OSHA Inspection: PCI SYNTHESIS

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $9,377 · Current $5,000 Reduced

General-duty citation text

29 CFR 1910.119(d)(3)(i)(C): Information pertaining to the equipment in process did not include electrical classification:    (a) Location - 9 Opportunity Way, Newburyport, MA:    On or about December 4, 2018, documentation sufficient to show or describe the extent of hazardous (classified) locations associated with the equipment in the selected process unit has not been compiled and maintained as process safety information.

Issued

Jun 4, 2019

Abate by

Dec 31, 2019

Penalty

Initial $13,127 · Current $12,000 Reduced

General-duty citation text

29 CFR 1910.119(d)(3)(i)(D): Information pertaining to the equipment in the process did not include relief system design and design basis:    (a) Location - 9 Opportunity Way, Newburyport, MA:    On or about December 4, 2018, documentation sufficient to show or describe the relief system design and design basis of the equipment in the selected process unit has not been compiled and maintained as process safety information.

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.119(i)(1): Pre-startup safety review was not performed when modifications to existing facilities significant enough to require a change in the process safety information were made:    (a) Location - 9 Opportunity Way, Newburyport, MA:    Rupture disks with a burst rating of 50 psig installed on 2,000 gallon glass lined pressure vessels in an existing facility were replaced with rupture disks with a burst rating of 100 psig and a pre-startup safety review was not conducted to ensure: construction and equipment was within design specifications, safety, operating, maintenance, and emergency procedures were in place and adequate, the requirements of management of change were met, and training was completed for each employee involved in operating the selected process unit.

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.119(l)(1): Procedures to manage changes to process chemicals, technology, equipment, and procedures, and changes to facilities that affect a covered process were not implemented:    (a) Location - 9 Opportunity Way, Newburyport, MA:    Rupture disks with a burst rating of 50 psig installed on 2,000 gallon glass lined pressure vessels were replaced with rupture disks with a burst rating of 100 psig and management of change procedures established by the employer were not followed.

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.119(l)(4): Process safety information required by paragraph (d) of this section was not updated when a change covered by this paragraph resulted in a change in the process safety information:    (a) Location - 9 Opportunity Way, Newburyport, MA:    Rupture disks with a burst rating of 50 psig installed on 2,000 gallon glass lined pressure vessels were replaced with rupture disks with a burst rating of 100 psig and the burst ratings for the rupture disks listed on P&IDs for the vessels were not updated.

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $9,377 · Current $8,000 Reduced

General-duty citation text

29 CFR 1910.119(d)(3)(ii): Compliance with recognized and generally accepted good engineering practices (RAGAGEP) has not been documented for the equipment in a covered process:    (a) Location - 9 Opportunity Way, Newburyport, MA:    On or about December 4, 2018, compliance with RAGAGEP, such as ASME Boiler and Pressure Vessel Code Section VIII Division 1, was not documented for equipment used in the manufacture pharmaceutical ingredients containing flammable liquids with respect to the condenser installed in the selected process unit.

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $13,127 · Current $12,000 Reduced

General-duty citation text

29 CFR 1910.119(e)(1): An initial process hazard analysis (hazard evaluation) on processes covered by 29 CFR 1910.119 has not been performed:    (a) Location - 9 Opportunity Way, Newburyport, MA:    On or about December 4, 2018, an initial process hazard analysis was not performed on the selected process unit, an active pharmaceutical ingredient manufacturing process involving the use flammable liquids with flash points below 100 Deg F. in excess of 10,000 lbs., to indicate the necessary safety precautions to take according to the incidence of use of highly hazardous chemicals in this particular facility.

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $9,377 · Current $5,000 Reduced

General-duty citation text

29 CFR 1910.119(f)(1)(iv): Written operating procedures providing clear instruction for conducting operations in a covered process safely and consistently with process safety information addressing safety systems and their functions have not been developed:    (a) Location - 9 Opportunity Way, Newburyport, MA:    On or about December 4, 2018, written procedures including the master production record, and other associated procedures, governing the operation of the selected process unit do not address safety systems and their function.

Issued

Jun 4, 2019

Abate by

Oct 11, 2019

Penalty

Initial $9,377 · Current $8,000 Reduced

General-duty citation text

29 CFR 1910.119(f)(3): operating procedures were not certified as current and accurate at least annually:    (a) Location - 9 Opportunity Way, Newburyport, MA:    On or about December 4, 2018, the written procedures associated with the operation of the selected process unit are certified as current and accurate every three years not annually.