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.