Can anyone provide me a draft protocol for cleaning validation of hormones.My client decided to start a multiple hormone Mfg facility.he requires to justify the cleaning of different male and female hormones using OEL ,i.e occpational exposure level…dont have any idea on this ,
You are combining two different subjects, i.e. OEL & MACO. OEL is an acceptable concentration of a hazardous substance in workplace air (µg/m3) and MACO is the acceptable residue in manufacturing equipment. So, you cannot correlate OEL and MACO
As you are manufacturing multiple products on your manufacturing line, identify the worst-case products and calculate the MACO.
Worst case previous product: Highest potent (lowest single dosage) & difficult to clean (lowest solubility in cleaning agent).
Worst case next product: Lowest batch size & low potent (highest daily dose).
mr veeraraju sory my question was little confusing thanks for ur prompt reply ,can u guide me with how to calculate ADE/PDE…for each products.
There are many ways for calculation of PDE. Based on dose, based on toxicity data, 10 ppm concept etc. Section 4.0 of APIC’s “Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants” has clearly explained these calculations, with examples.
just to add there is a difference between the above mentioned formula and ADE/PDE. This is different from the calculation mentione dabove. The above mentioned formula is for calculation of MACO whereas PDE is permissible daily exposure and is based on NOEL. Please refer draft guideline by EMEA on this and you will get it. If you dont find the link post a message i will send you the link.
pleae send me the link kalyan