N.J. Admin. Code § 13:39-11.14

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-11.14 - Personnel cleansing and garbing requirements

(a) All personnel who engage in compounding sterile preparations shall comply with the following requirements before entering the buffer area:

1. Personnel shall remove personal outer garments (for example, bandanas, coats, hats, jackets, scarves, sweaters, vests), all cosmetics, and hand, wrist, and other visible jewelry or piercings (for example, earrings, or lip or eyebrow piercings);

2. The wearing of artificial nails or extenders is prohibited while working in the compounding area. Natural nails shall be kept neat and trimmed;

3. Personnel protective equipment shall be donned in the following order:

i. Dedicated shoes or shoe covers;

ii. Head and facial hair covers (for example, beard covers in addition to face masks);

iii. Face masks; and

iv. Eye shields, if required;

4. A hand and forearm cleansing procedure shall be performed. Personnel shall remove debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using either lint-free disposable towels or an electric hand dryer; and

5. Personnel shall wear non-shedding gowns with sleeves that fit snugly around the wrists and enclosed at the neck, that are designed for buffer area use.

(b) Following the completion of all steps in (a) above, and once inside the buffer area, personnel shall perform antiseptic hand cleansing, using a waterless alcohol-based surgical hand scrub with persistent activity following manufacturers' recommendations. Once hands are dried thoroughly, personnel shall don sterile gloves. Gloves shall be routinely inspected for holes, punctures, or tears, and shall be replaced immediately if any are detected.

1. Gloves become contaminated when they make contact with non-sterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing sterile 70 percent Isopropyl Alcohol (IPA) on all contact surface areas of the gloves and letting the gloved hands dry thoroughly. Routine application of sterile 70 percent IPA shall occur throughout the compounding process and whenever non-sterile surfaces (for example, vials, counter tops, chairs, and carts) are touched.

(c) When compounding personnel exit the cleanroom during a work shift, the exterior gown may be removed and retained in the cleanroom if not visibly soiled, and may be re-donned during that same work shift only. Shoe covers, hair and facial hair covers, face masks/eye shields, and gloves, however, shall be replaced with new ones before re-entering the buffer area, and proper hand hygiene shall be performed, consistent with (a) and (b) above.

N.J. Admin. Code § 13:39-11.14

New Rule, R.2013 d.084, effective 6/3/2013.
See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).
Former N.J.A.C. 13:39-11.14, Quality assurance program for compounded sterile preparations, recodified to N.J.A.C. 13:39-11.24.