MEDIA FILL VALIDATION IN PHARMA

A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution.

1. SOP for Process Simulation Study (Media Fill)
2. SOP for Post Media Fill Cleaning and Startup of Production Line
3. SOP for Cleaning after Media fill
4. Aseptic Process Simulation of Media Fill Validation Protocol
5. Hold Time Validation for Sterilized Media (Prepared Media Plates and Tubes)
6. SOP for Destruction of Media fill Vials and Ampoules
7. SOP for Incubation and Observation of Media Fill Containers
8. SOP for Batch Numbering System for Media Fill
9. SOP for Receipt, Incubation, Observation & Discard of Media Fill Vials & Inoculated Membrane
10. SOP for Process Simulation Study (Media Fill)
11. SOP for Aseptic Process Simulation (Media Fill Run)
12. SOP for Media Fill
13. PIC/S Guideline for Media Fill
14. Media Fill Pre-Requisite
15. Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs
16. Media Fill (PDA)
17. Over Flow Capacity
18. Media Fill (An Overview)
19. PROCESS SIMULATION STUDY (MEDIA FILL) PLANNER
20. PROCESS SIMULATION STUDY (MEDIA FILL) EXECUTION RECORD
21. MEDIA FILL FAILURE INVESTIGATION REPORT
22. MEDIA FILL PROCESS FLOW FOR AMPOULE LINE
23. MEDIA FILL PROCESS FLOW FOR DRY POWDER INJECTION
24. MEDIA FILL PROCESS FLOW FOR LIQUID VIAL LINE
25. MEDIA FILL PROCESS FLOW FOR THREE PIECE LINE

Dry Powder Injection

1. Media Fill Protocol for Dry powder Line
2. Media Fill Report for Dry powder Line
3. Process Simulation Study (Media Fill) Protocol for Dry Powder Injection
4. Media Fill Validation Protocol
5. Attachment A
6. Attachment B
7. Attachment C
8. Attachment D
9. Attachment E
10. Attachment F
11. Attachment G
12. Attachment H
13. Attachment I
14. Performance Qualification Protocol for Process Simulation Study (Media Fill)
15. Performance Qualification Report for Process Simulation Study (Media Fill)
16. Media Fill BMR (7.5 ml)
17. Aseptic Process Simulation or Media Fill Validation Protocol
18. Media Fill BMR (7.5 ml) Dry Powder Injection
19. Media Fill BMR (10 ml) Dry Powder Injection
20. Media Fill BMR (20 ml) Dry Powder Injection
21. Sampling Plan for Dry Powder Injection
22. Summary Report for Dry Powder Line 20 ml

Three Piece Injection

1. Media Fill Protocol for Three Piece Line (Suspension)
2. Media Fill Report for Three Piece Line (Suspension)
3. Media Fill BMR (Three Piece) 5 ml
4. Media Fill BMR (Three Piece) 10 ml
5. Media Fill BMR (Three Piece) 15 ml
6. Sampling Plan for Three Piece
7. Summary Report for Three Piece Line 5 ml

Ampoules

1. Media Fill Protocol for Ampoule Line
2. Media Fill Report for Ampoule Line
3. Media Fill BMR (1 ml Ampoule)
4. Media Fill BMR (2 ml Ampoule)
5. Media Fill BMR (5 ml Ampoule)
6. Media Fill BMR (10 ml Ampoule)
7. Sampling Plan for Ampoule Line

Liquid Vials

1. Media Fill Protocol for Liquid Vial Line
2. Media Fill Report for Liquid Vial Line
3. Media Fill BMR (2 ml Vial)
4. Media Fill BMR (5 ml Vial)
5. Media Fill BMR (10 ml Vial)
6. Media Fill BMR (20 ml Vial)
7. Media Fill BMR (30 ml Vial)
8. Media Fill Report for Liquid Vial Line
9. Sampling Plan for Liquid Vial Line
10. Summary Report for Liquid Vial Line 30 ml