Phar 15.30(12) (12) “ISO Class 7” means conditions in which the air particle count is no greater than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air.

Phar 15.30(13) (13) “ISO Class 8” means conditions in which the air particle count is no greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air.

Phar 15.30(14) (14) “Isolator” means an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air operated at a continuously higher pressure than its surrounding environment and is decontaminated using an automated system. An isolator uses only decontaminated interfaces or rapid transfer ports for materials transfer.

Phar 15.30(14g) (14g) “Low-risk level compounded sterile preparations” means preparations compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices. The low-risk level sterile compounding process involves only transfer, measuring, and mixing, using no more than three commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations.

Phar 15.30(14r) (14r) “Medium-risk level compounded sterile preparations” means preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The medium-risk level sterile compounding process includes complex aseptic manipulations other than single volume transfer, and requires an unusually long duration, such as that required to complete dissolution or homogeneous mixing.

Phar 15.30(15) (15) “Primary engineering control” means a device or zone that provides an ISO Class 5 environment for sterile compounding.

Phar 15.30(16) (16) “Restricted access barrier system (RABS)” means an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air that allows for the ingress or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. RABS include compounding aseptic isolators and compounding aseptic containment isolators.

Phar 15.30(17) (17) “Sterility assurance level of 10-6” means an equivalent to a probability that one unit in a million is nonsterile.

Phar 15.30(18) (18) “Segregated compounding area” means a designated, unclassified space, area, or room that contains a primary engineering control.

Phar 15.30(19) (19) “Urgent use compounded sterile preparation” means a preparation needed urgently for a single patient and preparation of the compounded sterile preparation under Category 1 or Category 2 requirements would subject the patient to additional risk due to delays.

Phar 15.30 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; CR 22-007: cr. (10m), (14g), (14r) Register July 2022 No. 799, eff. 8-1-22.

Phar 15.31 Phar 15.31 Facility design and environmental controls.

Phar 15.31(1) (1) General. Facilities shall meet all of the following requirements:

Phar 15.31(1)(a) (a) Be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites.

Phar 15.31(1)(b) (b) Be accessible only to designated personnel.

Phar 15.31(1)(c) (c) Have a heating, ventilation, and air conditioning system controlling the temperature and humidity.

Phar 15.31(2) (2) Segregated compounding area. A segregated compounding area shall meet all of the following requirements:

Phar 15.31(2)(a) (a) Be located in an area away from unsealed windows and doors that connect to the outdoors, or significant traffic flow.

Phar 15.31(2)(b) (b) Be located in an area which is not adjacent to construction sites, warehouses, and food preparation areas.

Phar 15.31(2)(c) (c) Have a defined perimeter.

Phar 15.31(2)(d) (d) Locate the primary engineering control at least one meter from any sink.

Phar 15.31(3) (3) Classified area. A classified area shall meet all of the following:

Phar 15.31(3)(a) (a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets shall be smooth, impervious, free from cracks and crevices, and nonshedding.

Phar 15.31(3)(b) (b) Work surfaces shall be constructed of smooth, impervious materials. All work surfaces shall be resistant to damage from cleaning and sanitizing agents.

Phar 15.31(3)(c) (c) Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks and crevices in which microorganisms and other contaminate can accumulate. All areas in ceilings and walls where the surface has been penetrated shall be sealed.

Phar 15.31(3)(d) (d) Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked or weighted and clipped.

Phar 15.31(3)(e) (e) Walls shall be constructed of a durable material, panels locked together and sealed or of epoxy-coated gypsum board.

Phar 15.31(3)(f) (f) Floors shall have a covering that shall be seamless or have heat-welded seams and coving to the sidewall. There shall be no floor drains.

Phar 15.31(3)(h) (h) Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted flush, and sealed.