Chemical Durability

Do you see a risk of glass delamination for your products? We have developed a delamination screening package to assess the likelihood for delamination occuring during the shelf life of your product.

Long before delamination is seen by the naked eye, pre-indicators for delamination can be discovered by appropriate analytical techniques. One single analytical result like hydrolytic resistance is not enough to evaluate the specific interaction between your product and the container wall.

A combination of tests investigating the solution, the container surface, and the surface near region allow a determination for the risk of glass delamination to occur.  Together with our knowledge about the various contributing risk factors, these tests can support you in determining the best container to avoid delamination for your specific product.

Adverse effects like particle formation or corrosive attack on the container surface are often observed during stability testing after an extended time of storage.

In order to shorten the testing period, we apply tailored accelerated stress tests in combination with advanced analytical methods. After only a few days instead of months or years, we can provide data to advise pharmaceutical companies on the suitability of the given formulation with the intended container.

Spiking studies are performed to assess the impact of leached compounds on particle formation or aggregation.

The elimination of particles starts with their reliable characterization. Visual and sub-visual particles are analyzed in terms of their size, number, morphology, and chemical composition.

Based on a combination of special analytical methods different formation, pathways can be distinguished. Popular examples are glass particles due to glass corrosion, compounds formed between drug and packaging leachables, precipitation due to exceeding saturation levels, external contamination, or a mixture thereof.

Understanding the particle origin and formation mechanism is the first step for developing strategies to avoid them in the future.

For the verification of container component and system specifications, standardized testing is routinely required.  These test methods are stipulated in the pharmacopeia’s (US/EP/JP) and industry bodies (ISO, DIN, ASTM).

We offer many test methods including alkalinity, hydrolytic resistance, glass composition, transmission, needle conformity, stopper conformity, particulate counting.