SOP for Batch Printing Machine (Semi Automatic) : Pharmaceutical Guidelines

SOP for Batch Printing Machine (Semi Automatic)

Standard operating procedure of Semi Automatic Batch Printing Machine used for batch number printing on cartons.

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 the 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 the 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 the 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 the roller is achieved.
5.1.7 Adjust the Block on BASE-PLATE in such a way that printing is uniform and in a proper place on the cartons.
5.1.8 Switch “ON” the mains.
5.1.9 Take the trial of overprinting on the carton.
5.1.10 When overprinting of batch details are satisfactory, get the signature from 2 Packing Pharmacist and Q.A. Person on over printed cartons. Continue overprinting 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 overprinted cartons in a 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 a 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





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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