Documentation in sterile B Area

Quality Assurance
1

Dear All,
Could you please explain about which type of paper or BMR/logbook sheet can be used to make entries and recording? Autoclavable??

Thanks

2

In aseptic area,where sterlie product is filling& sealing carried out, only autoclave able paper can be used for online recording of data.
Himedia, merk, steritek USA , providing such papers.

3

Thanks Rakesh,

What about if logbooks will be used for machine and area cleaning logbook,
How the validity of sterility is defined? also sterilisable pen or presterilised pens can be used ?

4

Sir as you know now a days there are visually glass window is available to view online activity.
And when there is question about log books then cleaning status can be documented throughout autoclave able paper or otherwise when IPQA person is providing line clearance.
So one or 2 Doc’s are enough to record the data.
Gamma radiated marker can be used in aseptic techniques.

1 Like
5

log books should be out of aseptic area and it should be maintained by telephonic discussion between aseptic area person and outside aseptic area person.