Stability Ensures Efficacy

Raw eggs can be stored for just four weeks. Beer keeps fresh for half a year, while rice should be thrown out if it has not been eaten after two years.  Bionorica is able to ensure stability through its sophisticated production processes and quality control.

The problem is generally the same with all natural products: they can change with time. This is the challenge facing Bionorica’s experts as well because their products are based on herbal constituents. For this reason, the aspect of stability already plays an important role in the development of  herbal products . Are the constituents influenced by light, air or moisture? What form of packaging is most suitable? And what should be the minimum shelf life? After all, would customers even consider taking herbal products they bought a year ago?

It is known that most products are used immediately after they have been purchased. "However, we still have to keep in mind that, under certain circumstances, some people may go back to products that have been stored in their cabinets for years," says Dr. Harald Schuhbaum, who, as Bionorica’s Director of Quality Control, is also responsible for checking product stability. In this case, the product should not only be absolutely safe, but its efficacy must also be fully preserved.

Bionorica also markets its products in Kazakhstan, where even lakes as large as the Caspian Sea freeze in the harsh cold of winter.

As it is, Bionorica already invests a great deal of time and effort to ensure the quality of its products.

 All samples are stored under conditions that comply with worldwide standards as laid down by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which, among other things, establishes the norms for the Earth’s various climate zones. Producers who market their products in Central Europe or North America have to test the stability of their pharmaceuticals at 25° Celsius and 60 percent relative humidity. For Mediterranean countries the stipulated conditions are 30° and 65 percent humidity, and for Southeast Asia 40° and 75 percent. Bionorica’s air-conditioned chambers can match the requirements of any of these climate zones. A data logger records what conditions prevail at what given time. "In this way, the stability control is absolutely reproducible," says Schuhbaum.

Not only the finished products, but also samples of the supplied plant material and the extracts obtained from them are tested. And not even that is enough for Bionorica’s experts. "We also examine the stability of the products in various packaging materials," says Schuhbaum, referring to the amount of material constantly computer controlled by hygrometers, thermometers and other devices.

The perishability of Bionorica’s long-established recipes and products is also regularly controlled. "We want to offer our customers complete safety," stresses Schuhbaum. Samples undergo extensive testing in clearly defined intervals in order to check for any possible deviations from the norm. In the first year, analyses are carried out every three months, in the second year every six months. After that, Schuhbaum’s staff check the samples once a year. The control process is only considered complete after five years.

The percentage of active ingredient is another key concern in quality control because consumers must be able to rely on the efficacy. Pharmacist Schuhbaum: "For these substances it must be shown that their content remains at between 95 and 105 percent of the initial concentration during shelf life. This range is also valid for synthetic active ingredients." But Schuhbaum is not only interested in the reference substances. With the help of a chromatogram, his team can determine whether the volume ratio of the individual constituents is unchanged. The experts also perform microbiological tests because it is crucial that product quality is not damaged by bacteria, yeasts or fungi. "We have never had serious problems in this respect," says Schuhbaum. And this is true for the entire stability control process.

But if there have never been any problems why bother with the whole procedure? "Because a key aspect of science-based herbal solutions is to be able to rely on quality – at all times and in every respect," explains Harald Schuhbaum and adds, "and it is precisely our responsibility to see to this quality."