Potent , most potent and non potent drugs (Cleaning Validation)

Dear All

Please help me on how can I categorize the API in Potent , most potent and non potent drugs during cleaning validation bracketing, to select the worst case.

Akhilesh Kushwaha
Baddi (India)

You must know the Occupation Exposure limit (OEL) in terms of milligrams per metercube of API that your company is manufacturing.Collect a list first and understand the GMP systems you are following.And plan a proper procedure to take a sample from the sufrace of used material.Take enough precuations that you do not contaminate neighbouring environments when you collect sample. Depending up on GMP’s and OEL you may use Ventilated Enclosures,Containment systems(RABS) , Closed Systems (Isolators) or at times Robotic systems.Make a proper validation plan and consider all importnt exposure, handling and disposal procedures.

It is commonly accepted that products are considered as potent when they present therapeutic doses lower or equal to 10 to 15 milligrams or 150 micrograms per kilogram of body weight. Moreover, in the field of environmental contamination, these products present an occupational exposure limit (OEL) lower than 10μg/m3 of breathed air per eight-hour working period. A product is considered as highly potent when this value of OEL is lower or equal to one microgram per cubic metre.

0.5 mg/m3 — LOW

0.05-0.01mg/m3 --Moderate

0.01-0.00001 mg/m3–Highly Potent

Less than 0.00001mg/m3–Extremely Potent

OELand PEL(Permitted daily Exposure Limit)both are same ?and How can i calculate OEL?

Please look this site.
The calculation is already posted.