The Hyde Analytical Lab is our centralized laboratory specializing in cleaning program development studies and associated analytical services. We partner with our clients to optimize cleaning programs using robust data-driven methodologies. Our science-based studies ensure regulatory compliance aligning with international guidelines and industry best practices.
Contact our lab team at [email protected] for help in developing a more robust cleaning program.
design. test. CLEAN.
Specialized skills, efficient execution
Comprehensive, impartial with continued process veriﬁcation
FDA, ICH, PDA, ISPE, ASTM alignment
Quality by Design (QbD), 6 Sigma principles
THE HYDE ANALYTICAL LABORATORY OFFERS A COMPREHENSIVE REVIEW OF CLEANING PROGRAM ELEMENTS ALONG WITH SERVICES TO PROMOTE OVERALL CLEANING PROGRAM SUCCESS.
VISUAL INSPECTION TRAINING
Establishing a visual inspection training program is a critical activity of any cleaning program strategy which leverages visual inspection as a sampling method. With the ultimate goal of empowering our clients to confidently and independently conduct future trainees, Hyde subject matter experts are available to travel on-site to conduct visual inspection qualification using methods that enable qualitative and quantitative evaluation of operators. Hyde delivers the qualification of trainees and future trainers, a test plan and training materials, and a final summary report.
VISUAL RESIDUE ASSESSMENT (VRA)
The development of a visual inspection program is a key component of the cleaning validation monitoring strategy. It is predicated on an understanding of the visual detection capability associated with the equipment design and the process soils themselves. The execution of VRA studies provides the qualitative and quantitative information necessary to understand if the process soils can be consistently detected under viewing conditions meant to simulate site constraints.
Degradation studies are performed using SDS-PAGE, UV-Vis, or HPLC / UPLC to evaluate and quantify residual fragments of protein or API following exposure to a simulated cleaning cycle. For products degraded by the high temperature or pH conditions of a given cleaning chemistry, product carryover limits may be determined by risk assessment in place of MAC calculations. This is especially valuable for facilities that may not have the established toxicology inputs required for standard MAC calculations in order to meet the expectations of regulatory agencies.
SWAB OPERATOR QUALIFICATION
Hyde will help establish the foundation for a successful swab sampling qualification program by traveling on-site to qualify a group of operators and future trainer(s) to conduct swab sample collection. Training includes a qualification protocol, classroom instruction, hands-on swab qualification, analysis of samples using the current detection method, summary report, presentation materials, and certificates of qualification.
OPTIMIZATION & DESIGN SPACE EXPLORATION
With an identified worst-case residue and cleaning agent selected, design space exploration uses a Design of Experiments (DOE) approach to the interdependency of temperature and chemical concentration. Design space exploration allows for a selection of optimal cleaning parameters that can be scaled up to pilot and production processes to reduce cleaning times, cleaning agent concentrations or temperatures, and cost.
MAXIMUM ALLOWABLE CARRYOVER OR RESIDUE (MAC/MAR) LIMIT DETERMINATION
The determination of acceptable carryover or residue limits for product soils, excipients, or cleaning agents into subsequent product batches. Acceptance limits are established to ensure the safety, quality, and efficacy of batches as a critical component of any cleaning program.
ANALYTICAL CLEANING METHOD DEVELOPMENT
Cleaning method development is performed in alignment with ICH Q2(R1) guidelines for the validation of analytical procedures. Once developed, Hyde will employ the method for analysis of swab and rinse recovery samples or validate at the client or third-party laboratory testing site.
The Hyde Analytical Laboratory develops assays required to assess equipment cleanliness and confirm the removal of product soils and cleaning by-products using various analytical methods. Additionally, drug product release methods may be developed and transferred to the desired third-party laboratory for routine testing.
Total Organic Carbon (TOC)
High Performance Liquid Chromatography (HPLC)
Ultra Performance Liquid Chromatography (UPLC)
“WORST–CASE” RESIDUE DETERMINATION
Utilizing an existing cycle or cycle identified during cleaning optimization studies, multiple residues are evaluated to establish a worst-case ranking matrix from a cleanability perspective. Identification of a worst-case residue can be leveraged to reduce full-scale cleaning validation activities and decrease costs.
SWAB AND RINSE RECOVERY STUDIES
Recovery studies are required to demonstrate that the analyte of concern can be recovered from equipment surfaces using the selected sampling method of swabbing or rinsing. Hyde performs formal swab and rinse studies to demonstrate accurate and repeatable recovery and establish recovery factors as needed.
CLEANING AGENT SCREENING & SELECTION
Determination of the most effective cleaning agent and assessment of the most suitable cleaning conditions for the particular residue. Cleaning agent screening studies may be used as a first step in the harmonization of cleaning cycles to increase operational efficiency or the development of unique cleaning chemistries for individual equipment operations to reduce cost and water usage.
CLEANING PROGRAM ASSESSMENT, CLEANING VALIDATION MASTER PLAN, & SOP DOCUMENTATION
Authoring high-level strategic and procedural cleaning program documentation.