.
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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