Process alarm and Its significance during pharmaceutical product manufacturing
Process alarm is those alarms which are generally generated during any processing like manufacturing, packaging, utility operation and each alarm generate with some reason which has some significance on the process so it is necessary to know the significance of that process alarm and it is necessary to understand those alarm and take appropriate actions so that impact on the final product or drugs can be minimized so now there is a question that how to define the criticality of all those alarms & define an action plan. Generally, why happen in most of the pharmaceutical industries people ignore all these alarms and simply acknowledge the same due to lack of knowledge about the process or due to unavailability of the approved procedure. It is necessary to define some procedures to identify, understand, define the criticality of process alarm, and to define the action plan once alarm generates.
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Below are common critical process parameters of manufacturing operation which directly affect product quality.
- Temperature: if the temperature goes high then it can degrade the API content which could generate process impurity.
- Pressure: some times high-pressure results leakage in process or low pressure can impact air jet cleaning of bottles etc. based on the process.
- Time: time can also directly impact process and product like homogenization, agitation, blending time impact mixing of drugs which impact the uniformity of dose/ content.
- Vacuum: in some process especially during oral liquid dose manufacturing vacuum are used to deaerate the bulk to remove excess foam.
- RPM (rotation per minute): apart from time rotation of an object like an agitator, blender, chopper, turret, homogenizer, etc. directly impact intermediate or final product quality.
To decide the criticality of each alarm first complete process needs to be completely mapped to identify each critical control process parameters and after that linkage of alarm with all those critical process parameters shall be identified and all those alarm details should be the part of the standard operating procedure of that particular piece of equipment where action plan should also be the part of this procedure which guide to the operator that what need to do once that particular alarm generates during processing.
The Challenge test of each alarm should be check at a defined frequency to check their adequacy and it is better if a challenge test can be done before starting and at the end of any manufacturing operation.
All the interlocking and alarm should also be verified during computer system validation to ensure its accuracy. Alarm management of any process is very important to safeguard the final product quality. Alarm management refers to effective design, operation, & implementation. Apart from the design, implementation, and operation, operator understanding is also important because if an operator doesn’t know the significance of the occurred alarm then the situation becomes more critical and finds product get impacted. The inability to diagnose and control all these abnormal conditions has huge cost impact on the economy.
The purpose of the Alarm management procedure is basically preventing or minimizing economic loss. In alarm management procedure following point should be included but not limited to…
- Determining the process alarm
- Documenting the alarm
- Monitoring and maintaining alarm message.
- Establishment of prioritizing to manage an emergency situation
So now check, Do you have that alarm handling procedure or not. If not then mapped the process and prepare standard operating procedures immediately to avoid any regulatory challenge in the future.