SOP for Batch Printing Machine (Semi Automatic)

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1.0  OBJECTIVE:

       To lay down the procedure for Operation of Batch Printing Machine (Semi Automatic).

2.0  SCOPE:

       This SOP shall be applicable for Batch Printing Machine (Semi Automatic) in packing area in Production department.

3.0  RESPONSIBILITY:

3.1  Execution              : Operator

3.2  Checking               : Production Pharmacist & Above

4.0  ACCOUNTABILITY:

       HOD-Production / Assigned Designee

5.0  PROCEDURE:

5.1  Operation

5.1.1  Production person shall ensure the cleanliness of the Batch Printing Machine (Semi Automatic), its part & area and ‘CLEANED’ label on it.

5.1.2  Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, Batch Details to equipment & area.

5.1.3  Packing Pharmacist will issue the stereo to operator as per SOP and record in “Stereo Record Register”.

5.1.4  Adjust the Block according to data given, Batch No., MFD., EXP., and M.R.P. etc. with flat rubber stereos.

5.1.5  Wet the roller of batch printing machine with Black Ink (For non-laminated cartons) or Plast Black Ink (For laminated cartons).

5.1.6  Rotate the roller by hand, so that uniformity of ink on roller is achieved.

5.1.7  Adjust the Block on BASE-PLATE in such a way that printing is uniform and in proper place on the cartons.

5.1.8  Switch “ON” the mains.

5.1.9  Take the trial of overprinting on carton.

5.1.10  When over printing of batch details are satisfactory, get the signature from 2 Packing Pharmacist and Q.A. Person on over printed cartons. Continue over printing and complete the batch.

5.1.11  Record the batch details in “Over Printing Log Book”.

5.1.12  Attach specimen carton to BPR and preserve one in printing department for reference up to three months in “Carton & Foil Specimen Register”.

5.1.13  Collect the over printed cartons in duly labeled container with batch details.

5.1.14  Switch “OFF” the mains & Affix “To be cleaned” label and fill the Equipment Log Book”.

5.1.15  Seal the container till taken for packing. Store the container in designated area provided. Return the used stereo to the packing pharmacist and destroy in presence of QA person.

5.2  CLEANING OF BATCH PRINTING MACHINE

5.2.1  Clean the roller with I.P.A. or thinner & wipe out with lint free dry clean Cloth.

5.2.2  When overprinting of laminated cartons is to be done after non- laminated cartons first clean the roller with I.P.A., wipe it with cotton cloths then apply Plast Black Ink on it.

6.0  ABBREVIATIONS:

6.1  SOP: Standard Operating Procedure

6.2  BPR: Batch Packing Record

6.3  Q.A.: Quality Assurance

6.4  HOD: Head of The Department

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