Hi everyone,
Can you tell me if one should establish a cleaning limit for oils, such as sesame oil /cottonseed oil, e the same way its normally done for active ingredients? Or is it not required since they are not active ingredients?
If so, how do you establish the oils cleaning limit, since they have no therapeutic dosages? Using the LD50 maybe?
Thanks.
[quote=jvcb]Hi everyone,
Can you tell me if one should establish a cleaning limit for oils, such as sesame oil /cottonseed oil, e the same way its normally done for active ingredients? Or is it not required since they are not active ingredients?
If so, how do you establish the oils cleaning limit, since they have no therapeutic dosages? Using the LD50 maybe?
Thanks.[/quote]
Yes, use the LD50 value. A calculation I’ve used in the past is below.
Limit = (LD50 x ABW x MBS) / (SF x LDD x SSA)
ABW - Average Body Weight of patients
MBS - Minimum Batch Size of next product
SF - Safety Factor (typically 1,000 or greater)
LDD - Lowest Daily Dose of next product
SSA - Shared Surface Area
I think you should perform the calculations and establish the limits, as this data can be very valuable in determining the level of testing you’ll perform on the oils. It may be that the limits are very high and you justify the use of visual inspection as your primary method of detection (assuming that the oils can be shown to be readily visible at safe levels).
[quote=darrel_jenkins]Yes, use the LD50 value. A calculation I’ve used in the past is below.
Limit = (LD50 x ABW x MBS) / (SF x LDD x SSA)
ABW - Average Body Weight of patients
MBS - Minimum Batch Size of next product
SF - Safety Factor (typically 1,000 or greater)
LDD - Lowest Daily Dose of next product
SSA - Shared Surface Area
I think you should perform the calculations and establish the limits, as this data can be very valuable in determining the level of testing you’ll perform on the oils. It may be that the limits are very high and you justify the use of visual inspection as your primary method of detection (assuming that the oils can be shown to be readily visible at safe levels).[/quote]
Thanks for your help.
What about cleaning limits for other excipients, such as benzyl alcohol? Can we determine the limits based on the LD50 too? Or based on pre-determined acceptable daily intakes (ADI)?
I noticed the WHO website has the ADI for some excipients used in the manufacturing of drug products, listed as food additives.