Text For Citation: 01 Item/Group: 001 Hazard:

29 CFR 1910.1000(d)(2)(i): An employee was exposed to a hydrogen peroxide and acetic acid mixture in excess of the cumulative exposure limit: SCA Pharmaceutical - Windsor, CT: The employer does not ensure that harmful exposures to hydrogen peroxide (HP) and acetic acid (AA) are prevented while employees clean with sporicidal disinfectants containing these chemicals on the room surfaces of the controlled not classified (CNC) area, the rooms of ISO Class 5 through ISO Class 8 cleanroom areas, and the surfaces of process equipment that are stored in those areas. a) This violation was most recently observed beginning in the evening of January 08, 2023, extending into the morning of January 09, 2023, when an employee was exposed in excess of the cumulative exposure limit to an HP and AA mixture while cleaning the surfaces of cleanroom areas with a Spor-Klenz Ready to Use Cold Sterilant (Product Code: 6525) product. The employee was exposed to 10.53 parts of acetic acid per million parts of air (ppm) and 0.72 ppm of hydrogen peroxide as an eight-hour time-weighted average (8-hr TWA) during a sample period of 290 minutes, using zero exposure for the unsampled portion of the 8-hour shift. With an equivalent exposure for the mixture of 1.77 and a mixture control limit of 1.08, it confirmed that an overexposure had occurred at the 95% confidence limit. The employee overexposed to the HP and AA mixture worked in the following areas: 1) ISO Class 8 Exit Rooms, 2) ISO Class 8 Pre-Gown Rooms, 3) ISO Class 8 Sporicidal Sanitization Rooms 4) ISO Class 8 Pre-gown Room 232 To abate this violation, in accordance with the permissible exposure limits prescribed by the Occupational Safety and Health Administration (OSHA), the employer must ensure that hydrogen peroxide and acetic acid exposures are either eliminated or reduced below a concentration of 1 ppm and 10 ppm, respectively, during full-shift overnight and weekend sanitization tasks that include, but are not limited by, cleaning the room of the controlled not classified (CNC) area, cleaning the rooms of ISO Class 5 through ISO Class 8 cleanroom areas, and cleaning the surfaces of process equipment in these areas. Prior violations referred to include an equivalent violation of this Occupational Safety and Health Standard during the following inspections: b) SCA Pharmaceuticals, LLC was previously cited for a violation of an equivalent Occupational Safety and Health Standard 29 CFR 1910.1000(a)(2), which was contained in OSHA inspection number 1278719, citation number 2, item number 1 group a, and was affirmed as a final order on December 26, 2018, with respect to a workplace located at 755 Rainbow Road, Windsor, CT 06095. c) SCA Pharmaceuticals, LLC was previously cited for a violation of an equivalent Occupational Safety and Health Standard 29 CFR 1910.1000(a)(2), which was contained in OSHA inspection number 1402208, citation number 1, item number 2 group a, and was affirmed as a final order on October 14, 2020, with respect to a workplace located at 755 Rainbow Road, Windsor, CT 06095.