Did you know that picking glass packaging for pharmaceuticals and medical products has many advantages over picking other popular materials such as plastic or aluminium? Although glass can sometimes be delicate to handle and prone to smashing easily when dropped, it does offer many beneficial properties that other materials do not.

Are you interested in learning more about glass packaging material in pharmaceutical? Contact us today to secure an expert consultation!

It&#;s Temperature Resistant

It&#;s extremely important that pharmaceuticals are kept at their optimal temperature, as any slight change can affect the medicine&#;s properties. Glass packaging is fantastic at regulating the temperature of products, as it doesn&#;t react to changing temperatures by losing structure or leaking chemicals.

It&#;s Non-Reactive To Chemicals

Glass is a strong non-reactive material, meaning that it it will not leak any matter into the liquid within any glass container. This feature is of course especially important for pharmaceuticals, as medicines are comprised of delicate balances of elements to create the correct mixture that will treat the patient. If anything is leaked into this fine balance, then it is likely that the medicine would not be as effective. Some types of plastic packaging can react with the contents within them, so it&#;s best to take the advice of Jens Heymann, Senior Vice-President of Europe & Asia Tubular Glass at Gerresheimer; &#;Drugs must be carefully examined at an early stage, ideally when clinical tests with the primary packaging begin. The pharmacist must ensure that all possible interactions between the contents and the packaging are recorded and assessed for risk.&#;

It Doesn&#;t Leak Or Seap

Some types of plastic can leak Bisphenol A (BPA), which is a chemical found in many types of plastic, that is thought could cause possible ill health effects to the brain and blood pressure when ingested. Although this fear is yet to be conclusively proved by science, if you have any doubts about using plastic to package your pharmaceuticals, then you need to opt for glass packaging for pharmaceuticals.

It Can Be Easily Sterilised

Sterilising glass is so easy because it can hold structure when exposed to high boiling temperatures, making it simple to kill off any harmful bacteria and germs. Glass can also be baked afterwards to dry it a controlled way and it won&#;t crack!

Here at Glass Bottles, we&#;ve got brilliant ranges of glass packaging for pharmaceuticals!

Medicine Bottles

Our collection of medicine bottles comprises 5 different ranges: Rectangular, Flask, Sirop, Apothecary and Winchester. All of these ranges are available in a choice of amber or clear glass, apart from the Rectangular and Flask ranges which are available in only amber and only clear glass respectively.

Our Apothecary Bottles look like they&#;ve come straight out of the middle ages, thanks to the old-fashioned glass stopper cap that comes with each bottle. It has a snug fit to preserve the freshness of the medicine inside, as well as giving the bottle a distinctive, quirky look. These bottles are available in sizes from 50ml to 250ml and are ideal for packaging tablets or supplements. The other ranges of medicine bottles are all perfect for packaging cough syrups, children&#;s liquid paracetamol and any other form of liquid medication.

Prices for our medicine bottles start from just 9p each!

Pill Jars

Our Pharmapac Jars are again available in a choice of amber or clear glass, and in sizes ranging from 30ml up to 500ml. You have the choice of purchasing these jars without a lid, or with the compatible screw on lids, which are available in black urea or white urea depending on the jar size. These lids are lined with rubber to keep the contents inside free from contamination and to prevent leakage. We think that these jars are simply ideal for storing pills, powders and supplements.

Prices start from just 23p each!

Lab Vials

Finally we have our lab vials, which are only available in clear glass. They come in all shapes and sizes, from thin to squat and ranging from 1.75ml to 30ml in capacity. They are ideal for use in laboratories, but also for use as a vessel to send out product samples in or even as packaging for your ranges of luxury essential or aromatherapy oils! Each vial comes complete with a snap on cap or stopper cap to stop any product from leaking.

Prices start from just 14p each!

Liked our guide to glass packaging for pharmaceuticals? Then we think that you&#;d also like our thoughts on why glass is a great packaging material for drinks!

Posted on 21st Sep by Alysha Bennett in Bottles, Interesting, Jars, Products. Tags: glass bottles, glass jars, glass vials, medicine bottles, pill jars.

The 10 most frequently asked questions on glass &#; Part I

We recently sat down with Dr. Bettine Boltres, our contact for scientific affairs and technical solutions for glass. In her role she is supporting pharmaceutical companies to address glass-related topics from a scientific perspective and to gain a deeper understanding of the material that holds their valuable drug products. Having done this for many years, we wanted to know what the most frequently asked questions are that she encounters. Please read Part 1 of our two-part series around the 10 most commonly asked questions around glass vials:

1. What is Type I glass and why is there sometimes an &#;A&#; or &#;B&#; designation?

The required quality for glass containers for pharmaceutical applications is described in global pharmacopeia, e.g., USP Chapter <660> Containers &#; Glass or Ph. Eur. 3.2.1. Glass Containers for Pharmaceutical Use. Apart from pharmacopeia, the different glass types are also described in standards, such as ISO and ASTM.

USP and Ph. Eur. have classified Type I glass as Borosilicate (BS) glass and Type III glass as soda-lime (SL) glass, each one with a certain limit for hydrolytic resistance. Typical BS glasses on the market are FIOLAX®, Corning®51-D / 51-V and NSV® 51. As it is an accepted custom to treat SL glass with ammonium sulfate on the inside to increase its chemical stability, this inner surface-treated SL glass was added in pharmacopeia and classified as Type II glass. Although there are different sub types of BS glass on the market, these are not differentiated in pharmacopeia. However, ASTM E 438 does distinguish between Type I Class A which is a BS glass with a lower thermal expansion, such as DURAN® or PYREX® glass and Type I Class B, which is a BS glass with a higher thermal expansion (alumino-borosilicate glass as per ASTM), known as FIOLAX®, Corning®51-D / 51-V or NSV® 51 glass.

ISO simply lists different glass compositions without labelling them as Type I or II or A or B.

As new glass compositions come to the market, pharmacopeia and standards need to find a way to accommodate them.A recent example is the Aluminosilicate glass composition that is used in Corning® Valor® Vials which is in the process of being added to the USP <660> chapter this year.

USP <660>, Ph. Eur. 3.2.1

Borosilicate

USP <660>, Ph. Eur. 3.2.1

Inner surface-treated soda-lime-silica

USP <660>, Ph. Eur. 3.2.1

Soda-lime-silica

For more information, please visit stopper in chemistry.

ASTM E 438 - 92

Low-expansion borosilicate glass

ASTM E 438 - 92

Alumino

-borosilicate glass

ASTM E 438 - 92

Soda-lime glass

2. What does the &#;R&#; in 2R mean?

Dimensional requirements for vials are laid out in ISO Injection containers and accessories. The first version of this standard was published as Injection containers for injectables and accessories in . ISO simultaneously worked on two versions, one for vials made of tubular glass (ISO -1: Part 1: Injection vials made of glass tubing) and for molded vials (ISO -4: Injection vials made of moulded glass). As these two production techniques produce quite different dimensional accuracy and tolerances, the requirements were set accordingly. To reflect the different production techniques also in the designation of the vials, an abbreviation for each technique was added. The German word for &#;tubular&#; &#;Röhre&#; was selected and lent the &#;R&#; to the injection vials made of tubular glass; the German word &#;Hüttenglas,&#; meaning &#;molded glass,&#; lent the &#;H&#; to the vials made of molded glass. So, the &#;R&#; behind a filling volume number (e.g., 2R) means that this tubular glass vial has the dimensions as given in ISO -1, while the &#;H&#; behind the number (e.g., 10H) means that this 10 mL vials was produced by molding and complies with the dimensional requirements from ISO -4.

However, as this background is not known to everyone, the &#;R&#; is sometimes also used for non-ISO vials, so we recommend to always double-check.

3. How strong is glass?

Unfortunately, this question cannot easily be answered. Because glass is a brittle material, its strength is not a material constant but very dependent on flaws occurring within the material or on its surface. In quite simple words: the more flaws, such as scratches and cracks, the glass has on its surface, the weaker it is. This reduces its theoretical strength which initially is in the GPa range to a practical strength of around 70 &#; 100 MPa. To quote Littleton, who was one of the pioneers in glass strength testing: &#;We do not measure the actual strength of the glass but the weakness of the surface.&#;

Also, for the sake of completeness, we want to mention that imperfections on an atomic level and stress from improper thermic treatment count as flaws.

A very comprehensive overview of how to avoid the introduction of surface flaws through handling is given in the PDA Technical Report 87 Current Best Practices for Pharmaceutical Glass Vial Handling and Processing. It is particularly useful in combination with PDA Technical Report 43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing: Covering Ampules, Bottles, Cartridges, Syringes & Vials.

Improving glass handling is a very efficient way of keeping as much as possible of the initial strength of the glass. But there is also a way of increasing the strength of glass which is to subject it to an ion exchange process where the sodium ions in the surface regions are replaced by larger potassium ions that build up a compressive layer and can hereby increase the practical strength of the glass significantly. An example for this is the Valor® Glass that is being used with different medicinal products, such as vaccines, biologics and lyophilized products on the global market.

4. Is glass inert?

A common belief is that glass is inert. If we look at the scientific definition of &#;inert&#; we can find in the Cambridge Dictionary: &#;Inert&#;substances&#;do not&#;produce&#;a&#;chemical&#;reaction&#;when another&#;substance&#;is&#;added,&#; and in the Oxford Dictionary: &#;A material that is very stable and does not readily take part in chemical reactions with other substances&#;. Based on these definitions, there is almost no inert material, except for certain gases. Most solid materials do interact with their environment, even if only on a very small scale. For example, glass does interact with aqueous solutions. This can be on the outside with the humidity from the air where it builds up a &#;water skin&#; or on the inside with the aqueous drug solution. The extent to which the reaction takes place is dependent on many different factors, such as initial state of the glass surface, pH value of the drug solution, chemical properties of the involved substances in the solution, filling volume, converting process and several more. Examples for interactions are ion exchange between the glass and the solution, chemical reactions that cause substances to precipitate, chemical reactions that lead to a dissolution of the upper glass surface layers, chemical attack that leads to delamination of the upper surface layer, etc. As it is individual for each drug solution / vial combination, the potential interactions should be examined through extractables and leachables studies. Additionally, the surface condition can be visualized using spectroscopy techniques like scanning electron microscopy energy-dispersive X-ray spectroscopy (SEM-EDX), Time-of-Flight Secondary Ion Mass Spectrometry (TOF-SIMS) or X-ray photoelectron spectroscopy (XPS).

5. How can I sterilize my glass vials?

There are different sterilization techniques out there that all come with their own advantages and disadvantages. A widely used method on the market is terminal sterilization, which is a final autoclaving step after the vials have been filled with the drug solution. This is commonly done for water for injection or other aqueous diluents. Autoclaving involves heating up to 121°C and typically keeping it there for around 20-30 minutes. Based on the European Medicines Agency (EMA) Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container terminal sterilization is the preferred method.

Given the fact that many biologics are sensitive to heat, terminal sterilization is sometimes not an option, and an alternative treatment needs to be applied. As biologics are typically filled using aseptic filling processes, the empty vials must be sterile already before introducing them into the filling process. Nowadays, this is usually done by using Ethylene oxide (EtO). Hereby, the vials are placed in nests and tubs or nested trays and introduced into a chamber where they are fumigated with EtO at up to 70°C for around 6 hours. A disadvantage here is presented by the toxic EtO residuals that need to be fully removed and the environmental burdens the EtO residuals cause.

There are also other techniques that can be used but come with their own caveats. In the medical device world, it is very common to use gamma or e-beam sterilization. Such radiation approaches can technically also be used for glass containers. However, due to the trace amounts of certain metals in the glass composition, the color of the glass will turn brownish/yellowish depending on the exposure time and the concentration of the radiation. This effect is neither affecting the physical intactness of the vial nor its chemical stability, but as a cosmetic implication &#; even though it will disappear after a certain time - it is not well accepted. While not very common, it is possible to use a special cerium-doped borosilicate glass that will not discolor. Additionally, gamma radiation needs Co60 as a radiation source, which is currently under debate for capacity constraints.

Based on those disadvantages, other existing techniques for sterilization / decontamination are being evaluated for glass containers, such as N2O, VHP, VPA, etc. As they also all come with their own caveats, the future of sterilization remains to be seen.

Look out for Part 2 of this blog series where Dr. Boltres will share the remainder of the top questions she gets asked about glass.

References:

1. Question:USP <660> Containers &#; Glass; United States Pharmacopeia ()
   Ph. Eur. 3.2.1. Glass Containers for Pharmaceutical Use; European Pharmacopoeia ()
   ISO : Guidelines on types of glass of normal bulk-production composition and their test methods; International Organization for Standardization ()
   ASTM E438 &#; 92 Standard Specification for Glasses in Laboratory Apparatus; ASTM International ()
   USP is announcing a proposal to modify the glass classifications in General Chapter and to create additional flexibility for packaging and storage requirements in specified monographs | USP-NF (uspnf.com)
2. Question:ISO -1: Injection containers and accessories - Part 1: Injection vials made of glass tubing; International Organization for Standardization ()
   ISO -4: Injection containers and accessories - Part 4: Injection vials made of moulded glass; International Organization for Standardization ()
3. Question:70-100MPa: Wagner, J, Müller-Simon, H, Lenhart, A. Practical strength of glass containers. Part 2. Influence of handling. Glastech. Ber. Glass Sci Technol. 67, , Vol. 7, pp. 196&#;201Littleton: Vogel, W. Glass Chemistry. 2. Aufl. Berlin: Springer, .
   PDA Technical Report 87 Current Best Practices for Pharmaceutical Glass Vial Handling and Processing; Parenteral Drug Association ()
   PDA Technical Report 43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing: Covering Ampules, Bottles, Cartridges, Syringes & Vials; Parenteral Drug Association ()
   Schaut, R., A., et al. (). Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers. PDA J Pharm Sci Technol, 71(6), 511-528. doi:10./pdajpst..
4. Question:Cambridge Dictionary: Retrieved 3 Jul. https://dictionary.cambridge.org/dictionary/english/inert
   Oxford Dictionary: https://www.oxfordreference.com/display/10./oi/authority.;jsessionid=98DAC50CA7A9D9FF5BC11C6
   Oxford Dictionary: Retrieved 3 Jul. , from https://www.oxfordreference.com/view/10./oi/authority..
   Boltres B. (). When Glass Meets Pharma. ECV INSIGHTS!. ISBN: 978-3--432-2
5. Question:EMA/CHMP/CVMP/QWP//: Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container; European Medicines Agency,

Trademarks mentioned:

Corning®, Valor®, and PYREX® are registered trademarks of Corning Incorporated.
All other trademarks appearing in this document are the properties of their respective owners.

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