SOP for Automatic Batch Printing Machine

Categories: Production , SOP

May 5, 2011

Standard operating procedure of automatic batch printing machine to print batch numbers on
cartons.

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
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 previous product.
5.1.2 Packing pharmacist will issue the stereo to 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 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 roller is achieved.
5.1.6 Adjust the master by fixing the stereo in such a way that printing is uniform and in proper
place of the cartons.
5.1.7 Switch “ON” the mains.
5.1.8 Take the trial of overprinted matter on 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 over printed cartons in 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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Further Reading:,

1. SOP for Cleaning of EPD Collator Machine with Strip Packing Machine Line
2. SOP for Cleaning of Semi-Automatic Cartoning Machine
3. SOP for Cleaning of Mini Roll Compactor
4. SOP for Cleaning of Tablet Counter
5. SOP for Cleaning of Semi Auto Induction Cap Sealing Machine
6. Terminal Sterilization of Sterile Pharmaceutical Preparations
7. Principle of Hygrometer and Its Use in Pharmaceuticals
8. Buffer Area and Its Maintenance in Sterile Manufacturing Facility
9. Importance and Maintenance of Pressure Differential in Manufacturing Area
10. Separate Manufacturing Facility is Required for Manufacturing of Penicillin and Non-
penicillin Products

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