C
chrisTRG
Hi all,
First post, so please be patient with me
I have recently taken on the position of Validation Specialist in my company, and with that I have inherited a half-validated process which requires a total re-write as far as I can tell :mg: .
Basically, we have up-scaled a media production process whereby a number of various types of buffer solutions are made by the introduction of chemical compounds (e.g. NaCl, MgCl2, EDTA etc) to specification (e.g. 5M NaCl, 0.9% Saline) to purified water. These solutions are then pH neutralised, made up to final volume, prior to sterilisation. For obvious reasons I cannot be too specific here, sorry!
The small-scale system involved 1/2L of these buffers being made up in small glass bottles followed by autoclave sterilisation. No verification was performed in the past.
The up-scaled version uses 100/200L drums to make up these solutions followed by filter sterilization. Filters are then integrity tested and a sample is taken from the flush bag for dry-weight analysis.
The main issue we are having is that the small scale process was not verified using dry-weight analysis, so we have no way to compare these process'. This is made more difficult by the fact that autoclaving the small bottles also reduces the volume of buffer solutions, affecting the dry-weight reading, which we obviously don't see in filter sterilisation, hence large discrepancies in values.
Is there a more effective way to analyze these buffers? Does the process actually require validation? Should we be comparing new with old, or is the new process a whole new validation project of its own? How can a range of acceptable tolerances be defined for validation?
Thanks
First post, so please be patient with me
I have recently taken on the position of Validation Specialist in my company, and with that I have inherited a half-validated process which requires a total re-write as far as I can tell :mg: .
Basically, we have up-scaled a media production process whereby a number of various types of buffer solutions are made by the introduction of chemical compounds (e.g. NaCl, MgCl2, EDTA etc) to specification (e.g. 5M NaCl, 0.9% Saline) to purified water. These solutions are then pH neutralised, made up to final volume, prior to sterilisation. For obvious reasons I cannot be too specific here, sorry!
The small-scale system involved 1/2L of these buffers being made up in small glass bottles followed by autoclave sterilisation. No verification was performed in the past.
The up-scaled version uses 100/200L drums to make up these solutions followed by filter sterilization. Filters are then integrity tested and a sample is taken from the flush bag for dry-weight analysis.
The main issue we are having is that the small scale process was not verified using dry-weight analysis, so we have no way to compare these process'. This is made more difficult by the fact that autoclaving the small bottles also reduces the volume of buffer solutions, affecting the dry-weight reading, which we obviously don't see in filter sterilisation, hence large discrepancies in values.
Is there a more effective way to analyze these buffers? Does the process actually require validation? Should we be comparing new with old, or is the new process a whole new validation project of its own? How can a range of acceptable tolerances be defined for validation?
Thanks