Top 70 FAQs on Sterile and Aseptic Techniques

It includes More than 70 Frequently asked Questions with answers FAQs on Sterile and Aseptic Techniques for Pharmaceutical Products –  For Beginners :

(Frequently asked Questions) FAQs on Sterile and Aseptic Techniques for Pharmaceutical Products –  It’s for Beginners :

1. What is a sterile Technique?  Sterile technique refers to the use of methods and procedures to achieve and maintain sterility, which is the complete elimination of all viable microorganisms, including bacterial spores. This can include the use of sterilization techniques such as autoclaving, filtration, and irradiation, as well as maintaining a sterile environment through proper cleaning and sanitation practices.
2. What is aseptic Technique ? Aseptic technique is use of methods and procedures to prevent the introduction of microorganisms into a sterile environment. This can include using sterile equipment and supplies, wearing sterile clothing such as gowns and gloves, and maintaining a sterile environment through the use of laminar airflow hoods or barrier isolators.
3. Why is it important to have sterile formulations? Sterile formulations are important because they are used to treat patients who may have weakened immune systems, Sterile formulations also help prevent the spread of infectious diseases.
4. What are the different types of sterile formulations? There are different types of sterile formulations including injectables, Form Fill Seal (FFS), Blow Fill Seal (BFS),  eye drops, Metered Dose inhalers (MDI) , and intravenous fluids.
5. What is terminal sterilization? Terminal sterilization refers to the process of sterilizing a finished product, such as an injectable, by exposing it to high heat or radiation. Terminal Sterilization will be done for product, When Product is filled in its container whereas in other hand Aseptic Technique is the techniques where product filtration is done i.e. Removal of Microorganism will be done by filtration before product filling and then it is filling the Respules/Bottles/Ampules.
6. What are the common sterilization methods used in the pharmaceutical industry? Common sterilization methods used in the pharmaceutical industry include steam sterilization, dry heat sterilization, gamma radiation, and ethylene oxide sterilization.
7. What is steam sterilization? Steam sterilization involves exposing the product or equipment to high-temperature steam under pressure, which kills microorganisms.
8. What is dry heat sterilization? Dry heat sterilization involves exposing the product or equipment to high temperatures without using moisture. This kills microorganisms by oxidation.
9. What is gamma radiation sterilization? Gamma radiation sterilization involves exposing the product or equipment to gamma rays, which kills microorganisms.
10. What is ethylene oxide sterilization? Ethylene oxide sterilization involves exposing the product or equipment to ethylene oxide gas, which kills microorganisms.
11. What are the factors that influence the choice of sterilization method? The factors that influence the choice of sterilization method include the nature of the product, the type of microorganisms that need to be eliminated, and the material of the product or equipment being sterilized.
12. What is the purpose of a biological indicator? A biological indicator is used to confirm that the sterilization process has effectively killed all microorganisms. It contains spores of heat-resistant bacteria that are killed when exposed to the sterilization process.
13. What is a cleanroom? A cleanroom is a controlled environment where the air is filtered to remove any airborne particles, and the surfaces are regularly disinfected to maintain a sterile environment.
14. What are the different classes of cleanrooms? Cleanrooms are classified based on the number of particles per cubic meter of air. The different classes include ISO 5 (Class 100), ISO 6 (Class 1,000), ISO 7 (Class 10,000), and ISO 8 (Class 100,000).
15. What is a lyophilized product? A lyophilized product is a product that has been freeze-dried, which involves removing water from the product to increase its stability and shelf life.
16. What are some of the challenges associated with producing sterile formulations? Some of the challenges associated with producing sterile formulations include the need for aseptic processing, the risk of contamination, and the high cost of equipment and materials.
17. What are some of the common contaminants found in sterile formulations? Some of the common contaminants found in sterile formulations include bacteria, fungi, and viruses.
18. What is an endotoxin? An endotoxin is a toxin that is released from the cell walls of certain bacteria when they are destroyed. Endotoxins can cause fever, shock, and other adverse effects in humans.
19. How are endotoxins removed from sterile formulations? Endotoxins are removed from sterile formulations by using a process called depyrogenation, which involves exposing the product or equipment to high temperatures.
20. What is a sterility test? Sterility Test is a test used to determine whether a pharmaceutical preparation or medical device is free from viable microorganisms. It involves incubating the product in a growth medium for a specified period of time to check for microbial growth. Sterility testing is important to ensure the safety and efficacy of sterile products.
21. What is mean by Microbial Limit Test ? The Microbial Limit Test is a Test used in the pharmaceutical industry to determine the total microbial count and the presence of specific microorganisms in a sample of a pharmaceutical preparation.
22. What is a media fill ? A media fill is a process used to validate the aseptic processing of a product by simulating the production process using a sterile growth medium.
23. What is a clean-in-place (CIP) system? A clean-in-place (CIP) system is a system used to clean the equipment in place without dismantling  it.
24. What is a fill-finish operation? A fill-finish operation is the process of filling a sterile product into its final container, such as a vial or syringe.
25. What is a Stopper? A stopper is a rubber or plastic component that is used to seal the opening of a vial or syringe.
26. What are some of the common issues that can occur during a fill-finish operation? Common issues that can occur during a fill-finish operation include contamination, overfilling or underfilling, and stopper defects.
27. What is a barrier system? A barrier system is a system used to protect a sterile environment from the surrounding non-sterile environment.
28. What is a Restricted Access Barrier System (RABS)? A Restricted Access Barrier System (RABS) is a type of barrier system used in aseptic processing that allows operators to work inside the sterile environment without the risk of introducing contaminants.
29. What is a glove port? A glove port is an opening in a barrier system that allows operators to reach into the sterile environment while maintaining a barrier between the sterile and non-sterile environments.
30. What is a laminar airflow system? A laminar airflow system is a system that provides a flow of filtered air in a controlled direction to maintain a sterile environment.
31. What is a cleanroom garment? A cleanroom garment is clothing worn by operators in a cleanroom to reduce the risk of introducing contaminants into the sterile environment.
32. What is an isolator? An isolator is a type of barrier system used in aseptic processing that provides a completely enclosed environment for sterile product handling.
33. What is a Class A Air environment? A Class A air environment is an environment with the highest level of air cleanliness and is required for aseptic processing.
34. What is an autoclave? An autoclave is a piece of equipment used to sterilize equipment and materials by exposing them to high-pressure steam.
35. What is a steam-in-place (SIP) system? A steam-in-place (SIP) system is a system used to sterilize equipment in place by exposing it to high-pressure steam.
36. What is a clean steam generator? A clean steam generator is a piece of equipment used to produce steam that is free of impurities and can be used for sterilization.
37. What is a vial? A vial is a small glass or plastic container used for storing sterile products.
38. What is a syringe? A syringe is a medical device used for injecting or withdrawing fluids from the body.
39. What is a pre-filled syringe? A pre-filled syringe is a syringe that is pre-filled with a sterile medication for injection.
40. What is a prefilled syringe filling line? A prefilled syringe filling line is a production line used for filling pre-filled syringes with sterile medications.
41. What is a blow-fill-seal (BFS) and Form Fill Seal (FFS) system? A blow-fill-seal (BFS) and Form Fill Seal (FFS)  is a system used for aseptically producing and filling containers in a continuous process.
42. What is a sterile filtration system? A sterile filtration system is a system used to remove microorganisms from a fluid to produce a sterile product.
43. What is an air sampler? An air sampler is a device used to collect air samples for the detection of microorganisms.
44. What is a temperature mapping study? A temperature mapping study is a study conducted to determine the temperature distribution within a piece of equipment or a room.
45. What is a cleanroom classification? A cleanroom classification is a rating system used to classify cleanrooms based on the level of air cleanliness and particle count.
46. What is a sporicidal agent? A sporicidal agent is a substance that is capable of killing bacterial spores, which are highly resistant to sterilization methods.
47. What is a depyrogenation oven? A depyrogenation oven is a piece of equipment used to remove endotoxins from glassware and other equipment by exposing them to high temperatures.
48. What is a gowning procedure? A gowning procedure is a set of steps that operators must follow to put on cleanroom garments and enter a cleanroom environment.
49. What is a spore strip test? A spore strip test is a test used to evaluate the effectiveness of a sterilization process by placing a spore-containing strip in a sterilization cycle and testing for spore survival.
50. Why is aseptic technique important in the pharmaceutical industry? Aseptic technique is important in the pharmaceutical industry because it helps prevent contamination, which can lead to product recalls, regulatory sanctions, and patient harm.
51. What are the basic principles of aseptic technique? The basic principles of aseptic technique include hand hygiene, sterilization of equipment and surfaces, use of sterile materials, and maintenance of a sterile field.
52. What is a Laminar airflow hood? A laminar airflow hood is a device used to create a sterile environment by directing HEPA-filtered air over a work surface.
53. What is aseptic gowning? Aseptic gowning is the process of doing sterile clothing, such as gowns, gloves, and masks, to prevent the introduction of contaminants.
54. What is aseptic filling? Aseptic filling is the process of filling and packaging sterile pharmaceutical products while maintaining aseptic conditions.
55. What is aseptic processing? Aseptic processing is the production of sterile pharmaceutical products while maintaining aseptic conditions.
56. What is media fill validation? Media fill validation is a test used to validate aseptic processing techniques by simulating the production of sterile pharmaceutical products with a sterile culture medium.
57. What is the purpose of an environmental monitoring program in aseptic processing? The purpose of an environmental monitoring program in aseptic processing is to detect and quantify potential sources of contamination in the production environment.
58. What are the components of an environmental monitoring program in aseptic processing? The components of an environmental monitoring program in aseptic processing include air sampling, surface sampling, and personnel monitoring.
59. What is a viable particle count? A viable particle count is a measure of the concentration of viable microorganisms in a sample.
60. What is non-viable particle monitoring? Non-viable particle monitoring is the measurement of the concentration and size distribution of non-living particles in the air.
61. What is a sterile gowning qualification? A sterile gowning qualification is a process used to evaluate the ability of personnel to don sterile clothing and maintain aseptic conditions.
62. What is a glove fingertip test? A glove fingertip test is a test used to evaluate the integrity of gloves worn during aseptic processing.
63. What is a disinfectant? A disinfectant is a substance or agent that is used to kill or eliminate microorganisms on non-living surfaces.
64. What is a sporicidal agent? A sporicidal agent is a disinfectant that is effective against bacterial spores.
65. What is a kill time? A kill time is the time required for a disinfectant to kill a specified percentage of microorganisms.
66. What is a disinfectant rotation program? A disinfectant rotation program is a program used to rotate the use of different disinfectants to prevent the development of resistant microorganisms.
67. What is the difference between sterilization and disinfection? Sterilization is the process of eliminating all forms of life, including microorganisms and bacterial spores, while disinfection is the process of reducing the number of microorganisms to a safe level.What is a sterile field? A sterile field is an area that is free from microorganisms and is used to maintain sterility during surgical procedures or aseptic processing.
68. What is a sterile transfer? A sterile transfer is the movement of sterile materials or products from one container or location to another while maintaining sterility.
69. What is a glove leak test? A glove leak test is a test used to detect leaks in gloves worn during aseptic processing.
70. What is the purpose of airlocks in aseptic processing facilities? Airlocks are used in aseptic processing facilities to prevent the entry of contaminants by creating a barrier between different areas of the facility.
71. What is the difference between a Class A and a Class B aseptic filling environment? A Class A aseptic filling environment is a higher level of sterility and requires the use of a laminar airflow hood or barrier isolator. Class B aseptic filling environment is a lower level of sterility and may not require the use of a laminar airflow hood or barrier isolator.