DeltaPV would be happy to support you in developing PDE/ADE reports.
Thanks to our database consisting of more than 2000 molecules and API's, all within various pharmaceutical routes, we can provide PDE values for your products for the cleaning validation approach.
You can request PDE/ADE report online for any API/Molecule by filling the table in the link.
For more detailed information about the reports, please click this link. A daily dose of a substance below which no adverse effects are anticipated, by any route, even if exposure occurs for a lifetime.
PDE values are obtained using scientific NO(A)EL or LO(A)EL results from animal studies
Identify compounds based on severity of hazard:
EMA considers ADE to be synonymous with PDE.
Documentation of ADEs/PDEs is critical as it demonstrates that the product owner has completed an appropriate hazard assessment and provides a scientific rationale for the recommended health-based limit to ensure patient protection.
HBELs should be derived by a qualified expert / experienced toxicologist.
The relevant calculations are carried out by the Toxicologist who is certified by the European Registered Toxicologist by the International Union of Toxicology (IUTOX) and the European Societies of Toxicology (EUROTOX). The European Registered Toxicologist title is evaluated every 5 years considering the Academic activity. All pharmacological and toxicological data (preclinical and clinical data) related to the active pharmaceutical ingredient should be evaluated scientifically.
"Reference: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" (EMA/CHMP/SWP/169430/2012).
"Reference: Setting HBELs Throughout the Product Life Cycle. Representing the International Society for Pharmaceutical Engineers" (ISPE)
DeltaPV has broad experience in occupational exposure limits (OEL) and calculation of
You can request OEL report online for any API/Molecule by filling the table in the link
Occupational exposure limits (OELs) are regulatory values which indicate levels of exposure that are considered to be safe (health based) for a chemical substance in the air of a workplace
Setting limits on the exposure of a specific substance helps employers to protect workers’ health from possible risks when using chemicals at work and to limit workers’ exposure to hazardous chemicals.
Occupational Exposure levels (OELs) derived by competent authorities or originator to ensure workers safety (WHO, OSHA, MAK) ECHA database of registered compound data During inspection be aware of challenges in identifying deliberate exclusion of data sources. If concerned about the risk from the product, refer the HBEL for expert assessment
Our Toxicologist are accredited by EUROTOX, ERT and for OEL Determination international and widely accepted Guidelines are reviewed to make a judgement about the risks to employees
Reference: Setting HBELs Throughout the Product Life Cycle. Representing the International Society for Pharmaceutical Engineers (ISPE)