10.

0    SAMPLING PROCEDURES &

SAMPLING PLAN:

I. SAMPLING PROCEDURE
                                      

 Prior to swab sampling, cleaned

         

equipment shall meet “Visual Clean”

criteria.
 After cleaning of the equipment visual
         

inspection shall be done and reported in

report.
 After Visual Inspection is found
         

satisfactory sampling shall be carried out.

 Use Hand gloves and mask during
         

sampling.

A).  For Swab Sampling:

Soak the swab for about 10 minutes in Purified water in a test tube. Swab the area of not less

than 100 cm2 and transfer the swab back into the test tube containing Purified water and cover

the same. Sonicate the test tube for about 2 minutes and filter the solution
 The Swabbing shall be done in horizontal
         

or vertical strokes like below shown

procedure in the marked area assuring
that the entire area is swabbed.
 
            

            

            

         

After swabbing, rinse the swabbing location by

        

purified water to remove the traces of solvent.

         through Whatman No. 2 filter paper.
          B).   For Rinse Sampling:
 Rinse the entire equipment with the
         

specified quantity of the Purified water

and collect the rinse in a clean container.
Remove appropriate quantity of rinse
sample and filter through Whatman No. 2
filter paper.
                  Prior to sampling, cleaned
equipment shall meet “Visual Clean”
criteria.
Sampling shall be carried out as per
current version of SOP No. SQA- 075
according to sampling diagram attached
in the Annexure I. Number Of locations
shall be sampled as mentioned below.   
  
II. SAMPLING PLAN:
            

a. Swab sample for chemical/Microbial

      

analysis
 Product Contact Sampling Locations Total
Name of
Surface Area Nos. of
Equipment
(In cm2) Swabs

 Outlet of feeder hopper (S3)

Sifter 100  Inner Surface of Sifter Bowl (S4) 4

 Sifter Sieve surface (S5)

        Gasket of Sifter Ring (S6)

 Discharge Valve (S7)

Rapid Mixer
100
 Below the chopper (S8)
4


Granulator    (RMG)
Below the Mixer  (S9)

  Gasket (S10)

 Discharge Chute(S11)

FBD/FBP 100
 Upper Plenum(S12)
4

 Product Bowl Sieve(S13)

 Bowl(S14)
       Blades of multimill (S15)
Multimill 100 2
        Sieve of multimill (S16)

 Side Wall Corner  (S17)


Blender 100 3
Discharge Port  (S18)
        Gasket (S19)


Compression 100 5
Machine Die Cavity of Turret (S20)

 Discharge Chute (S21)

 Inner Surface of Hopper – (S22)

  Punch Tip – (S23)

 Inner Surface of Die – (S24)

b. Rinse Sampling For Chemical/

      

Microbial Analysis

Name of Equipment Sampling Locations Quantity of rinse (ml)

Collect the 500 ml rinse samples after rinsing the

FBD/FBP Outlet of hose pipe (R1) equipment with purified water.

Collect the 500 ml rinse samples after rinsing the

Compression machine
Outlet of hose pipe (R2) equipment with purified water.

III. SAMPLING PLAN FOR CHEMICAL

            

ANALYSIS
(NON CONTACT PARTS):
 Swab Location Sample No

Wall NC 1
Ceiling NC 2
Return Grill NC 3
Wall NC 4
Ceiling NC 5
Return Grill NC 6

CHEMATIC DIAGRAM WITH SAMPLING

LOCATIONS FOR EQUIPMENTS:

a) SIFTER
      
b) RMG
     

c) FBP/FBD