For the pharmaceutical industry, the performance of glass containers, vials, ampoules and syringes is critical to the ultimate success of the product. When there are issues related to packaging your products in glass, you can count on American Glass Research to provide answers. Our expertise in the areas of fracture analysis, flaw identification, testing, defect evaluation, contaminant identification and glass durability has proven invaluable to our pharmaceutical clients. This is especially true when the FDA and other regulatory agencies are involved.

The consulting services of primary interest to pharmaceutical clients are listed below:

Flaw Identification/Evaluation
Through visual examination and quantitative determinations, the nature of flaws in glass articles can be characterized.  Some flaws are cosmetic and can lead to poor product appearance while others are functional and can reduce glass surface strength and potentially lead to failure. Knowing the severity of a flaw will promote a fact-based decision process when considering the potential for performance problems.

Performance Testing
An evaluation of expected container performance can be obtained with a well-designed test protocol. Testing samples through the application of anticipated loads such as internal pressure (lyophilization), vertical load (stoppering), strap action (capping and crimping), thermal shock (depyrogenation and lyophilization) and impact (handling) will provide the information needed to proceed with confidence.

Fracture Diagnosis
The highly developed science of fracture diagnosis involves the examination of broken glass to identify the root cause of the failure. When glass breaks, it will adhere to well-established patterns while providing valuable information as to exactly how, when and why it broke. Fracture diagnosis can reveal the answers to these critical questions.

Contaminant Identification
At virtually any point in the process stream, glass articles can become contaminated with unwanted foreign materials.  These flaws are not only unsightly, but can also present concerns over strength loss, product performance, brand image, and, in the worst cases, consumer health. Proper identification of these contaminants is essential.

Glass Quality
Knowing that your pharmaceutical glassware is of the highest quality in regards to composition, permanent residual stress and durability is essential. AGR has the capabilities to ensure that your expectations of quality are being met.

Line Audit
A detailed examination of the filling can be performed to identify areas or procedures that may lead to breakage or performance problems. The entire operation is assessed visually. In addition, quality procedures relating to handling are reviewed. Drawing from extensive experience in the evaluation of filling lines, areas of concern are identified and useful recommendations are made.

Design Analysis
Computer design analysis provides both quantitative and graphical predictions of the magnitude and location of stresses generated throughout a container when various loads are applied. These stress results are compared to known service requirements of the container such as filling line speed, closure application forces or thermal loads. If the comparison shows any indication of potential underperformance, modifications to the design or service requirements are recommended.

Training Seminars
Pharmaceutical-specific seminars along with sessions on fracture analysis and design analysis offer a valuable combination of classroom instruction, demonstrations and hands-on workshops. All of the seminars offerings can be customized to suit the needs and requirements of our clients.