Environmental monitoring - viable particle sampling
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This document discusses environmental viable airborne particle testing as part of an environmental sampling program for compounding areas. It outlines that sampling should occur at minimum every 6 months in all compounding areas and include sampling locations, collection methods, frequency, air volume, time of day, and action levels. Active air sampling using a volumetric impaction sampler is called for, collecting a volume of 400mL to 1L. The growth media (TSA and malt extract agar) is incubated and colony forming units per cubic meter are counted and action levels determined. Areas exceeding action levels should be remediated and resampled.
Environmental monitoring - viable particle sampling
- 1. Environmental Monitoring Viable Airborne Particle Testing
- 2. Environmental viable airborne particle testing is part of a good environmental sampling (ES) program designed to ensure that compounding area(s) maintain acceptably low viable particle levels.
- 3. Your sampling plan for viable airborne testing should include sampling locations, collection methods, frequency, air volume to test, time of day testing will occur, and action levels
- 4. Sampling for airborne viable particles must be conducted based on a risk assessment of your facilities compounding activities
- 5. However, testing must occur at a minimum every 6 months in all compounding areas (PECs, buffer areas, ante areas, and areas adjacent to segregated compounding areas) as part of the recertification process
- 6. Viable air sampling may be performed by properly training in-house personnel, or may be contracted to a qualified third party.
- 7. Sampling must include multiple locations within each ISO Class 5 environment (PECs) and in the secondary engineering controls (ISO Class 7 buffer areas and ISO Class 8 ante- areas)
- 8. Sampling must also be performed in segregated compounding areas at greatest risk of contamination (e.g., work areas near the ISO Class 5 environment, counters near doors, pass-through boxes, and so on)
- 9. For low-, medium-, and high-risk level compounding, air sampling shall be performed at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning.
- 10. Locations must include zones of air backwash turbulence within laminar airflow workbenches (LAFW) and other areas where air backwash turbulence may enter the compounding area (doorways, in and around ISO Class 5 primary engineering control and environments)
- 11. For low-risk level CSPs with 12-hour or less BUD prepared in an aseptic isolator located outside of a clean room that maintains an ISO Class 5 area in its interior, perform air sampling at locations inside the ISO Class 5 environment and other areas in close proximity to the ISO Class 5 environment
- 12. It’s important when performing viable particle sampling to use both an appropriate collection method as well as an appropriate growth medium
- 13. active air sampling to be performed using a volumetric impaction sampler. USP Chapter <797> calls for: *or other suitable media that supports the growth of fungi use of 2 media for air sampling: Soybean– Casein Digest Medium for bacteria and malt extract agar* for fungi in high-risk compounding areas
- 14. Volumetric impaction samplers use a solid or adhesive medium, such as agar, for particle collection. Air is drawn into a sampler and accelerated, producing laminar air flow onto the collection surface (agar plate or contact plate filled with a suitable agar medium)
- 15. Active sampling means that air samples are collected under working conditions, i.e. while compounding is taking pace
- 16. It is suggested that the volume of air sampled be between 400mL and 1L* *subject to recommendations by the manufacturer of the sampling device and volume needed to meet limits of detection for ISO rating of area tested
- 17. At the end of the air sampling activities, the microbial growth media plates are recovered and their covers are taped closed, and they are inverted and incubated at a temperature and period of time conducive to multiplication of microorganisms
- 18. The TSA (a.k.a. Soybean-Casein Digest Agar Medium) used to test for bacteria should be incubated at 30°C to 35°C (86°F - 95°F) for 48 to 72 hours
- 19. The Malt Extract Agar - or other suitable fungal media - should be incubated at 26°C to 30°C (79°F - 86°F) for 5 to 7 days *
- 20. Growth media should be incubated outside the sterile prep area according to the manufacturer's recommendations
- 21. Following incubation, the number of discrete colonies of microorganisms are counted and reported as colony-forming unit (cfu) per cubic meter (1000mL) of air and documented on an environmental sampling form CFU is a unit used to estimate the number of viable bacteria or fungal cells in a sample
- 22. Action levels are determined on the basis of cfu data gathered at each sampling location and trended over time
- 23. However, regardless of cfu count, the growth of highly pathogenic microorganisms1 must be immediately remedied with the assistance of a competent microbiologist, infection control professional or industrial hygienist 1. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts can be potentially fatal to patients receiving CSPs
- 24. Action levels for cfu count are listed below in Table 2 Table 2 adopted from: The United States Pharmacopeia, 37th rev., and The national formulary, 32nd ed. USP General Chapter <797>. Pharmaceutical Compounding - Sterile Preparations. Rockville, MD: The United States Pharmacopeial Convention; 2014.
- 25. Any cfu count that exceeds its action level should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location.
- 26. Sources of contamination may include HVAC systems, damaged HEPA filters, and changes in personnel garbing or work practices.
- 27. Areas exceeding action levels should be remediated back into compliance Review results Analyze lab data Compare to established levels Review organisms recovered Investigate cause Establish corrective actions Eliminate Problem Clean area and resample Implement procedures to prevent reoccurrence
- 28. If an activity consistently shows elevated levels of microbial growth following corrective action, competent microbiology personnel should be consulted
Editor's Notes
- #15: Settling of particles is dependent on particle size and may be influenced by air movement. Therefore, the number of cfu's on a settling plates may not always relate to concentrations of viable particles in the environment sampled.
- #16: Settling of particles is dependent on particle size and may be influenced by air movement. Therefore, the number of cfu's on a settling plates may not always relate to concentrations of viable particles in the environment sampled.