drpressure
Chemical
- Mar 24, 2015
- 1
Hello all:
Within the context of a GMP oral solid dosage plant, I am curious if anyone out there has any experience with establishing a defendable protocol for cleaning of equipment of unknown history, particularly the product contact stainless steel parts. Some potential examples where this would be needed is when procuring equipment from the used market or when borrowing equipment from a development area.
Electro-polishing is potentially an aggressive option as it involves total removal of the top layer of metal. However, this is not preferred as the routine approach due to cost and complexity. Chemical passivation may also be an alternative but this method seems to be more difficult to defend in the absence of hard data demonstrating that any and all potential surface contaminants are removed / safely degraded and without a general test method (e.g. swabs) with which to confirm effectiveness.
Does anyone know of any published precedent or guidance on this topic or any industry sources that have tackled the issue?
Thank you in advance.
Within the context of a GMP oral solid dosage plant, I am curious if anyone out there has any experience with establishing a defendable protocol for cleaning of equipment of unknown history, particularly the product contact stainless steel parts. Some potential examples where this would be needed is when procuring equipment from the used market or when borrowing equipment from a development area.
Electro-polishing is potentially an aggressive option as it involves total removal of the top layer of metal. However, this is not preferred as the routine approach due to cost and complexity. Chemical passivation may also be an alternative but this method seems to be more difficult to defend in the absence of hard data demonstrating that any and all potential surface contaminants are removed / safely degraded and without a general test method (e.g. swabs) with which to confirm effectiveness.
Does anyone know of any published precedent or guidance on this topic or any industry sources that have tackled the issue?
Thank you in advance.
