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International regulations consider parenterals as high risk for adverse consequences from their packaging. Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants.
Parenterals are products intended to be applied directly to the human body. Therefore, parenteral products must be free from microorganisms, pyrogenic substances and other visible particles. Since contaminated parenteral drug products will cause serious health problems for the patient, sterility assurance and package integrity testing are of great importance in parenteral drug production.
One of the parenteral products package test methods is “Vacuum decomposition technology”
It is a non-destructive Container Sealing Integrity test method used to detect leaks in package seals. Proven to be the most practical and sensitive vacuum-based leak testing method, Vacuum Decay Technology is capable of detecting leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials.