Material Selection for Recovery Studies
This document provides Hyde recommendations for which materials of construction (MOCs) should be chosen for evaluation when performing recovery studies.
Use of USP Total Organic Carbon for Cleaning Validation
This reference document presents the Hyde Analytical Laboratory’s position on the use of the USP <643> [4] compendial method for analysis of cleaning validation or verification samples.
Regulatory Expectations and Industry Practices for Recovery Studies
This reference document discusses the regulatory expectation for performing recovery studies.
Case Study – Recovery Study Program Support
Recovery Study Program Support Analytical & Swab Sampling Method Development, Recovery Studies, & Remote Training EPCMV Cell Culture Confidential Client Download this case study 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 […]
Case Study – Visual Inspection Support
Visual Inspection Support Visual Residue Assessment (VRA) Study and Visual Inspection (VI) Training EPCMV Cell Culture Confidential Client Download this case study Project Description It is an agency expectation that staff are trained to visually inspect equipment for residues following cleaning. This training must be formal and include a detailed SOP. If visual inspection is […]
Case Study – Surface Roughness Sampling
TOC Recovery, Microbial Evaluation, and Cleaning Evaluation Surface Roughness Sampling Study EPCMV Cell Culture Confidential Client Download this case study Project Description This surface roughness study was performed at the Hyde Analytical Laboratory using a Sievers M9 Analyzer and an EnSURE Touch Luminometer. The impact of stainless-steel surface roughness on cleaning activities was investigated through […]
Case Study – Bioreactor Cleaning
Bioreactor Cleaning Study Cleaning Characterization of Bioreactor Air-Liquid Interface (ALI) Residue EPCMV Cell Culture Confidential Client Download this case study Project Description The ALI residue created in bioreactors is known to be a cleaning challenge during cleaning activities. Bioreactors have a long incubation time (e.g., 3-10 days) and a high packed cell volume (PCV), which […]
Case Study – VHP Permeation
Vaporized Hydrogen Peroxide Permeation Study Vaporized Hydrogen Peroxide Permeation Study EPCMV Cell Culture Confidential Client Download this case study Project Description This project utilized the Hyde Analytical Laboratory’s MBRAUN MB-Purge Box Glovebox Isolator and a Drager X-am 5100 Gas Detector for the initial proof-of-concept study at the Louisville laboratory. Hyde then performed a cycle evaluation […]
Case Study – Lab Rouge
Selection of an Alternative Acid for De-Rouging Activities Rouge Removal and Passive Layer Maintenance Study EPCMV Cell Culture Confidential Client Download this case study Project Description The Hyde Analytical Laboratory was contracted to support a client with an internal initiative to remove phosphorus-based agents from the facility by evaluating the feasibility of replacing cleaning agents […]
Case Study – Degradation Study
Protein Degradation Evaluation for Product Changeover Degradation Study EPCMV Cell Culture Confidential Client Download this case study Project Description Cleaning cycle conditions of extreme pH and temperature (60°C 80°C) are known to result in protein degradation [1]. Traditional maximum allowable carryover (MAC) assessments based on acceptable or permissible daily exposure (ADE or PDE) assume intact […]