Cleaning Validation  & Decommissioning Project

PSC Hired a Validation Specialist Who Stayed Within Budget and the Time Frame Set Originally by PSC and the Client.

  • Area: Greater Los Angeles
  • Key Account Manager: Justin Cantor
  • Project Type: CQV

About this Project

OBJECTIVE

CQV Cleaning Validation Project and Current Decommissioning Project

SERVICES

Corporate initiative to upgrade facility compliance level from cosmetics production to meet regulatory expectations of OTC manufacturing. PSC initiated work with a site audit to perform a gap analysis and identify compliance deficiencies. Remediation tasks were associated with each of these findings and combined into a WBS structured by compliance streams (e.g. C/Q/V, CAPA, training). PSC deployed a team of consultants to triage critical issues, and then validation engineers to perform cleaning validation and equipment qualification of all production equipment. 

Justin Cantor

Chief Strategy Officer

JCantor@biotech.com

sales@biotech.com

A dashboard was utilized to manage issues, track status, and communicate progress with site management. Subsequent projects included major facility renovations to resolve structural issues while maintaining ongoing GMP production. PSC was responsible for managing the mechanical upgrade aspects of the site master plan. PSC routinely supports facility shutdowns and equipment upgrade projects. Current responsibilities include site decommissioning.

EQUIPMENT USED

  • Kaye Validator
  • Additional SIM for Kaye 2000
  • iRTD-400 Probe
  • LTR-140 Bath
  • HTR-400 Bath
  • Data Loggers
  • Kaye Feed Thru Device
  • Pressure Transducer
  • CLiMET (laser particle counter)
  • Low Pressure Gas Flowmeter
  • CLiMET (Microbial Sampler)
  • Shortridge Air Data MultiMeter
  • Druck Pressure Testing
  • Gas Flowmeter
  • SVMS Steam Quality
  • Thermocouples
  • Scissor Lift
  • Specialized PPE
  • Specialized Tools

PROJECT SUCCESS

Cleaning validation was completed, including manual cleaning, validated loads in qualified parts washers, and validated automated tank cleaning with qualified CIP system. Equipment qualification was completed. Remediation phase was successfully concluded on schedule and transitioned to routine quality system management with ongoing support from PSC.

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