1. (a) A studio or temporary location is required to utilize instruments that have been prepared as described in §229.409(a)-(c) of this title (relating to Tattooing and Body Piercing Instruments and Jewelry). The studio or temporary location shall use sterilization equipment that is approved by the United States Food and Drug Administration for the purpose of sterilization, and adequate in size to accommodate necessary utensils and instruments. A copy of the manufacturer's recommended procedures for operation of the sterilization unit(s) must be available for inspection by an authorized agent.
2. (b) Each person responsible for the sterilization of instruments shall be able to demonstrate to the department's authorized agent the correct sterilization procedures and the proper operation of autoclave and/or dry heat sterilization equipment.
3. (c) After each use, the reusable instruments shall be cleansed to remove blood and tissue residue before sterilization as described in §229.409(n) of this title.
4. (d) Instruments requiring sterilization shall be packed in packages approved for the sterilization unit. Instruments shall be packed individually, or as a set provided such set is intended to be used for a single procedure. Each package shall be labeled with the date of sterilization and the initials of the person sterilizing the instruments. Packaged sterilized instruments shall be kept in a sterile condition and stored in a clean dust-tight container when not in use.
5. (e) Each package of instruments sterilized shall be monitored for sterilization by the use of chemical/heat sensitive indicators.

6. (f) Each studio or temporary location shall maintain sterilization records. The information shall be permanently recorded and made available for examination by an authorized agent in the studio for at least two years from the date of the last entry. These permanent records shall be maintained at the studio and shall include the following:

   1. (1) date of sterilization;
   2. (2) quantity and type of instruments to be sterilized; and
   3. (3) name or initials of the individual sterilizing the instruments.
7. (g) Sterilized instruments stored in an approved manner and not used within 30 days after sterilization shall no longer be considered sterile and shall be resterilized before use, unless the studio or temporary location utilizes presterilized instruments sterilized by the manufacturer. If presterilized instruments are used, the artist shall obtain documentation from the manufacturer that describes the method of sterilization utilized by the manufacturer and the manufacturer's recommendations for storage and maintenance of sterility. This documentation shall be available for inspection by an authorized agent. The artist shall follow the manufacturer's instructions for storage and maintenance of sterility.

8. (h) One of the following methods of sterilization shall be used.

   1. (1) Autoclave--steam under pressure:

      1. (A) 121 degrees Celsius (250 degrees Fahrenheit) and a pressure of at least 15 pounds per square inch for not less than 30 minutes after the chamber of the autoclave has reached the required temperature and pressure; or
      2. (B) as specified in the manufacturer's operator's manual.

   2. (2) Dry heat sterilization:

      1. (A) 160 degrees Celsius (320 degrees Fahrenheit) for not less than one hour under atmospheric pressure after the sterilizer has reached the required temperature; or
      2. (B) as specified in the manufacturer's operator's manual.

Source Note:The provisions of this §229.407 adopted to be effective April 23, 2000, 25 TexReg 3272.