Sirs
Is there any guidline says to insatll the pressure measuring device on AHU (supply air) to measure the differential pressure across all filters for non steril oral solid and steril preparation ?
How can we measure the remaining water droplet in the bottle after drying process in the bottle liquid filling area and is there any specification for amount of water?
Asir
Hi Asir
There is no requirement to validate the AHU output, there is, however, a requirement to validate the room conditions that are mandated for the operations you are carrying out.
The URS should have specified this, and the DQ should have validated that the conditions specified, were in accordance with the regulatory requirements. I.e. what air flow regime, temperature control, humidity control were required by the manufacturing process.
You are therefore required to specify these requirements in your OQ, and validate that the requirements are achieved.
If these are required then you are required to be able to demonstrate that all product batches you produced, have been produced under these conditions. This either means continuous recording of room conditions, or validating that any failure of conditions, brings in alarms, records the failure, and stops production.
The AHU must be validated to ensure it conforms to cGMP requirements, (dirty bag filters are alarmed, drip-trays are s/s, heating / cooling coils are drip free, and not ferrous, all critical gauges are calibrated,)
After drying process, there should be no water droplets in bottles, if there is then your drying process has failed. It is not desirable and in breach of cGMP’s to hold bottles in a an open and wet condition. At the end of your drying process ensure the bottles are inverted ands purged with clean sterile air.
Through trials establish the time required along with quantity of air required to ensure every bottle is dry and droplet free. Validate this as part of the washing drying process. This removes the requirement you enquired about.
Ensure bottles are kept inverted or closed until filling is taking place.
Regards
Alex Kennedy
Hi Asir
There is no requirement to validate the AHU output, there is, however, a requirement to validate the room conditions that are mandated for the operations you are carrying out.
The URS should have specified this, and the DQ should have validated that the conditions specified, were in accordance with the regulatory requirements. I.e. what air flow regime, temperature control, humidity control were required by the manufacturing process.
You are therefore required to specify these requirements in your OQ, and validate that the requirements are achieved.
If these are required then you are required to be able to demonstrate that all product batches you produced, have been produced under these conditions. This either means continuous recording of room conditions, or validating that any failure of conditions, brings in alarms, records the failure, and stops production.
The AHU must be validated to ensure it conforms to cGMP requirements, (dirty bag filters are alarmed, drip-trays are s/s, heating / cooling coils are drip free, and not ferrous, all critical gauges are calibrated,)
After drying process, there should be no water droplets in bottles, if there is then your drying process has failed. It is not desirable and in breach of cGMP’s to hold bottles in a an open and wet condition. At the end of your drying process ensure the bottles are inverted ands purged with clean sterile air.
Through trials, establish the time required along with quantity of air required to ensure every bottle is dry and droplet free. Validate this as part of the washing drying process. This removes the requirement you enquired about.
Ensure bottles are kept inverted or closed until filling is taking place.
Regards
Alex Kennedy