Quality by Design,Risk by Perception
[Abstract] The pharmaceutical liquid mixing process system is a production process system that directly affects the final product quality, therefore, it shall be validated. It is very crucial regarding how to confirm the focuses of validation.
[Keywords] Liquid mixing process; validation; direct influence on system; biological products; blood products; aseptic preparations; oral liquid
With the improvement of the industrial technology and computer technology, the automatic liquid mixing process system with CIP/SIP function is increasingly used in the Chinese pharmaceutical industry to replace the simple independent liquid mixing tank to complete the preparation of various materials in the pharmaceutical process. The pharmaceutical liquid mixing process system is considered as a production process system that directly affects the final product quality, therefore, it shall be validated.
When considering the validation of the liquid mixing process system, the main consideration is its purpose. Liquid mixing process systems of different purposes will have different influences on the product quality, for example, the semi-finished product preparation system for non-terminally sterilized products will be slightly different from the liquid mixing process system for upstream buffer preparation in the biological product raw liquid production in terms of criticality. Endotoxin, bioburden, and product content (including homogeneity) are focused on during preparation of most liquid preparations, while temperature, and content (including homogeneity) are usually controlled during preparation of upstream buffers, and the endotoxin, and bioburden shall also be inspected for the upstream buffers of many biological products; similarly, the control indexes for oral liquid will be much different, especially for the viscous liquid and suspensions, the mixing homogeneity is the main focus. The following table lists the product types of liquid mixing process system and the corresponding product quality information for attention.
|
Biological products |
Upstream solution |
Concentration, temperature, and microbial limit |
|
Media |
Asepsis (or sterilization) |
|
|
Downstream buffer or chromatography elution, etc. |
Concentration, temperature (if needed), homogeneity, microbial limit, and endotoxin |
|
|
Blood products |
Protein separation |
Concentration, temperature, homogeneity, and endotoxin |
|
Purification |
Concentration, temperature (if needed), homogeneity, microbial limit, and endotoxin |
|
|
Terminally sterilized products |
Concentrated solution preparation |
Concentration, and homogeneity |
|
Diluted solution preparation |
Concentration, homogeneity, and microbial limit |
|
|
Non-terminally sterilized products |
Preparation |
Concentration, homogeneity, microbial ... Read More
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