Is it required Bioburden test for Disinfectant

(Anvesh Jupak) #1

Dear friends ,Any body kindly share information regarding the My question is, Is it required Bioburden test for Disinfectant…If yes ,wich regulatory guidelines is giving full information regarding the above.i.e

(Dr. Ahmed Mohamed Awad) #2

The following statement is present in WHO Annex 6 ,current EU (PIC/S) Annex 1 , Draft 2017 EU (PIC/S) Annex 1

“Disinfectants and detergents should be monitored for microbial contamination”

However PDA (Parenteral Drug Association) sent a suggestion to EMA regarding modifying this statement to be more clear as illustrated in the following snapshot from PDA comments on Draft 2017 EU (PIC/S) Annex 1

The following is the link for the full document of PDA comments on Draft 2017 EU (PIC/S) Annex 1 which PDA sent to EMA

Note the New updated EU (PIC/S) Annex 1 is expected to be approved and published before July 2019 (this new guideline was written by EMA in cooperation with PIC/S and WHO, and many organizations such as PDA and ISPE contributed to its revision)

(Anvesh Jupak) #3

Thank You Sir, For your kind information…

1 Like
(Thyagarajan Parthasarathy) #4

In WHO guideline, it was claerly cited that the disinfectants which is used in the Grade A and Grade B should be sterile hence we should suppose to check.