Section Ph 404.06 - Compounding Environment(a) Each compounder shall ensure there is sufficient space for the type and amount of compounding done.(b) Each compounder shall ensure there is appropriate space for orderly placement of equipment and materials to prevent mix-ups between ingredients, containers, labels, in-process materials and finished preparations.(c) Each compounder shall ensure it has procedures to prevent cross-contamination.(d) Each compounder shall ensure areas used for sterile preparation are separate and distinct from areas used for non-sterile preparation.(e) Each compounder shall have a well-lighted compounding environment.(f) Each compounder shall ensure all heating, ventilation and air conditioning systems are controlled to maintain a constant temperature 24 hours per day, 7 days per week.(g) Each compounder shall maintain a bulk storage area that is adequately arranged and proper temperature and humidity maintained.(h) Each compounder shall supply hot and cold potable water for hand and equipment washing in the compounding area, and soap or detergent and single-use towels or driers shall be readily available.(i) Each compounder shall ensure all compounding areas are maintained in a clean and sanitary condition.(j) When compounder uses hard-wall construction, the finished surface shall provide a non-porous, durable and washable surface.(k) The compound area shall meet the following requirements:(1) All ceilings shall be smooth, impervious, free from cracks and non-shedding, such as plastic covered clean room grade ceiling tiles, and all tiles shall be sealed;(2) All floors shall be smooth, impervious, free from cracks and non-shedding, and the floor must be of seamless vinyl;(3) All fixtures shall be smooth, impervious, free from cracks and non-shedding. All fixtures shall be mounted to wall in a way that seals any space between wall and fixture;(4) All shelving shall be smooth, impervious, free from cracks and non-shedding;(5) Counters shall be smooth, impervious, free from cracks and non-shedding;(6) All cabinets shall be smooth, impervious, free from cracks and non-shedding;(7) Ceiling to wall junctures shall be covered or caulked to avoid cracks;(8) Inlaid ceiling panels shall be impervious and hydrophobic;(9) Ceiling panels shall be caulked around the perimeter to seal them to frame;(10) Floors shall be overlaid with wide sheet vinyl flooring with heat welded seams and coving to the sidewall;(11) There shall be no dust-collecting overhangs;(12) There shall be no windowsills;(13) Exterior lens surface of ceiling light fixtures shall be smooth, mounted flush, and sealed;(14) There shall be no sinks in primary and secondary compounding areas;(15) There shall be no floor drains in primary and secondary compounding areas;(16) Carts shall be made of stainless steel wire or sheet metal with cleanable casters;(17) Carts shall be mobile;(18) All surfaces shall be designed to provide effective cleaning;(19) All surfaces shall be resistant to damage by cleaning agents;(20) There shall be no cardboard containers in buffer area at any time;(21) There shall be no computers, printers, radios and refrigerators in the buffer area at any time;(22) The bulk storage area shall be maintained in a clean and sanitary condition;(23) Trash shall be disposed of in a safe, sanitary and timely manner; and(24) All components, containers and equipment shall be stored off the floor in a manner to prevent contamination and permit inspection and cleaning of the compounding and storage area.(l) Each compounder shall ensure equipment is of appropriate design and size for the compounding that is performed.(m) Each compounder shall ensure that all equipment is of appropriate design such that the surface that contact pharmaceutical components, in-process materials or finished preparations is not reactive, additive or adsorptive.(n) Each compounder shall ensure that all equipment is thoroughly cleaned immediately after use to avoid cross-contamination.(o) Each compounder shall ensure all equipment is stored to prevent it from contamination and is located to facilitate its use, maintenance, and cleaning.(p) Each compounder shall ensure all equipment used for allergenic ingredients is appropriately handled, cleaned and stored immediately after use.(q) Each compounder shall ensure all work surfaces are cleaned of loose materials and residue from spills before compounding.(r) Each compounder shall ensure all floors in the buffer area and ante area are mopped daily with a cleaning and disinfecting agent at a time when no aseptic compounding is in progress.(s) Each compounder shall approve all cleansing and sanitizing agents considering compatibilities, effectiveness, and presence of inappropriate or toxic residues.(t) Each compounder shall ensure the following requirements are met: (1) Mops, wipes, sponges, and other cleaning materials shall be non-shedding and dedicated for use only in the sterile compounding area;(2) Cleaning tools shall be replaced as soon as they are identified as unsuitable for use;(3) All cleaning materials shall be disposable and discarded after one use;(4) All trash shall be collected in suitable plastic bags and removed on a daily basis with minimal agitation;(5) Workspaces shall be cleaned and sanitized daily including all buffer room carts, equipment, workbenches, work surfaces, and floors, and document the activity;(6) Storage shelving in buffer and ante areas shall be emptied of all supplies, cleaned, and sanitized at planned intervals at least monthly;(7) Walls and ceilings in buffer and ante areas shall be cleaned at least monthly; and(8) All equipment shall be clean, properly maintained, validated and documented at appropriate intervals as defined by USP Standards.N.H. Admin. Code § Ph 404.06
#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.