1. (a) A tattoo studio or temporary location is required to utilize tools and equipment for tattooing that have been properly sterilized and kept in a sterile condition. The tattoo 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 needles, tubes, tips, and other necessary utensils and equipment. 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 equipment 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 tattooing equipment shall be cleansed to remove blood and tissue residue before sterilization as described in §229.409(h) of this title (relating to Tattooing Equipment).
4. (d) Each package of equipment sterilized shall be monitored for sterilization by the use of chemical/heat sensitive indicators.
5. (e) Equipment requiring sterilization shall be packed in packages approved for the sterilization unit. Equipment shall be packed individually, or as a set provided such set is intended to be used for a single tattoo procedure. Each package shall be labeled with the date of sterilization and the initials of the person sterilizing. Packaged sterilized equipment shall be stored in a clean dust-tight container when not in use.

6. (f) Each tattoo 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 tattoo 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 equipment to be sterilized; and
   3. (3) name of individual sterilizing the equipment.
7. (g) Sterilized equipment 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 equipment sterilized by the manufacturer. If presterilized equipment is used, the tattooist 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 tattooist 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 been evacuated of air and has reached the required temperature; 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 March 1, 1994, 19 TexReg 1110; amended to be effective August 23, 1996, 21 TexReg 7660; amended to be effective July 12, 1998, 23 TexReg 6957.