http://www.askaboutvalidation.com/forum/ Cleaning Validation - what are your methods en Thu, 09 Sep 2010 08:14:49 GMT vBulletin 60 http://www.askaboutvalidation.com/forum/images/misc/rss.jpg http://www.askaboutvalidation.com/forum/ http://www.askaboutvalidation.com/forum/showthread.php?t=3465&goto=newpost Thu, 02 Sep 2010 18:21:52 GMT I am trying to calculate the MACO for a mouthwash so the acceptable daily intake is not applicable. Would the following calculation be acceptable? ... I am trying to calculate the MACO for a mouthwash so the acceptable daily intake is not applicable. Would the following calculation be acceptable?

MACO = mg analyte product A divided by kg batch size of product A x weight in kg of the smalles batch size (product B) divided by a safety factor of 1000 x product contact surface area of shared equipment.

For example:6.63 kg of sodium fluoride per 600 kg batch = 6, 630,000 mg/600 kg =11,050 mg NaF/kg batch
11,050 mg NaF/kg x 19 F- /42 NaF = 4999 mg Fluoride ion/kg batch
Shared equipment = 21,106 in2
Safety factor = 1000
Smallest batch size = 6000 kg

Calculation:

MACO = 4999 mg F- x 600 kg (smallest batch) =0.1421 mg Fluoride Ion/in2
Kg batch 1000 x 21,106 in2

Therefore, for a 9 in2 swab area, the maximum allowable fluoride residue is 1.28 mg F- .
Thus this make sense? ]]> CLEANING VALIDATION gsmith4341 http://www.askaboutvalidation.com/forum/showthread.php?t=3465 http://www.askaboutvalidation.com/forum/showthread.php?t=3458&goto=newpost Tue, 31 Aug 2010 18:53:47 GMT Hello, Do we require cleaning in between two lots of same product or we can go ahead without cleaning? As product has same formulations there is... Hello,

Do we require cleaning in between two lots of same product or we can go ahead without cleaning? As product has same formulations there is no variation in components except two different lots.

Is there anything on FDA website about strictly following any guideline about this issue? ]]> CLEANING VALIDATION centenary http://www.askaboutvalidation.com/forum/showthread.php?t=3458 http://www.askaboutvalidation.com/forum/showthread.php?t=3439&goto=newpost Tue, 24 Aug 2010 16:00:45 GMT Hi,

I am trying to locate the regulation which "allows for substitution of cleaning reagents if they are at least equivalent to the detergents used during the validation process".

Can somebody help me in located this external requirements as applicable for medical devices industry?

Thanks,
Priyanka ]]> CLEANING VALIDATION priyankak http://www.askaboutvalidation.com/forum/showthread.php?t=3439 http://www.askaboutvalidation.com/forum/showthread.php?t=3425&goto=newpost Wed, 18 Aug 2010 12:56:10 GMT hello, I would like to know the microbiological standards for surface cleaning validation. could you help me please!!!!! best regards, ... hello,

I would like to know the microbiological standards for surface cleaning validation. could you help me please!!!!!

best regards,

ismahane. ]]> CLEANING VALIDATION ismahane http://www.askaboutvalidation.com/forum/showthread.php?t=3425 http://www.askaboutvalidation.com/forum/showthread.php?t=3424&goto=newpost Wed, 18 Aug 2010 03:39:26 GMT WHAT ARE THE ADVANTAGES OF H202 FUMIGATION SYSTEM (decontamination system perticularly for filling line) OVER H202 FOGGERS WHAT ARE THE ADVANTAGES OF H202 FUMIGATION SYSTEM (decontamination system perticularly for filling line) OVER H202 FOGGERS ]]> CLEANING VALIDATION ravi asalkar http://www.askaboutvalidation.com/forum/showthread.php?t=3424 http://www.askaboutvalidation.com/forum/showthread.php?t=3423&goto=newpost Tue, 17 Aug 2010 11:23:36 GMT Dear Forum Professionals, I have to perform cleaning validation for herbal extracts (API) process. I have experienced cleaning validation for... Dear Forum Professionals,

I have to perform cleaning validation for herbal extracts (API) process. I have experienced cleaning validation for finished drug product, but herbal extracts are very new to me.

The process is very simple. Natural sourced herbal plant will be extracted with ethyl alcohol, filtered, and concentrated to make viscous extract. The process equipment is multi-use with other products. I’ve tried to find some good resources to describe cleaning validation for herbal extract, but I couldn’t. My concern is as below.

Firstly, product grouping is an issue. If solubility data and/or toxicity data will be available, then the product grouping is much easier, but the information is absence.

Secondly, how to establish acceptance criteria? There is no dose information, as well LD50 toxicity data. In this case, what am I supposed to do?

Thirdly, what analytical method will be utilized? Herbal extract has very low level of active ingredient (approximately 2%). Is the analytical method specific for active ingredient?

I have completely no idea of this work. Please advise me to the right direction.

Thanks in advance,

HJ ]]> CLEANING VALIDATION hjkwon http://www.askaboutvalidation.com/forum/showthread.php?t=3423 http://www.askaboutvalidation.com/forum/showthread.php?t=3420&goto=newpost Tue, 17 Aug 2010 06:21:39 GMT Dear All , Can a facility that produced penicillin dosage forms be decontaminated and renovated for production of non-penicillin solid dosage... Dear All ,

Can a facility that produced penicillin dosage forms be decontaminated and renovated for production of non-penicillin solid dosage forms provided there is no further penicillin production in the renovated facility and what docoumnation/ cleaning validation reqiured can anyboudy explain in brief ?


Regrds

Himanshu C ]]> CLEANING VALIDATION himanshumb http://www.askaboutvalidation.com/forum/showthread.php?t=3420