Section Ph 404.07 - Engineering Controls(a) Each compounder shall ensure the PEC, LAFW and BSCs provide ISO Class 5 air quality;(b) Each compounder shall ensure the buffer room maintains a minimum of an ISO Class 7 air quality;(c) Each compounder shall ensure the buffer room is designed to reduce the risk of contaminants being blown into the primary compounding area, or PCA. To be considered a clean room, buffer area must meet specific air quality, HEPA filtration, air changes per hour, and room pressure differentiation criteria to provide at least ISO Class 7 air quality.(d) Each compounder shall ensure that within the buffer area, the PEC should be kept away from excess traffic, doors, air vents, or anything that could introduce contaminates into the workbench.(e) Each compounder shall ensure that the anteroom is separate from buffer area.(f) Each compounder shall ensure that the anteroom provides ISO Class 8 air quality, or ISO Class 7 air quality, depending on the connecting buffer area.(g) Each compounder shall ensure the anteroom area should store an adequate amount of gowning supplies but should not be part of high traffic area or corridor.(h) Each compounder shall ensure the anteroom is used to un-carton and sanitize all supplies to be taken into buffer area.(i) Each compounder shall ensure sure the anteroom contains:(1) Hand sanitizing equipment;(2) Proper gowning equipment and space to accommodate gowning activities;(3) Faucet handles that shall be designed to be hands-free; and(4) That the buffer area can be accessed without the use of hands.(j) Each compounder that only compounds low and/or medium risk preparations, the ante room may be in the same area as the buffer room, separated by a line of demarcation. However, a separate ante room shall be the preferred method.(k) Each compounder that compounds high risk preparations, the buffer room and the ante room shall be 2 separate rooms.(l) Each compounder shall ensure all supplies brought into the buffer area are non-permeable, non-shedding, and resistant to disinfectants.(m) Each compounder shall ensure all materials exposed to patient care areas are kept out of the buffer area.(n) Each compounder shall ensure the PECs are cleaned and disinfected at the beginning of each shift, before each batch, at least every 30 minutes during compounding, when surfaces are visibly soiled, and when surface contamination is known or even suspected.(o) Each compounder shall ensure all interior working surfaces are cleaned and disinfected of LAFW from top to bottom, back to front, away from the HEPA filter. Cleaning shall be performed with purified water, and disinfecting with sterile 70% isopropyl alcohol or similar antimicrobial, residue-free sanitizing agent.(p) Each compounder shall ensure nothing shall be permitted to come in contact with the HEPA filter. This includes cleaning solutions, aspirate from syringes, or glass from ampules, which shall not be broken towards the filter.(q) Each compounder shall ensure air exchange with the surrounding environment shall not occur unless the air is first passed through a microbial retentive filter such as a HEPA system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared, the exhaust air from the isolator shall be appropriately removed by properly designed building ventilation.N.H. Admin. Code § Ph 404.07
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05
Amended by Volume XXXV Number 18, Filed May 7, 2015 , Proposed by #10812, Effective 4/18/2015, Expires 4/18/2025.