Table of Contents
1.0 OBJECTIVE of Blister Packing Machine
1.1 To provide the written guidelines for cleaning and operation of blister packing machine.
2.0 SCOPE of Blister Packing Machine
2.1 The scope of this SOP is for the cleaning and operation of blister packing machine.
3.0 RESPONSIBILITY:
3.1 Execution: Operator
3.2 Production Executive
4.0 ACCOUNTABILITY:
4.1 Production Head
5.0 Procedure For Cleaning and Operation of Blister Packing Machine
5.1 Procedure for cleaning of Blister Packing Machine
5.1.1 Remove “TO BE CLEANED” tag from the machine.
5.1.2 Remove Hopper, Bowl, Dust Collecting Dish, Tablet Feeding Roller, Channel and tablet guide plate from its position.
5.1.3 Transfer the parts of step no 5.2 to the washing area after keeping it in a specified S.S. (stainless steel )container.
5.1.4 Cleaning the parts of Step no 5.3 as per the SOP for cleaning of equipment.
5.1.5 Bring it back to the department and keep in a specified storage cabinet
5.1.6Dry cleaning the machine using clean lint free clothes and remove tablets of previous product.
5.1.7 Unwanted material if any move from tablet machine before cleaning of machine and properly clean of tablet machine in production area.
5.1.8 Record the data in equipment cleaning record as per Annex- 1 of this Standard operating procedure.
5.1.9 FREQUENCY : Product to product change over.
5.2 Procedure for cleaning of Blister Packing Machine
5.2.1 Collect the required change parts from storage cabinet and take it to the blister packing room.
5.2.2 Switch “ON” the AC and Dehumidifier as to maintain Temperature and relative humidity through the operation and record it in Batch packing record as mentioned specific interval.
5.2.3 Mount forming and sealing rollers, channel and web plate at it’s position on the machine.
5.2.4 Mount printing gears, cutting gears and cutting die.
5.2.5 Switch “ON” the Mains and heaters to get require temperature for operation of blister pack machine and also switch “ON” the chilled water circulation pump motor.
5.2.6 Fix the pvc (poly vinyl chloride roll, printed foil and set the forming and sealing by running the machine without loading the tablets.
5.2.7 Out the stereos on the printing unit drum and ensure the over coding quality for Correctness and clarity.
5.2.8 Then initially run the machine to check cutting quality of blister for shape, dimensions, symmetry of the pockets and printing of stereos on it at the current space.
Operation: .
5.2.9 Affix “STAGE LABLE or TAG” on the machine in production department.
5.2.10 Taking Line clearance from Quality Assurance department as per respective standard operating procedure.
5.2.11 Loading the tablets in to the hopper and set vibe-speed, infield motor speed and run the machine to collect blister for doing leak test as per respective sop of production department.
5.2.12 After performing the Leak test start the machine and record the data in the respective log.
5.2.13 Records of leak test machine operation. Keep Machine setting and rejected tablet blisters in a separate container with proper.
5.2.14 Identification, for de-foiling and repacking at the end of the packing of the whole batch.
5.2.15 Check the blister for Batch detail coding, empty pocket, broken tablets, improper cutting etc. as per requirement shown in BPR.
5.2.16 PRECAUTION: Always keep the sealing heater LOCKED in up hold position when there is no sealing materials in between sealing heater and support sealing roller.
6.0 ABBREVIATIONS of Blister Packing Machine
EFF. : Effective
Mfg. : Manufacturing