Phar 15.33(7)(7) Floors, walls, ceiling, and shelving in the classified and segregated compounding areas are cleaned when no aseptic operations are in progress. Cleaning shall be performed in the direction from cleanest to dirtiest areas.

Phar 15.33(8)(8) All cleaning tools and materials shall be low-lint and dedicated for use in the buffer room, ante room and segregated compounding areas. If cleaning tools and materials are reused, procedures shall be developed based on manufacturer recommendations that ensure that the effectiveness of the cleaning device is maintained and that repeated use does not add to the bioburden of the area being cleaned.

Phar 15.33(9)(9) Supplies and equipment removed from shipping cartons shall be wiped with a suitable disinfecting agent delivered from a spray bottle or other suitable delivery method. After the disinfectant is wiped on a surface to be disinfected, the disinfectant shall be allowed to dry, during which time the item shall not be used for compounding purposes.

Phar 15.33(10)(10) Entry points on bags and vials shall be wiped with small sterile 70% isopropyl alcohol swabs or comparable method for disinfecting, allowing the isopropyl alcohol to dry before piercing stoppers with sterile needles and breaking necks of ampules. The surface of the sterile 70% isopropyl alcohol swabs used for disinfecting entry points of sterile package and devices may not contact any other object before contacting the surface of the entry point. Particle generating material may not be used to disinfect the sterile entry points of packages and devices.

Phar 15.33(11)(11) When sterile supplies are received in sealed pouches designed to keep them sterile until opening, the sterile supplies may be removed from the covering pouches as the supplies are introduced into the ISO Class 5 primary engineering control without the need to disinfect the individual sterile supply items.

Phar 15.33 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; CR 22-007: am. (10) Register July 2022 No. 799, eff. 8-1-22.

Phar 15.34Phar 15.34 Immediate-use compounded sterile preparations. Immediate-use compounded sterile preparations are exempt from the requirements described for low-risk level, Category 1, and Category 2 compounding sterile preparations only when all the following criteria are met:

Phar 15.34(1)(1) The compounding process involves simple transfer of not more than three commercially manufactured sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers’ original containers and not more than two entries into any one container or product of sterile infusion solution or administration container or device.

Phar 15.34(2)(2) Unless required for the preparation, the compounding procedure is a continuous process not to exceed 1 hour.

Phar 15.34(3)(3) During preparation, aseptic technique is followed and, if not immediately administered, the finished compound sterile preparation is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other compound sterile preparations, and direct contact of outside surfaces.

Phar 15.34(4)(4) Administration begins not later than 4 hours following the start of the preparation.

Phar 15.34(5)(5) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the compounded sterile preparation shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared it, and the exact 4-hour BUD and time.

Phar 15.34(6)(6) If administration of the compounded sterile preparation has not begun within 4 hours following the start of preparation, it shall be promptly, properly, and safely discarded.

Phar 15.34 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; CR 22-007: r. and recr. Register July 2022 No. 799, eff. 8-1-22.

Phar 15.35(1)(1) Sterilization methods employed shall sterilize while maintaining its physical and chemical stability and the packaging integrity of the compounding sterile preparations. The efficacy of sterilization and depyrogenation of container closure systems performed in the pharmacy shall be established, documented, and reproducible.

Phar 15.35(2)(2) Pre-sterilization requirements shall meet all of the following:

Phar 15.35(2)(a)(a) During all compounding activities that precede terminal sterilization, including weighing and mixing, compounding personnel shall be garbed and gloved in the same manner as when performing compounding in an ISO Class 5 environment. All pre-sterilization procedures shall be completed in an ISO Class 8 or better environment.

Phar 15.35(2)(b)(b) Immediately before use, all nonsterile measuring, mixing, and purifying devices used in the compounding process shall be thoroughly rinsed with sterile, pyrogen-free water and then thoroughly drained or dried.

Phar 15.35(3)(3) Sterilization shall be performed utilizing one of the following methods:

Phar 15.35(3)(a)(a) Sterilization by filtration. Sterilization by filtration involves the passage of a fluid or solution through a sterilizing grade membrane to produce a sterile effluent. Filtration may not be used when compounding a suspension when the suspended particles are removed by the filter being used. This method shall meet all of the following:

Phar 15.35(3)(a)1.1. Sterile filters used to sterile filter preparations shall meet all of the following requirements:

Phar 15.35(3)(a)1.b.b. Be certified by the manufacturer to retain at least 107 microorganisms of a strain of Brevundimonas diminuta per square centimeter of upstream filter surface area under conditions similar to those in which the compounded sterile preparations will be filtered.

Phar 15.35(3)(a)1.e.e. Yield a sterile filtrate while maintaining pre-filtration pharmaceutical quality, including strength of ingredients of the specific compounded sterile preparations.

Phar 15.35(3)(a)2.2. The filter dimensions and liquid material to be sterile filtered shall permit the sterilization process to be completed rapidly without the replacement of the filter during the filtering process.