Rules to Get DTSC Certification Neutralex
Rules to Get DTSC Certification Neutralex in california
If you want to get DTSC Certification Neutralex, there are a few rules you need to follow. These will ensure that you meet the requirements of the DTSC certification program.
Reagents
The California Department of Toxic Substance Control (DTSC) recently certified Scigen’s Neutralex(r) technology for safe treatment of spent formalin wastes. This certification is valid for three years, from the date of issuance.
The DTSC evaluation included evaluation of SCIGEN’s management, customer service, quality assurance, documentation procedures, and testing. The evaluation also included participation in field demonstrations at two health care facilities.
For a more detailed description of the DTSC evaluation of SCIGEN’s NEUTRALEX technology, see the DTSC Technology Certification Evaluation Report. It is available to the public on the DTSC’s CalSAFER portal.
The DTSC certification for neutralex program is designed to facilitate regulatory acceptance. While the program provides in-depth, independent review of technologies, it does not supersede the authority of the applicable regulatory agency. If the manufacturer fails to comply with the requirements of the regulation, DTSC can notify importers or retailers.
Scigen’s NEUTRALEX technology uses a patented reaction of a sulfuric reducing agent with formaldehyde in a near-neutral pH. As a result, the chemical reaction products are not insoluble polymeric compounds. However, the exact chemicals involved in the process are unknown.
The NEUTRALEX process requires the use of reagents that are shipped to the user in powdered form. These reagents are packaged in five-gallon containers and must be used in conjunction with a Material Safety Data Sheet. Once the reagents are applied, they are allowed to stand for 15 minutes. In addition, users must follow proper work practices, read material safety data sheets, and know the location of the nearest eyewash.
SCIGEN’s documentation includes procedures for internal audits, testing, and complaint handling. The company also maintains a toll-free number for the public.
Although the DTSC certification for neutralex program promotes the growth of the California environmental technology industry, it does not make warranties about the performance or safety of the products manufactured by the company. Rather, the agency believes the manufacturer’s products can achieve the performance levels they advertise.
As such, the DTSC certification program does not certify the performance of formaldehyde formulations containing other ingredients. Such treatment may be regulated by other local or state government permitting authorities.
Scigen’s Neutralex(r) is one of several formaldehyde neutralizers. SCIGEN also offers the FormaGO product, which is effective at neutralizing glutaraldehyde.
Requirements for DTSC Certification
The California DTSC certifications for neutralex provide (CETCP) provides a method for the detection of polynuclear aromatic compounds. It also provides a real-time, in-situ screening process.
- This program certifies environmental technologies that have been tested for the treatment of hazardous waste.
- In doing so, CETCP identifies technologies that meet quality standards,
- eases regulatory burdens,
- promotes the growth of the environmental technology industry in California.
- SCIGEN’s NEUTRALEX technology is an effective way to treat liquid 10% neutral buffered Formalin,
- waste generated by automated histopathology tissue processors. However,
- A user must comply with the regulations governing hazardous waste treatment.
For this certification, DTSC reviewed the technology and evaluated its effectiveness. The evaluation included discussions with the end users. Additionally, DTSC staff visited the SCIGEN facility.
They observed the treatment and observed the reagents being used.
Before a facility can be certified by DTSC, it must satisfy all applicable requirements. These include identification of the person conducting the treatment, the date of the treatment, the quantity of the treated waste, and the pH of the waste. Other data quality objectives will depend on the type of certification being sought. DTSC’s certification program includes two types of certification. A certification may last for one or three years.
NEUTRALEX proprietary
NEUTRALEX is a proprietary mixture that contains key ingredients, including sulfuric acid and formaldehyde. When the reagents are mixed with waste, the waste reacts to produce a formaldehyde-free product. There are no insoluble polymeric reaction products
Users of NEUTRALEX
Users of NEUTRALEX need to use safety equipment and follow standard operating procedures. The treatment must take place in a secondary containment system. Each treatment must be recorded in a log sheet. Using eye protection is recommended. Also, the NEUTRALEX reagents must be used in a five-gallon container.
Requirements for SCIGEN’s NEUTRALEX technology
SCIGEN’s Neutralex Technology for Treatment of Formaldehyde Wastes is a technology that can reduce formaldehyde concentrations to less than 10 ppm in waste from automated tissue processors. This technology is certified by the Department of Toxic Substances Control (DTSC) as a hazardous waste treatment.
According to the DTSC certification for neutralex evaluation report, “DTSC certified the Scigen Neutralex technology as an effective method of treating liquid 10% neutral-buffered formalin wastes generated by automated histopathology tissue specimen preservation.”
DTSC certification for neutralex requires that the technology is used according to SCIGEN’s standard operating procedures, as well as complying with the applicable regulatory requirements. The DTSC also requires that the user document the procedures and maintain records. For example, the records must document the quantity and quality of the treated wastes, the person performing the treatment, and the proper ventilation at the health care facility.
DTSC certification for neutralex evaluations included discussions with the end user and staff at SCIGEN’s facility. DTSC personnel also visited Kaiser-Berkeley, one of the eight facilities using the NEUTRALEX technology. These facilities generate two to three gallons of histopathology waste per day.
At the Kaiser-Berkeley facility, staff performed the treatment and poured samples into pre-labeled sample jars. A technician then analyzed each sample using the screening test kit that SCIGEN supplies. Using ASTM Method D-2194, SCIGEN isolated seventy-five percent of the compound predicted by the mechanism.
Although SCIGEN does not submit QA/QC data, DTSC personnel reviewed SCIGEN’s laboratory notebooks and product research. Those notebooks provided an account of the development of the technology. DTSC staff found the experimental data to be supportive of the mechanism.
SCIGEN has documented its own procedures for calibration, internal audits, and customer services. The company also has a toll-free telephone number for questions and complaints.
In addition, the company provides a five-gallon container for the reagents. The reagents are to be used in conjunction with a Material Safety Data Sheet and a log sheet. All of these requirements help to ensure the safety of the technology.
The certification program has been implemented in California to promote the growth of the state’s environmental technology industry. It also allows DTSC to certify technologies that meet quality standards, ease regulatory burdens, and facilitate the acceptance of the technology by the regulatory community.
