Regulation .10 Minimum Requirements for Equipment.
Regulation .10 Minimum Requirements for Equipment.LinkCopy Citation
A.
The permit holder shall provide at least the following equipment that is maintained in working order:
(1)
Adequate refrigerator and freezer space (if applicable);
(2)
A sink and wash area in the anteroom;
(3)
Appropriate waste containers for:
(a)
Used needles and syringes; and
(b)
Cytotoxic waste including disposable apparel used in its preparation, if applicable;
(4)
Laminar air flow workstation or compounding aseptic isolator that meets USP 797 Standards, dedicated for products other than antineoplastics;
(5)
If applicable to types of preparations compounded, biological safety cabinet, or compounding aseptic isolator that meets USP 797 Standards, dedicated for use with antineoplastics or other hazardous sterile preparations;
(6)
Appropriate filters and filtration equipment; and
(7)
A device for light/dark field examination.
B.
If used, the permit holder shall provide the following equipment that is maintained in working order, calibrated, or certified where appropriate:
(1)
Autoclave;
(2)
Automated compounding devices (for example, total parenteral nutrition compounding pumps);
(3)
Electronic balance;
(4)
Convection oven;
(5)
Thermometers or other temperature device; and
(6)
Incubator.