Phar 15.38(1)(e) (e) Cleanroom behavior.

Phar 15.38(1)(f) (f) Sterilization and depyrogenation.

Phar 15.38(1)(g) (g) Use of equipment.

Phar 15.38(1)(h) (h) Documentation.

Phar 15.38(1)(i) (i) Use of primary engineering controls.

Phar 15.38(2) (2) Evaluation. Compounding personnel shall successfully complete an initial and annual evaluation which includes all of the following:

Phar 15.38(2)(a) (a) Visual observation of hand hygiene and garbing.

Phar 15.38(2)(b) (b) Visual observation of aseptic technique.

Phar 15.38(2)(c) (c) Gloved fingertip and thumb sampling.

Phar 15.38(2)(d) (d) Media-fill tests.

Phar 15.38(3) (3) Gloved fingertip. Successfully gloved and thumb sampling is measured by samplings resulting in zero colony-forming units no fewer than three times. Sampling shall be performed on sterile gloves inside of an ISO Class 5 primary engineering control. Gloved fingertip and thumb sampling in a RABS or an isolator shall be taken from the sterile gloves placed over the gauntlet gloves. When gloved fingertip sample results exceed action levels defined by the pharmacy, a review of hand hygiene and garbing procedures, glove and surface disinfection procedures and work practices shall be performed and documented.

Phar 15.38(5) (5) Records. The pharmacy shall maintain written policies and procedures for the initial and ongoing training and evaluation of persons involved in compounding sterile preparations. Documentation of all training, assessments, gloved fingertip tests and media-fill simulations shall be maintained by the pharmacy for 5 years and made available to the Board upon request.

Phar 15.38 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.