- Objective:To lay down a procedure for Control of Sieves and Screens of different Equipments.
- Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company.
- Responsibility
- Production Supervisor / Officer shall be responsible for implementation of the procedure as per this SOP.
- Head-Production / designee shall be responsible for compliance of this SOP.
- Accountability:
- Head-Production and Head QA shall be accountable for compliance of this SOP.
- Abbreviations and Definitions:
- SS : Stainless Steel
- BIS : Bureau of Indian Standard
- BSS: British Standard Sieve
- ISO: International Organization for Standardization
- MM : Material Management
- Procedure
- INDENT OF SIEVES AND SCREENS:
- Sieves and Screens shall be indent as per required sieve number and screen size.
- Indent shall be raised by Production Supervisor / Officer.
- Indent for the sieves and screens shall be made as per coding specification.
- Indent shall be approved by Head-Production / designee and submit to MM department.
- MM department shall send the purchase order to the manufacturer.
- INSPECTION ON RECEIPT:
- Number of Sieves and Screens received, shall be checked as per Purchase Order.
- Sieves and Screens Coding shall be checked as per Purchase Order.
- Integrity of Sieves and Screens shall be checked by Nominal Aperture Calibrator with Magnification.
- For 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.
- The distance between adjacent parallel wire (Nominal Aperture) is measured in both wrap and weft direction.
- Ten such readings shall be taken all over the mesh
- The average of these readings shall be the nominal aperture of the wire mesh.
- The 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.
- For the mesh size 40-200. The calibrator shall be placed on the wire mesh and count the number of wires in 2.5 mm.
- Multiply the counted number of wires with 10 it gives the number of wires in a linear inch, i.e. 25.4mm.
- The wire diameter of a particular mesh shall be taken from Annexure-7.
- The nominal aperture size of the wire mesh shall be calculated by using the formula given below.
- INDENT OF SIEVES AND SCREENS:
D = Diameter of wire
N = Mesh count = Number of wires/linear inch
Nominal Aperture size = (25.4/N)-D.
- All 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.
- On receiving new sieve / screen entry shall be made in Change Parts Register as per Annexure-1.
- Each 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.
- For 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.
- The identification number for the sieves or screen of the equipment shall be as following:
- Fisrt 2 digits shall denote name of the equipment like VS for Vibro 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.
- Vibro Sifter / Sifter: The numbering shall start with abbreviation of VS 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 VS-008-001.
- Same procedure follow for all Sieves and Screens of Different Equipment’s.
- Each sieve / screen shall be certified by its manufacturer for its material of construction, sieve no., and sieve size.
- Record of the sieves / screen and their identification numbers shall be maintained in Change Parts Register (Annexure-1)
- In 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 Administration Department through Engineering Department for disposal after affixing the label ‘SCRAP ITEM’ duly filled and singned by Production Supervisor / Officer.
- After 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.
- Sieve / Screen Status Register shall be maintained as per Annexure-2.
- Forms and Records
- Sieves / Screen Inventory Register- Annexure-1
- Sieves / Screen Status Register – Annexure-2
- International Sieve Comparison Table – Annexure-3
- Tolerance on Aperture Width – Annexure-4
- Sieve/Screen Inspection record – Annexure-5
- Standard Wire Diameter and Permissible Variations – Annexure-6.
- Distribution
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production, Quality Assurance, Administration and Engineering.
- History
| Date | Revision Number | Reason for revision |
| – | 00 | New SOP |
Annexure-1
Sieves / Screen Inventory Register
| Date | Supplier Name | Invoice No. with date | Item description | Quantity | Mother Equipment Name & ID Number | Assigned Identification Number | Remarks OK / Not OK | Signature & Date |
Annexure-2
Sieves / Screen 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-3
International Sieve Comparison Table
| SNo | AMERICAN US STD
/ ASTM E11 1987 |
BRITISH BS 410 1986 | FRENCH AFNOR NFX11-501 1987 | GERMAN DIN 4188 1977 | |||
| Alternative Inch/Mesh | Aperture mm/µm | Equipvalent BS MESH | Opening mm/µm | Equipvalent TAMIS No. | Aperture mm | Approx DIN No. | |
| 1 | 35 sieve | 500µm | 30 | 500µm | 28 | 0.500 | 12 |
| 2 | — | — | — | 450µm | — | 0.450 | — |
| 3 | 40 sieve | 425µm | 36 | — | — | 0.430 | 14 |
| 4 | — | — | — | 400µm | 27 | 0.400 | 16 |
| 5 | 45 sieve | 355µm | 44 | 355µm | — | 0.355 | — |
| 6 | — | — | — | — | — | 0.340 | 18E |
| 7 | — | — | — | 315µm | 26 | 0.315 | — |
| 8 | 50 sieve | 300µm | 52 | — | — | 0.300 | 20 |
| 9 | — | — | — | 280µm | — | 0.280 | — |
| 10 | 60 sieve | 250µm | 60 | 250µm | 25 | 0.250 | 24 |
| 11 | 70 sieve | 212µm | 72 | 224µm | — | 0.224 | — |
| 12 | — | — | — | 200µm | 24 | 0.200 | 30 |
| 13 | 80 sieve | 180µm | 85 | 180µm | — | 0.180 | — |
| 14 | — | — | — | — | — | 0.170 | 35E |
| 15 | — | — | — | 160µm | 23 | 0.160 | — |
| 16 | 100 sieve | 150µm | 100 | — | — | 0.150 | 40 |
| 17 | — | — | — | 140µm | — | 0.140 | — |
| 18 | 120 sieve | 125µm | 120 | 125µm | 22 | 0.125 | — |
| 19 | — | — | — | — | — | 0.120 | 50 |
| 20 | 140 sieve | 106µm | 150 | 112µm | — | 0.112 | — |
| 21 | — | — | — | 100µm | 21 | 0.100 | 60 |
| 22 | 170 sieve | 90µm | 170 | 90µm | — | 0.090 | 70 |
| 23 | — | — | — | 80µm | 20 | 0.080 | — |
| 24 | 200 sieve | 75µm | 200 | — | — | 0.075 | 80 |
| 25 | — | — | — | 71µm | — | 0.071 | — |
| 26 | — | — | 240 | — | — | 0.067 | 90E |
| 27 | 230 sieve | 63µm | — | 63µm | 19 | 0.063 | — |
| 28 | — | — | 300 | — | — | 0.060 | 100 |
| 29 | 270 sieve | 53µm | — | 56µm | — | 0.056 | 110 |
| 30 | — | — | 350 | 50µm | 18 | 0.050 | 120 |
| 31 | 325 sieve | 45µm | 400 | 45µm | — | 0.045 | — |
| 32 | 400 sieve | 38µm | — | 40µm | 17 | 0.040 | — |
| 33 | — | — | 440 | 36µm | — | 0.036 | 130 |
| 34 | 450 sieve | 32µm | — | 32µm | — | 0.032 | — |
| 35 | 500 sieve | — | — | 25µm | — | 0.025 | 200 |
| 36 | 635 sieve | — | — | 20µm | — | 0.020 | — |
| 37 | — | — | — | — | — | 0.016 | — |
| 38 | — | — | — | — | 0.010 | — | |
Annexure -4
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-5
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 —————–
Annexure-6
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 % |
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