Standard Operating Procedure for compression machine or rotary Compression Machine.
1.0 Purpose
The purpose of this SOP is to establish a standard procedure for operating the compression machine.
2.0 Scope
This SOP will be applicable for the compression machine in the compression area of the production section.
3.0 Responsibility
3.1 Machine Operator is responsible for operating the Compression Machine.
3.2 Production Pharmacist is responsible for the implementation of this SOP.
3.3 HOP is responsible to ensure the implementation of this SOP.
3.4 Quality Assurance Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Production Pharmacist will ensure that the compression machine and the area are properly cleaned.
4.2 Production Pharmacist will ensure that the compression machine and Area is labeled with Cleaned label status.
4.3 Before starting the operation of a compression Machine ensure that the machine is installed with tooling as mentioned in BMR or batch manufacturing record.
4.4 The production Pharmacist should ensure that all the tooling is properly installed, meaning punches are free to move in dies and dies are tightly screwed.
4.5 After ensuring that hoppers and feed frames are installed correctly, award line clearance.
4.6 After production line clearance, take line clearance from the QA officer.
4.6 After line clearance, add powder or granules in the hoppers of the compression machine and ensure that the pressure rollers and weight regulators are neutral.
4.7 Rotate the machine manually to ensure proper filing of feed frame housings and dies.
4.8 Operate the machine at jog speed, apply little pressure and adjust the weight of the tablet according to BMR or batch manufacturing record.
4.9 When required tablet weight is achieved apply more pressure to set hardness and thickness of tablet according to the batch manufacturing record.
4.10 When required tablet weight, hardness and thickness are achieved, turn on the tablet deduster and metal detector & increase the speed or RPMs of the compression machine.
4.11 Adjust tablet weight, hardness and thickness again if required.
4.12 Take samples for in-process testing and after clearance of all the parameters compress the whole batch.
4.13 After compression, turn off the machine,affix to be cleaned label and record the activity in the logbook.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 rpm: Rounds per minute
5.3 BMR: Batch Manufacturing Record
5.4 QA: Quality Assurance
5.5 HOP: Head Of Production
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