Product Failure Analysis

The product quality is the prime consideration in any pharmaceutical, because it involves human health. Drug quality is easily affected by environment factors such as light, temperature, humidity, and microorganism during its usage and storage. Improper usage and storage may lead to product defect or failure, resulting in drug quality decline. Pharmaceutical products are strictly regulated, and the product defects or failure are intolerable since they have potential hazards to patients, which can eventually cause serious consequences. Product defects or failures may cost a company millions of dollars and seriously damage its reputation. A failure analysis testing usually is required when a product's quality and shelf-life suddenly decline, or when foreign particles/contaminants are found in product, or when customers complaint about product quality. The analysis and determination of the cause of product failure is particularly important for pharmaceutical companies.

When your product fails, a test is necessary for you to know the cause and how to implement the solution. Generally, failure analysis is more dependent on experience as many unanticipated factors could contribute to failures. Alfa Chemistry has worked with pharmaceutical companies for decades, and our experts are experienced in pharmaceutical products failure analysis. Our experience almost covers all types of drug products. Whether the failure is caused by the raw materials, defects in product design, or an unknown contamination from the production and processing, we can rapidly offer a reliable solution and accurately determine the cause of your product failure. Our scientists can solve a variety of failure analysis problems including:

• Inappropriate raw materials

• Poor product design

• Process related issues

• Unknown contamination

• Improper use of the product

Depending on the nature of your problem, a wide range of instrumentation in our failure analysis labs are available for our scientists. We can bring a wide array of non-destructive and destructive analytical methods to solve your problem. Through obtaining some necessary information for a thorough investigation like the micro-structural, elemental and molecular information, we can quickly and accurately determine the cause of your product's failure.

Microscopy

• Optical microscopy

• Scanning electron microcopy (SEM)

• SEM/EDS

Microscopy techniques enable detailed investigations of micro structures and particles.

Chromatography

• GC/MS

• HPLC

• LC/MS

• IC

Chromatography methods are used to identify an unknown substance or contaminant on a product.

Thermal Analysis

• TGA-FTIR

• DSC

Thermal analysis provides some valuable information like differences in composition, thermal history and stabilization of a product.

Spectroscopy

• FTIR

• Raman

FTIR and Raman microscopy are suited to determine the chemical nature and the origin of all kinds of particles, inclusions and other microscopic contaminations.

After completing the analysis, we provide clients a comprehensive failure analysis report, the recommendations on preventing product failure in future is also included in our reports. Our team of highly qualified and experienced technical staff are willing to work with you to develop and deliver testing and analytical solutions regarding your product failure. Looking forward to hearing from you.