SOP for Automatic Batch Printing Machine

1.0 OBJECTIVE

To lay down the procedure for operation and cleaning of Automatic Batch Printing Machine.

2.0 SCOPE

This SOP shall be applicable for Automatic Batch Printing Machine 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 Check machine for cleanliness, free from any leftover carton or Catch covers & rubber stereos of a previous product.
5.1.2 Packing pharmacist will issue the stereo to the operator as per SOP and record in “Stereo Record Register” and get line clearance from QA person.
5.1.3 Adjust the Block according to data given, Batch No., MFD., EXP., and MRP. Etc. with flat rubber stereos.
5.1.4 Wet the roller of the batch printing machine with Book Black Ink (For non-laminated cartons) or Plast Black Ink (For laminated cartons).
5.1.5 Rotate the roller by hand, so that uniformity of ink on the roller is achieved.
5.1.6 Adjust the master by fixing the stereo in such a way that printing is uniform and in the proper place of the cartons.
5.1.7 Switch “ON” the mains.
5.1.8 Take the trial of overprinted matter on the carton.
5.1.9 When over printing of batch details are satisfactory, get the signature of from Packing Pharmacist and Q.A. Person on over printed Cartons. Continue and complete the batch.
5.1.10 Record Batch details in “Over Printing Log Book”.
5.1.11 Attach specimen carton/ catch cover to BPR and preserve one in printing department for reference.
5.1.12 Collect the overprinted cartons in a duly labeled container with batch details.
5.1.13 Switch “OFF” the mains & Affixed “To Be Cleaned” label and fill the Equipment Log Book”.
5.1.14 Seal the container till taken for packing. Store the container in a designated area provided. Return the used stereo to 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 dry lint-free 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 lint-free cloth the apply Plast Black Ink on it.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 IPA: Isopropyl Alcohol
6.3 BPR: Batch Packing Record
6.4 QA: Quality Assurance

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