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Inspection and Handling of Sieves and Screens

Standard Operating Practices (SOP) for the receipt, checking, passivation, storage, and disposal (handling) of Sieves/Screens.

Procedure for Handling of Sieves and Screens

1.0   PURPOSE:

    • The purpose of this SOP is to lay down the procedure for inspection & handling of Sieves and Screens.

2.0   SCOPE:

    • This SOP is applicable to the receipt, checking, numbering, passivation, usage, storage and disposal of-
      • Sieves
      • Mill screens,
      • Co-mill screens,
      • Roll Compactor (Alexander  Werk) screens,
      • Quadro Co-mill and
      • Quadro sifter screen

3.0   REFERENCES:

    • In House
    • SOP for Cleaning of newly received SS part, SS fabricated parts.       

4.0   RESPONSIBILITY – SOP FOR SIEVES AND SCREENS:

    • The operator shall be responsible for Cleaning and Storage of sieve/screen as per the defined procedure.
    • Production Supervisor shall ensure cleaning and storage of the sieve/screen as per the defined procedure.
    • Ensure the numbering of the sieves/screens.
    • Production Supervisor shall arrange for the destruction of damaged sieves & screens.
    • Production Supervisor shall provide training to the new operators before involving in operation and maintain all necessary records.
    • Department Head/Designee shall be responsible for the follow-up and review of the SOP.
    • Quality Assurance shall ensure proper usages of the sieves/screens before use and to authorize the destruction of damaged sieves & screens.
    • Maintenance shall arrange for the destruction of damaged sieves & screens.
    •  QA Head shall be responsible for the Compliance and approval of the SOP.

5.0   ABBREVIATIONS– SOP FOR SIEVES AND SCREENS:

    • AL: Alexander Werk Roll Compactor
    • BMR: Batch Manufacturing Record
    • CM: Comminuting Mill
    • QDM: Quadro Co-Mill
    • QDS: Quadro Sifter

7.0   PROCEDURE FOR HANDLING OF SIEVES AND SCREENS:

    • Sifter Sieves:

    • On receipt, check the sieve for receipt quantity and size on sieve mentioned by the supplier against delivery challan or PO.
    • Clean the sieve by using a clean dry cloth and then checked for engraved mesh size against the delivery challan.
    • The Engineering head, Production head, or designee shall verify the certificate received from the supplier of newly received sieves.
    • Number all-new sieves in continuation from the earlier sequence.
    • Example: For the first sieve of 60 mesh, if 900 mm diameter the number shall be given G/900/60#/001, Similarly for the first sieve of 30 mesh having 750 mm diameter, sieve number – G/750/30#/001.

    • Where-

      • G: Granulation,
      • 750/900: Diameter and,
      • 30#/60#: Mesh size
      • 001: Serial Number.
    • Check the sieve for its intactness visually and no rupture or damage should observe.
    • Record spot observation in sieve checking Report (Annexure-1).
    • If any rupture or damage observed at the time of receipt. Reject the sieve and returned to the supplier.
    • Check the sieve for its mesh number, by checking the number of opening per linear inch at 5 different locations, horizontally and vertically at each location.
    • Check the numbers with calibrated scale magnifier / Densitometer.
    • In case of checking with scale magnifier to convert reading into inch multiply it with 2.54.
    • In case of densitometer if reading is taken on ¼”, ½” and 1” scale, multiply the reading with 4, 2 and 1 respectively, to get the value per inch. Record the readings in the Sieve checking report (Annexure-1).
    • Acceptance criteria are ±2% mesh size. Accept the sieve, if the opening corresponds to the acceptance criteria as per sieve checking report (Annexure-1) to the sieve mesh size printed on the ring of the sieve then the sieve is to be accepted.
    • In case there is a difference between the number of perforations and the sieve size written on the sieve ring then the sieve is to be rejected and returned to the supplier.
    • If the sieves mesh size is 100# or more than 100#, no need to check visually through Scale magnifier/Densitometer.

    • Attach the supplier certificate to Sieve checking report (Annexure-1).

    • A record of the same is made in the Sieve and Screen Inventory Register (Annexure-3).
    • The accepted sieve is then passivated as per SOP of ‘Cleaning of newly received SS parts, SS fabricated Parts of equipment.
    • Follow the SOP of ‘Cleaning and Operation of Vibratory Sifter’ for the cleaning of sifter sieves.
    • If any sieve is damaged. Destroy the sieve by handing over to the maintenance department after taking destruction approval from the department head and QA.
    • The user department shall assign Disposal record number as 00X.
    • Where X is the serial number. (Example: Assign the number very first damaged sieve/screen disposal record number as 001 then followed by 002, 003…..)
    • Record the destruction details in the Sieve and Screen Inventory Register (Annexure-3).

    • Screen for Comminuting mill and Co mill:

    • On receipt, check the screen for receipt quantity and pore size on-screen mentioned by the supplier against delivery challan or PO.
    • Clean the screen by using a clean dry cloth and then checked for engraved screen size against the delivery challan.
    • Engineering head, Production head, or designee shall verify certificate received from the supplier of newly received screens.
    • Check the screen for its intactness visually and no damage observed.
    • Record spot observation in Screen checking Report (Annexure-2).
    • If any damage observed at the time of receipt. Reject the screen and returned to the supplier.
    • Check the screen for its pore size in mm, by using calibrated scale magnifier (up to 6mm) and calibrated Vernier calipers (more than 6mm) at 6 different locations.
    • Record the readings in the Screen checking report (Annexure-2).

    • Acceptance criteria are ±2% of the pore size.

    • If the pore size corresponds to the acceptance criteria as per the screen checking report (Annexure-2) to the screen size engraved on the screen. Then accept the screen.
    • Number the new screen in continuation from the earlier in sequence.
    • Example: For the first screen of 1 mm, and 150 mm diameter the number –
      • G /CM150/1.0mm/001,
    • For second no of 1 mm screen, and diameter 150 mm –
      • G/CM150/1.0mm/002.
    • Similarly for the first screen of 2.5 mm of 300 diameters, screen no. –
      • G/CM300/2.5mm/001.

    • Where-

      • G: Granulation
      • CM: Comminuting mill (Clit mill)
      • 300: Diameter of Clit mill
      • 2.5: Screen size
      • 001: Serial Number
    • The new screen for the Co mill is to be numbered in continuation from the earlier in sequence.
    • Example: For the first screen of 10 mm for 250-liter RMG the number – G/RMG250/10.0mm/001,
    • for the second number of 10 mm screen for 250-liter RMG- G/RMG250/10.0mm/002) and
    • Same step to follows for the numbering of the screen for 600-liter RMG and 1200 liter RMG.
    • Where-
      • G: Granulation
      • RMG: Rapid Mixer Granulator
      • 250:  Capacity of Rapid Mixer Granulator
      • 10.0 mm: Screen Size
      • 001/002: Serial Number
    • In case there is a difference between the pore size and the screen size written on the screen then the screen is to be rejected and returned to the supplier.
    • A record of the same is made in the Sieve / Screen Inventory Register (Annexure-3).
    • The accepted screen is then passivated as per SOP of ‘Cleaning of newly received SS parts, SS fabricated Parts of equipment.
    • Follow the SOP of ‘Cleaning and Operation of Comminuting mill and Co mill for the cleaning of the screen.
    • If any screen is damaged. Destroy the screen by handing over to the maintenance department after taking destruction approval from the department head and QA.
    • Record the destruction details in the Sieves/Screens Inventory Register (Annexure-3).

    • Screen for Alexander Werk Roll Compactor:

    • On receipt, check the screen for receipt quantity and pore size on-screen mentioned by the supplier against delivery challan or PO.
    • Clean the screen by using a clean dry cloth and then checked for engraved screen size against delivery challan.
    • Engineering head, Production head, or designee shall verify certificate received from the supplier of newly received screens.
    • Check the screen for its intactness visually and no damage observed.
    • Record spot observation in Screen checking Report (Annexure-2).
    • If any damage observed at the time of receipt. Reject the screen and returned to the supplier.
    • Check the screen for its pore size in mm, by using calibrated scale magnifier (up to 6mm) and calibrated Vernier calipers (more than 6mm) at 6 different locations.
    • Record the readings in the Screen checking report (Annexure-2).
    • An acceptance criterion is ±2% of the pore size.
    • If the pore size corresponds to the acceptance criteria as per the Screen checking report (Annexure-2) to the screen size engraved on the screen.
    • The number of new screens in continuation from the earlier in sequence.
    • Example: For the first screen of 1.0 mm, and 220 mm diameter the number – G/AL220/1.0mm/001,
    • For second no of 1.0 mm screen, and diameter 220 mm – G/AL220/1.0mm/002.
    • Where-
      • G: Granulation
      • AL: Alexander Werk Roll Compactor
      • 220: Diameter of Roll Compactor
      • 1.0 mm: Screen size
      • 001, 002; Serial Number of Screen

    • Screen for Quadro Co-Mill and Quadro Sifter:

    • On receipt, check the screen for receipt quantity and pore size on-screen mentioned by the supplier against delivery challan or PO.
    • Clean the screen by using a clean dry cloth and then checked for engraved screen size against the delivery challan.
    • Engineering head, Production head, or designee shall verify certificate received from the supplier of newly received screens.
    • Check the screen for its intactness visually and no damage observed.
    • If any damage observed at the time of receipt, the screen is to be rejected and returned to the supplier.
    • Number the new screen of Quadro Co-mill in continuation from the earlier in sequence.
    • Example: For the first screen of 062G of Quadro Co-mill the number – G/QDM/062G/001,
    • For the second no of 062G of Quadro Co-mill screen – G/QDM/062G/002).

    • Where-

      • G  :       Granulation
      • QDM:  Quadro Co-mill
      • 062:  Screen size
      • G:  Grater
      • 001/ 002: Serial Number of the Screen
    • Number the new screen of Quadro Sifter in continuation from the earlier in sequence.
    • Example: For the first screen of 039R of Quadro sifter the number – G/QDS/039R/001.
    • For the second no of 039R of Quadro sifter screen – G/QDS/039R/002).

    • Where-

      • G: Granulation
      • QDS: Quadro Sifter
      • 039: Screen size
      • R: Round
      • 001, 002:  Serial Number of the Screen

    • Handling of Sieves/Screens before & after operation:

    • The supplier certificate of all Sieves/Screens to be attached to the Sieves/Screens checking report.
    • Check the Sieves/Screens for size as per BMR by checking the size engraved on it.
    • Ensure the cleanliness of the Sieves/Screens before starting the operation.
    • Visually inspect the Sieves/Screens for the blockage of holes against the light source. There should not be any blockage.
    • Check the integrity of Sieves/Screens visually & ensure intactness of the same.
    • Enter the Sieves/Screens No. in the BMR.
    • After completion of the operation check the integrity of Sieves/Screens visually & ensure intactness of the same.
    • Record the utilization of Sieves/Screens in Sieves/Screens Utilization Record, as per Annexure–4.
    • If any damage is observed, immediately stop further processing & intimate to superior.
    • Remove such damaged Sieves/Screens from the department & send for destruction as per Annexure – 5 with destruction approval from Department head.QA and maintenance dept.
    • Record all details in the Sieves/Screens inventory register as per Annexure-3.
    • If any Sieves/Screens taken from or returned to Sieve/ Screen storage rack it should be cleaned before & after use.
    • Sieves/Screens inventory register to be maintained in the first week of every month.

8.0   ANNEXURES –HANDLING OF SIEVES AND SCREENS :

Annexure 1: Sieve Checking Report

Supplier report No.:________________ Date of Checking: ____________

Supplied by: ___________________ Date of receipt: ___________

Spot Observation (Intact / Damage) :__________________________________

Sieve No.: ______________ Sieve size:__________________

ID No. of Scale magnifier / Densitometer: ________ Calibration due on: ________

Procedure: Check the number of holes for one linear inch as mentioned in the diagram and mention the observation in the data sheet. In case of densitometer if reading is taken on ¼”, ½” and 1” scale, multiply the reading with 4, 2 and 1 respectively, to get the value per inch.

Diagram:

SOP for Sieves and Screens

Location Position Reading Remarks
1 Horizontal
Vertical
2 Horizontal
Vertical
3 Horizontal
Vertical
4 Horizontal
Vertical
5 Horizontal
Vertical

 

Acceptance Criteria : ± 2% of the Sieve Number

Performed by: ________ Date:_________          Checked by: __________Date:_______

Annexure 2: Screen checking Report

Supplier report No.:______________Date of Checking: ________

Supplied by: _________________ Date of receipt: _____________

Spot Observation(Intact / Damage) :___________________________

Screen No.: ________________ Screen size:________________

ID No. of Scale magnifier / Vernier calipers: ________ Calibration due on: __________

Procedure: Check the pore size in mm as mentioned in the diagram and mention the observation in the data sheet by using calibrated scale magnifier up to 6mm and calibrated vernier caliper for more than 6mm screen.

Diagram:

SOP for Sieves and Screens - Screens

Location Position Reading Remarks
1 Top-1
2 Top-2
3 Middle-1
4 Middle-2
5 Bottom-1
6 Bottom-2

 

Acceptance criteria: ± 2% of the Screen Number

Performed by: ________ Date:_________          Checked by: __________Date:_______

Annexure 3: Sieves/Screens Register

RECEIPT

 DESTRUCTION
Sieve/Screen Size Sieve/Screen No. Remark Date of Destruction Disposal Record No. Remark

Annexure 4: Sieves/Screens Utilization Record

Prepare the Log with the following table content…

    • Sr. No.
    • Issue Date
    • Issued by
    • Product name
    • Batch No.
    • Sieve No.
    • Screen No.
    • Cleaned by
    • Checked by
    • Returned by
    • Returned Date
    • Remarks

Annexure 5: Disposal Record for Sieves/Screens

Date:
Item:
Disposal Record No. :
Sifter Sieve Number:
Mill Screen Number:
Reason for Disposal:

 

Disposed by: Checked by : Approved by: Received by :
Operator Production Q.A Department Head QA Head/

Designee

 Engineering
Sign/Date

Annexure 6: Screen checking report of Quadro Co-mill /Quadro Sifter.

Report No.:  
Date of Checking:  
Date of Re-inspection:  
Supplied by:  
Date of receipt:  
Spot Observation (Intact / Damage):  
Screen No.:  
Screen size:  
Remark:  

 

Done by (Sign/Date) Checked By (Sign/Date)

 

 

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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