The injectable dry filling area is a completely sterile area of the company that is a strictly controlled area. The high-level alertness is mandatory to main the atmospheric condition in the filling area of the dry powder filling area of Injectable. Every step in the production area 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 best way to address the requirement of conditions an approved SOP for dry powder filling operation should be followed.
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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 vial filling sterile Area.
- Check the vials, Rubber closures, Aluminum seals for compliance with the specification given below.
- Vilas: 7.5ml, 10ml, 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 sterile piston assembly in the powder-filling machine and set all parameters for smooth filling.
- Transfer the sterile powder to 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 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 continues run and check individual weight variation at the start up of the batch record in 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 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 stoppers vials are sealed on the vial-sealing machine
6.14. Record the details of filling, stopper and sealing.
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