likely to withstand hot environments.
The easy-to-mould glass makes it suitable for storing neutral aqueous and acidic chemicals.
What Is Type III Glass?
Type III glass is made up of 75% silica, 15% sodium oxide, and 10% calcium oxide. The remaining 5% of the glass consists of small amounts of magnesium, potassium, and aluminium oxides. The use of these small quantities helps the glass become more versatile. The aluminium oxide benefits the glass as it improves its chemical durability. Meanwhile, the magnesium oxide helps the glass become easier to mould at lower temperatures.
Type III glasses can be used in parenteral and non-parenteral practices, as well as being suitable for storing aqueous solutions. This type of glass is much more versatile.
The Key Differences
Although the types of glass boast similarities, such as being made up of similar materials and being suitable for similar preparations, there are some key differences.
Manufacturing process
The manufacturing process of the glass types varies depending on the industry. The listed manufacturing processes of glass containers are listed above.
Cost
Type III glass is the most affordable and type I glass is the most expensive. Type III glass is more readily available, due to type I glass needing extra manufacturing to make it more durable and resistant. Type II glass costs a little more than type III glass seeing as it requires a sulfur treatment (and sometimes dye) to help it resist UV rays.
Availability
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The most common glass is type III, which makes up 90% of glass production worldwide. Hence, type III glass is much more readily available.
With a treatment of sulfur on the inside, type III glass transforms into type II glass. Hence, it can be readily available too.
Type I is less available due to its more excessive manufacturing process, which makes it more durable.
Use
Type III glass is the most common packaging solution for pharmaceuticals, as well as everyday household containers. It is often referred to as soda-lime-silica glass and makes up 90% of the world&#;s glass containers.
Type II is less chemically stable and is, therefore, less common than type III glass. It is ideal for chemicals that can react to light in pharmaceutical preparations as type II glass is often dyed. The colour of the bottle can block UV rays and therefore, protect the contents from the reaction.
Type I glass is more common for pharmaceutical use only, as they provide greater heat and chemical resistance, which makes them more reliable and much safer. Type I glass is often referred to as borosilicate glass and is used for heat products, such as light bulbs, fire glass, storing jet fuel, and acid.
Overall, there are plenty of options to choose from for pharmaceutical packaging solutions. For practices and preparations that require more durable and resistant packaging, type I glass is highly recommended. It can resist heat as well as thermal shock and chemicals, which makes it much safer and ensures that the contents will not be affected. For those seeking more affordable and less durable packaging, type III and type II glass is ideal and practical.
Type II glass is suitable for medical preparations that require blockage from UV rays. The colourants used on type II glass helps them become protective for chemicals that can easily react to light. Choosing the right type of glass will benefit your preparations due to the easiness of sterilisation, safety, and resistance.
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Product Description
The glass grain hydrolytic resistance tester in medicinal glass packaging is an essential quality control test designed to assess the chemical stability of glass material against water. This test helps to determine the extent to which the packaging materials will interact with the pharmaceuticals they contain, potentially affecting the stability and safety of the medications. The hydrolytic resistance of glass grains is a crucial property that measures the durability of glass when exposed to water. This test evaluates how well glass grains withstand hydrolytic attack, which is essential for ensuring the quality and longevity of glass used in various applications, especially in pharmaceuticals and packaging.
The Glass Grain Hydrolytic Resistance Tester (GGHRT) is a specialized instrument designed to measure the hydrolytic resistance of glass grains. This device is essential for assessing the durability and stability of glass materials when exposed to water and other liquids.
The GHR-01A Glass Grain Hydrolytic Resistance Tester is applicable for the preparation of water resistance samples of glass granules used in medical glass products such as infusion bottles, injection bottles, ampoule bottles, and oral liquid bottles.
Based on the requirements for water resistance sample preparation of glass granules, the process intelligently carries out the crushing of glass and automatic vibratory sieving, featuring a high degree of automation in the equipment.
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ISO 719: Glass - Hydrolytic resistance of glass grains at 98&#; - Test method and classification
ISO 720: Glass - Hydrolytic resistance of glass grains at 121&#; - Test method and classification
The glass sample is placed into the mortar, where the pestle automatically descends and smashes the glass product into fragments. The tester then automatically vibrates the set of sieves, separating the qualified samples from the glass granule waste for collection.
1. Smartly automated, the tester combines crushing and vibration sieving into one unit, selecting standard-compliant sample sizes.
2. HMI screen operations ensure straightforward human-machine interaction.
3. With less manual handling, sample preparation is safer for personnel.
4. Safety devices shield against glass splatters, maintaining test integrity.
5. The eco-friendly process includes specialized glass waste collection.
6. Automated sieving boosts test precision.
7. A limit switch function adds automatic safety measures.
8. Its vertical design lessens gravitational effects on samples, ideal for larger sizes.
Mortar/Pestle Dimension
Φ50/Φ48 mm
Sieve A Aperture
425μm
Sieve B Aperture
300μm
Sieve O Aperture
600μmμm
Sieve Shaking Duration
5min
Gas Pressure
0.5 Mpa
Gas Port Size
&#;6 mm
Power
AC 110~220V 50Hz