# Cleaning Validation MAC vs Per Swab Limit

Hi,

Can anybody help me to select the best approach from following two, to evaluate the cleaning result.

Option 1: Individual swab results of each equipment in the equipment train will evaluate against the per swab limit. ( mcg/ 100 cm2)

Option 2: Cumulative carry over of all the equipment in the equipment train will evaluate against the MAC limit. (mg)

Example
Equipment Train consist of EQ1, EQ2, and EQ3 equipment.
EQ1
Location Result (mcg/100cm2) Suraface area Result (mg)
Per swab limit Carry over
1 4 2000 0.322
2 3.2
3 16.1
4 2.1
5 6

EQ2
Location Result (mcg/100cm2) Suraface area Result (mg)
Per swab limit Carry over
1 3 2000 0.5
2 4
3 25
4 7
5 1

EQ3
Location Result (mcg/100cm2) Suraface area Result (mg)
Per swab limit Carry over
1 4 2000 0.2
2 8
3 10
4 2
5 9

Limit 15 mcg/100 cm2 for individual
Total SA 6000 cm2
MAC 63 mg

Based on the data
EQ1 and EQ2 Fail in the individual limit
But all are pass if we cumulate carry over of all three (1.02 mg) and compare it with MAC.

which option do we need to take 1 or 2?

[quote=Punit]Hi,

Can anybody help me to select the best approach from following two, to evaluate the cleaning result.

Option 1: Individual swab results of each equipment in the equipment train will evaluate against the per swab limit. ( mcg/ 100 cm2)

Option 2: Cumulative carry over of all the equipment in the equipment train will evaluate against the MAC limit. (mg)

Example
Equipment Train consist of EQ1, EQ2, and EQ3 equipment.
EQ1
Location Result (mcg/100cm2) Suraface area Result (mg)
Per swab limit Carry over
1 4 2000 0.322
2 3.2
3 16.1
4 2.1
5 6

EQ2
Location Result (mcg/100cm2) Suraface area Result (mg)
Per swab limit Carry over
1 3 2000 0.5
2 4
3 25
4 7
5 1

EQ3
Location Result (mcg/100cm2) Suraface area Result (mg)
Per swab limit Carry over
1 4 2000 0.2
2 8
3 10
4 2
5 9

Limit 15 mcg/100 cm2 for individual
Total SA 6000 cm2
MAC 63 mg

Based on the data
EQ1 and EQ2 Fail in the individual limit
But all are pass if we cumulate carry over of all three (1.02 mg) and compare it with MAC.

which option do we need to take 1 or 2?[/quote]

Dear Mr.Punit

Please note carryover of individual equipment as well as cumulative limit for total equipment train should comply with pre defined limit.

Thanks