Walk in Stability Chamber in Pharmaceutical

Description of Walk in Stability Chamber in Pharmaceutical

Walk in stability test chamber is used to test the law of changes in raw materials or pharmaceutical preparations over time under the influence of specific temperature and humidity, to provide scientific basis for the production, packaging, storage, and transportation conditions of drugs, and to establish the validity period of drugs through experiments.

Drug stability tests include influencing factor tests, accelerated tests and long-term tests.

1. Factor tests：High temperature test (not exceeding 60C) and high humidity test (usually not exceeding 75%)

2. Accelerated tests：The samples are divided into three batches, which are observed for 6 months in the environment of 40℃±2℃/75%RH±5%RH and 25℃±2℃/60%RH±5%RH respectively, at 30℃ ±2℃/65%RH±5%RH Observe for 12 months in an environment .

3. Long-term tests: Observe in the environment of 25℃±2℃/60%RH±5%RH and 30℃±2℃/65%RH±5%RH for more than 12 months.

Effects of Low Humidity

Static buildup is a major effect of relative humidity levels dropping below 45 percent. The accumulation of static charges can dry out medications, affecting the intended behavior of any solvents used in production. The excess static can also cause products to dry out and crumble, or stick together, leading to problems during tablet pressing and packaging.

Effects of High Humidity

High humidity causes products to absorb the excess moisture in the air, which can be just as destructive as environments with low humidity. Too much humidity can compromise potency and effectiveness, leading to degradation or even toxicity in some products. The potential for danger comes when relative humidity levels reach 60 percent or more; giving viruses, bacteria, mold, fungi and mites the opportunity to grow.