dear all
what shaould be the temperature limit in solid oral dosage facility , as in india we have same facility and we have kept limit is NMT 28° C. . is that ok…is any guideline speak about it…
please revert
with warm regards
No guideline would speak on this issue. The reason is that it should be product specific. You need to know, understand and control all your operations based on the behavior of materials like exciepients and APIs in that temperature and also the comfort of staff working in such areas.
You cannot have same temperature and humidity when you deal with Paracetamol and Omeprazole.
One is stable another should be operated below 20C with a controlled humidity as it is hygroscopic in nature.
You are in a best position to decide it as you know on what products you work.
thnaks sir,