Dear Sir,
we are manufacture Ferrous ascorbate, zinc sulphate monohydrate and follic acid tablets , but after packing we are facing the pocket swelling problem.
when we kept a tablet in Container without packing the tablet should be in good condition, the problem occur after packing only
Packing of this tablet is on Alu Alu machine.
Regards,
Suresh Doifode
Dear,
Incident to be raised…
Investigation to be made not limited to:
1.Production process
2. Packaging process and blistering parameters, correct tooling used-forming?..(comparison with proof samples)
3. Review of Process flow
4. Review of packaging materials and analysis report.
3. Review of stability studies report.
4. Comparison with previous samples and QC analysis impact?
CAPA and action…
Thanks
Dear,
I want to Know the technical reason behind this . Not, to complete documentation only.
tablet inside the swelling pocket remain intact?Beter to understand if u share pic of pocket n tab.
Ferrous ascorbate easily absorbs moisture which might be the cause for the cracking accompanied
by swelling, maintain rigid room conditions to prevent moisture uptake.A reduction in the size of the granules might also help. Tablets maybe have poor hardness,you need add more adhesion.
Respected sir,
This is what we too face in our firm. Since bulging (swelling of packet) happens only in Tablets but not in capsules. The mode of packing used by Mr. Suresh Doifode was Alu-Alu, which is an extreme barrier against moisture etc., So the problem is somehow with the API or the formula used which lead to release gas. So why upon storage it lead to bulging but not coz of packing.
In some cases bulging is due to problem in foil used.we do face same problem.
Respected mam,
May i know, whether u have rectified this problem by use of packing material or any changes in formulation.
if it is may i know which packing material or method used, lead this problem to get rectified.
and whether it happens in tab or capsule.,