9.

0              ACCEPTANCE CRITERIA:

A. For Visual Inspection Criteria:

    

 There shall not be any visual evidence of

         

previous product on the product contact

parts and other equipment surface after
cleaning.
 
B. 10 ppm Criteria:
     

 Not more than 10 ppm of previous

         

product residue shall appear in the Next

Product.

C. 0.001 % Dose Criteria:

    

 Not more than 0.001 % of previous

         

product residue shall appear in the

maximum daily dose of the next product.

D. For Microbial Contamination:

    
 Sr. Swab Acceptance limit
 
No. Sample
01 Total NMT 100 CFU/Swab
Bacterial
Count
02 Total NMT  10  CFU/Swab
Fungal
Count
              Based on these acceptance
criteria lowest value shall be
considered for determination of
cleaning validity.

Cleaning Procedure: Reference SOP

            

(Page No. 7/17) & SOP No. PRT-022

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


Sifter 100 4
Outlet of feeder hopper (S3)
  Inner Surface of Sifter Bowl (S4)

 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)

 Die Cavity of Turret (S20)

Compression
 Discharge Chute (S21)


Machine
100 Inner Surface of Hopper – (S22) 5

 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