Holding Time Studies on the Formulated Ready to Fill Bulk

MEDICAL DEVICE 21 CFR PART 820 (The Regulations)
1

Dear Forum Members,

Can any one suggest that , how to establishing a Holding Time Studies on the Formulated Ready to fill bulk & their requirements ?

Best Regards
Rajanikanth17

2

it depends on your facilities .i mean the cooling system and the circulation system .as per my experiance the holding time can be up to 24 hours before filling in final container before sterilization but under continuas circulation throuh HE to maintain the solution temperature up to 8Celius degree. but after filling not more than 8 hours to sterilised.

may i understand your quistion
thanks

babikir musaad

3

The criterion in this are
Sterility
Endotoxins
Disintegration of Products(Stability of batches during post filling at a predetermined temp)
Leachates if any(This is not possible as the final product is stored in SS vessels)
If in vaccines any seperation of Toxins/Antigens from Adjuvants-Zeta potential problem
PH CHANGE or shift (Buffer problems)
Toxicity considerations.
Most of the above will be determined during developmental study.