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Swab/Rinse Limit
      Calculator

ASTM E3418 Safe Limit Calculator

To be used in Conjunction with the ASTM E3418 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices




Industry Type


Sample Type


HBEL (mcg)
Min Batch Size (kg)
  
Swab Area (cm2)
Optional
% Recovery





% Carbon
 
 
Max Daily Dose (mg)
Total Surface Area (cm2)
  
Dilution Volume (mL)
                 
           
                 
 
MSC (mcg)
      
MSSR (mcg/cm2)
  
         
   
Safe Swab Limits
    
ppm in sample
ppm adjusted for Recovery
ppm as TOC
                 
ppb in sample
ppb adjusted for Recovery
ppb as TOC
           
           



ASTM E3418 Safe Limit Report

For Pharmaceuticals/Biologics

Provided By

Date Performed

ValueDate

INPUT DATA

Product Name

Subsequent Product Name

Valueproductname

ValueSubProductname

HBEL 

(mg)

Smallest Batch Size 

(kg)

 Area 

(cm2 )

%Recovery (optional)

ValueHBEL

ValueSmallestBatchSize

ValueRinseArea

ValueRecovery

ValueMaxDailyDose

VlaueTotalSurfaceArea

ValueRinseVolume

ValueCarbon

Max Daily Dose 

(mg)

Total Surface Area 

(cm2 )

Volume 

(mL)

%Carbon (optional)

CALCULATIONS

Maximum Safe Carryover = 

HBEL × SBS 

      MDD

Maximum Safe Surface Residue  = 

HBEL × SBS 

MDD x TSSA

Safe Limit (drugs) = 

 

HBEL × SBS × RA

MDD x TSSA x RV

Limit adjusted for %Recovery = 

Limit x RRF (decimal)

Limit adjusted for %Carbon = 

Limit/ %C (decimal)

where:

HBEL = health based exposure limit of residue (from ADE/PDE monograph),

SBS = smallest batch size of the next product in the equipment/manufacturing train,

RA =  rinse area (area rinsed during sampling),

MDD = maximum daily dose of the next product,

TSSA = total shared surface area of the equipment/manufacturing train in contact with the product

RV = volume of solvent used to rinse the residues from the equipment surface

RRF = rinse recovery factor from recovery study

%C = percent carbon in compound under study

RESULTS

Maximum Safe Carryover (mg)

ValueMaximumSafeCarryover

Parts Per Million

ValuePartsPerMillion

PPM Adjusted For Recovery

ValuePPMAdjustedForRecovery

PPM As TOC

ValuePPMAsTOC

Maximum Safe Surface Residue (µg/cm2 )

ValueMaximumSafeSurfaceResidue

Parts Per Billion

ValuePartsPerBillion

PPB Adjusted For Recovery

ValuePPBAdjustedForRecovery

PPB As TOC

ValuePPBAsTOC














 

ASTM E3418 Safe Limit Report for Medical Devices

Provided By

Date Performed

ValueDate

INPUT DATA

Product/Residue Name

Valueproductname

HBEL

(mg)

  Area

(cm2 )

%Recovery (optional)

ValueHBEL

ValueRinseArea

ValueRecovery

VlaueTotalSurfaceArea

ValueRinseVolume

ValueCarbon

Total  Device Surface Area

(cm2 )

Volume

(mL)

%Carbon (optional)

CALCULATIONS

Maximum Safe Surface Residue  =

HBEL

TDSA

 Safe Limit (Medical Device) =

 

HBEL × RA

TDSA x RV

Limit adjusted for %Recovery =

Limit x SRF (decimal)

Limit adjusted for %Carbon =

Limit x %C (decimal)

where:

HBEL = health based exposure limit of residue (from ADE/PDE monograph),

RA = swab area (area swabbed during sampling),

TDSA = total device surface area of the device in contact with the patient

RV = volume of solvent used to rinse the residues from the equipment

SRF = swab recovery factor from recovery study

%C = percent carbon in compound under study

RESULTS

Maximum Safe Surface Residue (µg/cm2 )

ValueMaximumSafeSurfaceResidue

Parts Per Million

ValuePartsPerMillion

PPM Adjusted For Recovery

ValuePPMAdjustedForRecovery

PPM As TOC

ValuePPMAsTOC

Parts Per Billion

ValuePartsPerBillion

PPB Adjusted For Recovery

ValuePPBAdjustedForRecovery

PPB As TOC

ValuePPBAsTOC