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SOP for dry powder filling operation

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Working Principle of dry powder filling machine

The injectable dry filling area is a completely sterile area in the company that is strictly controlled with a multidoor system. High-level alertness is mandatory to maintain the atmospheric condition in the filling area of the dry powder’. Every step taken in the production of dry filling requires a written SOP. It is very important to check the relative humidity and temperature of the filling room to avoid any quality issues with the product. The right way to work in the dry powder filling section is to follow the SOP for dry powder filling operation.  

SOP for dry powder filling operation

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SOP for dry powder filling operation

1. Objective: To lay down a procedure for Dry Powder Filling Operation.

2. Scope: The procedure of this SOP shall be applicable to the Production Department of XYZ Pharma. (Injection Section)

3. Responsibility:  Production Chemist

4.  Accountability: Production Manager

5.  Abbreviations :            

S.O.P.: Standard Operating Procedure

RH: Relative Humidity

QA: Quality Assurance

AHU: Air Handling Unit

LAF: Laminar Air Flow

Procedure for dry powder filling: 

  • The air handling system should be on at least three hours before filling operation and monitor Temp, R.H., and positive pressure of the room.
  • Transfer the clean, sterilized vials, Rubber closures, and Aluminium seals into the vial-filling sterile Area.
  • Check the vials, Rubber closures, and Aluminum seals for compliance with the specification given below.
  • Vilas: 7.5ml, 10ml, and 20ml colorless glass vials with 20mm standard mouth finish.
  • Rubber Closures: 20mm, gray Buty1 Rubber Closures.
  • Aluminum Seals: 20mm.
  • Run the filling machine without dosing collect 10 empty sealed vials and take the average weight.
  •  Fix the sterile piston assembly in the powder-filling machine and set all parameters for smooth filling.
  • Transfer the sterile powder to a sterilized machine hopper under LAF

Set the filling parameters as followers:  

       a) Target fill weight per vial.

       b) Upper/lower control limit. 

6.8 Start the filling and observed the fill weight of filled vials with respect to filling piston No. After two full rounds of filling run and adjust if required.

6.9 Expose the Agar plates during the filling operation as per the SOP.

6.10  Continue the filling and stopper if the parameters comply with standards.

6.11  Collect 16 vials from the filling wheel in the continuous run and check individual weight variation at the start-up of the batch record in the filling chart. Reconstituted the contents of each vial with 5ml of water for injection, mix to dissolve, and check for solubility & visual particulate matter of reconstituted solution.

6.12  Carry out the following in-process check during the filling.

 a. Collect 16 vials in the continuous run and check for individual weight variation every hour and check the 3 vials’ weight every ½ hours and record in the filling chart.

 b. Collect Approx. 16 vials every 4 hours and reconstituted each vial with 5ml of water for injection and check solubility and visual particulate matter of solution.

6.13. The stopper vials are sealed on the vial-sealing machine

6.14. Record the details of filling, stopper, and sealing.

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