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Medioint Lifescience PVT - LTD.: Standard Operating Procedure
Medioint Lifescience PVT - LTD.: Standard Operating Procedure
1.0 PURPOSE:
To lay down the procedure for receipt, storage, usage, and integrity record of sieves.
2.0 SCOPE:
This SOP is applicable to provide the written guidelines for receipt, storage, usage, and
integrity record of sieves in production at Medioint Life science Pvt. Ltd., Pithampur.
3.0 RESPONSIBILITY:
3.1 Production Operator/Production Officer/Executive and above shall be responsible for receipt,
storage, usage, and integrity of sieves.
3.2 Quality Assurance Officer/Executive and above shall be responsible for verify the integrity
record of sieves
3.3 Accountability:
Head of Production Department to ensure implementation of this SOP.
Head of Quality Assurance Department to ensure compliance of procedure.
4.0 SAFETY AND PRECAUTION:
5.0 ABBREVIATION:
SOP - Standard Operating Procedure
PRD - Production Department
END - Engineering Department
F - Format
Pvt. Ltd. - Private Limited
M.P. - Madhya Pradesh
SLS - sodium lauryl sulfate
6.0 DEFINITION:
Not Applicable
7.0 PROCEDURE
7.1 RECEIPT
7.1.1 On intimation of receipt from stores, collect all the sieves
7.1.2 Check the integrity of individual sieves as per step no. 7.3
7.1.3 Remark ‘OK’ for pass sieves and ‘Not OK’ for sieves which fail the integrity test. Return backs
the defective sieves to stores.
7.1.4 Allot code no. as per Coding SOP to the pass sieves and transfer the respective storage area.
7.1.5 Record the observations in PRD 020/F01.
7.2 Storage
7.2.1 After completion of activity clean and place sieve/screen in virgin polybag, label, and store
dedicated almira.
7.3 INTEGRITY SIEVES
7.3.1 Integrity of sieve shall be checked on the following occasion
a) Newly received sieve.
b) Before starting the manufacturing activity for any batch.
c) After completion of the batch.
7.3.2 Newly received sieve.
7.3.2.1 Remove the sieve from polybag
7.3.2.2 Hold the sieve and keep it against the tube light
7.3.2.3 Rotate clockwise and anticlockwise direction and check visually against light
7.3.2.4 Ensure that the sieve wires are in equal distance when compared to another.
7.3.2.5 Check for the intactness / damage of wire in sieve or screen.
7.3.3 Before starting the manufacturing activity for any batch and After completion of the batch.
7.3.3.1 Hold the sieve and keep it against the tube light
7.3.3.2 Rotate clockwise and anticlockwise direction and check visually against light
7.3.3.3 Ensure that the sieve wires are in equal distance when compared to another.
7.3.3.4 Check for the intactness / damage of wire in sieve or screen.
7.3.3.5 Integrity of sieve shall be counterchecked by IPQA person.
7.3.3.6 After checking by IPQA person wrap the sieve in polybag after cleaning and drying of the
sieve.
7.3.3.7 In case of integrity failure, reject and destroy the sieve and replace with new one.
7.3.3.8 Record the status of the sieves to be used for the product and after use of the product in the
PRD 020/F02.
7.5 Acceptance Criteria: Sieve should be in intact position and no deformation in distance.
8.0 FREQUENCY:
8.1 Before starting of the batch and After Completion of the Batch. Record the status of the sieves
to be used for the product and after use of the product in the PRD 020/F02.
9.0 SUPPORTING DOCUMENTS:
Format No. PRD 020/F01 : Sieves inventory record
Format No. PRD 020/F02 : Integrity checking record of sieves
Format No. QAD 002/F11 : Format for History Sheet.
10.0 REFERENCE:
In House.