How many alarms were there from granulation to coating and in also elmach blister packing machines,where it’s located.
There is no specific requirement to have number of alarms in the manufacturing areas. It all depends upon criticality of the processes and the set operating limits.For example, there could alarm system for,
- HVAC system, when the required temperature or air pressure differential values cross the specified limits.
- in coating areas if solvent vapours cross threshold limits (fire safety)
- When smoke detector sensors get activated due to smoke, fire
- Fire alarms to manufacturingredients areas
- In sterile core areas, if particulate matter count exceeds class 100 requirements.
- In storage cabinets of stability samples, if temperature exceeds specified limits.
Other than production…means i am talking about elmac blister pack machine …alarm generate for NFD system,Sealing count,forming count ,printing rejection ,empty pocket,other defect related to product…
Yes, you can have these alarms. Please ensure that these alarm systems are validated to ensure those work properly and should be challenged periodically to ensure their functioning over a period of time.
- List item
se al arms
Alarms are generally defined during installation set up for equipment and facilities as per requirement.
Alarms are accompany with the sensors to prevent any risk, alert, information or hazard
List of the Alarm you can find from two documents.
- User Requirement Specification
- Equipment Manual