Scientech provides Extractable and Leachable services that would address the risk associated with using certain CCS to ensure a safe delivery of your product.
Extractables and Leachable studies help mitigate degradation risks, preventing issues such as cracking, discoloration, and chemical leaching into drug products.
Extractables and Leachable studies of container closure systems (CCS), medical devices, and processing equipment reduce the risk degradation resulting from the presence of heat, light, oxygen, and various external influences, such as sterilization.
Such degradation can manifest itself as cracking, discoloration, or surface blooming/exudation and can severely impact the mechanical properties of the CCS. Stabilizers and other additives are often incorporated into polymers of the CCS to prevent this degradation. Plastics and Rubber CCS are more susceptible to leaching unwanted chemicals into the drug products.
cGMP compliant
FDA registered
DEA licensed
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