1.0 OBJECTIVE
To lay down the procedure for Operation of De-blistering Machine.2.0 SCOPE
This SOP shall be applicable for De-blistering Machine in Packing area at Production department.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production/Assigned Designee5.0 PROCEDURE
5.1 Production person shall ensure the cleanliness of the De-blistering Machine, its part and ‘CLEANED’ label on it.5.2 Before starting the operation production person get the line clearance from Q.A person and affix the status label with Product Name, Batch Details to equipment & area.
5.3 Replace cleaned status label with under process status label with date and signature of a pharmacist.
5.4 Connect the machine to the supply point.
5.5 Put on the main switch. The indicating lamp will glow.
5.6 Start the green push button. Check the rotation of the shaft as per direction is shown on the machine.
5.7 Shift the rubber roller towards the shaft by moving the lever in the anticlockwise direction and lock the position of the roller by tightening the knob provided on the side plate.
5.8 Set the guide plate left-hand side (LHS) and right-hand side (RHS) as per the width of the blister and fix the position by tightening in one of the various tapped holes given on the guideway holder for adjustment.
5.9 Set the blades one on LHS and other on RHS such that the blades are touching the extreme edges of the blister. Set the middle blade at the center of the blister. Now tighten the blades on the shaft by grub screws provided on the blades.
5.10 Insert the blister through the guides.
5.11 As the strip moves forward, the tablets get de-blistered and fall in the tray while the de-foiled blister gets collected in a waste box kept below the exit chute.
5.12 Check that all the tablets are de-blistered. Check for breakage of any tablets.
5.13 If breakage of tablets is observed or product is not de-blistered, set the rubber roller properly by moving the holder. Also, set the blade/ guide blade such that the strip is properly supported on them during De-blistering.
5.15 After the batch is completed, ensure the absence of tablets in the various parts of the machine.
5.16 Affix “To Be Cleaned” label & fill the “Equipment Log Book”.
Related: SOP for Blister Pack Machine
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 RHS: Right Hand Side
6.3 LHS: Left Hand Side
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