SOP on Control of Sieves and Screens

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1.0Objective:
To lay down a procedure for Control of Sieves and Screens of different Equipments.
2.0Scope
This Standard Operating Procedure is applicable for formulation plant of pharmaceutical company.
3.0Responsibility
3.1Production Supervisor / Officer shall be responsible for implementation of the procedure as per this SOP.
3.2Head-Production / designee shall be responsible for compliance of this SOP.
4.0Abbreviations and Definitions
SS :Stainless Steel
BSS :British Standard Sieve
BIS :Bureau of Indian Standard
ISO :International Organization for Standardization
SOP:Standard Operating Procedure
MM :Material Management
QA :Quality Assurance
5.0Procedure
5.1INDENT OF SIEVES AND SCREENS:
5.1.1Sieves and Screens shall be indent as per required sieve number and screen size.
5.1.2Indent shall be raised by Production Supervisor / Officer.
5.1.3Indent for the sieves and screens shall be made as per coding specification.
5.1.4Indent shall be approved by Head-Production/designee and submit to MM department.
5.1.6MM department shall send the purchase order to the manufacturer.
5.2INSPECTION ON RECEIPT:
5.2.1Number of Sieves and Screens received, shall be checked as per Purchase Order.
5.2.2Sieves and Screens Coding shall be checked as per Purchase Order.
5.2.3Integrity of Sieves and Screens shall be checked by Nominal Aperture Calibrator with Magnification.
5.2.4For the mesh size less then 40 the calibrator shall be placed on the wire mesh and the individuals Opening is visualized by using the fine tunings.
5.2.5The distance between adjacent parallel wire (Nominal Aperture) is measured in both wrap and weft direction.
5.2.6Ten such readings shall be taken all over the mesh
5.2.7The average of these readings shall be the nominal aperture of the wire mesh.
5.2.8The nominal aperture size shall be compared with the standard size specified in Annexure-3 and Annexure-4 and if it falls within the specified tolerance the sieve is accepted.
5.2.9For the mesh size 40-200. The calibrator shall be placed on the wire mesh and count the number of wires in 2.5 mm.
5.2.10Multiply the counted number of wires with 10 it gives the number of wires in a linear inch, i.e. 25.4mm.
5.2.11The wire diameter of a particular mesh shall be taken from Annexure-VII.
5.2.12The nominal aperture size of the wire mesh shall be calculated by using the formula given below.
D = Diameter of wire
N = Mesh count = Number of wires/linear inch
Nominal Aperture size = (25.4/N)-D.
5.2.13All the screens and sieves shall be of SS 316 material of construction with lead free welding (e.g. argon arc welding) and shall comply with BIS / ISO / BSS or Pharmacopoeial standard.
5.2.14On receiving new sieve / screen entry shall be made in Change Parts Register as per Annexure-1.
5.2.15Each sieve shall be coded with Identification Number either engraved / written on its SS parts or silicon part, or shall be labelled (written) under the transparent silicon or Teflon ring.
5.2.16For numbering of the sieve or screen, first two letters shall represent the type of equipment then a ‘dash’ then size of the mesh in three digits again ‘dash’ and finally serial number in three digits.
5.2.17The identification number for the sieves or screen of the equipment shall be as following:
Fisrt two digits shall denote name of the equipment like MS for Machenical Sifter
Third digit shall denote dash (-)
Fourth, fifth and Sixth digit shall denote mesh size e.g. For mesh size 5 shall be written as 005
Seventh digit shall denote dash (-)
Eight, ninth and tenth digit shall denote serial number of the sieve / screen.
5.2.18Machenical Sifter / Sifter: The numbering shall start with abbreviation of MS as equipment name, then sieve size in number (in the case of wire mesh) and finally serial number of the sieve e.g.
Sieve with sieve size of 8 mesh shall be numbered as
MS-008-001, MS-008-002 etc.
Sieve with sieve size of 100 meshes shall be numbered as
MS-100-001, MS-100-002 etc.
5.2.19Each sieve / screen shall be certified by its manufacturer for its material of construction, sieve no., and sieve size.
5.2.20Record of the sieves / screen and their identification numbers shall be maintained in Change Parts Register (Annexure-I)
5.2.21In case any damage is observed during inspection prior to use , the same sieve / screen shall be immediately discarded by marking ‘Rejected’ with a permanent marker on its ring duly signed by Production Supervisor / Officer with date. Rejected sieve / screen shall be sending to Engineering Department for disposal after affixing the label ‘SCRAP ITEM’ duly filled and singned by Production Supervisor / Officer.
5.2.22After use sieve / screen shall be cleaned along with its parent equipment considering it a part of parent equipment comply its SOP and after cleaning cover with the stretch wraps and keep in the sieve storage area.
5.2.23Sieve / Screen Status Register shall be maintained as per Annexure-II.
6.0Forms and Records
6.1Sieves / Screen Inventory Register -Annexure-I
6.2Sieves / Screen Status Register -Annexure-II
6.3Tolerance on Aperture Width -Annexure-III
6.4Sieve/Screen Inspection record -Annexure-IV
6.5Standard Wire Diameter and Permissible Variations -Annexure-V
7.0Distribution
7.1Master Copy – Documentation Cell (QA)
7.2Controlled Copies – Production, Quality Assurance,   Administration and Engineering.
  • History
        Date
              Revision Number
                              Reason for revision
           –
00
                                                                      New SOP
                                                              Annexure-I
                                          Sieves / Screen Inventory Register
Date
Supplier Name
Bill No. or Invoice No. with date
Item description
Quantity
Mother Equipment Name & ID Number
Assigned Identification Number
Remarks OK / Not OK
Signature & Date
                                                            Annexure-II
                                        SIEVES / SCREENS STATUS REGISTER
Mother Equipment Name: ……………………………
Mother Equipment Identification Number: ……………                   Date …………………
S. No.
Description
Identification Number
Total quantity
Checked By
Total rejected quantity in numbers
Quantity Left in Numbers
Sent for disposal (date)
Sent for disposal (By)
                                                             Annexure-III
                                              Tolerance on Aperture Width
Nominal Aperture Width In Micrometers
Tolerances Of Average Aperture In Percentage
I000 to 500 microns
+ / – 5%
400 to 200 microns
+ / – 6%
I60 to 100 microns
+ / – 7%
80 microns
+ / – 8%
63 microns
+ / – 9%
50 microns
+ / -10%
40 microns
+ / – 11%
32 microns
+ / – 13%
25 microns
+ / – 15%
20 microns
+ / – 17%
   Annexure- IV
                      Standard Wire Diameter and Permissible Variations    
Sieve Size
Mesh
Wire Diameter In Microns
Tolerance on Wire Diameters
4.75 mm
4
1016
-15 % to +30 %
3.35 mm
6
914
-15 % to +30 %
2.80 mm
7
813
-15 % to +30 %
2.36 mm
8
711
-15 % to +30 %
2.00 mm
10
508
-15 % to +30 %
1.70 mm
12
416
-15 % to +30 %
1.40 mm
14
416
-15 % to +30 %
1.18 mm
16
375
-15 % to +30 %
1.00 mm
18
375
-15 % to +30 %
850 microns
20
416
-15 % to +30 %
710 microns
24
345
-15 % to +30 %
600 microns
30
254
-15 % to +30 %
500 microns
36
193
-15 % to +30 %
425 microns
40
213
-15 % to +30 %
355 microns
44
233
-15 % to +30 %
300 microns
50
193
-15 % to +35 %
250 microns
60
172
-15 % to +35 %
212 microns
70
152
-15 % to +35 %
180 microns
80
132
-15 % to +35 %
150 microns
100
101
-15 % to +35 %
125 microns
120
81
-15 % to +35 %
106 microns
150
61
-15 % to +35 %
90 microns
170
61
-15 % to +35 %
75 microns
200
50
-15 % to +35 %
                                                    Annexure -V 
                                    Sieve/ Screen Inspection Record
Date___________________                 Sieve / Screen Size No________________
Supplier Name___________                 Received By_________________________    
          
Size of Sieve/Screen.
                                                         Location
Av .Size
 
1
2
3
4
5
6
7
8
9
10
 
 
 
 
 
 
 
 
 
 
 
  
Inspected By /Date   —————–

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