059-17 Wyo. Code R. §§ 17-14 - Sterilization and Depyrogenation

(a) Pharmacy staff shall sterilize all CSPs that contain nonsterile components or that come into contact with nonsterile devices during any phase of compounding, within six (6) hours after completing the CSP.

(b) Pharmacy staff shall sterilize the CSP in a method without degrading its physical and chemical stability or the packaging integrity.

(c) Pharmacy staff shall document a description of the sterilization process, including temperature, pressure (if applicable), duration, permissible load conditions for each cycle, the use of biological indicators and endotoxin challenge vials, and be readily retrievable.

(d) Pharmacy staff shall document results of terminal sterilization. Documentation shall include, but is not limited to, the temperature, pressure, duration, permissible load conditions for each cycle, and the used of biological indicators and endotoxin challenge vials.

(e) Equipment used to terminally sterilize CSPs shall be appropriately maintained, calibrated, and cleaned. Maintenance, calibration and cleaning shall be documented by pharmacy staff.

(f) Depyrogenation processes shall meet the following requirements:

(i) Depyrogenation shall be used to render glassware, metal, and other thermostable containers and components pyrogen-free;

(ii) The duration of the exposure period shall include sufficient time for the items to reach the depyrogenation temperature;

(iii) The items shall remain at the depyrogenation temperature for the durations of the depyrogenation period;

(iv) The effectiveness of the depyrogenation cycle shall be verified and documented initially and annually thereafter using endotoxin challenge vials to demonstrate the cycle is capable of achieving a 3-log reduction or more in endotoxins;

(v) The effectiveness of the depyrogenation cycle shall be re-established for any changes to the depyrogenation cycle; and

(vi) Items that are not thermostable shall be depyrogenated by rinsing with sterile, non-pyrogenic water, and thoroughly drained or dried immediately before use in compounding.

(g) Sterilization by filtration shall meet the following requirements:

(i) Sterilizing filters shall be sterile, depyrogenated, have a nominal pore size for 0.22 microns or small, and include labeling for pharmaceutical use;

(ii) Sterilizing filters labeled "for laboratory use only" shall not be used for compounding CSPs;

(iii) Sterilizing filters shall be certified by the manufacturer to retain at least 107 microorganisms of a stain of Bredundimonas diminuta per square centimeter of upstream filter surface area under conditions similar to those in which the CSPs will be filtered;

(iv) The designated person(s) shall use available published information, supplier documentation, or direct challenge to ensure sterilizing filters:

(A) Are chemically and physical compatible with all ingredients in the CSP;

(B) Are chemically stable at the pressure and temperature conditions that will be used; and

(C) Have enough capacity to filter the required volumes.

(v) Pharmacy staff shall integrity test filters used to sterilize a CSP according to the manufacturer's recommendations. If multiple filters are required for the compounding process, each filter shall pass a filter-integrity test;

(vi) CSPs prepared using a filter that fails an integrity tests shall be discarded, or, after investigating the cause of the failure and selection of an appropriate filter, re-filtered for sterilization no more than one additional time; and

(vii) Pharmacy staff shall pre-filter a CSP when it is known to contain excessive particulate matter, performed using a filter of larger nominal pore size to remove gross particulate contaminants before the CSP is passed through the sterilizing-grade filter.

(h) Sterilization be steam heat shall meet the following requirements:

(i) All materials shall be directly exposed to steam under adequate pressure for the length of time necessary, as determined by use of appropriate biological indicators, to render the items sterile;

(ii) The duration of the exposure period shall include sufficient time for the entire contents of the CSP and other items to reach sterilizing temperature;

(iii) Items shall remain at the sterilizing temperature for the duration of the sterilization period;

(iv) CSPs shall be placed in the autoclave to allow steam to reach the CSPs without entrapment of air;

(v) Prior to filling ampules and vials that will be steam sterilized, solutions shall be passed through a filter with a nominal pore size no larger than 1.2 microns for removal of particulate matter;

(vi) Sealed containers shall be able to generate steam internals. Stoppered and crimped vials shall contain a small amount of sterile water to generate steam;

(vii) Deep containers shall be inverted or placed on their sides at a downwardsloping angle to minimize air entrapment, and to facilitate condensate drainage, or shall shave a small amount of sterile water placed in them before steam sterilization;

(viii) Porous materials and items with occluded pathways shall only be sterilized by steam if the autoclave chamber has suitable cycles for dry goods;

(ix) The effectiveness of steam sterilization shall be verified with each sterilization run or load by using appropriate biological and physiochemical indicators and integrators. Verification shall be documented;

(x) The steam supplied shall be free of contaminants and generated using water per the manufacturer's recommendation.

(xi) A calibrated data recorder or chart shall be used to monitor each cycle and identify cycle irregularities; and

(xii) The date, run, and load numbers of the steam sterilizer used to sterilize a CSP shall be documented.

(i) Sterilization by dry hear shall meet the following requirements:

(i) The duration of the exposure period shall include sufficient time for the entire contents of the CSPs and other items to reach the sterilizing temperature;

(ii) The CSP and other items shall remain at the sterilizing temperature for the duration of the sterilization period;

(iii) The effectiveness of the dry hear method shall be verified and documented with each sterilization run or load, using appropriate biological indicators and confirmation methods;

(iv) The dry heat oven shall be calibrated. Calibration shall be documented;

(v) A calibrated data recorder or chart shall be used to monitor each cycle and identify cycle irregularities; and

(vi) The date, run, and load numbers of the dry heat oven used to sterilize a CSP shall be documented.

Notes

059-17 Wyo. Code R. §§ 17-14

Adopted, Eff. 5/13/2021.