- (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.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04 New. #8316, eff 3-26-05, EXPIRED: 3-26-13 New. #10812, eff 4-18-15