Administrative Code

Virginia Administrative Code

Part VIII. Special Requirements for Steam Sterilization

Article 8
Radioactive Materials

9VAC20-120-580. Application.

The requirements of this part apply to all steam sterilizers (autoclaves) that sterilize regulated medical waste.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 8.1, eff. June 29, 1994.

9VAC20-120-590. Performance standards.

All sterilizers for regulated medical waste shall maintain the following level of operational performance at all times:

1. Operational temperature and detention. Whenever regulated medical wastes are treated in a steam sterilizer, all the regulated medical waste shall be subjected to the following operational standards (at 100% steam conditions and all air evacuated):

a. Temperature of not less than 250°F for 90 minutes at 15 pounds per square inch of gauge pressure;

b. Temperatures of not less than 272°F for 45 minutes at 27 pounds per square inch of gauge pressure; or

c. Temperatures of not less than 320°F for 16 minutes at 80 pounds per square inch of gauge pressure.

Equivalent combinations of operational temperatures, pressure and time may be approved by the director if the installed equipment has been proved to achieve a reliable and complete kill of all microorganisms in regulated medical waste at design capacity. Written requests for approval of an equivalent standard shall be submitted to the director. Complete and thorough testing shall be fully documented, including tests of the capacity to kill B. stearothermophilus. Longer steam sterilization times are required when a load contains a large quantity of liquid.

2. Operational controls and records.

a. Steam sterilization units shall be evaluated under full loading for effectiveness with spores of B. stearothermophilus no less than once per month.

b. A log shall be kept at each steam sterilization unit that is complete for the preceding three-year period. The log shall record the date, time and operator of each usage; the type and approximate amount of regulated medical waste treated; the dates and results of calibration; and the results of effective testing described in subdivision 2 a of this section. Where multiple steam sterilization units are used, a working log can be maintained at each unit and such logs periodically consolidated at a central location. The consolidated logs shall be retained for three years and be available for review.

c. Except as described in subdivision 2 d of this section, regulated medical waste shall not be compacted or subjected to violent mechanical stress before steam sterilization; however, after it is fully sterilized it may be compacted in a closed container.

d. Except as provided in 9VAC20-120-550, 9VAC20-120-600 E or 9VAC20-120-650 D, regulated medical waste shall be ground or shredded into particles that are no larger than an approximate size of 0.75 inches in any dimension. If size reduction takes place prior to treatment, it shall occur in a closed unit immediately preceding the treatment unit. Size reduction following treatment must occur within 24 hours of leaving the treatment unit. Transfer from a grinder or shredder to or from a treatment unit shall be under forced draft ventilation that removes fumes from the operations area to a safe discharge.

e. All process units for the preparation or treatment of regulated medical waste shall be in closed vessels under a negative pressure atmospheric control that filters all vents, discharges, and fugitive emissions of air from the process units through a high efficiency particulate air (HEPA) filter with an efficiency of 99.97% of 0.3 microns. Air and gases which have themselves been sterilized by the process are not required to pass through a filter.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 8.2, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-600. Disposal of treated wastes.

A. Solid waste that has been steam sterilized and managed in compliance with these regulations is no longer regulated medical waste and is solid waste. Steam sterilized solid waste may be compacted.

B. All shredded or ground solid waste that has been steam sterilized shall be placed in opaque plastic bags and sealed. The bags may not be red in color. Where bulk sterilization is used and the solid waste is compacted or immediately placed in closed bulk solid waste management containers, which are more than 64 gallons in volume, the repackaging of the solid waste in bags is not required.

C. Regulated medical waste that has been treated must also be ground or shredded in accordance with 9VAC20-120-590 2 or packaged and labeled in accordance with subsection E of this section.

D. Regulated medical waste treated in compliance with Part VII, Part VIII or Part IX shall be deemed to be treated in accordance with this chapter. Regulated medical waste not treated in accordance with this chapter shall not be transported, received for transport or disposal, or disposed of in any solid waste management facility.

E. Steam sterilization facilities in operation on July 1, 1994, and small scale processes providing treatment in accordance with this part of no more than 100 pounds of regulated medical waste per day (monthly average) are not required to shred or grind the waste. Facilities that do not grind or shred the waste must seal the treated waste in an orange plastic bag and securely attach a tag or label with the following message in indelible ink and legible print of a 21-point or greater typeface:

"The generator certifies that this waste has been treated in accordance with the Virginia Regulated Medical Waste Management Regulations and is no longer regulated medical waste.

Treated: (include date treatment performed)

Generator: (include name, address and telephone number of generator)."

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 8.3, eff. June 29, 1994.

9VAC20-120-610. Compliance with other parts of this chapter.

In general, sterilizer facilities shall comply with all other parts of this chapter. The site of the sterilizer facility is a storage facility and must comply with Part V of this chapter. Management of spills or the opening in an emergency of any regulated medical waste package, shall comply with 9VAC20-120-270 and 9VAC20-120-280.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 8.4, eff. June 29, 1994.

9VAC20-120-620. [Reserved].

Historical Notes

Derived from Virginia Register Volume 10, Issue 18, eff. June 29, 1994.

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