Operator Exposure Level - OEL

[ajaya.padhi]

Dear Friends,

Can anybody come up with a suggestion how to Sample & calculate/measure the OEL (Operator Exposure Level) for highly potent drugs ?

Say for example Finasteride drug..

Looking forward to hearing from you all.

AP

[DURGA PRASAD]

Calculation of OEL
OEL = ((N(L)OAEL) x BW) / (SF x α x V)
OEL: Occupational exposure limit
N(L)OAEL: No (lowest) observed adverse effect limit
BW: Body weight (70kg)
SF: Safety factor which considers uncertainties data (animal to human
variability in response, interindividual variability, and so on)
α: Degree of absorption (100 per cent in the absence of data)
V: Volume of air inhaled during an eight-hour working day


There are 2 classifications followed in OEL
1.Merck Classification
2.Safe Bridge Classification.

Regards
Durga Prasad

[Sanjiv]

Can anyone please inform
what is the OEL level required in Solid dosage plant for hormonal druges and not hormonal drugs?
What are the agencies involved in giving OEL level certificate to a pharma plant? Is it outside agency or a particular agency can only do this job?

Sanjiv Desai

[DURGA PRASAD]

You take OEL based on what product you manufacture.
OEL is tested by 3rd party in line with Regulatory guide lines.
Please enquire this in your place.
Probably you can enquire Klenzaids for this job in Mumbai.

[Affygility]

Calculation of OEL
OEL = ((N(L)OAEL) x BW) / (SF x α x V)
OEL: Occupational exposure limit
N(L)OAEL: No (lowest) observed adverse effect limit
BW: Body weight (70kg)
SF: Safety factor which considers uncertainties data (animal to human
variability in response, interindividual variability, and so on)
α: Degree of absorption (100 per cent in the absence of data)
V: Volume of air inhaled during an eight-hour working day


There are 2 classifications followed in OEL
1.Merck Classification
2.Safe Bridge Classification.

Regards
Durga Prasad

Actually, there are many different classification systems. Depends on your company's specific engineering controls. With advancements in containment technology, I've seen 4,5, and 6 band systems. I explain this in the video below.

[DURGA PRASAD]

Fantastic explanation.
Thanks a million for your time,posting vedio and explaining very well.
We shall certianly contact you. Thanks again for sharing your contact details.
Regards

[DURGA PRASAD]

http://www.aioh.org.au/downloads/doc...ngBNaumann.pdf