SOP for Sterilization Reel Sealer : Pharmaceutical Guidelines

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SOP for Sterilization Reel Sealer

Standard operating procedure of sterilization reel sealer (Rotary Heat Sealer) used for packing and sealing of materials for sterilization.

1.0 PURPOSE

To lay down the procedure for Operation and Maintenance of Sterilization Reel Sealer.

2.0 SCOPE

This SOP is applicable for operation and maintenance of sterilization reel sealer (Rotary Heat Sealer) used for packing and sealing of materials for sterilization in QC Microbiology Laboratory.

3.0 RESPONSIBILITY

Trained Microbiologist and Lab Assistants are responsible to perform the activity as per SOP.

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Operation

5.1.1 Connect the mains lead to the sealer and to an earthed power socket.
5.1.2 Switch on the ON/OFF switch.
5.1.3 Check set temperature by pressing ‘Temp: + or –’ keys. The set temperature will be displayed; set temperature should be 180°C. If required set the temperature to 180°C using ‘Temp: + or –’ keys.
5.1.4 Wait till the temperature reaches the pre-set temperature of 180°C is reached, this is indicated by two beeps and display status will change from ‘Too Low’ to ‘OK’.
5.1.5 Adjust the input guide adjustment knob for the seal seam position to required position. For sealing of empty reels preferably adjust the knob to the front or middle position and for sealing packed reels/pouches adjust the knob to back or middle position.
5.1.6 Feed the empty pre-cut reels or packed reels from the left side of the machine through input guide, the reel will roll automatically and collect the reels or packs on the right side. While sealing packed reels take precautions to feed only the reel into the roller and no material comes inside the roller.

5.2 Maintenance

5.2.1 Clean the external surface of the unit with a lint-free cloth with 70% IPA or suitable disinfectant.
5.2.2 If any problems arise to contact the engineering department or authorized service provider of required repair and maintenance.

6.0 ABBREVIATIONS

6.1 SOP – Standard operating procedure
6.2 QA – Quality assurance
6.3 QC – Quality control
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