Sterile Systems

  1. Sterile Areas Classification in the Injectable Pharmaceutical Industry: A Deep Dive into Cleanroom Standards and Best Practices
  2. Procedures (SOP) for Bubble Point Test for Filters: A Comprehensive Guide
  3. Procedures (SOP) for Forward Flow Test (Diffusion Test) for Filters: A Comprehensive Guide
  4. Procedures (SOP) for Pressure Hold Test for Filters: A Comprehensive Guide
  5. Procedures (SOP) for Water Intrusion Test for Filters: A Comprehensive Guide
  6. Procedures (SOP) for Filters Integrity Test Using Aerosols: A Comprehensive Guide
  7. Pharmaceutical Sterile Products: Importance, Types, Regulatory Requirements, and Impact on Health Sector
  8. The Science of Washing and Siliconizing Seals and Plugs for Sterile Injectable
  9. Cleaning of Non-Aseptic Areas in Sterile Injectables Manufacturing Facility
  10. Mastering the Change Room Procedure for Pharmaceutical Aseptic Areas
  11. What is Biofilm, Its Formation, Contamination, and Effects on Sterile Water
  12. Biofilm Formation in Water Systems: Mechanism Overview
  13. Procedures and Steps for Control and Removal of Biofilm in Sterile Water System
  14. Biofilm Sensors: Types, Specifications and Uses
  15. Standard Operating Procedure for Mechanical, Chemical, Acid Washes, and Hot Water Sanitization: Cleaning and Disinfection of Biofilm
  16. Electrochemical Treatments for Removal of Biofilm in Pharmaceutical Sterile Water Systems
  17. Ozonation Treatment for Biofilm Removal from Sterile Water Systems in the Pharmaceutical Industry
  18. Ultrasound Cleaning of Biofilm for Sterile Water Systems in the Pharmaceutical Industry
  19. Science Behind Ultrasound Cleaning & Biofilm Removal
  20. Basics and Science Behind Ozonation for Biofilm Removal
  21. Fumigation in Cleanroom Area of Microbiology Laboratory: A Critical Overview
  22. Validation of Fumigation in Cleanroom Area: Validating Purity Needs Sterility From Start to Finish
  23. Media Fill Test for Sterile API Manufacturing Process Air Handling Unit and Its Working Process
  24. Epoxy Flooring and Its Benefits in Pharmaceuticals
  25. Sanitation of Cleanroom Area in Pharmaceutical Manufacturing
  26. Restricted Access Barrier System (RABS) in Pharmaceuticals Criteria for Selection of Clean Room Garments in Pharmaceuticals
  27. Media Fill Test Failure Investigation
  28. Maintenance of Pharmaceutical Clean Area: FDA Recommendation Contamination Control Strategies for Manufacturing Area
  29. Buffer Area and Its Maintenance in Sterile Facility
  30. How to Eliminate Microbial Contamination from Classified Area
  31. Difference Between Aseptic and Sterile Conditions
  32. Fungus in Pharmaceutical Cleanrooms: Types, Origins, and Decontamination Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals
  33. Smoke Study in Cleanroom Areas
  34. Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas
  35. Essential Steps for Setting up a Pharmaceutical Cleanroom
  36. 4 Biggest Problems In Sterile Pharmaceutical Manufacturing
  37. Sterile Pharmaceutical Manufacturing Area Cleaning
  38. What Do You Need to Know About the Stability of Injectable Drugs
  39. Blow Fil Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Paly Alpha Olefin (PAO) Used in HVAC Validation
  40. Mode of Action of Disinfectant Solutions
  41. Cellulose Membrane Filters Used in Pharmaceuticals
  42. Checklist for Audit in Sterile Area
  43. SOP for Finger Dab
  44. SOP for METONE Laser Particle Counter
  45. SOP for Sterile Dress Cabinet
  46. SOP for Cleaning of Sterile Dress Cabinet
  47. SOP for Environmental Monitoring by Non Viable Air Particle Count
  48. SOP for Validation of Clean Area and Equipment Lying in Clean Area
  49. SOP for Microbiological Integrity Testing of Vials
  50. SOP for Entry in and Exit from the Suspension Manufacturing
  51. SOP for Environmental Monitoring of Aseptic Area by Air Sampling for Viable Count using Air Sampler SOP for Environmental Monitoring of Aspetic Area: Finger Prints and Gown Sampling
  52. SOP for Environmental Monitoring of Parenteral Processing Area by RODAC Plate and Swab
  53. SOP for Environmental Monitoring of Aseptic Area: Non Viable Particle Count of Air
  54. SOP for Environmental Monitoring of Parenteral Processing Area by Settling Plate Count Method SOP for Cleaning of Clean Area (Sterile Area)
  55. SOP for Inspection of Media Fill Vials and Qualification of Inspectors
  56. SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area
  57. SOP for Collection and Testing of Samples During Process Simulation SOP for Disposal of Media Fill Vials
  58. SOP for Personnel Monitoring for Microbial Contamination in Aseptic Area Isolators and Their Use in Sterile Manufacturing
  59. Human Generated Contamination in Cleanroom and its Control
  60. Role of RH and Temperature in Dry Powder Injection Manufacturing Difference between Sterilization and Depyrogenation
  61. Aseptic Processing Area and Its Maintenance
  62. Key Differences between LAF and Biological Safety Cabinet Requirement of Active and Passive Air Sampling in Controlled Areas
  63. Different Types of Hand Disinfectants Used in Pharmaceuticals
  64. Difference between Fumigation and Fogging
  65. GMP for Sterile Pharmaceutical Manufacturing
  66. Controlled area in Sterile Pharmaceutical Manufacturing
  67. Possibilities of Contamination in Sterile Products
  68. Prevention of Microbial Contamination in Manufacturing
  69. Critical and Non-critical Areas in Pharmaceutical Manufacturing
  70. Difference between Injection and Infusion
  71. Protective Gears used in Pharmaceutical Sterile Areas
  72. Airlocks and Change Rooms in cGMP Facility
  73. Top 10 Tips for Sterility Test
  74. Problems Associated with Pharmaceutical Cleanroom Areas
  75. Favourable Conditions for Microbial Growth in Cleanroom Area
  76. Why do We Expose Media Plates for 4 Hours in Cleanroom Areas? How Sterilization of Parenteral Products is done by Radiation?
  77. Filter Validation in Sterile Manufacturing
  78. Monitoring in Sterile Filling Area
  79. Difference between Sterile and Pyrogen Free
  80. Preparation Process for Water for Injection (WFI) in Pharmaceuticals
  81. Is Fungal Count Acceptable in Pharmaceutical Classified Area? Role and Calculation of Air Changes per Hour in Clean Room Area Terminal Sterilization of Sterile Pharmaceutical Preparations
  82. Degyrogenation in Injection Manufacturing
  83. Types of Airlocks and Requirement in Pharmaceutical Controlled Areas Sterile Area (Cleanroom) Qualification
  84. Incubation Conditions for Fungus and Bacteria Using Common Media
  85. Handle Microbial Cultures in Separate Room
  86. Identification of Environmental Isolates
  87. Layout for Injection Manufacturing Unit
  88. Pass boxes in Classified Areas
  89. Design of a Sterile Facility in Pharmaceuticals
  90. Why 70% Isopropyl Alcohol (IPA) is used as Disinfectant in Pharmaceuticals?
  91. Lyophilization of Parenteral Pharmaceutical Products
  92. Different Types of Diffusers Used in Pharmaceutical Clean Rooms (Controlled Area)
  93. A Different Approach to Validation and Re-validation of Washing Machine and a Depyrogenation Tunnel
  94. Pyrogen Test and Its Determination Using Rabbits
  95. Sterile Pharmaceutical Dosage Forms – Parenteral Preparations
  96. Performance Qualification of Isolator Systems
  97. Water for Injection (WFI) System Validation Process
  98. Parenteral Added Substances
  99. Clean Room System in Sterile Pharmaceutical
  100. Validation of Supporting Processes in Pharmaceuticals
  101. An Overview of ISO 14644 Clean Room Classification
  102. High-Efficiency Particulate Air (HEPA) and Its Significance in Sterile Pharmaceutical Preparations Summary
  103. of ISO 14644 (ISO Cleanliness Classes)
  104. Media Fill Validation -SVP
  105. Clean Rooms and Controlled Areas (Sterile Area Classification)
  106. Personnel Monitoring in Sterile Area
  107. Sterility Testing by Direct Inoculation Method
  108. Sterility Testing Procedure
  109. Media Fill Validation Test in Sterile Pharmaceutical
  110. Best Practices in Pharmaceutical Drainage and Drain Control
  111. Protecting Pharmaceutical Facilities and Equipment from Foul Drain Contamination
  112. Drainage Systems in Pharmaceutical Manufacturing: Protecting Product Integrity and Environmental Safety
  113. Materials and Design Considerations for Pharmaceutical Drainage Systems
  114. Microbiological and Physico-Chemical Monitoring of Pharmaceutical Drainage Systems
  115. Qualifying Drainage Systems, Design, Installation, and Operation