Case Study - Recovery Study Program Support - Hyde Engineering + Consulting For Medicines Manufacturing

Recovery Study Program Support

Analytical & Swab Sampling Method Development, Recovery Studies, & Remote Training

EPCMV Cell Culture

Project

Description

This recovery study was performed using Sievers M9 TOC Analyzers and investigated multiple materials of construction including 316L stainless steel, EPDM, silicone, and PTFE. The study also investigated recovery for 3 and 7-day hold times for swab and rinse samples. The analytical method, once developed, was validated on-site at the client manufacturing facility by a Hyde Technical Resource.

This project also included scope for Hyde to draft a recovery study protocol for the client to own for future studies, as well as a remote training session on how to perform recovery studies.

Study

Overview

This study included total organic carbon (TOC) analytical method and recovery studies (swab and rinse) on multiple materials of construction (MOC). Initial testing showed the TOC analytical method was acceptable for use, however, swab recovery studies demonstrated inadequate recovery of residues across the tested range.

TOC analytical method and swab method development were initiated to improve the method and soil recovery. Development resulted in an improved analytical and swab method, achieving excellent recovery from all surfaces.

Scope

and Deliverables

Analytical method development
Swab sampling method development
Analytical method on-site validation
TOC swab and rinse recovery studies on multiple MOCs
Full summary report with data packages
Remote training session for recovery studies

Solutions, Results,

and Accomplishments

Recovery Study Program Support

Project

Study

Scope

Solutions, Results,

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