OSHA Inspection: SCA PHARMACEUTICALS, LLC

Issued

Apr 27, 2023

Abate by

Feb 28, 2024

Penalty

Initial $156,259 · Current $15,000 Reduced

Hazardous substances 00201470

General-duty citation text

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.

Issued

Apr 27, 2023

Abate by

Feb 28, 2024

Penalty

Initial $0 · Current $15,000

Hazardous substances 00201470

General-duty citation text

29 CFR  1910.1000(e): Feasible administrative or engineering controls were not determined and implemented to achieve compliance with the limits prescribed in 29 CFR 1910.1000(a) through (d):  CNC and Cleanroom Area:  The employer does not ensure that feasible administrative or engineering controls are determined and implemented to prevent or reduce harmful exposures to hydrogen peroxide (HP) and acetic acid (AA), while employees clean surfaces with sporicidal disinfectants containing these chemicals. Employees are exposed in excess of the permissible exposure limits prescribed in 29 CFR 1910.1000(a) through (d):  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 employer did not make a determination for feasible administrative or engineering controls that would limit or reduce these exposures when an employee, who was overexposed to a mixture of HP and AA, cleaned 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 feasible administrative or engineering controls are determined and implemented to reduce or eliminate exposure of hydrogen peroxide and acetic acid below a concentration of 1 ppm and 10 ppm, respectively. Controls must take into consideration workplace conditions during full-shift overnight and weekend sanitization tasks, among other possible exposure times and tasks, while cleaning takes place in the controlled not classified (CNC) area and the cleanrooms of ISO Class 5 through ISO Class 8 cleanroom 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 1402208, citation number 1, item number 2 group b, and was affirmed as a final order on October 14, 2020, with respect to a workplace located at 755 Rainbow Road, Windsor, CT 06095.

Issued

Apr 27, 2023

Abate by

Feb 28, 2024

Penalty

Initial $66,970 · Current $15,000 Reduced

General-duty citation text

29 CFR  1910.1200(h)(3)(i): The employee training did not include the methods and observations used to detect the presence or release of a hazardous chemical in the work area:   a) Controlled not Classified (CNC) Area:  The employer fails to provide training that covers the methods and observations used to detect the presence of the hazardous chemicals included in the products used while employees clean the CNC area with cleaners, which include, but are not limited to, sporicidal disinfectants such as Spor-Klenz Ready To Use Cold Sterilant (Product Code: 6525). Failure to add detection methods in the employee training, is putting employees at a greater risk of elevated exposures to hazardous hydrogen peroxide and acetic acid chemicals within Spor-Klenz, which is among the hazardous products used. To abate this violation, the employer must ensure that employee training covers the appropriate methods and observations that are established to detect the presence of chemicals used in the CNC area, including the appropriate detection method for the chemicals contained in Spor-Klenz, among other cleaners in use.   b) ISO Class 5 through ISO Class 8 Cleanroom Areas:  The employer fails to provide training that covers the methods and observations used to detect the presence of the hazardous chemicals included in the products used while employees clean the classified cleanroom areas with cleaners, which include, but are not limited to, sporicidal disinfectants such as Spor-Klenz Ready To Use Cold Sterilant (Product Code: 6525). Failure to add detection methods in the employee training, is putting employees at a greater risk of elevated exposures to hazardous hydrogen peroxide and acetic acid chemicals within Spor-Klenz, which is among the hazardous products used. To abate this violation, the employer must ensure that employee training covers the appropriate methods and observations that are established to detect the presence of chemicals used in the classified cleanroom areas, including the appropriate detection method for the chemicals contained in Spor-Klenz, among other cleaners in use.   SCA Pharmaceuticals, LLC was previously cited for a violation of an equivalent Occupational Safety and Health Standard 29 CFR 1910.1200(h)(1), which was contained in OSHA inspection number 1278719, citation number 1, item number 5 group c and was affirmed as a final order on December 26, 2018, with respect to a workplace located at 755 Rainbow Road, Windsor, CT 06095.

Issued

Apr 27, 2023

Abate by

Feb 28, 2024

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR  1910.1200(h)(3)(ii):Employee training did not include the physical and health hazards of the chemicals in the work area:  a) Controlled not Classified (CNC) Area:  Employee training does not include the physical and health hazards associated with chemicals that are used in the CNC area. This includes, but is not limited to, the hazards of using Spor-Klenz Ready To Use Cold Sterilant (Product Code: 6525), a hydrogen peroxide and acetic acid containing disinfectant product. Failure to inform employees of the health hazards associated with this exposure such as lung damage, respiratory distress, headaches, and nausea has exposed them to these acute and chronic symptoms while working with and near the chemicals. To abate this violation, the employer must ensure that employee training includes the physical and health hazards related to these hazardous products used in the CNC area.   b) ISO Class 5 through ISO Class 8 Cleanroom Areas:  Employee training does not include the physical and health hazards associated with chemicals that are used in the classified cleanroom areas. This includes, but is not limited to, the hazards of using Spor-Klenz Ready To Use Cold Sterilant (Product Code: 6525), a hydrogen peroxide and acetic acid containing disinfectant product. Failure to inform employees of the health hazards associated with this exposure such as lung damage, respiratory distress, headaches, and nausea has exposed them to these acute and chronic symptoms while working with and near the chemicals. To abate this violation, the employer must ensure that employee training includes the physical and health hazards related to these hazardous products used in the classified cleanroom areas.    SCA Pharmaceuticals, LLC was previously cited for a violation of an equivalent Occupational Safety and Health Standard 29 CFR 1910.1200(h)(1), which was contained in OSHA inspection number 1278719, citation number 1, item number 5 group c and was affirmed as a final order on December 26, 2018, with respect to a workplace located at 755 Rainbow Road, Windsor, CT 06095.

Issued

Apr 27, 2023

Abate by

Feb 28, 2024

Penalty

Initial $0 · Current $15,000

General-duty citation text

29 CFR  1910.1200(f)(6)(ii): Workplace labeling. The employer did not ensure that each container of hazardous chemicals in the workplace is labeled, tagged or marked with a product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.  a) Sanitization of Classified and Controlled not Classified (CNC) Areas:  The employer fails to provide hazard awareness in that they are not ensuring that each container of hazardous chemicals in the workplace is labeled, tagged, or marked with a product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals. Employees regularly transfer Spor-Klenz solvents from 3.2 L containers into approximately 1-L sized containers labeled "Sanotex-II Perforated Dry Surface Wipes" that are not labeled with the product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals in the Spor-Klenz poured over the wipes used to sanitize surfaces.  To abate this violation, the employer must ensure that each secondary container is labeled with the product identifier and words, pictures, symbols, or combination thereof, which provides general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.   b) Sanitization of Compounding Materials:   The employer fails to provide hazard awareness in that they are not ensuring that each container of hazardous chemicals in the workplace is labeled, tagged, or marked with a product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals. Employees regularly transfer Spor-Klenz solvents from 3.2 L containers into approximately 1-L sized containers labeled "Sanotex-II Perforated Dry Surface Wipes" that are not labeled with the product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals in the Spor-Klenz poured over the wipes used to sanitize surfaces. To abate this violation, the employer must ensure that each secondary container is labeled with the product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.    SCA Pharmaceuticals, LLC was previously cited for a violation of an equivalent Occupational Safety and Health Standard 29 CFR 1910.1200(h)(1), which was contained in OSHA inspection number 1278719, citation number 1, item number 5 group c and was affirmed as a final order on December 26, 2018, with respect to a workplace located at 755 Rainbow Road, Windsor, CT 06095.