Before buying a Stability Chamber you must have a clear knowledge on how the various components that are critical to the equipment and must be fully checked before you decide on your purchase.
You are aware of its function and that is the reason you have decided on purchasing this large scientific refrigerator if we can call it that. Replicating different temperature variations, humidity, and light differences for a long period, this equipment is critical in determining the efficacy of a compound under various natural conditions. A much-in-demand instrument mostly by the pharmaceutical companies who make drugs go through long periods of stability testing before studying their performance. The readings help in making the drugs maintain their quality under various temperature and climatic differences. The shelf life of the drug is determined and assigned after it has been tested in a stability chamber.
Who sets the stability guidelines?
The stability testing guidelines were determined by the International Conference on Harmonization (ICH), the World Health Organization (WHO), and other state and country authorities. The testing rules differ related to the product being tested for its stability. Pharma products have a stability testing procedure and guidelines available from various resources. Veterinarian medicines follow a certain stability testing guideline and other scientific findings follow their separate guideline depending on the substance under testing and the category it belongs to.
When a new product is being used for stability testing what does the test determine?
The quality, purity, potency, and identity of the product and its performance after a long period of storage.
The difference in its appearance, product degradation assay, microbiological testing, rection to moisture dissolution is the standard testing procedures on a given sample.
If the test is on a microbiological sample the test would include sterility efficacy of the preservative and the microbial count for liquid injectable preparations.
Particle size and polymorphic and enantiomeric purity are other test forms.
Apart from the product performance, the packaging performance for pharma drugs is highly significant as packaging integrity is directly related to product safety.
The reaction of products to light is significant in natural surroundings.
Compounds react differently and undergo a chemical stability variation. This may affect their appearance, chemical composition, consistency, if the product is a liquid the clarity of the solution may differ over a length of time, and the effect of moisture can impact the substance’s physical and chemical composition over time.
Why is the stability testing significant?
Products such as drugs or vaccines whose performance needs to maintain the same efficacy regardless of the climatic changes as the product may be traveling to different parts of the world. The product will be shipped to different corners of the world in shipments and will require days of storage in heavy cartridges, crossing different climatic conditions until it reaches its destination. The IHC has divided the world into five climatic zones with different temperatures and relative humidity.
| Climatic Zone | Temperatures | Humidity |
| Zone I | 21 °C (± 2 °C) | 45% RH (± 5%) |
| Zone II | 25 °C (± 2 °C) | 60% RH (± 5%) |
| Zone III | 30 °C (± 2 °C) | 35% RH (± 5%) |
| Zone IV | 30 °C (± 2 °C) | 65% RH (± 5%) |
| Zone IVb | 30 °C (± 2 °C) | 75% RH (± 5%)ASEAN Nations |
| Refrigerated | 5 °C (± 3 °C) | None |
| Frozen | 15 °C (± 5 °C) | None |
Therefore, a drug produced in India when shipped to the USA will need to travel Zone IVb to Zone I & II. The drug stability must be established from the source zone to the zones that it crosses to the final destination zone. In the case of pharma companies’ stability replication testing of the different climate, types are therefore critical.
What specifics must you consider for your stability chamber?
When you are thinking of purchasing a stability chamber your product should maintain three significant features. Control, conditioning, and construction.
Control
The chamber is controlled by a microprocessor. A multifunctional keypad sets the parameters such as the product and air temperature, ramp soak, alarm, temperature log, hot and cold mode, humidity, alarm for temperature excursion, door open, power breakdown, failure of a sensor, clock at real-time password entry and service prompt.
Conditioning
The interior should maintain a uniform temperature and humidity. The operational temperature and humidity range should follow the stability value that the equipment prescribes. Factory set electrically operated heaters manually programable with automatic cutout should take care of the cabinet warming. Excessive temperature conditioning should be maintained by the equipment.
Construction
The construction should be double walled preferably stainless steel or ridged stainless-steel frame. Insulation filling between the inner and external chambers should be of high-density PUF. The chambers should be well provided with steel wire mesh cable and removable trays.
The refrigeration system should have a CFC-free compressor and be hermetically sealed for quiet operation.
Automatic water filling and low water safety device to maintain humidity.
Quiet operation motorized blower assembly for air circulation.
Safety features for over-temperature protection over current protection and low and high-temperature limits and time delay for compressor switch along with many other features must consider features.
Before purchasing some important considerations
Measure the space where you want to fit the stability chamber, the dimensions should match. Check the power supply, a dedicated outlet circuit with the requisite amp, circuit breaker for precautionary tripping must be in place.
The product should have access to drainage space and spilled samples should have a special disposal facility. iGeneLabserve comes up with its Stability Chamber model that is easy to install and maintain. The operating instructions are explained in detail in the manual and the company provides adequate installation support and troubleshooting guidance. Visit https://www.igenels.com/ to look through the product catalog.