Cleaning validation
Cleaning validation plays a crucial role to verify the effectiveness of cleaning procedures and ensure no risks are associated with cross contamination which harms the patient safety.Cleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used in the equipment below the scientifically set maximum allowable carryover level.
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Toxicological evaluation
Limits for residue carryover should be based on the toxicological evaluation of the active materials. These evaluations should be verified by a toxicologist (or equivalent) and performed in accordance with current guidance.Read More
Lowest published toxic dose
The Lowest published toxic dose (Toxic Dose Low, TDLo) is the lowest dosage per unit of body weight of a substance known to have produced signs of toxicity in a particular animal species. When quoting a TDLo, the particular species and method of administration are typically stated.Read More
Cleaning verification
Cleaning verification is a process gathering of evidence through chemical analysis after each batch/campaign to show that the residues of the previous product or cleaning agents have been reduced below the scientifically set maximum allowable carryover level.Read More