Hemp stability test in climate chamber
To provide high quality pharmaceutical products and their raw materials, regular tests must take place. Starting materials, intermediate- and end products undergo tests under various conditions both in the development and in the manufacturing phase. This includes a stability test in the climate chamber. How long does a substance remain stable under constant conditions and how does the quality change when the influencing factors are modified? These are questions that can be answered using a climate chamber. The stability tests take place according to the ICH guidelines.
Medicinal cannabis or medical cannabis is now used as a medicine for many diseases. Consistent quality is an important criteria for the therapeutic success. Even when the hemp plants are stored, the content of the ingredients must not fall below a certain reference level. Likewise, no decomposition products should accumulate. From the stability studies, the examiners derive storage recommendations and durabilty. Specific stability test requirements are defined for each product, which are equivalent to the climatic conditions during storage in practice. For the hemp stability test, an ambient temperature of 25 degrees Celsius and a relative humidity of 60 percent are simulated. The examination takes place over a period of one year.
With a modern climate test chamber, you can achieve constant conditions with complete documentation during the rather long test phase.
Cannabis as a medicine
The most well-known ingredient in the cannabis plant is THC, or tetrahydrocannabinol. Cannabis has fallen into disrepute due to the psychoactive properties of THC. However, phytocannabinoids also have positive properties that can be used for therapeutic purposes. With the so-called medical cannabis, a controlled use in certain clinical patterns take place. Medical cannabis is a generic term for various cannabis strains with variable levels of THC, CBD and numerous other phytocannabinoids. Medicinal cannabis is approved as a medicinal product based on a doctor’s prescription. The production of different formulations takes place from the trichomes of cannabis flowers. The extracted ingredients serve as starting materials for the pharmaceutical industry.
Phytocannabinoids act, among others, via the cannabinoid receptors CB1 and CB2. The receptors are distributed throughout the body and act as docking points for endocannabinoids – endogenous substances such as anandamide and 2-AG. The Endocannabinoid System (ECS) is involved in the regulation of many physiological processes. These include:
- Immune defense
- Pain perception
- Memory function
- Stress reaction
- Sleep and wake phases
Similar to the endocannabinoids, the phytocannabinoids also influence these processes as soon as they enter the body. Through the regulation of diverse biological processes, they are said to have anti-inflammatory, calming and pain-relieving effects. Some phytocannabinoids also have antibiotic, neuroprotective or antispasmodic properties, which means that medical cannabis is used for the following diseases, for instance:
- Rheumatic diseases
- Inflammatory processes
- Chronic pain
- Depression or anxiety
However, response to therapy varies from patient to patient. The reason lies in the distribution of the cannabinoid receptors, which can vary individually. In addition, a cannabis cultivar must be chosen that has high levels of phytocannabinoids, which provide relief from the corresponding clinical pattern. If this is the case, symptoms can be reduced and the quality of life may be significantly improved.
Stability testing according to ICH specifications
If a certain cultivar of cannabis is used for medicinal purposes, a stability test takes place for every cultivar. The hemp plant, the flowers or their processing products are tested in the climate cabinet on their storage ability and durability. For climate zone II, the long-term test must be carried out under the standard conditions of 25 degrees Celsius and 60 percent relative humidity. These conditions are established by law in the ICH guidelines. ICH stands for International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
Clitec climate cabinets – product variants
Climate chambers are ideal for achieving the required climate conditions over a long test period, regardless of the outside temperature. Whoever uses medicinal cannabis or industrial hemp for the extraction of phytocannabinoids during the product development phase cannot avoid extensive testing during the product development phase. Clitec offers you the right product for every step. Innovative climate cabinets, freezers or incubators help you at the highest level in the development, production and industrialization of your hemp products.
A climate cabinet for product testing can be realized in many variants. All solutions – whether as climate cabinets or walk-in chambers – convince with precision. An exact regulation of light, temperature and humidity is guaranteed. Whether for plant growth or for storage simulation – climate chambers can be used in many different ways. For standardized test methods in industry, for research or for training purposes: The innovative technology ensures convenient operation, easy programmability and high-precision functionality. The documentation of your settings is always guaranteed. Modern color displays inform you at any time about the actual and the target conditions.
Environmental simulation in the climatE test chamber
The climate test chambers offered by Clitec meet the ICH requirements according to Q1A and Q1B and correspond to the leading industry standards. The following stability- and photostability test cabinets are currently available:
- FitoClima 600, reach-in chamber, volume: 600 liters
- FitoClima 1200 , reach-in chamber, volume: 1200 liters
Thanks to the build up design, the climate cabinets can be positioned space saving, but offer effective use of the interior space. The climate cabinets are immediately ready for use and do not have to be assembled first. Various interior design options are possible by inserting multiple levels.
Innovative climatE test chambers: test conditions at the push of a button
A climate control cabinet should meet the relevant industry standards. ICH, FDA and GMP compliant cabinets can be used in a variety of test procedures. Once programmed, you have the possibility to retrieve the test conditions at the push of a button. All you have to do is only to fill the chamber with your samples. Modern constructions with stainless steel lining for optimal cleaning are available in different volume sizes. Comprehensive technical support, from commissioning to maintenance, is guaranteed when you purchase your stability test chambers from Clitec.