Dear All,
Does any body help about scoop cleaning validation
scoop…? you mean like to scoop product by hand from one container to another? if so, use a disposable scoop- that’s the easiest. otherwise if a scoop is your only product contact item it is cheaper to dedicate a re-usable scoop to that project than it is for the lab to do the test procedure validation and analysis for swabs…
Scoop what we use is made up of SS316. We have 3 different scoop pairs.Once after use we will wash them with mild detergent and then with Hot DM water and give a rinse with Hot DM water. This rinse samples are taken once in 15 days to see normally any cross over of detergents or potential API’s from them.This was validated by swab and Rinse methods.
Probuck certainly gave a great idea to use a disposable scoop. This is possible in US/EU .Its not possible in India as these are expensive and SS material and fabrication is much more cheaper in India.
Hi All,
I Do agree with Mr. Durga.
Gr8 methodology one can utilize & in addition to this one can also use the dedicated SS-316 scoops [Project / Product dedicated]. It simplify the procedure.
No need to cleaning validation, only physical cleaning is required after & before use.
Happy Reading !
DOSE IT REALLY REQUIRED TO PERFORM cv OF SCOOP
THEIR IS NO AS SUCH DIFFICULT TO CLEAN AREA IN SCOOP AND WE ARE JUSTIFIYING THE EQUIPMENT SUCH AS RMG COMM. MACH. WHICH ARE HAVING REALLY DIFFICULT TO CLEAN AREA ON THAT BASIS CAN WE JUSTIFY THAT THE SCOOP HAVE NO MAJOR ROLL IN CROSS CONTAMINATION.
PLS DO YOUR VALUABLE COMMENTS ON THIS.
shreeshail_123@yahoo.co.in
Every company should have a seperate Dispensing and Sampling Kit
This is a rule of GMP.
If you follow GMP guidelines every equipment must be cleaned and cleanliness has to be verified by a validated method.
We all know scoops do have different sizes and different materials like API’s, Excipients,Vitamines etc are dispensed and sampled.
We have to ensure that these supporting material transferring equipment must be clean to prevent cross over from one API to another API thus causing some dangers to patient compliance.
“If you think scoop cannot aid in cross contamination , then there is no point in cleaning the LAF after dispensing/sampling since it plays an Indirect part”.
Here we are talking about logical scources–especially in antibiotic industries cross contamination pose a major risk to patients.
Regards
Scoop validation is important when scoops are used to dispense only APIs or shared between APIs and excipients. The cleaning procedures for manufacturing and packaging equipment are validated and these equipment only contain comparatively small percentage of API, whereas the scoops are used to dispense 100% pure API so small carryover can cause huge contamination. Yes, it is excellent idea to use disposable or dedicated scoops but if not then scoops should be validated. However to make it simpler the scoops can be dedicated to dosage forms.
Regards
Neena