Contec Healthcare recommended best practices for cleaning and disinfecting floors: For best results, begin at the farthest corner of the room and mop backward toward the door.
Use slightly overlapping strokes, in an S-curve pattern, ensuring complete coverage. Disinfectant dwell time is critical. Remember that mops and cleaning supplies should be dedicated to the cleanroom floors and stored in the ante area. Additional Recommendations:. Effective, fast-acting, one-step disinfectant cleaner. Mopping system with disposable microfiber covers for cleaning and disinfecting cleanroom floors.
Minimum Cleaning Frequency: Daily, when no aseptic operations are in progress. Minimum Cleaning Frequency: Daily. Use slightly overlapping strokes, not circular motions.
Replace used wipes often. When disinfecting counters or other hard, non-porous surfaces, dwell time is critical. Follow directions on the label to ensure efficacy is achieved. USP develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.
For more information on other compounding chapters click here. USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. Review their work plan and past meeting summaries.
Your participation is integral to the standard setting process. Stay involved and sign up to receive updates from USP. The nature of your activities conducted in a supporting clean room area determines its classification. USP requires that the area immediately adjacent to the aseptic processing line meet, at a minimum, Class 10, ISO 7 standards under dynamic conditions.
An area classified at a Class , ISO 8 air cleanliness level is appropriate for the anteroom used for garbing. You will need to take both air and surface samples.
Impaction on a media plate is the preferred method for viable air sampling. Settling plates that were once suggested in earlier National Formulary guidelines are not permitted in the USP revision since all sampling must now be volumetric. Surface sampling is required in all ISO classified areas on a periodic basis. In addition, "media-fill tests" must be conducted at least annually by each person authorized to make sterile compounds to verify that they can do so aseptically.
Sampling for airborne viable particles must be conducted based on a risk assessment of your compounding activities. The sampling sites you select must include multiple locations within each ISO Class 5 environment, ISO Class 7 and 8 areas and in the segregated compounding areas at greatest risk of contamination e. For low, medium, and high-risk level compounding, perform air sampling at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning.
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. Consideration must be given to the overall effect the chosen sampling method may have on the uni-directional airflow within a compounding environment. For low-risk level CSPs with hour or less beyond-use date 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 that are in close proximity to the ISO Class 5 environment.
During your sampling, in addition to documenting sample location, volume of air collected, etc. Media used for surface sampling must be supplemented with additives to neutralize the effects of disinfecting agents e. Air Sampling : Using an impaction sampler collect as much air as possible without drying the media. The revision bulletin requires a sampling volume of to liters of air, subject to recommendations by the manufacturer of the sampling device and the volume needed to meet the limits of detection for the ISO rating of the area being tested.
When swabbing is used in sampling, the area covered should be at least 24 cm 2 but no larger than 30 cm 2.
0コメント