Pharma glass recalls: Causes and preventative measures

Biomedical & pharmaceutical leadership and expertise

We have over 40 years’ combined experience in performing chemical and pharmaceutical testing for world-leading brands in the glass and pharmaceutical industries. Our experts have published scientific papers in this area and are members of the TC2 and TC12 technical committees.

View the full leadership team
Amy Ashton

Amy Ashton

Chemistry Laboratory Manager
Amy manages the chemistry department at Glass Technology Services and is a leading expert in chemical durability and elemental migration. Amy also assists the Quality Department as Technical Quality Manager. Read More

Areas of expertise:

Pharmaceutical glass packaging Quality assurance Method development and validation
Dr Marlin Magallanes

Dr Marlin Magallanes

Principal Technologist
Marlin has been working in the field of glass since 2006. As a Principal Technologist she oversees our bio-medical projects, as well as managing links with academic partners. Read More

Areas of expertise:

Glass and glass-ceramic materials for biomedical applications Glass manufacturing process Glass characterisation
Graham Morris

Graham Morris

Product Performance Manager
Graham is the manager of the Product Performance team and has worked at Glass Technology Services since 2014. He specialises in the failure analysis of glass articles from a range of sectors, utilising both optical and scanning electron microscope techniques to identify and interpret fracture markings. Read More
Martyn Marshall

Martyn Marshall

Melting and R&D Lead
Martyn has over 30 years’ experience in the design, development and production of silicate and non-silicate glasses for both commercial and scientific use, working globally with glassmakers. Read More
Dr Nick Kirk

Dr Nick Kirk

Technical Director
Nick is a glass expert with decades of experience in all aspects of sustainability, glass production, and product design across the global glass supply chain. Read More

Areas of expertise:

Glass production Sustainability and recycling Product design
Will Smith

Will Smith

Senior Technical Analyst
Will has over 6 years of experience in the glass industry, focusing on chemical and analytical techniques. His focus being pharmacopoeia and the suitability of glass products for the pharmaceutical industry. Read More
Abby Mills

Abby Mills

Senior Technologist
Abby has over 5 years' experience in Chemistry and Analytical techniques with glass materials, her main focus being ICP-OES analysis of heavy metals in glass and trace elemental analysis, as well as providing a range of analysis for the pharmaceutical industry. Read More
Daniel Capon

Daniel Capon

Technical Manager
Daniel is a specialist in glass analysis and focuses on XRF and SEM. He has worked in the glass industry since 1999 and overseas our glass properties and environmental departments. Read More

Biomedical & pharmaceutical glass services

Glass failure analysis

Glass failure analysis

Pharmaceutical companies are ultimately responsible for ensuring the stability of the containers their products are stored in. Using glass failure (or fracture) analysis, we can offer assurances by completing preventative quality assessments and performance testing to ensure due diligence.

Our glass failure analysis also enables us to determine the root cause of a glass breakage in the event of product failure. This comprehensive service combines glass fractography, laboratory analysis and microscopy, on-site investigation, auditing, inspection and expert witness support (if required by a failure scenario).

As well as specialist expertise, we can guarantee independence, confidentiality, speed and flexibility. 
 

Products this service is relevant to:

Glass delamination studies

Glass delamination studies

We offer both investigative analysis where delamination is suspected, and propensity studies for assessing delamination risk. This includes the suggested approach detailed in the United States Pharmacopoeia and referred to in the European Pharmacopoeia.
 

We work with pharmaceutical companies to ensure a glass container’s suitability for the pH of the product, the processing involved (including sterilisation and autoclaving) and the handling and storage conditions for the filled product. We also carry out studies at pre-determined temperatures, relative humidity levels, and over time periods that simulate the actual or accelerated ageing of filled products. This can predict the delamination propensity, determining the suitability or compatibility of different drug formulations.
 

We also offer two standard delamination study packages with the option to be able to tailor this to your specific requirements.
 

Products this service is relevant to:

Conformity to dimensional specifications

Conformity to dimensional specifications

We help glass manufacturers measure and verify the critical dimensions of a product against specific requirements. Our intricate measuring processes can prevent issues related to packaging and decorating glass containers, such as the application of lids and labels. 

The areas we measure include thread dimensions, internal bores, verticality or ovality, depending on the product and your needs.
 

Products this service is relevant to:

Pharmaceutical testing and verification

Pharmaceutical testing and verification

We are leading experts in pharmaceutical glass verification. We provide pharmaceutical testing and a range of analytical, quality assessment, mechanical testing and specialist services for glass used throughout the industry.

We regularly batch test pharmaceutical glassware for a range of global pharmaceutical manufacturers, importers and suppliers, verifying pharmaceutical compliance, dimensional specifications and mechanical performance properties.
 

Products this service is relevant to:

Extractable elements analysis (according to ICHQ3D)

This service is used to determine the amount of elemental impurities and migration in drugs products. The test method involves an accelerated test procedure to encourage leaching of specified elements from the glass inner surface. These elements are defined by the ICH Q3D as elements to be quantified with defined limits within the document itself.

Pharmaceutical manufacturing line auditing

In order to identify the point in the supply chain that could be responsible for a product issue identified by our product testing and analytical team, a line audit of the pharmaceutical production process from receipt of raw materials to dispatch can provide further supporting information to determine a possible point and how this can be overcome to eliminate the product issue. We have experience in many different glass production processes and will also be able to advise on possible production process improvements to maximise productivity.

Bespoke glass development and manufacture

Our experts provide a series of small-scale melting trials to confirm the suitability of new raw materials in glass production. We use comparative melting trials to establish differences between compositions or refining systems. The normal trial we offer is based on melting four glasses. The melts are all made to produce 250g of glass. We study the melting and refining of each formulation for 30, 60, 90 and 120 minutes, at a temperature comparable with the customer’s melting temperature.

The trials can also improve melting and refining performance and identify possible contamination. Plus, from an environmental perspective, it enables us to recycle more waste products.
 

Bespoke dissolution glass development and testing

The dissolution behaviour is an important characteristic of glasses used in biomedical applications. We can help you develop an understanding of the dissolution behaviour of your particular glass composition by relating dissolution processes to the glass morphology and chemistry combined with practical dissolution testing.  

Glass composition analysis

We can verify and benchmark compositional variations in your pharmaceutical containers. Our experts can analyse standard and exotic glass compositions, including commercial (soda-lime-silicate) and borosilicate glass. And they can diagnose production, batch and contamination issues. 

We use ISO/IEC 17025 accredited composition analysis to identify glass, raw materials, refractories, dusts and other inorganic materials. The analysis is typically carried out by x-ray fluorescent spectrometry (XRF). But for exotic/specialist glasses, specific requirements or trace element analyses, additional methods can be used. They include wet chemistry, atomic absorption spectroscopy (AA) and inductively coupled plasma optical emission spectrometry (ICP-OES). 
 

Client testimonials

Glass Technology Services has been a great partner…

Glass Technology Services has been a great partner and a vital part of MediSurge’s process to get our product to our customers. We receive great communication from the team that is both professional and timely. Our ability to service our customers hinges on this and we are very appreciative of our continued partnership with them.


Joe McDonough, Supply Chain Manager, MediSurge

The chemistry team at Glass Technology Services provide an invaluable service…

The chemistry team at Glass Technology Services provide an invaluable service analysing chemical composition and physical properties of our ceramic powders. They provide results in compliance with the relevant international standards and regulatory requirements. Their technical support is excellent and it gave us confidence in the routine and one-off analysis work they perform for us.


Dr. Henry R. Foxhall PhD CEng FIMMM, Technical and Operations Manager, Plasma Biotal

Additional services

R&D and innovation

We have unrivalled glass expertise across a broad range of sectors and can help you develop and optimise your scientific glass applications.

Training & webinars

Our in-house and external training courses teach organisations about various areas of glass production, such as packaging, analysis, and performance.

Consultancy

Our technical experts can provide you with market advantage, knowledge and technical input to processes or products, or develop entirely new and innovative glass formulations, uses or treatments.

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