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Phase II, preparing for a regulator visitBerkeley, CA

Hazardous waste turnaround for a small-molecule pharma developer

Anonymized — clinical-stage small-molecule pharma

The challenge

A routine internal review surfaced multiple hazwaste issues — mislabeled accumulation containers, undocumented satellite accumulation areas, and a 90-day container about to go over. A regulator visit was on the calendar for the following month.

3

Weeks to restore full hazwaste compliance

0

Waste-related findings at regulator visit

30

Days notice before the scheduled inspection

100%

Of generators trained before inspection day

What we did

  • 1

    Completed an emergency waste stream re-profiling across the facility.

  • 2

    Re-labeled and consolidated all accumulation areas; documented every SAA.

  • 3

    Coordinated a compliant disposal event with the site's hazwaste vendor.

  • 4

    Rewrote the site's waste SOPs and trained all generators before the visit.

Before & after

Before

  • Mislabeled accumulation containers across the facility
  • Satellite accumulation areas (SAAs) undocumented and out of compliance
  • 90-day container approaching regulatory limit
  • No updated waste SOPs or trained generators on record

After

  • All waste streams re-profiled, relabeled, and properly categorized
  • Every SAA documented, signed, and compliant
  • Emergency disposal event completed ahead of the regulator visit
  • Updated SOPs deployed; all generators trained and signed off

The outcome

  • Full hazwaste compliance restored within 3 weeks.

  • Regulator visit resulted in zero waste-related findings.

  • Site transitioned to a recurring monthly EHS support engagement.