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FINISHED PRODUCTS

  

FINISHED PRODUCTS

Common additives and degradation products in packaging systems will be leached into drugs during the storage, transportation and use of finished products and eventually be ingested by patients. The final products will also have an impact on packaging systems, such as glass erosion and flaking. The compatibility project evaluates the compatibility between the packaging system and the final product by extractables and leachables testing.

Production Process Components

PRODUCTION PROCESS COMPONENTS

The production process components can be Single-Use Systems, silica gel pipes, 316L stainless steel pipes, filter elements and ultrafiltration membrane packages, etc. In the process of cleaning and sterilization, the production system leaches various additives and their degradation products. Compatibility project evaluates the compatibility between production systems and process liquids through extractable and simulated extractable experiments.

DRUG DELIVERY DEVICE

  

DRUG DELIVERY DEVICE

Drug delivery devices are usually medical devices with short contact time, such as disposable sterile syringes and disposable sterile infusion devices. Because of the short delivery time, the common additives DEHP and TOTM plasticizers in drug delivery devices need to be investigated in general. In addition, in order to investigate the effects of drugs, the adsorption effect of drug delivery devices on the active ingredients of drugs should also be investigated. Compatibility project evaluates the compatibility of drug delivery devices and drug solutions through extractable experiments, simulated clinical experiments and adsorption experiments.

TOXICOLOGICAL EVALUATION

  

TOXICOLOGICAL EVALUATION

Compounds have different toxicity according to their structural types. Traditional toxicological evaluation methods are obtained by animal experiments. However, due to the long time and high cost of research, more scientific and rapid toxicological evaluation methods need to be selected. Toxree and other software were used to evaluate and classify the toxicology of compounds by TTC method to determine the acceptable limits of compounds.