Is it Essential that worker should use glove during the empty ampule or vails filling in tray for washing? if anyone have proper SOP please send me at [email protected]
It is always a good practice to wear hangloves (Non surgical rubber gloves and not cloth) while handling empty ampoules for feeding to the ampoule washing machine. This is to avoid human contamination such as fibre shedding, stains, dirt entering empty vials.
jo hm dry injection m fill weight check krte h in process work m
Hm uss powder ko reuse q ni krte
Plz sir iska reason btaye sir
As per GMP any samples withdrawn for any type of test or analysis should not be taken back in the main stream of production. This is because there are liklely chances of samples getting contaminated in the QC / IPQC Laboratory due to its exposure to lab environment, chemicals, moisture and other contaminants. Also for sterile products may loose sterility.
However, in exceptional cases like filled weight check of injection samples, if the containers / vials are not opened and if those remain intact (sealed) without loosing its integrity then such samples may be taken back for further packing only with the approval of QA and ensuring necessary documentation in the Batch records.
Sir agr hm fill weight sterile area m he check kr rhe h
Means fiiling area m
kya uss powder ko reuse kr skte h
Also give reason
for no /yes
No please. You cannot use such powder which is taken out of vials and weighed for fill weight check even in sterile area. This is beacuse there is potential of this powder getting cotaminated through manual handling and loosing sterility as the powder is exposed in non-critical zone in sterile area where weighing balance is placed. Moreover, there are chances of ingress of non-viable / vialble particles in the powder while handling in non-critical zone. Hence this proposal would be very risky.
You may take appropriate measures to minimise the quantity of vials to be taken for fill weight check by properly validating the filling operation. This would avoid unnecessary losses of the powder. You may also think of automation of filling line including in-process checks.
The quantity of vials (powder) taken for fill weight check should be taken into consideration for final reconcilliation of the batch. Hence there is no question of getting low yield.
This is beacuse there is potential of this powder getting cotaminated through manual handling and loosing sterility as the powder is exposed in non-critical zone in sterile area where weighing balance is placed in Under LAF and Open Sterile Container Under LAF Only
Filling And Sealing has been Proceed Under LAF .
When Fill Weight set Under LAF then Powder to be Used on owner Risk.
Yes, there will be always a high risk to re-use this powder which is exposed in non-critical zone in the sterile area. Therefore, I suggest that such practice should be discouraged.
I think the in-process quantity is not too much.
Better to proceed with filling machine and also never reuse the in-proces quantity specially for sterile products.
In case of sterile product packaging ,sampling process , any probable contamination process prone to loose product sterility
I have already suggested not to re-use powder (injction) which was used for fill weight check.
Yes, there are many ways of contamination of sterile product thereby loosing its sterility.
For example but not limited to,
- Human intervantions during vials filling, caping (stoppering) and sealing (crimping) operations
- Machine breakdown (Filling, stoppering and sealing machines)
- More number of persons and excessive personnel movements in the sterile area
- Inadequate protection to the core sterile area (such as LAFs, RABs, manual operations etc.)
- Poor environmental controls