compounder sterile products Interview Questions and Answers

1. What are compounded sterile products (CSPs)?

   • Answer: CSPs are sterile drug preparations made by compounding pharmacies, tailored to meet specific patient needs not readily available as commercially manufactured products. They are prepared from bulk drug substances or commercially available products and involve manipulations such as reconstitution, dilution, and mixing.

2. What are the different types of CSPs?

   • Answer: CSPs are categorized by risk levels (low, medium, high) based on the preparation method and environmental conditions. They can also be classified by route of administration (e.g., intravenous, intramuscular, ophthalmic).

3. Explain the importance of USP <797> and USP <800> guidelines.

   • Answer: USP <797> provides standards for compounding sterile preparations to prevent contamination. USP <800> addresses hazardous drugs and outlines safety practices for handling and disposal to protect personnel and the environment.

4. What are the key principles of aseptic technique?

   • Answer: Key principles include maintaining a sterile field, using sterile supplies and equipment, performing hand hygiene rigorously, minimizing air movement, and working within a controlled environment (e.g., cleanroom).

5. Describe the different types of cleanrooms used in CSP compounding.

• Answer: ISO Class 5 (or better) is required for the primary engineering control (PEC), like a laminar airflow workbench (LAFW). The buffer room surrounding the PEC is typically ISO Class 7, and the ante-area is often ISO Class 8. These classifications refer to the number of particles per cubic meter of air.

6. What is a laminar airflow workbench (LAFW), and how does it work?

   • Answer: A LAFW is a primary engineering control that provides a unidirectional airflow to sweep contaminants away from the sterile compounding area. It works by pulling air through a HEPA filter, creating a clean air stream.

7. What are HEPA filters, and why are they important in CSP compounding?

   • Answer: HEPA filters (High-Efficiency Particulate Air) remove at least 99.97% of particles 0.3 microns in size or larger, effectively eliminating airborne contaminants and ensuring a sterile compounding environment.

8. Explain the concept of garbing and its importance in CSP compounding.

   • Answer: Garbing refers to the process of donning sterile attire (gown, gloves, mask, shoe covers) in a specific sequence to minimize the introduction of contaminants into the cleanroom.

9. What are the different types of gloves used in sterile compounding?

   • Answer: Sterile compounding uses powder-free, sterile, non-latex gloves are typically preferred. Chemotherapy compounding may require specific glove types for added protection.

10. What are the procedures for cleaning and disinfecting a cleanroom?

    • Answer: Cleaning and disinfection procedures are rigorous and follow specific protocols. They involve cleaning surfaces with detergents followed by disinfection with sterile wipes or solutions. The procedures are documented and frequently audited.

11. What is environmental monitoring, and why is it crucial in CSP compounding?

    • Answer: Environmental monitoring involves regularly testing the air and surfaces within the cleanroom for microbial contamination. It helps ensure the sterility of the environment and identifies potential contamination sources.

12. Explain the importance of proper labeling of CSPs.

    • Answer: Accurate labeling is crucial for patient safety. Labels must include the medication name, strength, quantity, route of administration, expiration date, and any relevant warnings.

13. What are the different methods for sterilizing equipment used in CSP compounding?

• Answer: Methods include steam sterilization (autoclaving), dry heat sterilization, and ethylene oxide sterilization. The choice of method depends on the type of equipment.

14. What is the role of aseptic verification testing?

    • Answer: Aseptic verification tests (like media fills) simulate the compounding process using a growth medium instead of a drug product to check for any microbial contamination. It validates the aseptic technique and the effectiveness of the cleanroom environment.

15. Explain the importance of proper disposal of hazardous waste generated during CSP compounding.

    • Answer: Hazardous waste, especially from chemotherapy compounding, requires specific disposal procedures to protect personnel and the environment. This often involves specialized containers and waste disposal services.

16. What is the role of quality control in CSP compounding?

    • Answer: Quality control ensures that all aspects of the compounding process adhere to USP standards and maintain the sterility and quality of the final product. This involves checks at every stage.

17. What is the importance of documentation in CSP compounding?

    • Answer: Meticulous documentation is essential for tracking the entire compounding process, ensuring compliance with regulations, and providing a record for audits and investigations in case of issues.

18. What are some common errors in CSP compounding and how can they be prevented?

    • Answer: Common errors include contamination, incorrect calculations, wrong ingredients, and improper labeling. Prevention involves thorough training, meticulous procedures, quality control checks, and a focus on aseptic technique.

19. How are the expiration dates for CSPs determined?

    • Answer: Expiration dating considers the risk level of the CSP, the type of components used, and storage conditions. USP guidelines provide guidance on determining appropriate expiration dates.

20. What are the different types of incompatibility that can occur in CSP compounding?

• Answer: Incompatibilities can be physical (precipitation, cloudiness), chemical (degradation, reaction), or therapeutic (antagonistic effects). Careful selection of components and compatibility checks are crucial.

21. Describe the process of preparing a low-risk level CSP.

    • Answer: Low-risk CSPs involve minimal manipulations in a cleanroom environment using sterile components and aseptic technique. Procedures involve careful preparation, visual inspection, and labeling.

22. What are the special considerations for preparing high-risk level CSPs?

• Answer: High-risk CSPs require more stringent aseptic technique, more thorough environmental monitoring, and often terminal sterilization (if possible). Greater care and attention to detail are crucial.

23. How is the sterility of a CSP verified?

    • Answer: Sterility is verified through aseptic technique, environmental monitoring, and potentially sterility testing for high-risk CSPs (although this is typically not practical for many CSPs).

24. What is the role of the pharmacist in CSP compounding?

    • Answer: The pharmacist is responsible for overseeing all aspects of CSP compounding, ensuring compliance with USP guidelines and maintaining the quality and safety of the products. They supervise technicians, approve formulations, and ensure appropriate documentation.

25. What is the role of the pharmacy technician in CSP compounding?

    • Answer: Pharmacy technicians assist pharmacists in the compounding process, performing tasks under the pharmacist's supervision. This includes preparing supplies, performing the compounding steps, and cleaning and maintaining equipment.

26. What is the difference between a primary and secondary engineering control?

    • Answer: A primary engineering control (PEC) is a device (e.g., LAFW) that provides an ISO Class 5 environment for compounding. A secondary engineering control (SEC) is a room (e.g., buffer room) that provides environmental control around the PEC.

27. Explain the importance of proper hand hygiene in CSP compounding.

    • Answer: Hand hygiene is paramount. Hands must be thoroughly washed and disinfected before garbing and throughout the compounding process to minimize contamination risk.

28. What are some common sources of contamination in CSP compounding?

    • Answer: Sources include personnel, equipment, air, and supplies. Proper procedures, regular cleaning, and environmental monitoring help minimize these risks.

29. What is the role of risk assessment in CSP compounding?

    • Answer: Risk assessment helps determine the appropriate level of control and procedures required for different compounding processes, ensuring patient safety.

30. What is a media fill test?

    • Answer: A media fill test simulates compounding using a sterile growth medium instead of drug product. It evaluates the aseptic technique and identifies potential contamination points.

31. Explain the concept of "beyond-use dating" (BUD) for CSPs.

    • Answer: BUD is the date after which a CSP should not be used. It's based on the risk level of the CSP and storage conditions.

32. What are the storage requirements for different types of CSPs?

    • Answer: Storage requirements vary based on the CSP's stability and risk level. Some require refrigeration, while others need to be stored at room temperature, protected from light.

33. How do you ensure the accuracy of ingredient measurements in CSP compounding?

• Answer: Accurate measurement is ensured through careful calibration of equipment, using appropriate measuring devices (e.g., calibrated balances, syringes), and performing double checks.

34. What are the regulations governing CSP compounding?

    • Answer: Regulations include USP <797>, USP <800>, state board of pharmacy regulations, and potentially other relevant federal or state laws.

35. How do you handle spills of hazardous drugs during CSP compounding?

    • Answer: Spills require immediate and careful cleanup using appropriate personal protective equipment (PPE) and spill kits, following specific protocols to minimize exposure and contamination.

36. What training is required for personnel involved in CSP compounding?

    • Answer: Training includes aseptic technique, cleanroom procedures, USP guidelines, and safety procedures related to hazardous drugs (if applicable).

37. What are the consequences of non-compliance with USP <797> and USP <800> guidelines?

    • Answer: Non-compliance can lead to citations, fines, suspension of operations, legal action, and most importantly, risk to patient safety.

38. Explain the concept of "sterile compounding aseptic isolator" (CAI).

    • Answer: CAIs are enclosed devices that provide a highly controlled environment for compounding, minimizing the risk of contamination. They are often used for hazardous drug compounding.

39. What are some examples of hazardous drugs commonly handled in CSP compounding?

    • Answer: Examples include many chemotherapeutic agents, certain hormones, and some immunosuppressants. The specific list is extensive and depends on the facility.

40. Describe the process of verifying the integrity of sterile packaging.

    • Answer: Verification includes visually inspecting packages for any damage, tears, or signs of compromise. Proper storage and handling are also crucial in maintaining integrity.

41. What are the different types of syringes used in CSP compounding?

• Answer: Syringes come in various sizes and types, including those with different needle sizes and luer-lock connections, depending on the drug and the procedure.

42. How do you manage and track inventory of drug substances and supplies used in CSP compounding?

    • Answer: Inventory management uses systems like barcoding, automated tracking software, and regular stock checks to ensure adequate supplies and prevent waste or expiry.

43. How do you investigate and address a potential contamination event in a CSP compounding area?

    • Answer: Investigation involves identifying the source, determining the extent of contamination, implementing corrective actions, and documenting the entire process. This may involve thorough environmental monitoring and staff retraining.

44. What are the key elements of a CSP compounding training program?

    • Answer: The program should cover aseptic technique, cleanroom procedures, USP guidelines, hazardous drug handling (if applicable), quality control, and documentation. It needs to be comprehensive and regularly updated.

45. How do you ensure the stability of CSPs after compounding?

    • Answer: Stability is ensured through proper storage conditions, using appropriate components, adhering to BUDs, and regularly monitoring for signs of degradation.

46. What is the importance of using appropriate personal protective equipment (PPE) in CSP compounding?

    • Answer: PPE protects personnel from exposure to hazardous drugs and prevents contamination of the compounding environment. It is crucial for both safety and maintaining sterility.

47. How do you ensure the accuracy of calculations when preparing CSPs?

    • Answer: Accuracy is ensured through double-checking calculations, using formulas correctly, employing technology like automated compounding systems, and following established procedures.

48. What are the potential consequences of using expired or deteriorated drug substances in CSP compounding?

    • Answer: Using expired or deteriorated substances can lead to ineffective medication, adverse reactions, and potential harm to patients.

49. Describe the importance of regular maintenance of equipment used in CSP compounding.

    • Answer: Regular maintenance ensures the proper functioning of equipment, prevents breakdowns, and helps maintain the cleanliness and sterility of the compounding area.

50. How do you handle complaints or adverse events related to CSPs?

    • Answer: Complaints are investigated thoroughly, documentation is reviewed, and corrective actions are implemented. This involves identifying the root cause and taking steps to prevent recurrence.

51. What is the role of continuous improvement in CSP compounding?

    • Answer: Continuous improvement involves regularly evaluating processes, identifying areas for enhancement, and implementing changes to optimize safety, efficiency, and quality.

52. Explain the concept of "cleanroom classification" and its significance in CSP compounding.

    • Answer: Cleanroom classification refers to the level of airborne particulate matter. ISO classifications (e.g., ISO Class 5, 7, 8) dictate the cleanliness requirements for different areas in a compounding facility.

53. How do you select the appropriate type of container for a particular CSP?

    • Answer: Container selection is based on the drug's compatibility, the route of administration, the volume, and stability requirements. Materials must be compatible with the formulation.

54. What are some examples of non-sterile compounding and how do they differ from sterile compounding?

    • Answer: Non-sterile compounding involves preparing non-sterile products (e.g., ointments, creams) with less stringent requirements for environmental control and aseptic technique compared to sterile preparations.

55. How do you ensure the accuracy and precision of automated compounding devices?

    • Answer: Accuracy is ensured through regular calibration, maintenance, and quality control checks. Software updates and adherence to manufacturer's instructions are also important.

56. Describe the process of preparing a Total Parenteral Nutrition (TPN) solution.

    • Answer: TPN preparation involves carefully calculating and mixing various nutrients (carbohydrates, amino acids, lipids, electrolytes, vitamins) under strict aseptic conditions in a cleanroom.

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