Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment Project

PSC® Biotech’s professional services group to perform comprehensive Gap Assessment on Cleaning Validation.
  • Area: Toronto, Ontario
  • Project Type: CQV

About this Project

OBJECTIVE

Perform Cleaning Validation Risk Assessment   

SERVICES

This client utilizes PSC® Biotech’s professional services group to perform Gap Assessment on Cleaning Validation on their manufacturing equipment to maintain regulatory compliance and expectations. PSC® validation engineers evaluated the appropriate records, performed a gap analysis, and identified areas for continuous improvement. Remediation tasks were associated with each of the findings and combined into a comprehensive quality risk assessment document.

PROJECT SUCCESS

The project was successful, and PSC Biotech maintains an ongoing partnership with this client.  

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Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

CQV | Qualification of AQUATHERM SWS sterilizer

On-site and off-site Pre-calibration and Post-calibration Verification of the Thermocouples or Wireless Data Loggers.
  • Area: Greater Kansas City Area
  • Project Type: CQV

About this Project

OBJECTIVE

CQV – Qualification of AQUATHERM SWS sterilizer (Syntegon)

SERVICES

The client engaged PSC™ to initiate the validation and qualification of a AQUATHERM SWS sterilizer (Syntegon) with a chamber of approximately 2500 ft3. Laboratory and Pharmaceutical Manufacturing equipment validations play a vital role to ensure the quality and effectiveness of the equipment being used for the development of manufactured products.

Our team of engineers efficiently completed the tasks of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). These tasks included writing and executing a Cycle Development Plan, an Installation and Operation Qualification (IOQ), and a Performance Qualification (PQ). PSC™ consultants performed these studies to cGMP standards. Our team worked closely with client engineers and equipment vendors to ensure that the equipment functioned properly. Equipment validations should be completed by professionals of life science services that offer a diverse team of highly qualified and experienced consultants.

PSC™ can provide on-site and off-site Pre-calibration and Post-calibration Verification of the Thermocouples or Wireless Data Loggers.

EQUIPMENT USED

  • iRTD-400 Probe
  • HTR-400 Bath
  • Ellab Probes (Wireless Data Loggers)

PROJECT SUCCESS

PSC™ engineers efficiently completed the task of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). PSC™ continues to remain engaged with the client for continued support, as well as any future equipment qualifications to establish GMP regulations throughout the entire manufacturing facility.

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CQV | Multiple Facilities Projects

CQV | Multiple Facilities Projects

CQV | Multiple Facilities Projects

PSC® Did the Entire CQV For This Organization
  • Area: Greater Los Angeles
  • Project Type: CQV

About this Project

OBJECTIVE

Commissioning, Qualification, Validation (CQV)

SERVICES

PSC® has been an essential service provider to client throughout the development and implementation of a new cell and gene therapy manufacturing facility. PSC® joined the project during the planning phase and conducted critical design review to ensure facility met cGMP expectations upon completion. Our consultants worked closely with architects, engineers, contractors, and equipment vendors to develop system turnover packages to support subsequent commissioning and qualification efforts. PSC® then performed commissioning and qualification of all facility, utility, and process systems to meet GMP production timelines.

PSC® provided project management services to ensure key milestones were achieved for supplying clinical trial material. Scheduling and coordination work was critical to meeting GMP readiness steps, and PSC® further supported system and facility release for production at each stage. PSC® consultants qualified laboratory equipment, including complex instruments with significant CSV involvement. As the facility transitioned to routine operations, PSC® continued supporting requalification of temperature controlled chambers. PSC® also provided technical writers to generate SOPs and perform manufacturing investigations, and provided QC techs to perform environmental monitoring. PSC® remains engaged with the client for qualification of new equipment and continuous improvement projects.

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

PSC® successfully supported the client’s project to develop a brownfield property into a cell and gene therapy manufacturing facility, performing cGMP operations for clinical trial material production within an aggressive timeline. PSC® partnered with the client and multi-discipline team members throughout the project life-cycle to achieve this success.

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Sterile Fill Laboratory Facilities

Sterile Fill Laboratory Facilities

Sterile Fill/Finish Manufacturing and Laboratory Facilities CQV Project

PSC® provided Commissioning, Qualification, and Validation services on sterile fill/finish manufacturing & laboratory facilities.
  • Area: Greater Durham Area
  • Project Type: CQV

About this Project

OBJECTIVE

CQV on sterile fill/finish manufacturing & laboratory facilities.

SERVICES

PSC® provided Commissioning, Qualification, and Validation services for the client’s sterile fill/finish manufactuirng and Quality Control laboratory facilities and utilities.

EQUIPMENT QUALIFIED

  • Facility
  • Emergency backup generator
  • Autoclaves
  • Pure steam
  • Compressed air
  • Nitrogen
  • Air Handling Units
  • Formulation Tank Validation

PROJECT SUCCESS

PSC® provided personnel with both extensive technical writing and validation execution experience to complete initial CQV execution, protocol writing, and report development for this facility start up project.

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Cleaning Validation Decommissioning Project

Cleaning Validation Decommissioning Project

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
  • 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. 

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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