Process Alarm And Its Significance

admin    |    02-03-2018

process alarm and its significance.jpg

Process alarm are those alarms which are generally generated during any processing like manufacturing, packaging, utilities operation and each alarm generate with some reason which have some significance on the process so it is necessary to know the significance of that 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 alarm & define action plan. Generally why happen in most of the pharmaceutical industries people ignore all these alarm and simply acknowledge the same due to lack of knowledge about process or due to unavailability of approved procedure. It is necessary to define some procedure to identify, understand , define criticality of process alarm and to define action plan once alarm generate. 


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Below are common critical process parameters of manufacturing operation which directly affect product quality.

  1. Temperature: if temperature goes high then it can degrade the API content which could generate process impurity.
  2. Pressure: some times high pressure results leakage in process or low pressure can impact air jet cleaning of bottles etc. based on process.
  3. Time: time can also directly impact process and product like homogenization, agitation, blending time impact mixing of drug which impact uniformity of dose/ content.
  4. Vacuum: in some process specially during oral liquid dose manufacturing vacuum are used to deaerate the bulk to remove excess foam.
  5. RPM (rotation per minute): apart from time rotation of an object like agitator, blender, chopper, turret, homogenizer etc. directly impact intermediate or final product quality.

To decide the criticality of each alarm first complete process need 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 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 generate during processing.

Challenge test of each alarm should be check at a define frequency to check their adequacy and it is better if challenge test can be done before starting and at end of any manufacturing operation. So now check , Do you have that alarm handling procedure or not. If not then mapped the process and prepare standard operating procedure immediately to avoid any regulatory challenge in future.



1 Comments:
dummy

Parveen    |    09-03-2018

Really it's a fact most of the operators simply acknowledge the alarm to stop the irritated beep sound without assess it's impact on the process and final product quality even they don't have a procedure  for the categorization of alarm and further action. 

Really nice thought on current situation of pharmaceutical industry. 

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